“Blood Feud: the man who blew the whistle on one of the deadliest prescription drugs ever” (NY: Dutton, 2011)  by Kathleen Sharp 

This is the true story of an expensive anti-anemia drug that came on the market for one purpose; was heavily promoted for several unproven uses; and how the drive for profits led two drug companies to commit fraud. Kathleen Sharp, a veteran investigative reporter, describes what happened from the perspective of a drug salesman whose company pressured him into achieving higher and higher sales targets. The drug maker provided a playbook of tactics known to manipulate physicians into writing more prescriptions and at higher, more dangerous, doses. Eventually, the drug salesman-turned-whistleblower comes to the horrifying conclusion that over a half a million people have died as a result of this drug. Its benefits, if any, remain unclear; its safety never established.  It is still on the market.

Central to the story is one of the first biotech drugs to go on the market. Erythropoietin is the man-made version of human erythropoietin, which is produced naturally in the body and stimulates the bone marrow to make red blood cells. Epo, as it is called, became known as a “blood booster,” sold by Amgen and Johnson & Johnson under the brand names: Procrit, Epogen, Aranesp, and Eprex (Europe).

Epo received FDA approval in 1989 to reduce cancer chemotherapy patients’ need for blood transfusions after it became known that the nation’s blood supply was infected with the HIV virus. In time, epo would be heavily promoted as an instant cure for chemotherapy-related fatigue and for anemia in kidney dialysis patients. (Disclosure: I am quoted in the book, speaking before the FDA Oncologic Drug Advisory Committee against J&J’s fraudulent direct-to-consumers advertising campaign for Procrit.)

The whistleblower ‘s story begins in 1992 when Mark Duxbury became a Procrit sales rep at J&J’s new biotech division, Ortho. Initially, Duxbury believed that he was selling an important quality-of-life enhancing drug for cancer patients suffering the debilitating effects of chemotherapy. Procrit, so he thought, would allow them to complete the treatment regimen.

The methods used by J&J to get its sales reps to turn Procrit into a blockbuster drug make for fascinating, though appalling, reading. Doctors were easily manipulated into prescribing more epo with rebates, secret discounts, honoraria, and other kickbacks.  In time, the entire Procrit sales force was encouraged by J&J to break the company’s own product license agreement with its partner Amgen. This agreement stipulated that J&J would stay away from the kidney dialysis market. (Amgen, maker of Aranesp, was the start-up company that did the original epo research.)

By 1993 Duxbury was a company award-winner for the greatest overall growth in sales in the western region of the U.S. He was rewarded with a higher income and an all expenses paid trip to a luxury resort. Still, J&J didn’t let up on the pressure to increase sales, making Duxbury conclude that the only way to meet his escalating quota was to “steal dialysis business”.

Doctors were encouraged to prescribe Procrit in high doses, particularly for cancer patients, because this would increase sales by hundreds of millions of dollars. That the deaths of about a dozen high-profile European cyclists were already linked to high dosing with epo (accessed via the black market) should have served as a warning.

This book is a goldmine of information about how the nation’s pharmaceutical companies inflate the cost of medicines while hiding the true cost from consumers as well as the government payers. What’s more, the drug makers in this story monitor doctors’ prescribing habits to determine the marketing strategies that work best; violate patient confidentiality laws by encouraging sales reps to troll medical records for the best drug-testing candidates; and use study participation to get doctors to prescribe epo for dangerous off-label purposes. Such tactics are not confined to the selling of epo.

Duxbury’s sterling career started to go downhill when he was deposed as a result of a lawsuit initiated by Amgen against J&J. (Depositions conducted over the course of several years serve as a major source for this book.) As a result, his own in-office memos revealed J&J’s orders to encroach on Amgen’s kidney dialysis territory.

Duxbury soon became a liability to his own company, which turned on him as if he were the one who thought up the illegal sales tactics.  He was fired in 1998. Many of the reps who had been instructed to sell Procrit for dialysis were also fired or resigned. Many would not learn—until years later—that their order to promote Procrit as an anti-anemia drug for kidney patients was an off-label use (unproven) use and thus a federal crime. (The FDA had approved Procrit to treat anemia only in cancer patients.)

The rest of the story involves Duxbury’s downward spiral— unemployment, lawsuits, depression, and self-destructive behavior—as he tried to alert the public about the dangers of epo.  The sinister way the Ortho division of J&J treated its own employee who, after all, was just following orders, should confirm your worst fears about corporate misbehavior. As Duxbury put it after his own lawsuit for wrongful termination turned up information new to him. “I was shocked to learn that everything I did at Ortho was illegal. They cheated not just the government but their own people too!”

Author Sharp says that the safety tests were never conducted for epo drugs, though such testing was required by the FDA contingent on approval. By the late 1980s, she states, “scientists knew that boosting red blood cells also thickened the blood, which increased the risk of clotting. Blood clots lead to strokes, heart attacks, and brain aneurisms.” What’s more, she writes, “No one could be sure that Procrit was safe at even recommended doses, according to several sources.”

In 2007 the FDA finally got around to protecting the public. The agency issued a warning about all epo drugs which by this time were also marketed for AIDS patients. New studies showed epo drugs associated with an increase in death, heart attack, stroke and tumor growth in subgroups of people with cancer and those with chronic kidney failure. Click here

Epo drugs continue to generate billions in annual revenues.  Duxbury’s whistleblower case is still making its way through the courts.

Maryann Napoli, Center for Medical Consumers©