US Pharm. 2010;35(4):64-66.
Two recently decided cases illustrate the point that pharmacists can easily step over the boundaries of legal behavior by pursuing business opportunities that, while profitable, are also illegal. Both cases involve compounding pharmacies that employed questionable habits of distributing steroids, hormones, and other specialty products that landed the pharmacist-owners and several other individuals in jail, with stiff fines and loss of their licenses to practice.
Case #1: “Operation Which Doctor”
A pharmacist-owner of a compounding pharmacy was recently convicted in Mobile, Alabama, on charges of illegal distribution of anabolic steroids and other drugs.1 The investigation alleged that illegal activities began in 2006. After a month-long trial and 4 days of deliberations, a federal jury also convicted the supervising pharmacist, two partial owners, and the corporate secretary of the pharmacy, along with the owner of a Colorado Internet anti-aging clinic, guilty of conspiracy in the same case. Acquitted were three employee pharmacists and an investor in the clinic. The investor was a Colorado sheriff’s deputy who started out as a customer.
Another individual, identified as an “alternative medicine practitioner” and a “naturopathic” medical doctor from Arizona, was indicted as a coconspirator and will be tried separately later this year. This Arizona physician fled to Latin America after he was indicted.2 He made contact with the U.S. Embassy in Costa Rica and returned to Florida in October 2009, where he was apprehended by federal authorities. This physician is charged with distribution of controlled substances, conspiracy to distribute, money laundering, and criminal forfeiture. According to prosecutors, he used steroids himself and conspired with the Alabama pharmacists to dispense and sell anabolic steroids for no legitimate medical purpose.
Earlier in the same case, a Colorado Springs business owner pled guilty to related charges of conspiracy to distribute steroids and money laundering in a scheme that netted $4 million.3 At least 17 physicians and executives of this business, who previously had pleaded guilty to steroids charges, testified that they colluded with the anti-aging clinic to supply steroids to bodybuilders, athletes, and other healthy customers.
In addition, 12 other individuals from Alabama, Colorado, and Tennessee were indicted after a long-term investigation into the distribution of anabolic steroids to physicians, gyms, and workout clubs nationwide. The convicted pharmacist-owner from Alabama was identified as a ringleader in the plot. Federal prosecutors filed a 198-count indictment against the individuals charged with these crimes.4 Each person who pled or was found guilty faces imprisonment of 5 to 12 years.
The pharmacists who filled the steroid prescriptions in Alabama claimed that they thought the orders were legitimate because they were signed by licensed physicians. The pharmacy profited in the millions of dollars from the conspiracy ring that included physicians writing fraudulent prescriptions during its operation from 2003 to 2006.5
Some of the drugs that were dispensed have been approved by the FDA only for use in fattening veterinary livestock and not for use in humans. The anabolic steroids that were dispensed included boldenone undecylenate (Equipoise); fluoxymes-terone (Halotestin); nandrolone (Deca); nandrolone decanoate (Durabolin); nandrolone decanoate/testosterone undecanoate (Nandrotest); oxandrolone (Anavar); oxymetholone (Anadrol); stanozolol capsules (Win-strol), injectable (Winstrol-V), and gel; and trenbolone acetate (“Fina”). Forms of testosterone that were dispensed include testosterone cypionate, testosterone decanoate, testosterone enanthate, testosterone “ICED,” testosterone isocaproate, testosterone phenylpropionate, testosterone propionate, and testosterone suspension.6
Records obtained by the Drug Enforcement Agency (DEA) during a raid of the pharmacy in 2006 showed that customers included baseball players Jose Canseco and John Rocker, professional boxer Evander Holyfield, and more than a dozen other athletes.7 This investigation later became known among law enforcement agencies as “Operation Which Doctor.”
Evidence showed that the clinic advertised in gyms, health clubs, and other spots to entice clientele across the country. One of the defendants boasted that he had customers in 41 states. The clinic recruited prescribers to issue the steroid prescriptions without ever seeing the patient in most cases. The clinic faxed the orders to the Alabama pharmacy, which was shipping as many as 250 packages per day. Many of the customers were under 21 and at least three teenagers obtained steroids from the pharmacy.8
Case #2: Fall of a Pioneer in Prescription Compounding
In a separate case taking place at almost the same time and involving similar charges, another compounding pharmacist, also from Colorado Springs, was convicted in federal court on 31 charges of illegally importing and distributing anabolic steroids and human growth hormone (hGH, sometimes called somatotropin) manufactured in China.9,10
The trial took nearly a month to complete, and jurors deliberated for 3 days before convicting the pharmacist.11 The jury determined that he should forfeit $4.8 million in assets and the land where the pharmacy was located. The sentence could include up to 20 years in a federal prison and a criminal fine of $250,000. Sentencing is scheduled to take place on April 29, 2010.
The pharmacy was once hailed as a pioneer in prescription compounding.12 At one time it employed 15 pharmacists and another 15 to 20 technicians who worked in the pharmacy’s laboratories. Physicians, primarily dermatologists, sought out the pharmacy for its ability to make custom compounds. The pharmacy specialized in making special orders from raw chemicals, a talent that was unique to the area at the time. Spurred by a book published in the early 1980s by Katharina Dalton on the use of progesterone in treating PMS,13 the pharmacist-owner took special interest in the emerging treatment of female health issues. As a result, he began to produce custom-made progesterone suppositories. Soon, physicians from all over the country were sending in prescriptions to be compounded, with over 90% of the hormone-compounding business originating from out-of-town prescribers. By 2003, the pharmacy employed an administrative staff of five and dozens of customer service representatives. The pharmacist began traveling the world lecturing physician and nursing groups on emerging therapies. Women’s health continued to be the prime focus. A chief operating officer and marketing director were hired to lead in strategic planning, finance, marketing, promotion, customer service, and client education. The goal was to double the business in a short time, but then things started to sour.
According to the indictment, the pharmacist-owner, along with two accomplices, “intended to devise a scheme to defraud physicians to whom they marketed…and the patients of those physicians…by means of materially false and fraudulent pretenses and representations.”14 The pharmacy was alleged to have combined FDA-approved medications with unapproved drugs for a new regimen specific to a patient. According to one organization, Pharmwatch, “The pharmacy is one of several that supply nonstandard products to offbeat physicians who do chelation therapy, mesotherapy, and other dubious treatments.”15
The jury also found the pharmacist guilty of two counts of conspiracy. In this case, testosterone was sold to bodybuilders who had no legitimate relationship with physicians. One of those counts charged that the pharmacist and others conspired to facilitate the sale of the Chinese-made hGH, which was misbranded and was not approved by the FDA, knowing it had been imported into the U.S. in violation of the law. The other conspiracy count charged that the pharmacist engaged in an illegal conspiracy to manufacture, distribute, dispense, and possess with intent to distribute anabolic steroids.
Included in the guilty verdict are 27 counts of distributing hGH, with 23 counts of selling the hormone to minors. The jury also found the pharmacist guilty of one count of facilitating the sale of smuggled hGH and one count of possessing with intent to distribute hGH. He was found not guilty of the single charge of receiving smuggled goods.
The jury disagreed with the pharmacist’s contention that the illegal drugs he distributed were not subject to FDA approval due to the lax restrictions on particular compounded drugs. The evidence revealed that the pharmacist had managed to distribute the drugs to physicians in Florida, Georgia, Illinois, and Indiana between April 2004 and February 2007.16
The pharmacy had claimed in advertisements that it is “one of the largest, most comprehensive compounding centers in North America.”17 It had been in trouble with the law on prior occasions. In 2005, the pharmacy was placed on probation by the Colorado Board of Pharmacy as a result of complaints that its pharmacists incorrectly dispensed medications as far back as 2002. The pharmacy was fined $50,000 and required to report how many prescriptions it dispensed to patients, physicians, and other pharmacies on a quarterly basis for 4 years.18 In 2004, it was fined $1,000 for failing to report a change in managers as required by state law. The Colorado Board of Pharmacy has revoked the pharmacist-owner’s license.19
Anabolic Steroids
According to the DEA, anabolic steroids are a class of drugs with a basic steroid ring structure that produce anabolic and androgenic effects. The chemicals are synthetically produced variants of the naturally occurring male hormone testosterone. Both males and females produce testosterone in their bodies: males in the testes and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue-building) steroids (the class of drugs).20 Athletes, bodybuilders, and others abuse anabolic steroids with the intent to improve athletic performance, muscle strength, and appearance.21
Anabolic steroid abuse has been associated with a wide range of adverse side effects ranging from those that are physically unattractive, such as acne and breast development in men, to others that are life threatening, such as heart attacks and liver cancer. Most of the effects are reversible if the abuser stops taking the drug, but some can be permanent. In addition to the physical effects, anabolic steroids can cause increased irritability and aggression.22 Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.23 The Anabolic Steroid Control Act of 2004 placed 32 additional steroids in Schedule III and expanded the DEA’s regulatory and enforcement authority.
The possession or sale of anabolic steroids without a valid prescription is illegal. Simple possession of illicitly obtained anabolic steroids carries a maximum penalty of 1 year in prison and a minimum $1,000 fine if this is an individual’s first drug offense. The maximum penalty for trafficking is 5 years in prison and a fine of $250,000 if this is the individual’s first felony drug offense. If this is the second felony drug offense, the maximum period of imprisonment and the maximum fine both double. While the above listed penalties are for federal offenses, individual states have also implemented fines and penalties for illegal use of anabolic steroids.24
Analysis
Steroids, growth hormones, and related drugs all have legitimate therapeutic uses, and compounding of specialty products for unique situations is at the core of good pharmacy practice. But, as demonstrated by the above cases, there are limits that cannot be exceeded, lest the power of law come knocking on your door. Compounding medications requires a prescription that comes from a licensed prescriber acting in the normal course of practice for an individual with whom the prescriber has a legitimate patient relationship, and is issued for a legal medical purpose. Staying within these guidelines will ensure that pharmacists are engaged in useful, valid practices.
REFERENCES
1. Kirby B. Jury finds 5 guilty in Mobile steroids conspiracy case. Alabama Live LLC. February 8, 2010. http://blog.al.com/live/2010/2. Vinton N, O’Keeffe M. Arizona naturopath Jesse Haggard faces music in steroid prosecution. NY Daily News. October 7, 2009. www.nydailynews.com/sports/
3. Associated Press. Mobile business owner pleads guilty to steroid distribution. October 19, 2009. http://wkrg.com/460434. Accessed February 17, 2010.
4. Baker M. Political grandstanding in Applied Pharmacy Services indictment for steroid distribution. MesoRx. January 23, 2010. www.mesomorphosis.com/blog/
5. Kirby B. Mobile steroids trial nearing end; Applied Pharmacy charged with supplying star athletes. Alabama Live LLC. February 2, 2010. http://blog.al.com/live/2010/
6. See Note 4, supra.
7. O’Keeffe M. Pharmacy owners indicted for role in performance-enhancing drug ring. NY Daily News. January 24, 2009. www.nydailynews.com/sports/
8. See Note 3, supra.
9. See, e.g., The Anabolic Network. www.steroid.com/Human-Growth-
10. Springs pharmacist convicted of importing, distributing steroids. The Denver Channel. February 2, 2010. www.thedenverchannel.com/news/
11. Springs pharmacist convicted of dealing steroids. KRDO. February 9, 2010. www.krdo.com/Global/story.asp?
12. Hurley B. College pharmacy pioneers prescription compounding. Colorado Springs Business J. February 21, 2003. http://findarticles.com/p/
13. Interview: Katharina Dalton, MD: progesterone and related topics. Int J Pharm Compound. Sept/Oct 1999. www.natural-progesterone-
14. McSwane D. Thomas Bader, Colorado Springs pharmacist, made millions in illegal steroid distribution to docs and minors—until a jury popped the bubble. Denver Westword Blogs. February 3, 2010. http://blogs.westword.com/
15. Barrett S. Compounding pharmacy indicted for illegal hormone sales. Pharmwatch. October 16, 2007. www.pharmwatch.org/comp/
16. Spring pharmacist gets 31 counts related to steroids and HGH distribution. Steroid Sources. February 8, 2010. www.steroidsources.com/
17. See Note 15, supra.
18. See Note 15, supra.
19. Barrett S. Compounding pharmacy operators charged with illegal growth hormone sales. Casewatch. June 24, 2009. www.casewatch.org/doj/college/
20. Anabolic steroids: hidden dangers. DEA. March 2004. www.justice.gov/dea/concern/
21. Drugs and chemicals of concern: anabolic steroids. DEA. June 2009. www.deadiversion.usdoj.gov/
22. National Institute on Drug Abuse Research Report Series. Anabolic Steroid Abuse. Revised August 2006. www.nida.nih.gov/PDF/
23. Id.
24. See Note 20, supra.
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