Compounding Pharmacy Indicted
for Illegal Hormone Sales
Stephen Barrett, M.D.
The College Pharmacy, of Colorado Springs, Colorado, its owner, a sales representative, and a sales representative from a company in Houston, Texas, have been indicted by a federal grand jury for the illegal importation and distribution of human growth hormone (hGH), from China. On August 28, Thomas Bader, age 63, who owned and operated the pharmacy, and Kevin Henry, age 56, a College Pharmacy sales representative, were arrested by Special Agents of the FDA's Office of Criminal Investigations, as well as agents from U.S. Immigration and Customs Enforcement, the Drug Enforcement Administration, and the FBI. Also charged was Bradley Blum, age 36, of Houston, Texas. Blum was a sales representative for a company facilitating the illegal importation of hGH from China . Federal laws restrict the use of hGH (also known as somatotropin) to the treatment that has been authorized by the Secretary of Health and Human Services . The FDA has never approved the distribution or use of any hGH manufactured in or imported from China. The indictment charges that the defendants repackaged Chinese-manufactured hGH and sold it to physiciansthroughout the country. .
The College Pharmacy is one of several that supply nonstandard products to offbeat physicians who do chelation therapy, mesotherapy, and other dubious treatments. Its catalog identifies it as "one of the largest, most comprehensive compounding centers in North America."  Compounded drugs are medications made by a pharmacist or other healthcare provider in response to a valid prescription for an individual patient. Compounded drugs may be made starting with medications approved by the FDA or with chemical ingredients according to a formula or recipe. They are not approved for safety and efficacy by the FDA and are not manufactured according to strict federal standards .
Bader, a licensed pharmacist has owned and operated College Pharmacy since 1974. Henry, who functioned as a sales representative for the pharmacy, was responsible for finding sources of drugs, including hGH, and also for selling and marketing products distributed by the company. The indictment alleges that both knowingly bought the hGH from companies that manufacture genetically derived hGH in China, including GeneScience. After the drug was imported into the United States, Bader allegedly directed his employees to repackage the Chinese hGH into vials labeled College Pharmacy. The indictment states that between September 2004 and March 2007, Bader advertised and marketed hGH and distributed the product by delivering it using various interstate carriers.
- Bader is charged with one count of conspiracy, ten counts of mail fraud, four counts of distribution of human growth hormone, one count of sale or facilitating the sale of smuggled goods, and one count of asset forfeiture.
- Henry is charged with one count of conspiracy, ten counts of mail fraud, four counts of distribution of human growth hormone, and one count of asset forfeiture.
- Blum is charged with four counts of distribution of human growth hormone, one count of sale of facilitating the sale of smuggled goods, and one count of asset forfeiture.
- The corporation College Pharmacy is also charged in all eighteen counts of the indictment.
The penalty for conspiracy as well as the penalty for the distribution of human growth hormone is up to 5 years in federal prison and a $250,000 fine. The penalty for mail fraud as well as receiving smuggled goods and facilitating the sale of smuggled goods is up to 20 years in prison and a $250,000 fine.
The indictment also includes an asset forfeiture count. The assets include approximately $4,100,000 in cash, and real estate that includes the pharmacy, a property in Iowa, properties in North Carolina, several properties in Florida, and other properties in Manitou Springs, Colorado Springs, Castle Rock, and Denver.
A local newspaper has reported:
- In 2005, the College Pharmacy was placed on probation for three complaints that its pharmacists incorrectly dispensed medication, one dating to 2002. The pharmacy board fined the company $50,000 and required it to report how many prescriptions it dispensed to patients, physicians, and other pharmacies on a quarterly basis for four years.
- In 2004, the company was fined $1,000 for failing to report to the board within 14 days when it changed pharmacy managers.
- Colorado's board of pharmacy has voted to initiate discpiplinary action against Bader .
- Colorado Springs based College Pharmacy, its owner, and others indicted for illegally importing and distributing human growth hormone from China. U.S. Department of Justice news release, Aug 29, 2007.
- Barrett S. Growth hormone schemes and scams. Quackwatch, Oct 16, 2007.
- Indictment. United States of America v. Thomas Bader, Kevin Henry, Bradley Blum, and College Pharmacy, Inc., Aug. 2007.
- College Pharmacy: Compounding Specialists. Catalog, undated, distributed at meeting of the International College of Integrative Medicine, Oct 2004.
- Bouts BA. The misuse of compounding by pharmacists. Quackwatch Nov 26, 2005.
- Nguyen K. Board calls for discipline of pharmacy. The Gazette, Aug 31, 2007.
This page was posted on October 16, 2007.