Five Years Ago, a Dallas Compounding Pharmacy's Mistake Killed Three People. Now, They Get a Slap on the Wrist
On March 30, 2007, 57-year-old Margrit Long went to the Center for Integrative Medicine in Portland, Oregon. She was given an intravenous dose of colchicine, a drug developed to treat gout but commonly prescribed, as in Long's case, to treat neck and back pain.
She'd been receiving the treatment for years, according to an article published two months later in the Portland Tribune, so when Long began feeling nauseated later that day, she figured she was coming down with something. She eventually drove herself to Portland's Providence St. Vincent Medical Center. Within hours, she was dead.
The state medical examiner's office later determined she had died of acute colchicine toxicity. Two days later, another patient of Center for Integrative Medicine turned up dead of the same cause. The death two weeks earlier of a Yakima, Washington, woman was also tied to the drug. Her daughter worked for the Portland clinic as a nurse, and had arranged for her mother to receive a dose from her doctor.
The deaths prompted an investigation by Oregon officials, then the FDA. The Center For Integrative Medicine closed, but Geoffrey Wiss, the physician who delivered two of the fatal doses, told the Portland Tribune that he was measuring doses based on the information on the label and that the clinic wasn't at fault.
The FDA investigation backed him up. The colchicine had come from ApotheCure, a compounding pharmacy in Dallas, and had been prepared not by a licensed pharmacist, as the law requires, but by a pharmacy technician. Further, the vials containing the drug were badly mislabeled. One of the batches ApotheCure delivered to the Portland clinic contained less than two-thirds the colchicine the label indicated. The second batch -- the one that killed Long and the two others -- contained six-and-a-half times the stated amount. Investigators pinned the screw-up on Gary Osborn, ApotheCure's owner.
Texas Attorney General Greg Abbott sued ApotheCure, Osborn and an ApotheCure subsidiary called Spectra Pharm Inc. in 2007. Osborn is a licensed pharmacist, and ApotheCure is licensed as a compounding center and pharmacy, but the AG's suit claimed they were operating outside the bounds of Texas law. The company was manufacturing drugs that weren't approved by the FDA and selling them in states where they weren't licensed to do business and to people who aren't licensed to prescribe them. The suit also charged that the manufacturing process was shoddy, with no records of how much of any given substance was included in a compound, no tests for the potency of a compound and a general lack of measures to ensure that drugs were mixed properly.
The feds indicted Osborn earlier this year, charging him with two counts of introducing a misbranded drug into interstate commerce, a misdemeanor. He pleaded guilty and was sentenced last month to one year probation and required to pay a $100,000 fine. Abbott's case wrapped up Tuesday with the court essentially forbidding Osborn from compounding illegal drugs and fining ApotheCure $200,000.
The AG's office sent out a press release touting the outcome as a success. Just keep in mind that Osborne still has his pharmacist's license and ApotheCure is still operating as a compounding pharmacy. Granted, this all happened five years before a Massachusetts compounding pharmacy caused a meningitis outbreak that killed 15 people and made everyone wonder why the places aren't better regulated, but still. Three people died. A year's probation, a $300,000 fine and a prohibition from doing something illegal seems awfully light.