Tuesday, February 03, 2009

Cephalon - Actiq: the migraine treatment was a success, unfortunately the patient died

Court documents link a Wichita-area doctor accused in 59 overdose deaths to a pharmaceutical company that illegally marketed to doctors a highly addictive narcotic for non-approved uses like treating migraines.

An Associated Press review of court documents show a connection between Cephalon Inc., one of the world's top 10 biopharmaceutical makers, and Dr. Stephen Schneider. In a separate case, Cephalon has admitted it illegally promoted Actiq — a potent, highly addictive painkiller.

Actiq is fentanyl in lollipop form. Fentanyl is a synthetic opiate approved by the U.S. Food and Drug Administration only for end-of-life cancer patients suffering severe pain.

The AP identified patients that had been only partially named in the doctor's 34-count indictment by reviewing his patients' malpractice lawsuits. One of those lawsuits also named Cephalon as a defendant.

Schneider and his wife, Linda, were charged in December 2007 with conspiracy, unlawful distribution of controlled substances, unlawful distribution of a controlled substance resulting in death, health care fraud, health care fraud resulting in death and illegal monetary transactions.

The indictment charges them with directly causing four deaths and contributing to 17 others. In total, the indictment links the clinic to 59 as part of the alleged conspiracy. A decision by a federal judge that would limit their trial to four deaths is under appeal.

The federal indictment alleges that between 2003 and 2007 more than 70 non-cancer patients at their Haysville clinic were prescribed Actiq.

Cephalon pleaded guilty in September 2008 to a criminal misdemeanor and agreed to pay a $425 million settlement in a separate federal case filed in Philadelphia. The Frazer, Pa.-based company admitted it broke the law by marketing Actiq and two other drugs to the nation's doctors for "off-label" uses.

In December 2008, the family of Robin Geist-Wick — a 45-year-old patient who died of fentanyl intoxication on May 15, 2007 — added Cephalon as a defendant in its wrongful-death lawsuit against Schneider and another doctor from his clinic, Lawrence Simons, who also had treated Geist-Wick.

Before her death, the El Dorado woman had written a letter to Schneider on Aug. 24, 2006, thanking him for easing the severe migraines she had suffered for more than 13 years. She first went to Schneider's Haysville clinic in July 2004.

"You listened to my mother, my husband and to me. You prescribed medicine for me that I had not ever heard of. It was at least worth a try. From that day on I have received my life back. Rarely since have I shed a tear because of pain," Geist-Wick wrote.

The family's attorney, Gary Patterson, deferred to the judgment of prosecutors when asked whether Schneider should be criminally prosecuted for her death.

"To me, the real case revolves — I guess I don't want to intervene in the criminal prosecution, you know — but I think the drug company is just about as much at fault as the doctor," Patterson said.


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