ApothéCure Inc.
| Industry | Pharmaceutical |
|---|---|
| Headquarters | Dallas, Texas, U.S. |
| Website | http://www.apothecure.com/ |
ApothéCure Inc. is a Dallas, Texas-based compounding pharmacy that specializes in custom compounded formulas and nutritional supplements for both patients and physicians. The business began operations in 1991. ApothéCure is a sister corporation of the Texas Institute of Functional Medicines.
Controversies
The Pennsylvania Department of Health issued a statewide alert in 2004 after three Pennsylvania patients had reactions following intravenous injections of the ApothéCure-supplied drug phosphatidylcholine.[1][2]
ApothéCure was investigated in 2004 following complaints that its compounds (testosterone and growth hormones) may have been illegally dispensed to patients, including a pregnant woman.[1] Pharmacy board officials found insufficient evidence to discipline the company but issued a letter of warning.[1]
In a later case in Pennsylvania, ApothéCure was one of several parties sued over the fatal administration of disodium EDTA to an autistic five-year-old boy in 2005.[3][4] Dr. Roy Kerry prescribed the drug for chelation therapy, which some people believe is helpful to treat autism.[3][4] However, this usage is not approved by the U.S. Food and Drug Administration (FDA).[3][4]
ApothéCure has been implicated in the March and April, 2007, deaths of three patients from the Pacific Northwest. The patients were each given intravenous colchicine, a substance commonly used in naturopathic medicine,[5] for treatment of back pain (an off-label use of the drug). Colchicine can be very toxic when given in high doses; due to incorrect labeling, the colchicine the patients received was ten times more concentrated than listed on the vials, resulting in toxic doses.[5][6][7] Over 3,500 vials of the drug, distributed nationwide, were recalled.[8][9]
Attorneys general in Oregon and Texas filed lawsuits against ApothéCure Inc. and the company's owner, Gary Osborn of Dallas, Texas.[10][11] The case is being jointly prosecuted between Oregon Attorney General Hardy Myers and Texas Attorney General Greg Abbott, asserting that "the company failed to follow standard safety practices and exceeded their authorized scope of practice as a compounding pharmacy".[12] According to Meyers, ApotheCure's error reflected a pattern of substandard care and was not an isolated incident.[12] The Texas suit alleges that the pharmacy "failed to use proper manufacturing practices, employed incorrect labels and made exaggerated claims about the benefits of its dietary supplements."[10]
In the 2007 deaths, there may have been several violations committed, including ApothéCure being unlicensed to sell drugs in Oregon.[1][12] In the year and a half prior, ApothéCure made 44 total sales of injectable colchicine to Oregon health professionals without a license to distribute in Oregon.[13] ApothéCure reached a settlement with the Oregon attorney general in April 2008. The settlement requires ApothéCure to pay $100,000 to the state, and a $500,000 civil penalty if the company wishes to sell products in Oregon again.[13][14] ApothéCure must also refund money from all of its 222 sales to Oregon consumers from 2004 through 2007.[13]
Wrongful death lawsuits were also filed against ApothéCure by the families of two of the colchicine victims; both families have reached confidential settlements with ApothéCure, while the third family is negotiating a settlement with the company.[13]
In 2012 the United States Department of Justice charged ApothéCure Inc. and its owner, Osborn, with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act. These charges were in connection with the misbranding which led to the three deaths in the Pacific Northwest.[15] Osborn and his corporation pleaded guilty to these charges.[16] Osborn was sentenced to home detention, one year of probation, and a $100,000 fine.[17] Separately, the company was sentenced to five years of probation and a $100,000 fine.[17]
References
- 1 2 3 4 "Drug firm has history", The Portland Tribune, May 4, 2007
- ↑ "PENNSYLVANIA DEPARTMENT OF HEALTH: HEALTH ADVISORY #15", August 6, 2004
- 1 2 3 "Boy dies 'from autism therapy'". Daily Mail. 10 July 2007. Retrieved 29 March 2013.
- 1 2 3 "Suit Filed in Child's Chelation Death". Casewatch. Retrieved 30 March 2013.
- 1 2 "Deaths sound an Rx alert", The Portland Tribune, April 20, 2007
- ↑ "Dallas company blamed in 3 deaths", The Dallas Morning News, Associated Press, April 27, 2007
- ↑ "Bad medicine led to deaths", The Portland Tribune, April 27, 2007
- ↑ "Custom-made meds may pose deadly threat", MSNBC, March. 11, 2009
- ↑ FDA - MedWatch - Recall Of Compounded Injectable Colchicine- All Strengths, Sizes and Lots
- 1 2 Plaintiff's position against Apothecure, Texas Attorney General, retrieved 12 December 2007
Texas Attorney General’s press release on case, retrieved 12 December - ↑ State of Oregon v. ApothéCure Inc. and Gary Osborn
- 1 2 3 "Oregon, Texas Sue Pharmacy Over Deaths", Houston Chronicle/Associated Press, Dec. 12, 2007
- 1 2 3 4 "State, drug maker settle", The Portland Tribune, April 18, 2008
- ↑ Settlement agreement with Oregon
- ↑ "U.S. Files Criminal Charges Against Dallas Company in Connection with Misbranded Drug Shipment That Led to Three Deaths", February 10, 2012
- ↑ "Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with Misbranded Drug Shipment", April 24, 2012
- 1 2 Attention pharmaceutical and medical device executives – ignorance is not bliss