Distributing or aiding and abetting in the distribution of (e.g. prescribing) growth hormone (and anabolic steroids) for antiaging, athletic enhancement and age-related decline in GH is illegal
The Secretary of HHS and thus the FDA have indicated that hGH for adults is allowed for only three conditions:
wasting syndrome of AIDS
short bowel syndrome
Adult Growth Hormone Deficiency Syndrome (AGHD)*
*AGHD is NOT simply the decline in hGH with age; it is a very specific, very rare condition (usually due to a pitutiary gland tumor or treatment of the tumor)that must meet two diagnostic criteria:
Biochemical diagnosis of adult GHD by means of a subnormal response to the standard growth hormone stimulation test (peak GH <0.5 ng/L)* and Clinical history: patients have adult GHD either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma or childhood-onset patients who were GH deficient during childhood.
*anti-aging clinics and websites selling hGH for anti-aging rarely if ever perform this stimulation test. If they did, they would almost never obtain results that would legally justify the administration of the drug!
The stimulation test is usually and should be performed by an endocrinologist and involves giving the patient growth hormone releasing hormone (GHRH), argenine or rarely insulin.
Human growth hormone (hGH) is a naturally occurring polypeptide hormone secreted by the pituitary gland and is essential for body growth. Daily secretion of hGH increases throughout childhood, peaking during adolescence, and steadily declining thereafter. In 1985, synthetic hGH was developed and approved by the FDA for specific uses. However, it is commonly abused by athletes, bodybuilders, and aging adults for its ability increase muscle mass and decrease body fat, as well as its purported potential to improve athletic performance and reverse the effects of aging.
Licit Uses:
Several FDA-approved injectable hGH preparations are available by prescription from a supervising physician for clearly and narrowly defined indications. In children, hGH is approved for the treatment of poor growth due to Turner’s syndrome, Prader-Willi syndrome, and chronic renal insufficiency, hGH insufficiency/deficiency, for children born small for gestational age, and for idiopathic short stature. Accepted medical uses in adults include but are not limited to the treatment of the wasting syndrome of HIV/AIDS and hGH deficiency. Dependent on the clinical presentation, pediatric dosages range from 24-100 microgram/kilogram/day and adult dosages from 0.9-25 microgram/kilogram/day, dependent on product. The FDA-approved injectable formulations are available as liquid preparations, or as powder with a diluent for reconstitution.
Chemistry and Pharmacology:
Using recombinant DNA technology, two forms of synthetic hGH were developed, somatropin and somatrem. Somatropin is identical to the endogenous pituitary-derived hGH, whereas somatrem has an extra amino acid on the N-terminus. Both synthetic forms have similar biological actions and potencies as the endogenous hGH polypeptide. Synthetic hGH also is chemically indistinguishable from the naturally occurring hormone in blood and urine tests.
hGH binds to growth hormone receptors present on cells throughout the body. hGH functions to regulate body composition, fluid homeostasis, glucose and lipid metabolism, skeletal muscle and bone growth, and possibly cardiac functioning. Sleep, exercise, and stress all increase the secretion of hGH.
The use of hGH is associated with several adverse effects including edema, carpal tunnel syndrome, joint pain, muscle pain, and abnormal skin sensations (e.g., numbness and tingling). It may also increase the growth of pre-existing malignant cells, and increase the possibility of developing diabetes.
hGH is administered by subcutaneous or intramuscular injection. The circulating half-life of hGH is relatively short half-life (20-30 minutes), while its biological half-life is much longer (9-17 hours) due to its indirect effects.
Illicit Uses:
Human growth hormone is illicitly used as an anti-aging agent, to improve athletic performance, and for bodybuilding purposes. It is marketed, distributed, and illegally prescribed off-label to aging adults to replenish declining hGH levels and reverse age-related bodily deterioration. It is also abused for its ability to alter body composition by reducing body fat and increasing skeletal muscle mass. It is often used in combination with other performance enhancing drugs, such as anabolic steroids. Athletes also use it to improve their athletic performance, although the ability of hGH to increase athletic performance is debatable.
Abuser Population:
Athletes, bodybuilders, and aging adults are the primary abusers of hGH. Because the illicit use of synthetic hGH is difficult to detect, its use in sports is believed to be widespread. Over the past few years, numerous professional athletes have admitted to using hGH. Bodybuilders, as well as celebrities also purportedly use it for its ability to alter body composition. Aging adults looking to reverse the effects of aging are increasingly using synthetic hGH.
Illicit Distribution:
The illicit distribution of hGH occurs as the result of physicians illegally prescribing it for off-label uses, and for the treatment of FDA-approved medical conditions without examination and supervision. Illicit distribution also involves diverted hGH obtained through theft, smuggled hGH illegally imported from other countries, and counterfeit hGH.
The illicit distribution of injectable synthetic hGH formulations is thought to be primarily through Internet pharmacies, as well as wellness and anti-aging clinics and websites. Internet pharmacies are often partnered with a physician willing to write prescriptions for a fee without a physical examination. Individuals may also obtain hGH without a prescription through the black market. hGH is often marketed with other performance enhancing drugs (e.g., anabolic steroids).
According to the National Forensic Laboratory Information System, law enforcement officials submitted 27 hGH items/exhibits to state and local forensic laboratories between 2004 and 2008. There were no hGH items submitted to federal laboratories during the same time period. The number of seized hGH items have increased recently; in 2006, 3 items were submitted to state and local laboratories; in 2007, 7 items were submitted; and 10 items were submitted in 2008.
Various oral preparations (e.g., sprays and pills) purported to contain hGH are also marketed and distributed. However, hGH is only bioavailable in the injectable form. The hGH molecule is too large for absorption across the lining of the oral mucosa and the hormone is digested by the stomach before absorption can occur.
Control Status:
Human growth hormone is not controlled under the Controlled Substances Act (CSA). However, as part of the 1990 Anabolic Steroids Control Act, the distribution and possession, with the intent to distribute, of hGH "for any use…other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services…and pursuant to the order of a physician…" was criminalized as a five-year felony under the penalties chapter of the Food, Drug, and Cosmetics Act of the FDA.
hGH is listed by the World Anti-Doping Agency and the International Olympic Committee as a performance enhancing drug barring athletes from using it.
Comments and additional information are welcomed by the Office of Diversion Control, Drug and Chemical Evaluation Section, Fax 202-307-1263, telephone 202-307-7183, or Email ODE@usdoj.gov.
(e)(1) ...whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services (see below for authorized uses which do not include anti-aging) under section 505 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both. (2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both. (3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act for the purposes of forfeiture under section 413 of such Act. (4) As used in this subsection the term ''human growth hormone'' means somatrem, somatropin, or an analogue of either of them. (5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection
.
STATE LAWS
Arizona
: Arizona Revised Statute, ARS 32-1996E states ‘A person
who dispenses human growth hormone in violation of this
chapter is guilty of a class 6 felony.’ The chapter being referenced
by this statute subsection is chapter 18, title 32.
Colorado
: Colorado classifies hGH as an anabolic steroid and thus
the laws under the state’s Uniform Controlled Substances Act of
1992 [C.R.S. § 18-18-102] apply to hGH.
Florida
: Under 458.331 of the Florida statutes: ‘‘ee) Prescribing,
ordering, dispensing, administering, supplying, selling, or giving
growth hormones, testosterone or its analogs, human chorionic
gonadotropin (HCG), or other hormones for the purpose ofmuscle
building or to enhance athletic performance. For the purposes of
this subsection, the term ‘‘muscle building’’ does not include the
treatment of injured muscle. A prescription written for the drug
products listed above may be dispensed by the pharmacist with
the presumption that the prescription is for legitimate medical
use.’’
Idaho
: Idaho classifies hGH as a schedule III controlled substance,
similar to anabolic steroids, under Idaho Code § 37–2709
Illinois
: Under this state’s Food, Drug, and Cosmetic Act, Chapter
410, § 410 ILCS 620/3.22, it is a criminal offense to distribute hGH
for anything but medical uses approved by the US Secretary of
Health and Human Services.
Kansas
: According to Statute 65–2837 (b), unprofessional conduct
shall include: ‘‘ (28) Prescribing, dispensing, administering or
distributing an anabolic steroid or human growth hormone for
other than a valid medical purpose. Bodybuilding, muscle
enhancement or increasingmuscle bulk or strength through the
use of an anabolic steroid or human growth hormone by a person
who is in good health is not a valid medical purpose.’’
Massachusetts
: This state lists all prescription drugs (including
growth hormone) as controlled substances
Maine
: This state lists all prescription drugs (including growth
hormone) as controlled substances.
Minnesota
: Under Minnesota Statutes Health Code, Chapter 152,
Drugs, controlled substances, Minnesota Statutes § 152.02, hGH is
classified as an anabolic steroid and therefore a schedule IV
substance.
Oklahoma
: ‘A licensed practitioner. . . shall not prescribe, dispense,
deliver or administer an anabolic steroid or human growth
hormone
. . . except for a valid medical purpose. A valid medical
purpose for the use of anabolic steroids or human growth
hormones shall not include bodybuilding, muscle enhancement
or increasing muscle bulk or strength of a person who is in good
health.’ [63 Okl. St. § 2–312.1]
Oregon
: Oregon classifies hGH as a controlled substance.
Rhode Island
: Rhode Island classifies hGH as a controlled substance,
schedule III drug. Under Rhode Island General Laws § 21-28-4.01
(E): ‘It shall be unlawful for a practitioner to prescribe, order,
distribute, supply or sell an anabolic steroid or human growth
hormone for (i) enhancing performance in exercise, sport, or
game, or (ii) hormonal manipulation intended to increase muscle
mass, strength or weight without a medical necessity. Any person
who violates this subsection is guilty of a misdemeanor and upon
conviction may be imprisoned for notmore than 6 months or a
fine of not more than $1,000 or both.’
Washington:
Washington state law classifies human growth
hormone as an anabolic steroid, under RCW 69.41.300. RCW
69.41.320 in turn states: ‘‘(1)(a) A practitioner shall not prescribe,
administer, or dispense steroids, as defined in RCW 69.41.300, or
any form of autotransfusion for the purpose of manipulating
hormones to increase muscle mass, strength, or weight, or for the
purpose of enhancing athletic ability, without a medical necessity
to do so. (b) A person violating this subsection is guilty of a gross
misdemeanor and is subject to disciplinary action under RCW
18.130.180.’’
West Virginia
: hGH is classified as a class III substance.
FTC Stops Diet Spam
A judge has halted the e-mail operation of a firm selling purported weight-loss and anti-aging products.
Grant Gross, IDG News Service
Sunday, August 26, 2007 5:00 AM PDT
A U.S. district judge has ordered a company to stop sending unsolicited e-mail marketing weight-loss and anti-aging products that allegedly did not work, the U.S. Federal Trade Commission (FTC) announced last week.
The operation sent unwanted e-mail messages in violation of the Controlling the Assault of Non-Solicited Pornography and Marketing Act, or CAN-SPAM Act, of 2003, the FTC said. The company's Web sites sold pills that allegedly caused significant weight loss and contained the plant hoodia gordonii under names such as HoodiaHerbal and Hoodia Maximum Strength.
The sites also sold allegedly natural products that were supposed to elevate a user's human growth hormone (HGH) level and thereby dramatically reverse the aging process under names such as Perfect HGH and Dr-HGH.
The claims made about the products were false or unsubstantiated, the FTC said in its complaint. The defendants falsely claimed that their supposed hoodia products cause rapid, permanent and substantial weight loss, as much as 40 pounds a month, the FTC said.
The defendants also falsely claimed that their supposed HGH products would cause a clinically meaningful increase in a consumer's growth hormone levels, the FTC said. The defendants falsely claimed that their HGH products would turn back or reverse the aging process, including lowering blood pressure, reducing cellulite, improving vision, causing new hair growth and improving sleep.
The FTC's spam database has received over 85,000 e-mail messages sent on behalf of the operation, the FTC said. Many of these e-mail messages were sent using Web form hijacking, in which the spammer injects the spam message into form fields on an innocent, third-party Web site, the agency said. The message appears to come from the victim Web site operator's mail server.
This is the first time the FTC has filed a case against spammers using this tactic.
The FTC accused the company of violating CAN-SPAM by sending commercial e-mail messages that contained materially false and misleading header information; contained deceptive subject headings; failed to provide clear and conspicuous opt-out links; and failed to include a physical postal address.
The judge has also ordered the company's assets to be frozen. A hearing scheduled for Monday will determine whether to extend the restraining order and the asset freeze, the FTC said.
January, 2007 FDA clarifies that it is illegal to prescribe, in addition to distribute or provide GH for antiaging or athletic uses
A January 23rd, 2007 "Detention Without Physical Examination (DWPE) Alert" clearly states, perhaps more than ever before, that it is not only illegal to market, provide or distribute GH for anti-aging and athletic use, it is also illegal for doctors to prescribe it for these uses and for anyone to market it for these uses. Following, is the key text.
FDA-approved HGH can be legally prescribedfor a limited number of conditions including:
* hormonal deficiency that causes short stature in children;
* long-term treatment of growth failure due to lack of exogenous GH secretion;
* long-term treatment of short stature associated with Turner syndrome;
* adult short bowel syndrome;
* adult deficiency due to rare pituitary tumors or their treatment; and
* muscle-wasting disease associated with HIV/AIDS.
HGH has important benefits, but also serious, known risks. Among the possible long-term side effects of HGH is an increased risk of cancer, and other dangerous side effects have been reported, including nerve pain and elevated cholesterol and glucose levels. For this reason, HGH is carefully regulated in the U.S.
The cost of approved HGH products is high, averaging several hundred dollars per dose. Because of this high cost, HGH drugs have been counterfeited and unapproved HGH products are offered for sale to U.S. consumers. For example, we have encountered HGH products imported as a lyophilized powder and declared as an active pharmaceutical ingredient (API) for pharmacy compounding. Some pharmacies promote compounded HGH for anti-aging purposes. It is sold as a"fountain of youth" in longevity clinics and to build bodymass, weight loss, increase libido, and gain stamina. None of these indications are in the labeling of the FDA approvedproducts.
The agency is aware of unapproved HGH finished dosage form products being imported into the U.S. and recently noted a large increase of HGH being offered for import for pharmacy compounding. If the drug is bought from foreign sources or over the Internet, safeguards built into the U.S. drug distribution system may be bypassed, placing consumers who use HGH at higher risk.
Section 303(e) (1) of the FDCA, 21 U.S.C. 333(e) (1), prohibits knowingly distributing, or possessing with the intent to distribute, HGH for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services (HHS) under section 505 of the FDCA (21 U.S.C. 355) and pursuant to the order of a physician. The Secretary of HHS has not authorized, for example, any HGH use for anti-aging, bodybuilding, or athletic enhancement. Thus, distributing, or possessing with the intent to distribute, HGH for these uses or any other unapproved use violates section 303(e) (1) of the FDCA. A violation of section 303(e)(1) carries up to 5 years imprisonment and fines and, if the offense involves an individual under the age of 18 years of age, up to 10 years imprisonment and fines.
HGH products are new drugs and cannot be legally marketed in the U.S. without an approved application. The few HGH products that have been approved for sale by FDA are sold either in liquid form or as lyophilized powders that are labeled for reconstitution by the health care professionals who dispense them.
Accordingly, FDA considers both imported HGH lyophilized powder products and liquid HGH products to be finished dosage form drugs, not APIs. Unless these products are the subject of approved new drug applications, they violate section 505 of the FDCA, 21 U.S.C. 355, and may not be legally imported into the U.S. [Perls: THEREFORE, IT IS ILLEGAL FOR PHARMACIES TO COMPOUND Growth Hormone FOR ANTI-AGING or ANY UNAPPROVED USE]:
Some HGH marketers may claim that their HGH drug products are intended for use in pharmaceutical compounding. These drugs should be evaluated on a case-by-case basis considering the factors in FDA Compliance Policy Guide, section 460.200, and the specific prohibitions set forth in section 303(e) of the FDCA, 21 U.S.C. 333(e). The use of HGH in pharmacy compounding is addressed in more detail, below.
Some HGH marketers may claim that their HGH products are dietary supplements. FDA first approved HGH as a new drug in 1940, and HGH was not marketed as a dietary supplement, or as a food, before then. Accordingly, HGH is excluded from the definition of a dietary supplement under section 201(ff) (1) of the FDCA (21 U.S.C. 321(ff) (3) (A)) because growth hormone was an article approved as a new drug under section 505 of the FDCA (21 U.S.C. 355) before its introduction as a dietary supplement.
If the District Offices have questions concerning the importation of Human Growth Hormone (HGH) they should contact CDER/OC/DNLC immediately.
Ada Irizarry 301-827-8967
KEYWORDS: HGH, human growth hormone, somatropin; somatrem
PREPARED BY: Nawab A. Siddiqui, DIOP, 301-594-3871 William G. Nychis/CDER/OC/DNLC 301-827-8959
CHANGCHUN, China Sept. 27 — The chief executive of a leading Chinese pharmaceutical company used e-mail aliases, offshore bank accounts and a network of drug traffickers to illegally distribute millions of dollars worth of human growth hormone in the United States, federal officials said in a criminal complaint, provided to The New York Times on Wednesday.
A 62-page affidavit by a special agent of the Food and Drug Administration details an extraordinary level of personal involvement in the trafficking and sale of the powerful hormones by Jin Lei, the founder and chief executive of the GeneScience Pharmaceuticals Company, one of China’s largest drug makers, based here in Changchun, in northern China.
The affidavit adds intriguing details and a rare look inside a major drug ring and the alleged role of a renowned businessman. It was unsealed Monday, but was not released publicly until The Times requested and received a copy of the electronic file on Wednesday.
As early as 2004, according to investigators, Mr. Jin was smuggling Jintropin, a growth hormone he named after himself, to the United States.
American investigators claim that through the use of various aliases, including Jack Edwards, John and Luis, Mr. Jin made deals with middlemen and distributors outside China and also instructed them to wire money to banks in the United States, Panama and China.
GeneScience even sold an insurance program offering to resend any package seized by customs officials, the government says. Investigators also say some of the GeneScience Jintropin drug shipments were labeled as toys, glassware or hair treatment.
In January 2006, a person the F.D.A. has now identified as Mr. Jin using an alias wrote to an American customer, warning, “US custom is tighten control, you should stop email directly to gensci anymore and delete all your records.”
A secretary who works for Mr. Jin, 42, said this week that he was not available for an interview, but colleagues and people who know him say they were surprised that the respected scientist and hard-charging entrepreneur would be caught up in a drug scandal.
“I contacted Jin Lei this morning. He’s not sure about the whole thing and can’t say anything to the media now,” said Zhou Weiqun, board secretary of GeneScience’s parent company, Changchun High Tech Group. “We’re trying to figure out the situation. But we trust Jin Lei. He has done a lot for our company.”
The charges against Mr. Jin and GeneScience were part of the largest crackdown in United States history on international trafficking in steroids and other illicit bodybuilding drugs.
On Monday, federal authorities said they had arrested 124 people and shut down dozens of crude drug-producing laboratories in a case the authorities called Operation Raw Deal.
Federal authorities did not release the names of athletes or others who might have been customers of the underground drug makers, but federal investigators said they had collected thousands of names and were combing through the database.
Officials from the F.D.A., Federal Bureau of Investigation, Drug Enforcement Administration and several other federal agencies, said China was the primary supplier of the illegal drugs and that 37 Chinese companies, mostly chemical wholesalers, were involved in the illegal drug smuggling, much of it arranged over the Internet.
The revelations come at a difficult time for Chinese authorities. China is already facing mounting pressure to improve the safety and quality of its food, toys and other exports after a series of consumer product safety scandals this year.
With Beijing set to play host to the 2008 Olympic Games, China is also being asked to deliver a drug-free Olympics — at a time when baseball, cycling and other sports have been damaged by doping scandals.
United States investigators named only one Chinese company, GeneScience, which was founded in 1996 by Mr. Jin, who graduated from Beijing University in 1985 and earned a Ph.D. in pharmaceutical chemistry from the University of California, San Francisco in 1994.
While studying in California, Mr. Jin also worked as a research scientist at Genentech, the American biotech company and one of the world’s leading producers of human growth hormones.
On campus, Mr. Jin was known as an ambitious graduate student. He earned the university’s top prize for his doctoral dissertation on antibodies that bind to human growth hormones.
“He was an energetic student,” said James A. Wells, a professor of pharmaceutical science at the University of California, San Francisco, who taught Mr. Jin and worked with him at Genentech. “He was outgoing and aggressive and definitely a man on a mission.”
After graduation, Mr. Jin told colleagues he wanted to return to China to start his own company and help children by producing human growth hormone.
“When he was leaving he had offers from the top postdoc programs,” Professor Wells said. “But he said he was going to start the first biotech company in China.”
Soon after returning to China he came to Changchun, an old chemical base here in northeast China, where he formed his own biopharmaceutical company in partnership with a state-owned company called the Changchun High Tech Group.
“Jin Lei always thinks big and has a vision,” said Zhou Weiqun, who works at Changchun High Tech. “We invested about $9 million in his company, and now we’ve made all that money back.”
GeneScience built a manufacturing lab in 1997, and a year later introduced its own patented human growth hormone, or H.G.H., called Jintropin, after Mr. Jin.
The company struggled in its early years, but by 2006, GeneScience said it controlled nearly 70 percent of China’s market in human growth hormones. The company also boasted that it was China’s most profitable pharmaceutical company.
But as early as 2004, according to investigators, Mr. Jin was also smuggling his company’s Jintropin into the United States.
The company had long boasted that its drug was a kind of cure-all that could enhance sex drive, heal wounds, improve memory and give bodybuilders that “monstrous, freaky size.”
“H.G.H. is the Mercedes of bodybuilding supplements,” read one Web advertisement for Jintropin. “Another reason Jintropin is so popular is that there is no method today for detection of it in the blood system, which allows drug tested competitors in many sports or bodybuilding to use this product freely without any negative ramifications.”
Investigators, however, say the company and Mr. Jin pushed the drug too far.
Mr. Jin and another person, possibly his secretary, “are involved in a worldwide conspiracy to smuggle H.G.H. from China into other countries, including the United States,” Jason Simonian, a special agent for the F.D.A. Office of Criminal Investigation, wrote in the affidavit unsealed this week.
But Mr. Zhou at the Changchun High Tech Group said he doubted that Mr. Jin was ever involved in the illegal trade. In an interview Thursday, he blamed shady distributors and counterfeiters.
“Between 2004 and 2006, there was a lot of counterfeiting of this drug,” he said. “We had a big problem with it. That may be what happened.”
Indeed, GeneScience’s Web site now warns, “GeneScience don’t sell or ship any Jintropin directly or indirectly to USA. Any unauthorized Jintropin appeared in USA should be considered as fake.”
But the case against Mr. Jin and GeneScience continued to mount into this year. Federal authorities say they have several informants who have provided incriminating evidence against Mr. Jin, who was charged Sept. 19 with 16 felony counts of smuggling, trafficking and money laundering.
“We would obviously not be bringing an indictment charging him with these offenses if we did not have evidence that it was him, and we do have that evidence,” Adi Goldstein, the assistant United States attorney prosecuting the case, said in a telephone interview Thursday.
Ms. Goldstein said United States agencies would contact their Chinese counterparts to “make whatever efforts are legally available to us to bring him to justice in the United States.”
The two countries do not have an extradition agreement.
Robert Clark Corrente, the United States attorney for Rhode Island, said in a statement Monday that federal agents had seized $3.4 million from the New York branches of two Chinese banks linked to the company.
Three of Mr. Jin’s alleged distributors or co-conspirators, from California, Shanghai and Slovenia, were also charged in Rhode Island.
Web sites catering to people who use human growth hormone are filled with talk of the case. “Man, bad news for all,” someone wrote on steroidsuperboard.com. “I wonder how many are talking and how many of the sources were stupid enough to keep client lists.”
Oddly, the Web site of Gene- Science lists as one of its milestones a 1997 visit to the company by Zheng Xiaoyu, the former head of China’s food and drug regulatory agency who was executed this year for corruption.
Mr. Jin and Mr. Zheng are pictured together on the Web site.
Correction: September 29, 2007
Because of an editing error, an article in Business Day yesterday about Jin Lei, a Chinese pharmaceutical executive who has been charged with felony smuggling and drug trafficking, referred incorrectly to a government affidavit that was filed in the case. It was filed in a Federal District Court electronic filing system, not an online Food and Drug Administration database. (The affidavit was by a special agent of the F.D.A.) Also because of an editing error, the article misstated the date Mr. Jin was charged. It was on Sept. 19 — not on Monday, which was the day the affidavit was unsealed.
TIMESUNION.COM
Steroid [HGH] plea called turning point
Albany prosecutors say guilty admission of Florida doctor will bolster case against pharmacy owners
By BRENDAN J. LYONS, Senior writer Click byline for more stories by writer. First published: Wednesday, July 25, 2007
ALBANY -- A well-known Florida obstetrician whose illicit prescription-drug clients included at least two pro wrestlers and a top bodybuilder pleaded guilty to a felony drug count Tuesday in connection with a nationwide steroids distribution network.
Dr. Claire D. Godfrey, 36, a former Mrs. Florida contestant who lives in central Florida's Seminole County, is the seventh person to plead guilty in the sprawling investigation.
Outside court, prosecutors called Godfrey's guilty plea a turning point in their case against Signature Pharmacy. The Orlando company, owned by husband-and-wife pharmacists Stan and Naomi Loomis, churned out millions of dollars in illegal prescriptions, mostly for steroids, through a maze of Internet-based "wellness centers" and complicit doctors, according to indictments filed in Albany County.
"This is an important plea," Albany County Assistant District Attorney Christopher Baynes said. "It bolsters our case against Signature... If this case ever went to trial, I think Claire Godfrey would be one of our star witnesses."
Brian Devane, an Albany attorney retained by Stan and Naomi Loomis, who have both pleaded not guilty, disputed prosecutors' assertion that Godfrey could help convict his clients.
"Stan and Naomi Loomis are not responsible for the crimes committed by Claire Godfrey," Devane said. "They continue to look forward to their day in court."
After being placed under oath in court, Godfrey said she was steered to several "rejuvenation clinics" by executives at Signature Pharmacy. Those clinics generally were boiler rooms staffed by non-medical workers who solicited clients over the Internet and by telephone and designed prescription drug packages for them, often containing steroids and other performance-enhancing drugs, authorities said.
Godfrey said she rarely had contact with any of the patients and was paid $50 per prescription. Over a six-month period ending in February, Godfrey wrote approximately $1.3 million worth of prescriptions, earning roughly $200,000, authorities said. [PERLS: That's $200,000/$50 = 4,000 prescriptions in 6 months!!!]
It's a felony in New York for a doctor to prescribe drugs without an in-person evaluation and Godfrey had many clients in this state, according to prosecutors.
Judge Stephen W. Herrick pressed Godfrey about whether those receiving the drugs needed them for legitimate medical purposes.
"Some were medically necessary, some were not," Godfrey admitted.
Godfrey is expected to lose her medical license because of her guilty plea. She willingly breached her ethical duties, and the law, and was caught on tape doing it, authorities contend.
In one instance, investigators retrieved e-mails they said showed Godfrey had "fined" a South Florida wellness center $5,000 for using her "signature stamp" without her knowledge. Authorities said Godfrey was alarmed that prescriptions had been authorized under her name when she wasn't paid.
Last August, Godfrey was heard on a wiretap calling Signature Pharmacy following a federal raid of a New Jersey wellness clinic. The clinic was one of about five such clinics for which Godfrey wrote prescriptions. Signature also did business with it. Last week, the man operating that clinic, Daniel McGlone, pleaded guilty to federal charges in Rhode Island.
In the telephone call between Godfrey and Tony Palladino, Signature's former corporate account manager, the well-known Florida OB-GYN physician sounded concerned.
"I'm curious if I'll be getting paid for this month," Godfrey said, according to a copy of the wiretap transcript.
On another occasion, agents were listening and watching when Godfrey had lunch in Orlando with a Signature Pharmacy executive and the operator of a Houston-area wellness clinic who was cooperating with authorities and had agreed to wear a microphone to the meeting.
The Texas man, Eugene Bolton, a former semi-pro football player who has since pleaded guilty, said that during the meeting they set up a deal for Godfrey to sign prescriptions for his company. At the meeting, Bolton said he handed Godfrey $1,750 in cash for prescriptions she'd already signed.
"She's accepted responsibility and will cooperate with the prosecutors and the court," said Donald T. Kinsella, Godfrey's attorney. Godfrey and her husband declined comment as they left the courthouse holding hands.
Among Godfrey's clients, according to law enforcement sources, were two pro wrestlers affiliated with World Wrestling Entertainment Inc., as well as Victor Martinez, 33, a top professional bodybuilderwho won the Arnold Classic bodybuilding competition in Ohio in March. The sources declined to identify the wrestlers.
In March, Albany County District Attorney David Soares characterized Martinez as an "unindicted co-conspirator" whom he said broke off contact with investigators months ago after pledging to cooperate in their probe. Soares said Martinez may face charges.
Herrick ordered Godfrey released on bond pending a sentencing that is scheduled for Sept. 18. Under a deal that requires Godfrey to testify against several other defendants, she would face five years' probation. For her guilty plea to second-degree criminal diversion of a prescription medicine, Godfrey could face between 2 and 6 years in state prison if she fails to cooperate, Herrick warned.
Godfrey is not the only doctor accused of writing steroids prescriptions for pro athletes. Last month, authorities confirmed that former WWE star Christopher Benoit, who murdered his wife and son before killing himself at their Georgia home, had obtained prescriptions for steroids that allegedly were signed by Dr. Gary Brandwein, a South Florida doctor also under indictment in Albany.
The prescriptions attributed to Brandwein were delivered to Benoit in 2005 and 2006, according to shipping records reviewed by the Times Union.
Baynes said authorities are continuing to examine how many pro wrestlers may have received steroids from Signature Pharmacy.
"We are looking for a pattern with other doctors in the case," he said.
Brendan J. Lyons can be reached at 454-5547 or by e-mail at blyons@timesunion.com.
New York Senator Schumer has intrduced a bill to make growth hormone a schedule III drug. Contact your congressman, particularly if they are on the Judiciary Committee, voicing your support of this bill!
S.877 Title: A bill to amend the Controlled Substances Act to add human growth hormone to schedule III, to prohibit the sale of prescriptions for controlled substances for illegitimate purposes, and for other purposes. Sponsor: Sen Schumer, Charles E. [NY] (introduced 3/14/2007) Cosponsors (None) Latest Major Action: 3/14/2007 Referred to Senate committee. Status: Read twice and referred to the Committee on the Judiciary.
Controlling the Abuse of Prescriptions Act of 2007 - Amends the Controlled Substances Act to add growth hormone, recombinant human growth hormone, or human growth hormone as a schedule III controlled substance; and (2) establish a good faith standard for practitioners in dispensing prescriptions of controlled substances.
Why human growth hormone is not a dietary supplement
It was called a drug by the FDA prior to the Dietary Supplements Health and Education Act (DSHEA)
It’s not ingestible
hGH, along with anabolic steroids, must, according to the Federal Food, Drug, and Cosmetic Act (FDCA) be prescribed by a physician who also provides subsequent supervision of the patient (See 21 U.S.C. § 353(b)(1)(B)
Operation 'Which Doctor'
Operation 'Which Doctor' is a co-operative multi-jurisdictional, law enforcement effort between the Albany County District Attorney's Office, New York State Health Department, Orlando Bureau of Investigation, and the Florida Attorney General working together to take down a nationwide distribution ring of anabolic steroids, Human Growth Hormones and other controlled substances, by targeting the ring's dirty doctors, its distributors that pose as clinics, and ultimately the ring's supplier Signature Pharmacy. Florida and Federal authorities have pending cases against similar clinics and their associates.
P. David Soares 6 Lodge Street Albany, New York 12207 (518) 487-5460 (518) 487-5093 FAX
Operation “Which Doctor” Defendants Arraigned
ALBANY , NY – Albany County District Attorney P. David Soares announced today that CLAIRE GODFREY, of Seminole County Florida was arraigned today on a (10) count indictment including the Criminal Sale of a Controlled Substance and Conspiracy in the Fourth Degree. Additionally NAOMI LOOMIS, ROBERT “STAN” LOOMIS, KENNETH MICHAEL LOOMIS, and KIRK CALVERT, all of Orlando Florida, were arraigned on (20) counts including Enterprise Corruption, (9) counts of Criminal Sales of a Controlled Substance in the Fifth Degree, (4) counts of Criminal Diversion of Prescription Medications and Prescriptions in the 1st Degree, (4) counts of Criminal Diversion of Prescription Medications and Prescriptions in the Second Degree, and Insurance Fraud in the Third Degree. The arraignments took place before the Honorable Thomas A. Breslin. If convicted on all counts, GODFREY faces a maximum term of up to 15 years in state prison; the LOOMIS’ and CALVERT face up to 25 years.
The indictments allege that on or about the 1st day of February, 2007 between the hours of 12:00 PM and 2:00 PM, at Church Road in the Town of Guilderland, NY, GODFREY did, when being a licensed medical practitioner, agree to sell a prescription for the controlled substances Chorionic Gonadotropin, Nandralone and Testosterone for a William Farmer, when she did not examine the patient or know of any legitimate medical need for the controlled substances. The indictment further alleges that she proceeded to sell these controlled substances to Mr. Farmer by receiving and signing a prescription for this customer whom she never saw in person as a patient. She is also alleged to have unlawfully agreed to sell a prescription for the controlled substance Testosterone Cypionate for a Thomas Dinota Jr., when she did not examine the patient or know of any legitimate medical need for the controlled substance. Additionally, the defendant is alleged to have, along with Signature Pharmacy, colluded to fail to report of the prescribing an dispensing of these prescriptions with the New York State Health Department in the City of Albany.
The Enterprise Corruption charge against the LOOMIS’ and CALVERT alleges that the defendants, from January 1, 2005 through January 10, 2007 in the county of Albany and other counties in the State of New York did intentionally conduct or participate in the affairs of a criminal enterprise by participating in a pattern of criminal activity by committing three or more pattern acts with the knowledge of the existence of the criminal enterprise “Signature Pharmacy”.
The alleged pattern of criminal acts includes:
Criminal Sale of a Controlled Substance in the 5th Degree in that the defendant on or about the 11th day of September 2006 at FedEx in the Village of Menands, NY did knowingly and unlawfully sell the controlled substances Anastrozole, Chorionic Gonadotropin, and Testosterone to another person through their affiliate MedXLife.
Criminal Sale of a Controlled Substance in the 5thDegree in that on or about the 25 th day of May, 2006, the defendants at 11 Century Hill Lane in the Town of Colonie, County of Albany, State of New York did knowingly and unlawfully sell the controlled substances Testosterone, Nandralone, and Chorionic Gonadotropin to another person through their affiliate MedXLife.
Criminal Diversion of Prescriptions Medications and Prescriptions in the 1st Degree in that between the dates of January 1 st 2005 and September 1 st 12006 at the Department of Health, in the City of Albany, County of Albany, State of New York and 280 Riverside Drive, Manhattan, New York, the defendants accepted and filled bogus prescriptions for drugs totaling in excess of $50,000 from their criminal associate CNA signed by a physician located in the state of New York (Dr. Ahmed Halima of 280 Riverside Drive, Manhattan, NY) with knowledge or reasonable grounds to know that here was no medical need for the medicine and/or that the prescriptions were bogus.
Criminal Diversion of Prescriptions Medications and Prescriptions in the 1st Degree in that between the dates of January 1 st 2005 and September 1 st 12006 at the Department of Health, in the City of Albany, County of Albany, State of New York and 100-01 Metropolitan Avenue, Suite 2F, Queens, New York, the defendants accepted and filled bogus prescriptions for drugs totaling in excess of $50,000 from their criminal associate Advanced Therapy/Metragen purportedly signed by a physician located in the state of New York (Dr. Abdul Almarashi as signed by Anna Marie Santi, a doctor suspended from practice) with knowledge or reasonable grounds to know that here was no medical need for the medicine and/or that the prescriptions were bogus.
Criminal Sale of a Controlled Substance in the 5th Degree in that on or about the 15 th day of December, 2006, the defendants at 1 FedEx in the Village of Menands, County of Albany, State of New York did knowingly and unlawfully sell the controlled substances Testosterone, Nandralone, and Chorionic Gonadotropin to another person through their affiliate Palm Beach Rejuvenation.
Criminal Diversion of Prescriptions Medications and Prescriptions in the 2nd Degree in that on September 5 th 2006 at 112 State Street, in the City of Albany, County of Albany, State of New York, between the dates of January 1 st 2005 and September 1 st 12006 at the Department of Health, the Capitol, in the City of Albany, County of Albany, State of New York and 100-01 Metropolitan Avenue, Suite 2F, Queens, New York, the defendants accepted and filled bogus prescriptions for drugs totaling in excess of $50,000 from their criminal associate Advanced Therapy/Metragen purportedly signed by a physician located in the state of New York (Dr. Abdul Almarashi as signed by Anna Marie Santi, a doctor suspended from practice) with knowledge or reasonable grounds to know that here was no medical need for the medicine and/or that the prescriptions were bogus.
Criminal Diversion of Prescriptions Medications and Prescriptions in the 1st Degree in that during the months of April through July, 2006, at 259 N, Middletown Road in the Town of Nanuet, County of Rockland, State of New York, the defendants did commit a criminal diversion act when their criminal associates Steven and Karen Lampert, also know as the Anti-Aging Centers did submit prescriptions, some obviously forged, for a drugs totaling in excess of fifty thousand dollars pursuant to an agreement wherein these prescriptions would be filled at Signature Pharmacy, 2200 Kuhl Avenue, Orland Florida with all parties knowing or having reasonable grounds to know that there was no medical need for the medicine and /or that the prescriptions were bogus.
District Attorney Soares acknowledged that these arraignments represented a major milestone in the war against the illegal sale of prescription drugs. “For too long, drug pushers have been selling their wares through the internet with seeming impunity. This case addresses a major loophole in the practice of the enforcement of our laws against the illegal sale and uncontrolled use of controlled substances,” Soares said.
GODFREY was released on $20,000 bond. LOOMIS et all were each released on $30,000 bond.
The next court date for all defendants is scheduled to take place in April 2007.
For further information contact: Heather Streeter Orth
OPERATION PHONY PHARM (Media-Newswire.com) - Kevin J. O’Connor, United States Attorney for the District of Connecticut, and Kimberly K. Mertz, Special Agent in Charge of the Federal Bureau of Investigation, today announced charges that have been brought against six individuals as a result of Operation Phony Pharm, an undercover investigation targeting the illegal sale of anabolic steroids, human growth hormone, and other controlled substances over the Internet.
In April 2006, the FBI’s Healthcare Fraud Unit in the District of Connecticut, initiated Operation Phony Pharm. Using several sophisticated investigative techniques, this initiative, which has included the assistance of the United States Postal Inspection Service, the Food and Drug Administration’s Office of Criminal Investigations, and the Drug Enforcement Administration, has targeted web sites and individuals who are selling Schedule II and III pharmaceuticals over the Internet without a doctor’s consultation or a legitimate legal written prescription. Operation Phony Pharm also sought to identify and close down underground laboratories in the U.S. that are making these drugs from raw materials obtained from outside the U.S.
‘The dangers associated with the improper use of steroids and human growth hormone are well documented,’ U.S. Attorney O’Connor stated. ‘However, this investigation has helped to shed light on additional troubling concerns, including the manufacture of these drugs in unsanitary kitchen and basement labs, and their subsequent sale on web sites, many of which are frequented by minors. Recently, the federal penalties for the manufacture, distribution and possession of anabolic steroids and HGH have increased, and we and our federal law enforcement partners will vigorously investigate and prosecute the unlawful trafficking and use of these substances in order to deter their use.’
In an Indictment unsealed on Friday, September 21, EDWIN F. PORTER, 41, of Chandler, Ariz.; MATTHEW J. PELTZ, 36, of Chandler, Ariz.; TYLER J. LUNN, 27, of Phoenix, Ariz.; and WALTER T. COREY, 37, of Cherleroi, Penn., are each charged with one count of conspiring to distribute anabolic steroids, and two counts of distribution of anabolic steroids. The Indictment alleges the defendants purchased raw steroid powder from China, manufactured anabolic steroids in home laboratories in both oral and injectable form, and distributed them to customers around the country through a MySpace.com profile and an Internet web site they created, www.anabolic-superstore.com.
If convicted, PELTZ, LUNN and COREY face a maximum term of imprisonment of 15 years and a fine of up to $750,000. As PORTER has also been charged with one count of making a false statement to the FBI during the course of this investigation, he faces a maximum term of imprisonment of 20 years and a fine of up to $1,000,000.
Also on Friday, BRIAN S. TOMPKINS, 29, of Deltona, Fl., pleaded guilty in Hartford to one count of distribution of anabolic steroids. TOMPKINS admitted that, from September 2006 to July 2007, he distributed anabolic steroids by mail to individuals who contacted him through his MySpace.com profile. He further admitted that, in July 2007, he purchased two kilograms of steroid powder from a supplier in China.
Earlier today, ALAN R. BLAIR, 52, of Wilton, Conn., pleaded guilty in Hartford to one count of distributing Human Growth Hormone without a prescription. BLAIR admitted that, from approximately November 2004 to April 2007, he distributed HGH to customers throughout the world using the web site www.jintropin.com. The HGH was shipped directly to BLAIR’s customers from a supplier in China. As part of his guilty plea, BLAIR has agreed to forfeit to the Government approximately $260,000 of illegal proceeds generated as a result of his operation.
TOMPKINS and BLAIR are each scheduled to be sentenced by United States District Judge Christopher F. Droney in December, at which time they face maximum terms of imprisonment of five years and fines of up to $250,000.
In December 2006, as a result of Operation Phony Pharm, a seventh defendant, Hiroshige Cranney, 25, of San Francisco, Calif., was charged with selling anabolic steroids through the Internet website www.sell.com. The steroids, which include dianabol, winstrol, deca-durabolin, anavar, testosterone, anadrol, and turanabol, were sold to buyers in Connecticut and around the country. The case was transferred to the Northern District of California, and, in August 2007, Cranney pleaded guilty to one count of illegal sale of anabolic steroids.
‘I want to acknowledge the ongoing efforts of the U.S. Postal Inspectors, FDA, DEA and other law enforcement agencies who are diligently working to disrupt the illegal production and trafficking of anabolic steroids and HGH,’ stated FBI Special Agent in Charge Mertz. ‘Operation Phony Pharm is an ongoing investigation, additional targets have been identified, and we expect more arrests.’
During the course of Operation Phony Pharm, the FBI became aware of Operation Raw Deal, an international investigation led by the Drug Enforcement Administration that was targeting the underground manufacture, conversion and trade of anabolic steroids. Since that time, Operation Phony Pharm and Operation Raw Deal have provided mutual assistance as these investigations have evolved.
Operation Raw Deal has focused on raw material manufacturers/suppliers in China and other countries; underground anabolic steroid laboratories in the United States, Canada and Mexico; numerous U.S.-based websites distributing materials, or conversion kits, necessary to convert raw steroid powders into finished product; and Internet bodybuilding discussion boards that are the catalysts for individuals to learn how to illicitly use, locate and discreetly purchase performance enhance drugs, including anabolic steroids. Many of the underground steroids labs targeted during this investigation advertise and are endorsed on these message boards.
Today, the United States Department of Justice announced that Operation Raw Deal, together with the charges announced today in Connecticut, represents the largest steroid enforcement action in United States history. As part of Operation Raw Deal, 143 federal search warrants were executed on targets nationwide, resulting in 124 arrests and the seizure of 56 steroid labs across the United States. In total, 11.4 million steroid dosage units were seized, as well as 242 kilograms of raw steroid powder of Chinese origin. As part of Operation Raw Deal, $6.5 million also was seized, as well as 25 vehicles, three boats, 27 pill presses, and 71 weapons. Enforcement activity took place in 27 states.
Approximately 50 people were arrested and 61 federal search warrants were executed on targets nationwide during the operation’s final takedown, which began on Sept. 14, 2007. The U.S. operation took place in conjunction with enforcement operations in Mexico, Canada, China, Belgium, Australia, Germany, Denmark, Sweden, and Thailand.
‘Whenever someone uses the U.S. Mail to send anything that they know is dangerous, illegal or counterfeit, postal inspectors are prepared to find them and arrest them in order to preserve the integrity of the mail,’ said Chief Postal Inspector Alexander Lazaroff of the United States Postal Inspection Service. ‘I am proud to partner in this operation to stop the suppliers of anabolic steroids and the customers who purchase them, so that the mail will not be an ingredient in this deadly recipe.’
According to the charges filed in connection with these investigations, worldwide manufacturers of the raw materials needed for steroids use websites to market their products and even provide guidance to potential customers. Steroid Internet message boards and chat rooms also use the latest technology in an effort to keep their business transactions ‘ and those of their customers ‘ anonymous. These web sites, chat rooms, and message boards also provide information about how to convert the raw material into finished steroid product and boast of their ability to resist law enforcement scrutiny. In addition, these sites promote and often sell ‘conversion kits’ that allow customers to convert raw materials into steroids themselves from home. Besides steroids, many websites targeted also offered other dangerous drugs and chemicals such as ketamine, fentanyl, ephedrine, pseudoephedrine, and GHB.
‘The FDA Office of Criminal Investigations takes this illegal conduct very seriously and fully supports the investigation and ultimate prosecution of these profiteers who endanger the public by formulating and selling unapproved illegal drugs, even when those who would be endangered are willing participants. These buyers are solely motivated by a desire to gain an unfair competitive advantage by using illegal performance-enhancing substances and the sellers are not concerned with the buyers' health but with making money,’ said Terry Vermillion, Director of the FDA Office of Criminal Investigations.
U.S. Attorney O’Connor stressed that an indictment is only a charge and is not evidence of guilt. Each defendant is entitled to a fair trial at which it is the Government’s burden to prove guilt beyond a reasonable doubt.
Operation Phony Pharm is being prosecuted by Assistant United States Attorney Edward Chang of the U.S. Attorney Office’s Computer Hacking and Intellectual Property Unit.
CONTACT:
U.S. ATTORNEY'S OFFICE Tom Carson ( 203 ) 821-3722 thomas.carson@usdoj.gov
AP New Jersey
NJ man agrees to plead guilty in steroid and Growth Hormone scheme
PROVIDENCE, R.I. -- A pharmaceutical company owner accused of marketing and distributing illegally prescribed anabolic steroids and human growth hormone has agreed to plead guilty to 50 counts, including conspiracy, health care fraud and money laundering.
Daniel McGlone of North Brunswick, N.J., who owns New Jersey-based American Pharmaceutical Group, agreed to a plea deal in federal court this month according to court documents. He is accused of illegally distributing human growth hormone and steroids to body builders in several states, and allegedly got some of the drugs from a Florida-based pharmaceutical company charged by New York authorities in a larger steroid case.
McGlone's attorney declined to comment except to confirm that the plea agreement had been filed in federal court.
Prosecutors say McGlone advertised in bodybuilder publications and recommended the drugs for anti-agingand weight-loss purposes. Federal law restricts the use or distribution of human growth hormone to specified medical uses, such as wasting disease associated with AIDS.
McGlone took orders over the phone and, prosecutors say, paid two New York doctors to write prescriptions for the drugs even though they never met or examined the patients.
Prosecutors say he made more than $860,000 through the scheme between April 2004 and August 2006. Authorities seized more than $125,000 and two Dodge Vipers from McGlone, according to federal court documents.
McGlone sent the prescriptions to pharmacies including Orlando, Fla.-based Signature Pharmacy, according to prosecutors. The company is not charged in the Rhode Island case.
One of the doctors in the scheme, Victor Mariani, pleaded guilty in March to conspiracy and illegal drug distribution charges.
The other doctor, Ana Maria Santi, who was stripped of her New York medical license in 1999, was scheduled to appear in court Friday. She had initially agreed to plead guilty, then declined to do so at a court hearing last month, claiming she had permission to forge the signature of a doctor living in a California nursing home.
Prosecutors said McGlone faces at least three years and 10 months in prison.
Lawyer [Rick Collins] gets needled for giving 'roid advice
BY MICHAEL O'KEEFFE DAILY NEWS SPORTS WRITER
Sunday, May 27th 2007, 9:37 AM
A Long Island criminal defense attorney nationally known as a steroid law expert and an outspoken critic of the war on performance-enhancing drugs could be in legal trouble himself.
Rick Collins, a former Nassau County prosecutor whose clients have included BALCO chemist Patrick Arnold, advised wellness centers and an Orlando pharmacy on how to skirt the law to sell steroids and growth hormone, a New York drug agent testified in a Florida courtroom earlier this month.
Mark Haskins, a senior investigator for the New York State Bureau of Narcotic Enforcement, told the Kissimmee court that Collins helped the companies maneuver through the "gray area" of steroid law, according to a transcript obtained by the Daily News. Haskins testified that some of the advice Collins gave was "in fact, illegal in New York state."
Collins, author of "Legal Muscle: Anabolics in America," received more than $40,000 from Palm Beach Rejuvenation, MedX Life, Oasis Longevity and Rejuvenation and other businesses involved in what Albany District Attorney David Soares has called a multistate scheme to sell steroids. Soares' investigation has resulted in 21 indictments and seven guilty pleas so far.
The May 18 hearing was held after defense attorneys in the case asked the Florida court to seal hundreds of pages of wiretap transcripts an Orlando task force had provided to Albany prosecutors. The defense attorneys argued that Albany authorities violated Florida law by showing the wiretap transcripts to an Albany County grand jury because the transcripts had been under seal at the time.
The defense attorneys appealed after Osceola County Circuit Court Judge John Kest ruled that Florida officials were entitled to share the wiretap transcripts. The appeals court ruled Friday that Florida officials and Albany prosecutors had acted properly.
Based on Haskins' testimony, the Florida court also agreed that there was evidence that Collins may have violated the law. Attorney-client conversations are privileged in the U.S. and can't be introduced as evidence in Florida unless they violate the state's crime-fraud exception.
Collins has not been charged with a crime and is identified in the transcript only as "Attorney A" because Florida court officials wanted to protect his privacy and the integrity of Soares' ongoing investigation. Several sources familiar with the Florida hearing, however, confirmed that Collins is "Attorney A" after his name was inadvertently disclosed in open court.
Haskins testified that Collins told a Long Island doctor named Norman Haywood - who has not been accused of criminal activity - not to use New York state official forms when writing prescriptions for steroids. New York state officials would be unable to monitor prescriptions if they were not written on official paperwork.
Haskins also said Collins coached another doctor on how to avoid detection for growth hormone prescriptions.
"He had stated that 'Attorney A' had told him with regards to growth hormone that just make sure their levels are a little low and to write a diagnosis that was hard to prove, like fibromyaglia," Haskins testified. "This doctor stated that he knew that this was probably illegal, but he did it anyway."
Collins, a popular source for reporters looking for a contrarian view on performance-enhancing drugs, did not return calls for comment. In interviews with the media and in public presentations, he argues that steroids, when taken responsibly by adult males, are beneficial.
The former bodybuilder testified before a congressional panel about steroid precursors in 2003.
Collins is also an actor who appeared in an episode of "The Sopranos," as well as numerous films made by Troma Entertainment, the New Jersey production company famous for its low-budget horror parodies. According to the Internet Movie Data Base, Collins' film credits include roles in "The Toxic Avenger," "Class of Nuke 'Em High" and "Citizen Toxie: The Toxic Avenger IV."
Shortly after investigators raided Signature Pharmacy and other businesses Soares has linked to the steroid ring, several defense attorneys told the Daily News and other media outlets that their clients did not have criminal intentions. They said their clients believed they were operating legally because they had consulted with Collins.
James E. Long, an Albany attorney who represents brothers Glenn Stephanos and George Stephanos of Palm Beach Rejuvenation in Jupiter, Fla., said his clients were introduced to Collins by "people at Signature." Both men have pleaded not guilty to drug charges.
"They paid him a reasonable legal fee and he came to their plant," Long said. "He never said they could not ship to New York."
With Christian Red and T.J. Quinn
Long Island physician Oreste Joe Bruni leaves Nassau County Police Headquarters in Mineola for his arraignment.
State Narcotic Enforcement agents Mark Haskins (l.) and Rick Boettcher load up boxes of evidence from Lowen Pharmacy in Bay Ridge.
Government officials and police gather evidence at Signature Compounding Pharmacy in Orlando in February.
Mark Haskins, senior investigator for the New York State Bureau of Narcotic Enforcement, leads crackdown of drug dens.
Inside a steroid [and GH] bust
Daily News takes you along for the ride
By T.J. QUINN DAILY NEWS SPORTS WRITER
Sunday, May 13th 2007, 6:20 PM
They were investigators for the state Bureau of Narcotic Enforcement, and they wanted to do a spot inspection of the mom-and-pop shop on the corner of 63rd and 3rd, where neighbors sometimes put chairs on the sidewalk so they have a place to kibitz, where you can pick up a prescription or buy a Mother's Day present and everything looks the same as it did 30 years ago.
Just last year Lowen's became a "compounding" pharmacy, meaning they didn't just stock drugs from outside suppliers anymore, they mixed their own with raw materials. Mark Haskins, senior investigator for the BNE, asked the pharmacy's operator, John Rossi, where he did his compounding.
"He opens a door, and there's this room with no windows about 10-by-18 with this woman in a surgical gown and mask mixing something in a bowl. Like the size of a bowl you'd make cookies in," Haskins says.
She wasn't making cookies, he says, She was mixing stanozolol, a powerful, popular anabolic steroid. Against a wall, a fax machine was churning out requests from all over the country for steroids and human growth hormone, up to 100 orders just in the four hours the four investigators were there. On another wall, stacks of 50 to 60 FedEx packages filled with steroids were ready to go. Investigators and prosecutors believe the names of numerous athletes, from high school to the pros, are on those orders.
Next to the woman were two lyophilizers, $37,000 gadgets that look like front-loading washing machines, used to freeze-dry liquid growth hormone. The powder is then mixed with sterile water and readied for sale.
Haskins and the other three agents started collecting what they estimated is $200,000 worth of steroids and human growth hormone. Some of it was manufactured at Lowen's legally, but most of the drugs were from a Chinese importer in California, and that company had no DEA or FDA license.
Rossi, listed in business records as the pharmacy's president, didn't call a lawyer when the agents arrived. He did help the investigators carry boxes out of the store and offered to buy them lunch, however. "Hamburgers," Haskins says. "We said, 'No, thank you.'"
The new front in the war on drugs isn't really like the ones that came before it. Cops may crash into crack houses and meth labs, but the ongoing, nationwide investigations into steroid trafficking are a different breed. Haskins and his partner Rick Boettcher, who confiscated drugs at Lowen's on Wednesday and then arrested Long Island physician Oreste Joseph Bruni in Mineola on Thursday for allegedly providing steroids to friends, are two of dozens of law enforcement agents who have upended the world of Internet steroid sales over the past three months.
But whether the topic is cocaine or HGH, a drug investigation is a drug investigation, Albany D.A. David Soares says. "This is a case about unfettered access to controlled substances," he says. "We're trying to stop a clear and present danger to people who want these substances. That's what it's been about from the start."
Haskins was given permission by the state Department of Health to share details of the raids he has conducted with the Daily News, and those details show how accused steroid dealers tried to rationalize that their activities were within the law.
There is nothing wrong with a compounding pharmacy making steroids, for example, but the woman mixing her brew was a tech, not a licensed pharmacist, which is illegal, Haskins says. And much of the additional steroids and human growth hormone the investigators found in the pharmacy were allegedly illegal Chinese imports.
There were classic steroids such as testosterone, stanozolol, oxandrolone, nandrolone, as well as HGH. A shelf was filled with human chorionic gonadotropin (HCG), which forces the body to keep making testosterone when a person is on steroids, and keeps the testes from shrinking.
"The place was really a bodybuilder's dream," Haskins says. "Anything you wanted for your cycle was there."
And Lowen's could turn a nice profit.
Haskins says the pharmacy bought 25 grams of somatropin, a synthetic form of HGH, for $75,000. One gram could be converted into 3,000 IU's, which would then sell for $6 to $18 a dose, meaning Lowen's could have sold from $450,000 to $1.35 million worth of HGH from a $75,000 investment.
Rossi could not show Haskins an invoice with a DEA number for the Chinese drugs, which the law requires. Haskins called DNP Importers, the Whittier, Calif., company that imported the drugs and sold them to Lowen's.
"The guy on the phone didn't even know what the DEA was," Haskins says.
Haskins was also part of the crew that raided a Florida anti-aging "clinic" called Palm Beach Rejuvenation in February, along with Florida Metropolitan Bureau of Investigation agents. The operation they unearthed looked more like "Glengarry Glen Ross" than "New Jack City," but was a successful enterprise in Internet steroid sales.
Investigators called it a "boiler room" operation, a far cry from a professional medical clinic. When customers who were interested in buying steroids found one of PBR's Web sites, they could find a number to call for more information. Those calls went to phones in a converted doctor's office, where a 10-by-10-foot room held three desks, and athletic-looking young men in their 20's who'd left jobs selling cars, real estate and mortgages to handle their questions. Most of these "counselors," none of whom went to college, kept their own stashes of steroids in their desks, disposed of needles in medical waste containers that sat next to bottles of Powerade and cans of Red Bull. "They all said, 'I've got a prescription for these,'" Haskins says. "They probably did."
They worked in polo shirts, jeans or khakis, read from sales scripts, telling callers that many professional athletes, doctors and lawyers had benefited from their hormonal products such as steroids and HGH. Anyone who contacted the Web site or called was considered a lead. The "counselors" would try to turn leads into prospects, and prospects into clients. Investigators were also taken aback to hear the counselors refer to the clients as "their patients."
They didn't just take orders, they told clients what drugs they should take. "They were prescribing drugs," Haskins says. The counselors would send the lists to friendly doctors by fax or e-mail, the doctors would either sign the faxes by hand or sign the e-mails with an electronic stamp, and forward the scrips to pharmacies like Signature in Orlando, which was raided in February, or Lowen's in Brooklyn. Haskins says he isn't sure how much the counselors made from their commissions, but the poorest young man in the room claimed to have made $110,000 last year. Most made twice that. They saw nothing wrong with what they were doing.
"You're 23 years old and you don't even have a college education and you're telling someone what drugs are best for you and you're making $200,000 a year? And you don't think there's something wrong with that? That maybe if something seems too good to be true it is?" Haskins says.
It's a question more agencies will be asking. Haskins says that since last week's raids he has gotten phone calls from "several" police departments from around the country that are concerned that similar scams are going on in their jurisdictions. New York's state Medicaid fraud inspector general and the state Office of Professional Discipline will be looking into Lowen's.
Haskins says Rossi told him that Lowen's had paid for a company called Global Resolutions to send a retired DEA agent to "check out" one Florida anti-aging center, South Beach Rejuvenation, that was sending his pharmacy prescriptions, and that South Beach had checked out just fine. But the report the retired agent's company sent to Lowen's said no such thing, according to Haskins.
According to his report, at South Beach "the consultants and the owner were all very large and muscular and appeared to be body builders. (One) consultant sat on a plastic box next to a credit card scanner and appeared to be entering numbers."
South Beach's Web site still offers immediate consultation for anyone seeking HGH or testosterone therapy.
Haskins is well aware of criticism from Albany police and other critics of Soares and the investigation that they are spending far too much time chasing steroids and not cocaine or heroin. But Haskins argues that his agency, which specifically deals with prescription drugs, is doing what it can to confront a public health issue, and he is finding growing support as his and other agencies continue their work.
"I've gotten calls from police agencies asking me about steroids in general," Haskins says, "But I also got a letter from a physical therapist who does work with teens. She said it's about time."
If it's illegal, how come quacks keep getting away with it?
In the words of one FDA official, "for the same reason drug dealers get away with selling drugs".
THE ULTIMATE SCAM
HGH sprays and pills are advertised all over the web and in anti-aging clinics and for hundreds of dollars. Yet, people who fall for buying these forms of HGH (if there is even any HGH in them) might as well be buying water.
Why? Because in the case of the spray, HGH is much too large a molecule (20,000 daltons) to be absorbed through the mucosa into the blood stream. In the case of pills, HGH is a protein and it is simply destroyed in the stomach without any effect.
JAMA (Journal of the American Medical Association) Provision or distribution of growth hormone for "antiaging": Clinical and legal issues. Authors: Thomas Perls MD, MPH, Neal R Reisman MD JD, and S Jay Olshansky PhD 2005 Oct 26;294(16):2086-90.
Provision or Distribution of Growth
Hormone for “Antiaging”
Clinical and Legal Issues
Thomas T. Perls, MD, MPH
Neal R. Reisman, MD, JD
S. Jay Olshansky, PhD
THE DISTRIBUTION AND MARKETING OF HUMAN GROWTH hormone (HGH or GH) via Web sites and antiaging clinics has grown into a multimillion-dollar antiaging industry.(1-4) Despite congressional hearings warning of deceptive marketing claims and the potential health and economic dangers associated with the antiaging industry,(5,6) and statements issued by the National Instituteon Aging (7-9) and the Federal Trade Commission,(10) the distribution and use of GH for antiaging is now common. For example, entering the terms “HGH” and “anti-aging” into the Google search engine generated 3,410,000 hits as of September 26, 2005, many representing Web sites and clinics marketing and selling GH. Worldwide annual sales of GH are estimated to be $1.5 to $2 billion.(4,11) Vance(12) has suggested that 30% of GH prescriptions
in the United States are for indications not approved by the Food and Drug Administration (FDA), which
would include antiaging and athletic enhancement. In 2000, Langreth(13) quoted an antiaging industry source as stating that 30 000 people were receiving injectible GH for antiaging at the time. United States officials reportedly estimated that 25,000 to 30,000 older individuals were treated with GH for antiaging in 2004.11 In 2002, one antiaging clinic reported that one third of its 4000 patients were spending $400 to $500 per month for GH injections.(11)
While precise figures on totalGHdistribution and use cannot be obtained, to estimate annual GH distribution in the United States, we contacted IMS Health (Fairfield, Conn), an independent pharmaceutical industry research company. IMS Health projects total national sales and prescription totals from a computerized panel of 22,000 retail pharmacies, including chain pharmacies, independents, mass merchandisers, and food store–based pharmacies, representing approximately 45% of the total prescription sales for the US retail market. IMS Health also collects information from approximately 50 mail service outlets representing 70% of the US mail service market (Brian Palumbo, written communication, IMS Health, April, 2005). Information from IMS Health indicates that a total of 212,921 new and refill GH prescriptions were filled by retail and mail service pharmacies in 2004 (Brian Palumbo, written communication, IMS Health, April 2005). These prescriptions
generated total sales of approximately $622 million ($427 million via mail services and $9.5 million via clinics), constituting 89% of sales for the class of drugs “anabolic hormones” (this class, for market surveillance purposes, includes GH) (Brian Palumbo, unpublished data, IMS Health, 2005). Of these GH prescriptions, 74% were for individuals aged 20 years and older and 43.7% were for individuals aged 40 to 59 years. These sales and prescription figures include legal prescribing for adultGHdeficiency (GHD, defined below) and AIDS wasting syndrome, but do not include distribution of GH from antiaging Web sites. In 2002, physicians within the antiaging industry estimated that 100,000 individuals obtained the drug without a prescription.(
11)
Prescribing and administering GH has become a routine intervention(
14) in an industry that is variably called “antiaging,” “regenerative,” “longevity,” or “age-management” medicine, although not all physicians using these designations administer GH to their patients. A nonsystematic viewing of numerous Web sites revealed that the cost of pills and sprays allegedly containingGHis substantial, with both costing the consumer as much as $200 to $300 for what marketers indicate as a month’s supply (T.T.P., unpublished data, 2005). By contrast, the injectible form of GH typically costs from $500 to $1000 per month.(13)
Clinical Effects of GH
Growth hormone has been documented to improve some measures of body composition, including increased muscle mass, reduced total body fat, improved skin elasticity, and reduced rate of bone demineralization,(15) but without positive effects on strength, functional capacity, or metabolism.(15-19) Furthermore, the positive effects may be shortlived: in a study of 148 patients with adult GHD (defined below), the modest beneficial effects on body composition (eg, 5% increase in lean body mass) disappeared for mostindividuals after 24 months of treatment, and 38% of study participants dropped out because of lack of subjective improvement. 20 In addition, the healthy lifestyle that patients who receive injectible GH are often encouraged to adopt, rather than the GH itself, may contribute to changes in body composition.
Growth hormone is associated with substantial adverse effects. In a clinical trial of healthy women (n=57) and men (n=74) aged 65 to 88 years, GH administered subcutaneously at an initial dose of 30 μg/kg, 3 times per week, then reduced to 20 μg/kg, was associated with carpal tunnel syndrome in 38% of women vs 7% of those taking placebo, and in 24% of men vs 0% taking placebo; edema in 39% of women (0% for placebo) and 30% of men (12% for placebo); and arthralgias in 46% of women (7% for placebo) and 41% of men (0% for placebo). Eighteen men treated with GH developed glucose intolerance or diabetes compared with 7 men in the nontreatment group.(
17)
In a placebo-controlled clinical trial of GH (0.1 mg/kg/d of GH) for AIDS wasting syndrome in 510 patients, the most common reasons for dose reduction and/or drug discontinuation were arthralgia, myalgia, edema, carpal tunnel syndrome, and elevated glucose and triglyceride levels, with 36% of individuals reporting arthralgias (vs 11% of those taking placebo), 30% reporting myalgias (12% for placebo), and 26% reporting peripheral edema (3% for placebo).21 Because of these high rates of adverse effects,22 nonsustained
improvements in quality of life
23,24 and anabolic effects,(24,25) and the drug’s high cost, even the treatment of AIDS wasting syndrome with GH has little support.23,26,27 The doses used in these studies are similar to those suggested by antiaging Web sites selling GH.
Another concern is the possibility of an increased cancer risk with long-term GH treatment28 and the potentiating effects of insulin-like growth factors (IGFs) on cancer.(29) Mukhina et al30 reported that autocrine production of GH by mammary carcinoma cells facilitates cellular growth and suggested that such growth may be sufficient to cause breast carcinoma to become invasive and metastatic. To our knowledge, no studies have assessed long-term efficacy or safety of GH administration as an antiaging intervention
in humans. Proponents of GH claim that aging is caused by an age-related decline in GH levels and therefore
GH supplementation can stop or reverse aging,(3,14) but scientific findings counter or fail to support this hypothesis.
Transgenic mice that produce supraphysiological levels of GH for their age have markedly reduced life spans and experience premature onset of age-related cognitive changes.
31 Rats with adult-onset GHD and decreased IGF-1 levels have a 30% decrease in tumor incidence and a 16% decrease in disease burden.32 Growth hormone–resistant and GH-deficient mutant mice experience substantially increased life spans.(33)
Legal Distribution of GH in the United States
As is the case for anabolic steroids, the legal provision and distribution of GH is narrowly defined. In 1988 and again in 1990, Congress amended the Food, Drug, and Cosmetic Act (FDCA) to enact more stringent controls with higher penalties for offenses involving the distribution of anabolic steroids and HGH [codified at 21 USC §333(e)(1)].34 In 1993, the provisions outlawing the distribution of specifically growth hormone were recodified as 21 USC §333(f) (pursuant to PL No. 103-80, §3(e), 107 Stat 775).
Section 303 (f)(1) of the FDCA permits distribution of HGH in connection with: (1) “treatment of a disease” or (2) “other recognized medical condition” that has been authorized by the Secretaryof Health and Human Services.(34,35)
Provision of GH islegal for children with short stature (defined as a height 2 SDs below the mean for the child’s age and sex) who have GHD, poor growth due to renal failure, Turner syndrome, or Prader-Willi syndrome, and for children small for gestational age (children who at birth were 2 SDs below the mean for weight or length or both who maintain a small body size beyond the age of 2 years)36 and for idiopathic short stature (37) (defined as height 2.25 SDs below the mean for age and sex, or the shortest 1.2% of children).(38,39)
In adults, the FDA has stated that distribution of GH is legal for only 2 conditions (S. Silverman, Director, Division New Drugs and Labeling Compliance, FDA, written communication, 2005 [may be viewed at http://www.bumc.bu.edu/centenarian]): wasting syndrome of AIDS (this does not include lipodystrophy(26)) and GHD, the latter of whichmust meet 2 diagnostic criteria40: biochemical diagnosis of adult GHD by means of a subnormal response to the standard growth hormone stimulation test (peak GH,5.0 ng/L); and patients who have adult GHD either alone or with multiple hormone deficiencies (hypopituitarism) as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma or patients who were GH deficient during childhood.
The stimulation test for GHD is performed with GH releasing hormone (or factor), arginine, glucagon, or insulininduced hypoglycemia. Only 1 case per 10 000 adults per year meet these criteria for the diagnosis of GHD; 3 cases per 10 000 also include adults who received GH treatment as children.(41) The prevalence of adult GHD in the United States is estimated to be 50 000, and the incidence is approximately 6000 per year, but a substantial portion of adults with GHD are not currently being treated with GH.(41) Measurement of IGF-1 levels (a proxy for GH levels) in older adults, when demonstrated to be lower than that of young adults, does not constitute a scientific(39,42) or legally(40) accepted diagnosis of GHD.
Marketing and Distribution of GH for Antiaging
In the United States, GH is commonly marketed, distributed, and prescribed for antiaging under the pretext of “offlabel use.”(14) However, off-label distribution or marketing of GH to treat aging or aging-related conditions is illegal. Unlike most FDA-approved medications, GH can only be distributed for indications specifically authorized by the Secretary of Health and Human Services(35)—aging and its relateddisorders are not among such indications.(43,44) Furthermore, the FDA has clearly indicated that GH is not a dietary
supplement.(
43) Growth hormone was approved as a drug by the FDA in 194043 prior to enactment of the 1994 Dietary Supplements Health and Education Act and, because it is a drug, it cannot be classified as a dietary supplement.(43) In addition, dietary supplements must be intended for ingestion.(45) The FDCA defines the term “dietary supplement” in 21 USC 321 (ff )(2)(A)(i) to mean a product that is “intended for ingestion.” Consequently, a product that is notintended for ingestion cannot meet the definition of a dietary supplement.(44) Growth hormone is bioavailable only in injectible form, and therefore this is another reason why it cannot be classified as a dietary supplement.(39)
The FDA’s position on the illegality of distributing GH as an antiaging treatment is conveyed in warning letters to Web sites marketing GH
43,44 (other warning letters can be viewed at: http://www.fda.gov/foi/warning.htm and entering the term “growth hormone”). The penalties chapter of the FDCA states under section 303 [333]35:
(f )(1) Except as provided in paragraph (2): whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.
(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act for the purposes of forfeiture under section 413 of such Act.
(4) As used in this subsection the term “human growth hormone”’ means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.
The penalties for distribution or provision of GH for antiaging purposes are substantial. Per the FDA’s letter to Dr. Perls: “Section 303 provides for up to five years in prison, or ten years if the offense involves a minor. It also permits courts to impose fines of up to $250 000 for an individual or $500 000 for an organization, or alternatively, twice the gross gain or loss from the offense (see 18 USC § 3571), as well as forfeiture of property used in or derived from violations of the HGH law.” (S. Silverman, Director, Division New Drugs and Labeling Compliance, FDA, written communication, 2005 [may be viewed at http://www.bumc.bu.edu/centenarian]).
Those who distribute GH via the Internet violate another law. Per the FDCA, GH must be prescribed by a physician who, “based upon an individualized determination of a proper course of treatment, authorizes the drug’s distribution to a patient under his supervision”34 (see also 21USC § 353[b][1][B]).(46) Review of numerous Web sites that sell GH reveals either no steps taken to provide such supervision, or in the case of those who claim to provide supervision, the law may still be violated if the supervising physician never meets the patient (examples available on request). Distributing drugs such as anabolic steroids or GH in this manner is termed “misbranding,” a practice that in other contexts has resulted in the prosecution and conviction of laypersons, pharmacists, and physicians as a felony.(34)
Common marketing practices regarding GH and related products may also be illegal. In a recent case brought before the US District Court by the Federal Trade Commission (FTC) regarding a defendant selling products claimed to contain GH,(47) the FTC stated several claims that illustrate findings that can lead to fines and disciplinary action:
1. “The dissemination of false advertisement for the purpose of inducing the purchase of a drug or device pursuant to 15 USC § 52(a) is an unfair or deceptive practice within the meaning of 15 USC § 45(a).”
2. “The defendant deceptively promotes and sells HGH products with claims that are wholly false and cannot be substantiated.”
3. “The defendant’s claims are false and cannot be substantiated with competent scientific evidence.”
Searching the Internet, numerous law-related Web sites, and specifically the FDA and US Department of Justice Web sites, reveals examples of lawsuits pertaining to distribution of GH for “antiaging.” Misleading claims led one company to voluntarily destroy $515 000 worth of its HGH product.(48) Another company pleaded guilty to the felony charge of illegally distributing GH without physicians’ orders, paid a $500 000 criminal fine, and forfeited $1.25 million in profits made in sales of approximately 100,000 bottles of its GH
oral spray.(
49) Two Oregon physicians were prosecuted by the Oregon attorney general, with the assistance of the FDA and the US Department of Justice, for misrepresenting GH to consumers “as a harmless panacea for the effects of aging” while prescribing, promoting, and selling GH at their clinic and via the Internet.(50,51) Two Florida businesses, named in an FTC complaint along with 2 individuals involved in the businesses, including one who is a physician, “agreed to a federal court order requiring them to pay up to $20 million in consumer redress—the largest monetary judgment ever obtained in an FTC health fraud case -to settle charges that they deceptively claimed that their pills and sprays would increase consumers’ human growth hormone (HGH) levels and provide anti-aging benefits.”(52) The FTC indicated that the total sales of their products, including the dietary supplement “ultimate HGH” and the sublingual sprays “Master HGH” and “Super HGH” exceeded $70 million. Importation and distribution of counterfeitGHhas also been prosecuted.
(53-55)
Responsibilities Regarding GH
Physicians and other health care professionals should be aware that current law explicitly prohibits the distribution of GH except for clearly and narrowly defined indications. Distribution for other uses, or off-label use, such as for antiaging, age-related conditions, and enhancing athletic performance, are illegal.(2,35,43,45) Although GH is not a schedule III drug, section 303 [333] f(5) of the FDCA clearly provides
the Drug Enforcement Administration with the responsibility of enforcing the laws governing human GH.
35
Given the clinical concerns and the legal issues involved, we believe that physicians or other persons who currently market, distribute, or administer GH to their patients for any reason other than the well-defined approved (ie, legal) uses of the drug, should not do so.
Pharmaceutical companies that manufacture GH should play a more effective role in making physicians and the public aware of the circumstances in which the marketing and distribution of GH are legal and illegal. Federal and state agencies should be allocated resources to better deal with the illegal distribution of GH.
Finally, the FDA and professional and lay organizations are in excellent positions to conduct awareness campaigns to educate physicians and the public about the legal and medical ramifications of GH use for antiaging.
Disclosure:
Drs Perls and Olshansky report that they are defendants in a lawsuit brought against them by the American Academy of Anti-Aging Medicine and others.
Funding/Support: Dr Perls is a Paul Beeson Career Development Award in Aging Research awardee (The American Federation of Aging Research and the Alliance for Aging Research). Dr Olshansky was supported by award K02 AG00785-05 from the National Institute on Aging and Boston University School of Medicine’s
Evans Medical Foundation.
Role of the Sponsors: The funding organizations played no role in the collection, management, analysis, and interpretation of the data; or in the preparation, review,or approval of the manuscript.
Acknowledgment: Dr Olshansky would like to thank his Epidemiology 400 class, fall 2004, for comments received during a classroom discussion on this topic. The authors also thank Leslie Smoot, MD, Mitchell Harman, MD, PhD, and Stephen Barrett, MD, for their insightful comments.
REFERENCES
1. Mehlman MJ, Binstock RH, Juengst ET, Ponsaran RS, Whitehouse PJ. Antiaging medicine: can consumers be better protected? Gerontologist. 2004;44:304-310.
2. Perls T. Anti-aging quackery: human growth hormone and tricks of the trade—more dangerous than ever. J Gerontol A Biol Sci Med Sci. 2004;59:682-691. 3. Rothenberg R, Becker K. Forever Ageless. Encinitas: California Healthspan Institute; 2001.
4. Bibby K, Davis J, Jones C. Biopharmaceuticals—moving to centre stage. Bio-People North American Biotechnology Industry and Suppliers’ Guide, IMS Global Consulting Web site. Available at: http://www.imshealth.com/vgn/images/portal/cit_40000873/43028586Bio_Moving_to_Centre_Stage.pdf. 2003. Accessibility
verified September 21, 2005.
5. US House of Representatives, Select Committee on Aging, Subcommittee on Health and Long-Term Care. Quackery: A $10 Billion Scandal . Washington, DC: US Government Printing Office; 1984. Publication No. 98-435.
6. US Senate Special Committee on Aging. Swindlers, Hucksters and Snake Oil Salesman: Hype and Hope Marketing Anti-Aging Products to Seniors. 107th ed. Washington, DC: US Government Printing Office; September 10, 2001.
7. Press release: growth hormone, sex steroid combination “not ready for prime time.” National Institute on Aging Web site. Available at: http://www.nia.nih.gov /NewsAndEvents/PressReleases/PR20021112GrowthHormone.htm. November 12,
2002. Accessibility verified September 26, 2005.
8. Sullivan M. “Anti-aging” hormones promise youth but remain unproven. National Institutes of Health Web site. Available at: http://www.nih.gov/news /HealthWise/Jan98/story3.htm. January 1998. Accessibility verified September 26, 2005. 9. Pills, patches, and shots: can hormones prevent aging? Age Page. National Institute on AgingWebsite. Available at: http://www.niapublications.org/engagepages /pills.asp. January 2005. Accessibility verified September 26, 2005. 10. “HGH” pills and sprays: human growth hype? FTC Consumer Alert. Federal Trade Commission Web site. Available at: http://www.ftc.gov/bcp/conline/pubs/alerts/hghalrt.pdf. June 8, 2005. Accessibility verified September 26, 2005. 11. Kaufman M. Growth hormone alters aging: study shows risks include diabetes, carpal tunnel syndrome. Washington Post. November 13, 2002:A2. 12. Vance M. Retrospective: can growth hormone prevent aging? N Engl J Med. 2003;348:779-780. 13. Langreth R. Sweet syringe of youth. Forbes.com Web site. Available at: http:
//www.forbes.com/global/2000/1211/0325134a.html. December 11, 2000. Accessibility verified September 21, 2005.
14. Lyle WG; Plastic Surgery Educational Foundation Data Committee. Human growth hormone and anti-aging. Plast Reconstr Surg. 2002;110:1585-1589. 15. Harman SM, Blackman MR. Use of growth hormone for prevention or treatment of effects of aging. J Gerontol A Biol Sci Med Sci. 2004;59:652-658. 16. Lange KH, Andersen JL, Beyer N, et al. GH administration changes myosin heavy chain isoforms in skeletal muscle but does not augment muscle strength or hypertrophy, either alone or combined with resistance exercise training in healthyelderly men. J Clin Endocrinol Metab. 2002;87:513-523. 17. Blackman MR, Sorkin JD, Münzer T, et al. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial.JAMA. 2002;288:2282-2292. 18. Marcus R, Holloway L, Gilliland L, Baylink DJ, Hintz RL, Sherman BM. Effects of short term administration of recombinant human growth hormone to elderly people. J Clin Endocrinol Metab. 1990;70:519-527. 19. Papadakis MA, Grady D, Black D, et al. Growth hormone replacement in healthy older men improves body composition but not functional ability. Ann Intern Med. 1996;124:708-716.
20. Verhelst J, Abs R, Vandeweghe M, et al. Two years of replacement therapy in adults with growth hormone deficiency. Clin Endocrinol (Oxf ). 1997;47:485-494. 21. Serostim LQ [somatropin (rDNA origin) injection] description. MedWatch. US Food and Drug Administration Web site. Available at: http://www.fda.gov/medwatch/SAFETY/2005/Feb_PI/Serostim%20LQ_PI.pdf. April 15, 2005. Accessibility verified September 21, 2005.
22. Koutkia P, Canavan B, Breu J, Torriani M, Kissko J, Grinspoon S. Growth hormone-releasing hormone in HIV-infected men with lipodystrophy: a randomizedcontrolled trial. JAMA. 2004;292:210-218. 23. Waters D, Danska J, Hardy K, et al. Recombinant human growth hormone, insulin-like growth factor 1, and combination therapy in AIDS-associated wasting:a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1996;125:865-872. 24. Schambelan M, Mulligan K, Grunfeld C, et al. Recombinant human growth hormone in patients with HIV-associated wasting: a randomized, placebocontrolled trial. Ann Intern Med. 1996;125:873-882. 25. Lee PD, Pivarnik JM, Bukar JG, et al. A randomized, placebo-controlled trial of combined insulin-like growth factor 1 and low dose growth hormone therapyfor wasting associated with human immunodeficiency virus infection. J Clin EndocrinolMetab. 1996;81:2968-2975.26. Roehr B. The many faces of human growth hormone. BETA. 2003;15:12-16.
27. James J. Involuntary weight loss: interview with Lisa Capaldini, MD. AIDS Treat News. 2005;411:2-3. 28. Swerdlow AJ, Higgins CD, Adlard P, Preece MA. Risk of cancer in patients treated with human pituitary growth hormone in the UK, 1959-85: a cohort study. Lancet. 2002;360:273-277.
29. Yu H, Rohan T. Role of the insulin-like growth factor family in cancer development and progression. J Natl Cancer Inst. 2000;92:1472-1489. 30. Mukhina S, Mertani HC, Guo K, Lee K-O, Gluckman PD, Lobie PE. Phenotypic conversion of human mammary carcinoma cells by autocrine human growth hormone. Proc Natl Acad Sci U S A. 2004;101:15166-15171. 31. Bartke A. Can growth hormone (GH) accelerate aging? evidence from GH transgenic mice. Neuroendocrinology. 2003;78:210-216. 32. Sonntag WE, Carter CS, Ikeno Y, et al. Adult-onset growth hormone and insulin-like growth factor I deficiency reduces neoplastic disease, modifies age-related pathology, and increases life span. Endocrinology. 2005;146:2920-2932.
33. Bartke A, Coschigano K, Kopchick J, et al. Genes that prolong life: relationships of growth hormone and growth to aging and life span. J Gerontol A Biol SciMed Sci. 2001;56:B340-B349. 34. Title 4 (Civil) Resource Manual. United States Attorneys’ Manual. 19 Human Growth Hormone/Steroids Statutory Overview. US Department of Justice Web site. Available at: http://www.usdoj.gov/usao/eousa/foia_reading_room/usam/title4/civ00019.htm. 1998. Accessibility verified September 21, 2005. 35. United States Code. Title 21: Food and Drugs, Chapter 9–Federal Food, Drug, and Cosmetic Act, subchapter III: Prohibited Acts and Penalties, Sec. 333. Penalties. GPO Access Web site. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite: 21USC333. January 7, 2003. Accessibility verified September 21, 2005. 36. de Zegher F, Hokken-Koelega A. Growth hormone therapy for children born small for gestational age: height gain is less dose dependent over the long termthan over the short term. Pediatrics. 2005;115:e458-e462. 37. FDA approves Humatrope for Short Stature. FDA Talk Paper. US Food and Drug Administration Web site. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01242.html. July 25, 2003. Accessibility verified September 21, 2005. 38. Wilson TA, Rose SR, Cohen P, et al. Update of guidelines for the use of growth hormone in children: the Lawson Wilkins pediatric endocrinology society drug andtherapeutics committee. J Pediatr. 2003;143:415-21. 39. Gharib H, Cook DM, Saenger PH, et al; American Association of Clinical Endocrinologists Growth Hormone Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use inadults and children—2003 update. Endocr Pract. 2003;9:65-76. 40. Tran D. FDA warning letter to Genentech Inc concerning promotional materials for Neutropin. US Department of Health and Human Services Web site. Available at: http://www.fda.gov/cder/warn/2003/11522.pdf. August 25, 2003. Accessibility verified September 21, 2005. 41. Pugeat M. Advances in growth hormone therapy: a new registry tool. HormRes. 2004;62(suppl 4):2-7. 42. Aimaretti G, Corneli G, Rovere S, et al. Insulin-like growth factor I levels and the diagnosis of adult growth hormone deficiency. Horm Res. 2004;62(suppl 1):26-33. 43. Chappell MA. FDA Warning letter addressed to Tony Stires, Global Internet Alliance. US Food and Drug Administration Web site. Available at: http://www.FDA.gov/foi/warning_letters/g4543d.htm. February 18, 2004. Accessibility verified September 21, 2005. 44. Costello G. FDA warning letter addressed to Alan Blair and Affordable HGH.com. US Department of Health and Human Services Web site. Available at: http://www.fda.gov/foi/warning_letters/g3461d.htm. July 30, 2002. Accessibility verified September 22, 2005. 45. Dietary Supplement Health and Education Act of 1994, Pub L No. 103-417, 103rd Congress (USC, Title 21 [Food and Drugs], Chapter 9 [Federal Food, Drug and Cosmetic Act], Subchapter II [definitions], §321). US Food and Drug AdministrationWeb site. Available at: http://www.fda.gov/opacom/laws/dshea.html. 2005. Accessibility verified September 27, 2005. 46. Title 21-Foods and Drugs, Chapter 9-Federal Food, Drug, and Cosmetic Act, Subchapter V-Drugs and Devices, Part A, Section 353, Exemptions and consideration for certain drugs, devices, and biological products. United States Code Web site. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:21USC353. 1998. Accessibility verified September 22, 2005. 47. Federal Trade Commission vs Creaghan A. Harry, Individually and Doing BusinessAs Hitech Marketing, Scientific Life Nutrition and Rejuvenation Health Corp.United States District Court for the Northern District of Illinois Eastern Division Website. Case 04C 790. Available at: http://www.ftc.gov/os/caselist/0423085
/040729memo0423085.pdf. July 28, 2004. Accessibility verified September 22, 2005.
48. Misbranded dietary supplements destroyed. FDA News. US Food and Drug Administration Web site. Available at: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00898.html. April 30, 2003. Accessibility verified September 22, 2005.49. Yang D. Utah company pleads guilty in illegal sale of human growth hormone.
US Department of Justice Public Affairs Web site. Available at: http://www.usdoj.gov/usao/cac/text_only/pr2003/137a.html. October 3, 2003. Accessibility verified September 22, 2005. .
50. Statement of William K. Hubbard, Associate Commissioner For Policy And Planning,US Food and Drug Administration before Committee on the Judiciary, United States Senate. US Food and Drug Administration Web site. Available at: http://www.fda.gov/ola/2004/importeddrugs0714.html. July 14, 2004. Accessibility
verified September 22, 2005.
51. Wanted List FBI, Steven Moos, MD. US Federal Bureau of Investigation Web site. Available at:http://www.fbi.gov/mostwant/fugitive/apr2005/aprmoos htm. April 2005. Accessibility verified September 22, 2005. 52. FTC targets bogus anti-aging claims for pills and sprays promising human growth hormone benefits. Settlement provides up to $20 million in consumer redress. (FTC File No. 032-3247, Civil Action No. 3:05CV170-RV-MD). For the Consumer. Federal Trade Commission Web site. Available at: http://www.ftc.gov/opa/2005/06/greatamerican.htm. June 9, 2005. Accessibility verified September 26, 2005. 53. Serono issues notification of counterfeit serostim. FDA press release. US Food and Drug Administration Web site. Available at: http://www.fda.gov/oc/po/firmrecalls/serono05_02.html. May 16, 2002. Accessibility verified September 22,2005. 54. FDA and the U.S. Attorney for the Western District of Texas announce guilty plea in drug counterfeiting case. FDA News. US Food and Drug Administration Web site. Available at: http://www.fda.gov/bbs/topics/news/2004/NEW01036.html. March 17, 2004. Accessibility verified September 22, 2005. 55. Statement of John M. Taylor III, Associate Commissioner for Regulatory Affairs before Permanent Subcommittee on Investigations, Committee on Governmental Affairs. US Food and Drug Administration Web site. Available at: http://www.fda.gov/ola/2004/importeddrugs0722.html. July 22, 2004. Accessibility
verified September 22, 2005.
All content on this website is opinion. No reference is made to, nor is there any intent to make any reference to any specific entity or individual as a quack or participating in quackery. Any such inference is incidental and not the objective or intent. Any newspaper articles or other media published here is the opinion of the author of the piece being reproduced here, not the producer of this website.
Do not rely on this website for your only medical advice. Before making decisions that impact upon your health, you should consult your health care provider.
