Whistleblowers say drug giants pushed dangerous dosages for profit - East Valley Tribune: Nation / World

Whistleblowers say drug giants pushed dangerous dosages for profit

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Posted: Tuesday, October 18, 2011 11:00 am

Drug companies Johnson and Johnson and Amgen battled each other so bitterly in a market share war that they pushed drugs and dosages jeopardizing patients' lives, said the author of a book about Johnson and Johnson whistle-blowers.

Kathleen Sharp's "Blood Feud" focuses on anemia drugs created by Amgen when the biotech giant was just a startup. Procrit, sold by Johnson and Johnson through what Sharp describes as a conflict-riddled partnership with Amgen, and Amgen's own Epogen and Aranesp all became popular, billion-dollar drugs.

The U.S. Food and Drug Administration in June said the drugs can cause fatal health problems for chronic kidney disease patients, including strokes and heart issues. Agency officials advised that doctors talk to their patients about the risks and that the drugs be administered in the lowest dose possible.

Four years earlier, FDA warnings included evidence suggesting higher doses of the drugs to patients with head and neck cancers could increase the progression of the diseases.

Amgen and Johnson and Johnson knew for many years about studies suggesting health risks related to the medications, Sharp said. But she said the companies pushed higher dosages of the drugs as early as the mid-1990s and constantly tried to invade each other's territory to gain more of the market, with Amgen reaching out to cancer patients and Johnson and Johnson aiming for people in dialysis.

"Bitter, bitter war," Sharp said. "It's kind of like an unmitigated corporate greed to push a product for no human need."

Amgen officials declined to comment on many of Sharp's allegations, saying that part of her book focuses on litigation between whistle-blowers and Ortho Biotech, a subsidiary of Johnson and Johnson that sold Procrit and is now known as Janssen Biotech. The lawsuit doesn't involve Amgen, said company spokeswoman Mary Klem.

Epogen and similar drugs created by Amgen are breakthrough biotechnology medications that help patients avoid blood transfusions, Klem said. She acknowledged there are safety considerations.

"Amgen's mission is to serve patients, and we have always been committed to the safe use and responsible marketing of our products," she said. "Everyone at Amgen is held to the highest ethical standard for doing the right thing for patients."

Mark Wolfe, a spokesman for Johnson and Johnson, said Sharp misrepresented data about the value of its drug Procrit.

"Our most immediate concern is that patients facing serious illnesses could be unnecessarily alarmed by Ms. Sharp's allegations, distortions and inaccuracies," he said.

Sharp defended her book and said that neither Johnson and Johnson nor Amgen agreed to repeated requests for interviews. An investigative journalist, she has written for The New York Times and Boston Globe and authored three previous books.

Mark Duxbury, a Johnson and Johnson division salesman turned whistle-blower, started contacting her seven years ago. He told her of how sales teams were being pushed to defraud Medicare and sell Procrit at dosages and for uses that endangered patients.

She said the book is based on hundreds of interviews and thousands of documents -- from Duxbury, a second whistle-blower, the FDA, congressional hearings and litigation involving Amgen, Ortho Biotech and others.

She also explores whistle-blower allegations that Ortho overbilled Medicare and paid kickbacks to doctors who prescribed Procrit.

Although her book focuses on Johnson and Johnson and its subsidiary, Ortho, Sharp said a similar whistle-blower case is being litigated against Amgen.

The litigation against Ortho has followed a roller-coaster ride that included a dismissal by a federal judge in 2008 and a reinstatement the next year. A hearing is set for December, although one of the whistle-blowers and a protagonist in Sharp's book died in October 2009.

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