Dr. Richard A. Rydze, a former team physician for the Pittsburgh Steelers, was questioned as part of an Albany steroids investigation that broke open in 2007. Rydze has been indicted on federal charges of conspiracy to distribute steroids and human growth hormone.
Two men accused of conspiring to distribute performance-enhancing drugs with prominent Downtown doctor Richard A. Rydze appeared in court Thursday. James Hatzimbes, 42, who ran the Pleasant Hills-based HSE Salon and Wellness Center, was arraigned before U.S. Magistrate Judge Maureen Kelly and pleaded not guilty to conspiracy to distribute anabolic steroids and human growth hormone. William Zipf, 57, formerly of Pittsburgh but now housed in a federal prison in Morgantown, made his initial appearance before Judge Kelly. He faces charges of conspiracy and health care fraud. Judge Kelly told him he could face as much as 20 years in prison for the conspiracy count, and 10 years for the multiple fraud counts. He will be arraigned on Tuesday. Dr. Rydze, who served as one of the Steelers' physicians for two decades until a separation in 2007, is the central figure in the 185-count indictment handed down last month and naming the three men. Two other men pleaded guilty last week in related cases. William M. Sadowski, 46, of McKees Rocks, and John F. Gavin, 51, of Valencia, formerly of Robinson-based ANEWrx, are set to be sentenced Feb. 26 for conspiring to improperly sell steroids and other drugs.
[James Arthur Ray, a self-help "guru", led an Arizona sweat lodge ceremony in October 2009 where three people died and a large number required hospitalization. The following is a posting from the website Science-Based Medicine, where the author David J. Kroll comments on Ray as a patient of John Crisler, a doctor of osteopathy, who runs a clinic called "All Things Male", in Lansing Michigan. Drugs prescribed by Crisler included: Testosterone, HCG, HGH, Arimidex and Finasteride. Kroll, a pharmacist, provides the following assessment...]
Dr. Crisler operates the website, allthingsmale.com, and offers in-clinic and online consultations. The frontpage of his site argues strongly that he is in the business of anti-aging therapies as shown lecturing to the American Academy of Anti-Aging Medicine and offering subscriptions to Life Extension Magazine. Further exploration of his website reveals that he specializes further in assessment of low testosterone levels, or hypogonadism.
Testosterone cypionate, hGH, hCG, Arimidex (anastrozole) and finasteride (sold previously as Propecia or Proscar, but now available generically). OK, that’s starting to make sense. Testosterone and human growth hormone (hGH) are anabolic agents. That is, they enhance the development of lean, skeletal muscle mass. But you might have some questions at first glance.
(For pharmacology students and professors, dissecting the endocrine pharmacology of this combination would make a great comprehensive qualifying examination question for graduate candidacy.)
Arimidex/anastrozole? Isn’t that used to treat estrogen-dependent breast cancer?
Finasteride? Isn’t that used to treat prostate cancer?
Let’s take a closer look at some of these drugs.
Testosterone cypionate is known as a “depot” form of testosterone that has a half-life of 5-8 days, sold as DEPO®-Testosterone in the US. Testosterone, the steroid hormone primarily responsible for secondary sex characteristics in men, is not active when taken orally because it is rapidly metabolized by the liver. Therefore, if one wishes to boost testosterone, it is commonly formulated into a gel or patch that slowly releases the hormone across the skin. But it is more effectively delivered by injection, usually into muscle. When combined with a fat-soluble compound like cypionic acid, the testosterone is slowly released from the injection site. According to a PowerPoint presentation available at Dr. Crisler’s website (here, 4.5MB), his regimen employs weekly injections of 100 mg testosterone cypionate, about double the manufacturer’s recommendation for treating clinical hypogonadism.
When I was interviewed by Dan Harris for ABC World News Sunday last weekend, we discussed in footage that did not appear whether testosterone qualified as an “anabolic steroid.” The public normally thinks of ultrapotent, clandestine compounds as being the anabolic steroids used by athletes. But in purely pharmacological terms, testosterone is a steroid based on its chemical structure and it has anabolic, or tissue-building, activity. However, testosterone is an anabolic steroid that we make naturally, men and women.
Hence, testosterone is an endogenous anabolic steroid. When injected as testosterone cypionate, this would be called the exogenous supplementation of an endogenous steroid. But true bodybuilders wouldn’t bother with something like testosterone when more potent and effective synthetic anabolic steroids are available on the clandestine market.
Arimidex (anastrozole) is classified as an “aromatase inhibitor.” You may not know that testosterone is the starting material for estradiol, the steroid hormone primarily responsible for secondary sex characteristics in women. Testosterone, which we all make from cholesterol as the starting material, is converted to estrogen by aromatase or CYP19, an enzyme that is highly abundant in the ovaries. When a woman is diagnosed with a form of breast cancer that required estrogen to grow, aromatase inhibitors are given to prevent the ovaries from making more estrogen from testosterone (Older drugs such as tamoxifen can also be given as they directly block the effects of estrogen on breast cancer cells themselves.)
We do not know if Mr. Ray was among the approximately 1% of breast cancers that occur in men. Former drummer of the rock band KISS, Peter Criss, is the most recently public of male breast cancer patients in the US.
However, it does not appear that Dr. Crisler is a board-certified oncologist, so there must be some other reason that he prescribed Arimidex to Mr. Ray. Men have some testosterone that gets converted to estrogen but usually it’s not enough to cause estrogenic side effects such as gynecomastia and testicular shrinkage. But when taking supplemental, supraphysiological doses of testosterone, the small amount of aromatase that men have will convert enough of it to estradiol such that they may experience some feminizing effects.
Interestingly, Dr. Crisler notes on slide #66 of his aforementioned PowerPoint presentation that anastrozole’s #1 use worldwide is in testosterone replacement therapy regimens. Unfortunately, a citation is not available to support that statement.
Finasteride prevents conversion by 5-alpha-reductase of testosterone to dihydrotestosterone or DHT, a form of the hormone that can cause benign prostatic hypertrophy, can promote prostate cancer, and is also partly responsible for hair loss. Hence, finasteride combats several side effects of testosterone supplementation. So, these testosterone injections can be combined with anastrozole and finasteride to maximize testosterone’s anabolic effect while minimizing “unsightly” side effects.
Human growth hormone (hGH) is a peptide normally produced in the pituitary gland that is also anabolic on its own and augments the muscle-building effects of testosterone. [Tom Perls: If there is augmentation, it is not significant according to studies cited elsewhere on hghwatch.com]
Human chorionic gonadotropin or hCG is normally the hormone produced by the placenta during pregnancy and is the hormone detected in the urine by home and clinical pregnancy tests. Yes, men taking this hormone would give a positive pregnancy test.
Understanding why hCG might be given in this cocktail requires that we revisit the hypothalamic-pituitary-gonadal axis (HPGA). Gonadotropin-releasing hormone, or GnRH, is produced in the hypothalamus of the brain and signals that pituitary gland to synthesize and release several peptide hormones that each share a common subunit: LH, FSH, TSH, and hCG. LH, or luteinizing hormone, when released from the pituitary gland and causes the testes to create mature spermatozoa and release testosterone. However, when too much testosterone is produced, or too much is available from external injection, a negative feedback loop suppresses LH secretion. Suppression of LH over time will cause testicular atrophy. It is thought that providing hCG will provide more of the subunit shared with LH, restoring LH levels. I am not convinced that this actually occurs. Restoring LH also is purported to increase the conversion of cholesterol to pregnenolone, a precursor or building block of testosterone. Believe it or not, this is an oversimplification of the pathway but I hope that gives you an idea of the rationale behind hCG use.
There were also some other drugs found in Ray’s room at the lodge prescribed by other physicians that included Diovan (valsartan), an antihypertensive of that competitively binds receptors for an endogenous vasocontrictor, angiotensin II, and an injectable relative of vitamin B12 called methylcobalamin. Although we don’t know for certain if Ray was taking the drugs prescribed by Dr. Crisler, investigators did at least find anastrozole and Genotropin brand of hGH, Propecia brand of finasteride, together with pregnenolone, the testosterone precursor. Also found were bags, suitcases, and pill boxes of energy supplements and amino acids. The complete litany of objects confiscated from his possession are detailed at the Prescott Newswebsite.
As mentioned at the outset, one of the biggest reasons investigators were interested in any drugs that might have been in Ray’s possession was that there may have been psychoactive substances that could have impaired his judgment or that of followers/clients in the sweat lodge at the retreat. Ray was reported by several eyewitnesses as being aggressive and aloof, and even unhelpful when medics arrived at the sweat lodge. Dan Harris at ABC News asked me if I thought that Ray’s pharmacopeia might have contributed to his state of mind.
This is very difficult to do for a plethora of reasons, not the least of which because I am not a physician nor am I privy to what drugs he was actually taking or his basal personality characteristics. However, I am a pharmacologist and did train in endocrinology during my postdoctoral fellowship and can make some general comments.
A person taking an anabolic steroid regimen (recall that testosterone is a natural anabolic steroid) is prone to mood swings, anxiety, and aggressive behavior. In “TRT: A Recipe For Success,” a Word document available at All Things Male, Dr. Crisler apparently makes note that the intent is not to create an anabolic steroid cycle but rather testosterone replacement therapy, where testosterone levels are targeted to the upper-level of a normal range. Unfortunately, we cannot be sure if Mr. Ray was taking the drugs as directed or at doses greater than those recommended.
A physician colleague also reminded me that some of the drugs on the search warrant could alone cause electrolyte disturbances that could be exacerbated by being in an enclosed area with hot stones where other people were vomiting and begging to get out after fasting for 36 hours. Specifically, testosterone can cause sodium retention and Diovan/valsartan can cause potassium retention. These ionic imbalances can certainly influence one’s state of mind and one can speculate that these imbalances would be made worse by fasting and dehydration.
Off-label drug prescribing This case also raises some questions as to how these drugs were prescribed in the first place. Sources close to Ray told ABC News that the “practical mystic” was being treated for a hormonal imbalance.
It is peculiar why a man of Ray’s means living in Carlsbad, CA, would be prescribed drugs by a physician in Michigan rather than seeing a board-certified endocrinologist or urologist at one of the outstanding medical centers in southern California.
Nevertheless, there are no laws that would have prevented Dr. Crisler from prescribing this regimen to Mr. Ray. To the contrary, physicians in the United States, whether they are MDs or DOs, are granted the latitude to prescribe any FDA-approved medicine for any indication they see fit. While it is illegal for drug companies themselves to promote “off-label” uses of drugs (i.e., indications for which the company has not received explicit FDA approval), a physician can legally prescribe a breast cancer drug to a man wishing to build lean muscle mass. I will leave it to my physician colleagues to comment on whether this falls under the standards of medical practice. In fact, the ethics of off-label prescribing would be an excellent separate issue to discuss in another post. [Tom Perls: Actually I disagree here. Most states do not allow the prescribing of anabolic steroids for muscle building and federal law cleaerly allows discribution of HGH only for uses allowed by the Secretary of HHS (FDA).]
But let us not forget that this is a very sad case where three people lost their lives and nearly two dozen people were hospitalized. Press accounts of the sweat lodge incident and subsequent investigation suggest that blame and potential criminal penalties will fall where they may. The Camp Verde Journalnoted in its 2009 roundup that:
Lawsuits have been filed by survivors, victims’ families and the Black Hills Sioux Nation, alleging Ray “committed fraud by impersonating an Indian,” thus violating the 1868 Treaty of Fort Laramie.
What we have offered here is a perspective on the pharmacology and toxicology of prescription hormone products and considerations of issues raised in publicly available documents and questions posed of us by the press. It is likely that several factors conspired to end up with this loss of life. As always, tragic events are what drive changes in laws and regulations.
Mike Fish/ESPN.comDr. Richard Rydze's long tenure on the Steelers' medical staff ended abruptly in 2007.
PITTSBURGH -- At 6:45 on a Friday morning in October, Dr. Richard Rydze is perched behind the cluttered desk in his second-floor corner office, surrounded by autographed Pittsburgh Steelers footballs and photos. Just over his shoulder, a window provides a view of the Monongahela River and, just beyond it, Heinz Field, home to the Steelers.
Rydze wears a thick Super Bowl XL ring on his right hand, a reward for his work during the Steelers' 2006 championship season. A nurse scurries about the expansive, awakening office in a white scrub top dotted with Steelers logos. A receptionist shows up wearing a black-and-gold Steelers jacket.
Clearly, this is a Steelers town, and Rydze is a Steelers guy. For 22 seasons, longer than the tenure of Franco Harris, Terry Bradshaw or any of the other Steelers icons, Rydze, 58, paced the Pittsburgh sideline as part of the medical team. Then suddenly, in the summer of 2007, like a free-agent rookie signed as training camp fodder, the bespectacled internal medicine specialist quietly parted ways with the Steelers.
The details are sketchy, but his split with the team came approximately four months after news reports identified him as the buyer of a substantial quantity of human growth hormone (HGH) from a Florida pharmacy during several months in 2006. HGH, a performance enhancer banned by the NFL and other major sports leagues, is the supplement of choice for some athletes because it can't be detected by current testing.
Rydze has not been charged with violating any laws. But in February 2007, two law enforcement officials dropped by his former downtown practice in the Heinz 57 Center office building to question him about the use of a credit card to buy about $150,000 worth of HGH and testosterone -- with a retail value approaching $1 million -- from Signature Pharmacy. That Orlando, Fla., compounding facility had been raided days earlier as part of a multiagency investigation into the online sale of steroids and other performance-enhancing drugs.
The doctor didn't turn over his records, but the investigators said he told them he was dispensing the HGH to elderly patients referred to him for help in healing tendon and ligament injuries. According to the two officials who questioned him that day, Rydze said he treated the patients early in the morning before his normal office hours at a University of Pittsburgh Medical Center (UPMC) facility.
Mike Fish for ESPN.comRydze placed his online orders here at Signature Pharmacy in Orlando.
"Because I was associated with the Steelers, the assumption was that I was giving everyone on the Steelers growth hormone or steroids," Rydze told ESPN.com in his first in-depth interview on the subject. "You say a team doctor for the Pittsburgh Steelers, and you are saying he is buying growth hormone from a pharmacy in Florida -- what the hell else are you going to think?
"That whole thing got way overblown. I was doing some kind of little bit of research back then and using growth hormone to help heal people with tendon injuries. That seems to be, in my estimation in looking at that hormone, the only role it really plays in helping people. It does seem to make you heal better, quicker. So we were using it with various orthopedic patients.
"It was never done in athletes. It was never with any Steelers."
But when news of Rydze's connection to the Signature Pharmacy story spread, it surprised many of his former colleagues and friends. Some assumed his involvement with HGH led to his split with the Steelers.
An NFL official said that although the league was concerned by the doctor's link to HGH, it allowed the Steelers to deal in-house with the issue. No one will say whether Rydze was forced out, but he is gone.
"I didn't know about any of [Rydze's patients being treated with HGH], and I was surprised to learn of it," said Dr. Julian Bailes, a neurosurgical consultant to the Steelers from 1988 to 1997 who is now chair of the department of neurosurgery at West Virginia University's School of Medicine. "And sorry that it happened, of course.
"I never saw it. I never would have suspected it when I was there. He is kind of a quiet, somewhat introverted person that we respected for his medical skills."
Pittsburgh's Past
Even before the controversy surfaced involving Dr. Richard Rydze and human growth hormone, the Pittsburgh Steelers had a history of associations with performance-enhancing drugs. For Mike Fish's chronicle of that past and what former Steelers' lineman Steve Courson called "the conspiracy of silence" concerning steroids and the NFL, click here.
Fish will discuss his stories about Rydze and the Steelers on "Outside the Lines" on ESPN on Friday, Jan. 15, at 3 p.m. ET.
UPMC's marketing deal with the Steelers calls for its doctors to serve on the team's medical staff -- the team also trains at a complex built by UPMC -- but four months after the investigators showed up in his office waiting room, he resigned from UPMC with little fanfare, Rydze said. A UPMC news release dated June 18, 2007 said, "Dr. Rydze has submitted his resignation from UPMC, effective Sept. 1, 2007."
Steelers president Art Rooney II, through a team spokesperson, declined comment for this story.
A UPMC representative said a confidential internal review found no wrongdoing in relation to Rydze's patient care.
And Leslie Amoros, a spokesperson for the Pennsylvania Department of State, which oversees the State Board of Medicine, said Rydze remains a licensee in good standing. When asked whether Rydze's connection to the online pharmacy purchases was reviewed, Amoros said, "At this point, we cannot confirm or deny the existence of any investigation."
Still, the longtime Steelers physician might have been skirting the law by injecting growth hormone to treat tendon and ligament injuries. That is the opinion of multiple medical and legal experts contacted by ESPN.com, as well as the investigators who discovered Rydze's HGH purchases from Signature Pharmacy.
That belief is supported by the Food and Drug Administration.
AP Photo/Edouard H.R. GluckDr. Julian Bailes, who worked with Rydze on the Steelers' medical staff, was surprised to learn Rydze was treating patients with HGH.
After consulting with legal counsel, FDA spokesman Chris Kelly issued a statement to ESPN.com, saying, "FDA has not approved any New Drug Application for a drug containing HGH for use in treating ligament/tendon injuries. If an FDA-approved drug containing HGH is being used for this purpose, it would fall within the prohibition described at 21 U.S.C. 333[e]."
That federal statute spells out that the distribution of HGH is legal only for the following conditions: short bowel syndrome, muscle-wasting disease associated with AIDS, adult growth hormone deficiency due to rare pituitary tumors and short stature in children. An FDA alert dated Jan. 23, 2007 further describes uses for which HGH can be legally prescribed, including "long-term treatment of growth failure due to lack of exogenous GH secretion."
None of those appears to apply to the patients Rydze was treating with HGH.
"The short answer is HGH is the only drug that cannot be lawfully distributed or prescribed for off-label uses," said bioethicist Maxwell J. Mehlman, director of the Law-Medicine Center at Case Western Reserve University. "If the doctor's argument were correct, then it basically creates a loophole that eliminates this unique status. It just wipes out that peculiar provision in the law, because off-label use almost by definition is informal research in the sense you are giving it to a patient, and it has not been approved for that."
Rydze's explanation for his use of HGH -- to treat tendon and ligament injuries -- raises eyebrows with those policing drug usage in the sports world, too.
“
I know [HGH] has caused me a lot of grief, simply because I believe in it and I know what it does.
” --Dr. Richard Rydze
"The off-label use is illegal," said Travis Tygart, chief executive of the U.S. Anti-Doping Agency. "It doesn't happen. Using [HGH] for tendon repair, he has admitted to a crime."
Indeed, experts make the point that pro athletes would be lined up outside league offices seeking therapeutic exemptions to use the banned drug after everything from Tommy John elbow surgery to an ACL knee operation if HGH could be injected legally to hasten recovery from tendon and ligament injuries.
But that isn't the case. NFL spokesman Greg Aiello said the league has never granted a therapeutic use exemption for HGH, including for healing purposes.
Nor has Major League Baseball been inclined to hand out exemptions.
"There are very limited purposes for which growth hormone can be legally prescribed," said Rob Manfred, MLB's executive vice president of labor relations and human resources. "I mean, you have got to be a dwarf or have wasting disease. … We don't have a lot of people with AIDS or who have dwarfism in our game."
Synthetic growth hormone originally came on the medical scene for the treatment of dwarfism in children. According to medical experts, excessive use of HGH is thought to cause the enlargement of organs, especially the heart, which can be dangerous and sometimes fatal. It also has been linked to diabetes, muscle and joint pain and hypertension, and some researchers believe it can accelerate cancer.
Rydze, though, said the danger of low-dosage growth hormone therapy is vastly overstated, and that HGH is wrongly associated with steroids. And although he acknowledged the sports community likely won't permit its use any time soon, he said athletes should be allowed access to HGH to heal injuries.
"I know it has caused me a lot of grief, simply because I believe in it and I know what it does," Rydze said. "And to deny people the effect to heal better -- that is the art of medicine, to make people heal. And using something off-label, which we use for many, many drugs … I don't see how someone can single out one thing and say you can't use it for off-label use. And you show me there is one side effect, and I'd be a believer. But I have never seen a side effect. And I just think it is just ignorance of people who don't know. They just hear about it, and they assume it is bad."
Rydze isn't alone among doctors in his liberal off-label approach to HGH, which has become increasingly controversial because of growing usage by practitioners of anti-aging medicine. Other advocates note its value as a healing agent. Even a medical consultant to pro sports leagues who asked not to be identified said he believes that in time, after emotions settle and adequate research is done, HGH could play a larger role in mainstream medicine because of its apparent ability to accelerate healing.
Off-label use for many drugs -- in other words, prescribing a drug for a purpose that differs from the one for which the product is approved -- is a widely accepted practice. Under current law, though, the FDA spells out the unique status of human growth hormone. In an e-mail to ESPN.com, another FDA spokeswoman, Susan Cruzan, wrote, "Human growth hormone is the only drug for which Congress has expressly prohibited the off-label distribution or possession with intent to distribute, making such distribution a crime under 21 USC 333."
Rydze described his research as "kind of a project of mine" to determine the healing effects of HGH, acknowledging he did not seek an FDA exemption. Nor, he said, has he compiled any research data yet.
AP Photos/Susan WalshUSADA's Travis Tygart says Rydze's use of HGH for tendon and ligament treatments is illegal.
Rydze told ESPN.com that during a five-year period, he injected about 200 patients with growth hormone. A significant number were referrals, mostly from orthopedists, he said.
Among the details Rydze provided to ESPN.com about his practice is the fact that four highly respected physicians currently serving on medical staffs of professional franchises in multiple leagues -- including the NFL, where the drug is banned -- wrote referrals to him for HGH therapy. Two of those doctors are also on staff at well-known sports orthopedic clinics recognized for treating millionaire athletes and celebrities.
Rydze indicated that none of the patients receiving HGH was a Steeler, or a professional team athlete.
But ESPN.com found that in an apparent conflict with NCAA doping rules, an orthopedist referred an injured soccer player at a top collegiate program to Rydze for separate rounds of growth hormone therapy -- including during the weeks just prior to the start of a season.
Rydze initially said the athlete didn't compete after receiving the treatment, but later said he couldn't recall details.
According to Mary Wilfert, staff liaison to the NCAA's Committee on Competitive Safeguards and Medical Aspects of Sports, the governing body issues "about five or seven or maybe even 10" medical exceptions each year for athletes to use growth hormone or testosterone. Wilfert declined to say whether the use of HGH has ever been allowed to aid in healing injuries, adding, "We don't have published lists of what would qualify for an exception."
Rydze indicated one NFL team orthopedist referred at least 25 patients -- none of whom was an active professional athlete -- to him for growth hormone therapy. In one instance, Rydze wrote a note that a patient was referred "to begin him on growth hormone therapy in order to expedite the healing and strengthening of his shoulder girdle prior to his return to work as a police officer."
One patient is the father of a current NFL player.
“
If information came forward about a team doctor prescribing to his other non-NFL patients those types of substances, it would raise concerns and questions.
” -- NFL spokesman Greg Aiello
Several others, according to Rydze, had lesser ties to the sports world: a marathoner suffering chronic hamstring injuries and another with Achilles tendinitis, a personal trainer with chronic hamstring woes, a former karate champion with bum elbows and knees and a Frisbee golf player coming off surgery.
An attorney received injections to relieve knee pain and, according to Rydze, wrote a letter to him before another round of treatments in March in which he said he hoped the "stupid publicity" wouldn't stop the doctor from prescribing HGH.
Rydze also indicated at least five other doctors, as well as the wife of a sixth, received growth hormone therapy from him.
"The orthopedic people sending people to me obviously believe it works, 'cause they see it work," Rydze said. "And if I can help people, then I am going to help them."
Aiello, the NFL spokesman, said clubs have been "advised" that team doctors should not use illegal steroids or growth hormone, particularly with an active player or his family.
"If information came forward about a team doctor prescribing to his other non-NFL patients those types of substances, it would raise concerns and questions," Aiello said. "And we would deal with it on a case-by-case basis, in this case as the Steelers did."
As Rydze spoke to ESPN.com in his Pittsburgh office, wearing a black knit shirt and casual slacks, he didn't appear to be flustered by inquiries about his practice. In a soft, calm tone, he denied any impropriety in his prescribing of HGH, noting he used it with patients deficient in growth hormone, which he believes is linked to slow healing.
However, Dr. Thomas Perls, a specialist on aging who has written articles on the subject for the American Medical Association, said that measuring insulinlike growth factor-1 (IGF-1) levels, as Rydze does, is not an adequate test in the proper diagnosis of adult growth hormone deficiency. (Growth hormone stimulates the liver and other tissue to secrete the hormone IGF-1, which in turn leads to bone growth and plays a key role in muscle and organ growth.)
Mike Fish for ESPN.comRydze told ESPN.com he injected about 200 patients with HGH in a five-year period.
"That is separate from asking the question, 'Could giving growth hormone help repair injuries faster?'" Perls told ESPN.com "That is a totally different thing from adult growth hormone deficiency syndrome, which is very rare and a failure of the pituitary gland to produce growth hormone when it needs to. And it requires a pathological diagnosis. You have to come up with what is wrong with the patient, with their pituitary gland. Usually, it is a cancer or treatment of the cancer . . . It is complicated. So much so that an endocrinologist should be doing this."
"There is off-label for everything," Rydze said, defending his use of HGH. "I mean, everything. Ninety percent of medicine is off-label. … We use seizure drugs for treating migraines. We use drugs all the time [for other uses]. I think this drug gets way overtalked about, way overplayed."
When told the FDA specifically prohibits the use of HGH for any unapproved purpose, Rydze said: "I'm not aware of that. It can't be used off-label? For what reason?"
Although Kelly, the FDA spokesman, told ESPN.com "it is not a legal practice" for a doctor to treat tendon or ligament injuries with HGH, enforcement for violations is rarely pursued unless a complaint is filed with the Drug Enforcement Agency or a state licensing board.
Marc Mukasey, a former assistant U.S. attorney, suggested prosecutors allocate their resources to go after traffickers of what are considered more dangerous drugs such as cocaine, heroin and, to a lesser extent, crystal methamphetamine, or ecstasy. Steroids prosecutions, with exceptions such as the BALCO case, are unusual. And human growth hormone is viewed by most law enforcement agencies as something less than an egregious societal problem.
"Why is nobody prosecuting it?" said Mukasey, the stepson of outgoing U.S. Attorney General Michael Mukasey. "Because there are too many guns and drugs and violent crime on the streets. That is the short answer."
Don Catlin, a respected chemist who ran America's first anti-doping lab in Los Angeles, said, "Nobody clamps down, so they just go ahead and do it. If somebody got a book thrown at them and had to pay a fee or spend some time in court, they'd stop. But there is really not much incentive. That is this whole thing with growth hormone: There are so many gimmicks out there on how to use it. Its name is enough to bring in a lot of people that want to get their growth better or feel better or last longer or whatever. It has been tried on everything under the sun."
Rydze said he has injected HGH into ailing knees and hips. He has used it to treat rotator cuff tears and tennis elbow, torn biceps and hamstrings, torn Achilles tendons. He has used it to stimulate knee cartilage production. He has injected it to try to help a patient avoid surgery, he said, as well as after surgery.
Initially, Rydze's name surfaced in connection with the investigation into wholesale purchases of HGH from Signature Pharmacy in Orlando, but ESPN.com has learned he also bought the drug from College Pharmacy in Colorado Springs between 2004 and 2007. The owner of that compounding pharmacy and one of its sales representatives have been indicted and are scheduled for trial in the spring. As in the Florida case, Rydze and others who purchased the drugs from College Pharmacy were not targeted.
An official close to the federal investigation of College Pharmacy said of Rydze, "He was one of the customers. … [He] showed up on the pharmacy client list." The official declined to address the number of purchases or the quantity of HGH Rydze made from College Pharmacy.
Investigators working the Signature Pharmacy case thought they'd found a major mover in the world of sports when Rydze's name first popped up in billing records. Here was a highly credentialed doctor, a team physician for an NFL franchise, purchasing bulk orders of growth hormone and testosterone from an online pharmacy under investigation. They didn't know to whom Rydze was giving the drugs. They knew from records only that the FedEx shipments from the pharmacy went to Rydze at his UPMC office: 339 Sixth Avenue, fifth floor.
AP Photo/Reed SaxonDr. Don H. Catlin, former director of the UCLA Olympic Analytical Laboratory, suggests HGH use is rising because authorities don't enforce the restrictions on it.
So in February 2007, the lead investigators -- Mark Haskins of New York State's Bureau of Narcotic Enforcement and Alex Wright of the Florida Metropolitan Bureau of Investigations -- drove about seven hours from a suburb north of New York City to interview Rydze in Pittsburgh. They told ESPN.com they probably didn't have jurisdiction to bring charges, but they said they wanted to hear his story. And they wanted to know whether athletes were linked to his purchases.
What they heard during their informal hour-long questioning didn't ease their suspicions. Rydze, they said, told them he used the HGH to treat tendon injuries and joint repair in older patients, including an unnamed ex-NFL player. They also said he spoke about the drug's possible value in the treatment of post-concussion syndrome, although Rydze told ESPN.com he didn't use it that way.
Both Haskins and Wright described Rydze as short on specifics. They said they still aren't sure who ultimately was given the HGH.
"Dr. Rydze provided no legitimate explanation for his prescribing of these drugs," Haskins told ESPN.com. "He couldn't come up with any patients, never mind the significant number he'd have to have shown to order the quantity of drugs that he did. And there were some questions as to his story. He was an employee of the University of Pittsburgh Medical Center, where they had a pharmacy. If this was legitimate, why then not use your own pharmacy?
"That is one of the things I questioned him on. I said, 'Doc, this is one of the biggest university medical centers on the East Coast, correct?' I said, 'Never mind the ones that are in the Pittsburgh area, but I am sure there are other pharmacists trained to compound, correct? So why then would you use a pharmacy in Florida and purchase drugs that you can't even verify are legit when you are at one of the most prestigious places in your state that could provide these things for you? And use your own credit card?' He could not provide an answer."
Falk Pharmacy, billed as the "flagship pharmacy of UPMC" on the health care provider's Web site, is located less than three miles from Rydze's old office. The facility stocks pre-prepared HGH from major labels such as Genotropin, according to pharmacist Marie McCon, who noted that other area pharmacies compound human growth hormone.
“
We did not receive one outside inquiry from anybody. Here we spent an hour with this guy. Nobody was concerned. The hospital never contacted us. Nobody cared what he said to us.
” -- Mark Haskins of New York State's Bureau of Narcotic Enforcement
Rydze told ESPN.com the price of the drugs was the reason he purchased from the Colorado and Florida compounding pharmacies rather than locally, saying, "I don't know how these pharmacies got their prices down so low."
Often, he said, HGH treatment is not covered by insurance, so his patients paid him directly.
Rydze said he learned about the online pharmaceutical vendors during conventions in Las Vegas of the American Academy of Anti-Aging Medicine (A4M). Rydze was an A4M member, as is Dr. Joseph Maroon, the Steelers' neurosurgeon and another UPMC physician. Maroon recently was appointed an A4M senior vice president. The Chicago-based A4M advocates the use of testosterone and human growth hormone as levels decline with age.
Steelers spokesman Dave Lockett indicated the team has no issue with its doctors' affiliations with A4M.
"Really, there are a lot of people who are members of that organization," Lockett said. "We do not have any concerns about Dr. Maroon."
When Rydze was asked whether he'd entertained concerns about the pharmacies from which he was ordering, he said, "No, I guess I was naive about it. They seemed like legit people. And they were advertising in the A4M magazine. I never heard anyone say a bad word about them until this all came down."
Haskins said neither New York nor Florida authorities are pursuing a further investigation of Rydze, but he acknowledged he spoke briefly about Rydze with NFL security chief Milt Aldrich after the Pittsburgh meeting. Aiello, the NFL spokesperson, confirmed Aldrich had spoken with investigators.
The two investigators said they are surprised that neither the Steelers nor UPMC followed up with them once Rydze's name was made public in connection with the investigation.
"We did not receive one outside inquiry from anybody," Haskins said. "Here we spent an hour with this guy. Nobody was concerned. The hospital never contacted us. Nobody cared what he said to us."
Rydze's new office is home to a private practice occupying the second floor of the Hartley-Rose Building, which is on the National Register of Historic Places. The entry on a narrow downtown cobblestone street leads to what once served as a factory and warehouse. The original red brick is exposed on the walls of the renovated office, and hardwood planks cover the high ceiling.
Rydze opened Optimal Health Center, LLC in September 2007. The scope of the practice ranges from corporate medicine/wellness and sports medicine to geriatrics and hormone therapy. Most days, he's in and at work by dawn, he said.
The waiting room is decorated with a pair of black-and-white photos of a young Rydze diving from a platform. In his youth, Rydze was an accomplished athlete. He won a silver medal in platform diving at the 1972 Munich Olympics, accomplishing the feat on the eve of the darkest day in Olympic history -- a Palestinian terrorist attack that left 11 members of the Israeli team dead.
He wears an Olympic ring on his left hand. He mentions he is one of only two people who have earned both an Olympic and Super Bowl ring, the other being the late Bob Hayes, who won Super Bowl VI as a wide receiver with the Dallas Cowboys and Olympic gold in the 100-meter dash and the 4x100-meter relay in 1964 in Tokyo.
Rydze's father was an international chairman for U.S. Diving. His brother, Bob, is the longtime diving coach at the University of Iowa and was the team leader for U.S. divers at this past summer's Olympic Games in Beijing.
Mike Fish/ESPN.comRydze's new office is in Pittsburgh's Hartley-Rose Building, which is on the National Register of Historic Places.
Rydze said he wasn't running from his association with the pharmacy investigation when he left UPMC and the Steelers, despite the perception. He claimed neither the team nor the NFL forced him out. Instead, he said the situation emboldened him to follow his goal of branching into private practice.
"They knew I wasn't doing stuff with the Steelers," he said of the team's management. "No, they never came to me and said, 'OK, you got to leave because of this matter.' But I had been looking at doing this [private practice] for five or six years now.
"I have a huge practice, and I can make better money doing it this way."
Rydze said there is nothing further to investigate. NFL and UPMC officials already have been to his office, he said, and "looked through every record and chart." But the bad press put a crimp in the number of referrals he was getting for HGH therapy, and that also factored into his decision to venture out on his own.
"I think it scared the orthopedic people away," he said. "They didn't want to send people anymore. So it was a dying science then. It impacted on me wanting to leave UPMC, because I wasn't free to do what I wanted to do. And I thought it was important research."
Rydze said he wasn't forced to leave UPMC, either, although his practice of growth hormone therapy apparently stirred debate within the largest medical provider in western Pennsylvania.
Asked whether UPMC officials knew HGH was being used in his practice there, Rydze said, "They had an issue that I was doing it on their grounds. I mean, it was kind of a complicated situation since I was doing it off-hours. I mean, they knew and they didn't know.
"I knew people in the UPMC program, in the higher authorities, who knew I was doing it. It was OK. And then there were other people who thought maybe I should be doing it on another site."
One of Rydze's longtime patients, former Steelers running back Merril Hoge, said he knew about the doctor's interest in HGH therapy; in fact, Rydze and Hoge discussed it as a possibility for his treatment in the years since he retired from the NFL. Hoge refers to Rydze as a "world-class doctor."
"The HGH stuff was for elderly people, for joint reproduction, stuff like that," said Hoge, who is now a pro football analyst for ESPN. "He never prescribed to a player. He never did it around me. … I'm passionate about training. He educated me on HGH. Talked about the benefits later in life.
"He talked about the aging process, recovery process, helping with allergies. My allergies are atrocious. I wanted to educate myself. I asked medical people about it. I asked Dr. Rydze. I never took any steps to take anything."
Hoge remains supportive of Rydze, saying the doctor has been miscast in and hurt by the controversy around the pharmacy investigation. So why, Hoge was asked, did Rydze leave the Steelers so willingly? Why didn't he put up a fight to save his association with the team?
"I don't think there was anything to fight," Hoge said. "He bought it. He didn't deny it. It's just how he used it."
And that's the issue. People are still left to wonder.
Mike Fish is an investigative reporter for ESPN.com. He can be reached at michaeljfish@gmail.com.
In our April issue, writer Pat Jordan took an interesting look at a group of doctors who are behind the longevity movement—those guys who pump their patients full of testosterone and human growth hormone and tell them they can live forever. One of the more colorful doctors in Dr. T to the Rescue was Alan Mintz, who ran the Cenegenics Medical Institute near Las Vegas. He was bombastic, overbearing and quite sure of himself, telling Jordan that “Cenegenics is more about aesthetics than longevity. We call it ‘age management.’ Our goal is the highest possible quality of life and sexual function, and then a quick death of a heart attack at 94. We don’t make outrageous claims about longevity.”
Good thing about that last line. Dr. Mintz died last week at the age of 64. We’ll let the irony speak for itself.
You've seen the ad. The old guy with the ripped bod. Wearing only jeans, he stands with one hip cocked and smiles affably into the camera.
Dr. Jeffry S. Life, who will turn 70 this year, promotes Cenegenics Medical Institute, which specializes in "age management medicine."
Life was at the Charleston Cenegenics office Tuesday to meet with some of his fellow chief medical officers from other regions.
Five Cenegenics locations are in the U.S. and plans are taking shape for international sites.
"There's no way of stopping aging, but we slow down the diseases of aging," said Life, who traded the easy, weight-room air of a man often inclined to remove his shirt for the demeanor of a professional physician.
The downtown office, in the tower above Saks Fifth Avenue, is crisp and modern. Frosted glass, sleek furniture and cork floor suggests Cenegenics is for people of a certain income.
Dr. Michale "Mickey" Barber, who opened the Charleston office five years ago, does not flinch at the term "concierge medicine."
"We are certainly a five-star service," Barber said. She has seen more than 100 percent growth in business in the last year.
For $2,995, patients receive a seven-hour health evaluation that includes bone-density testing and a full lab work-up of 90 different tests. Fitness, strength and cognitive function are also measured. No forms of insurance are accepted.
To get people in top form and keep them there, Cenegenics doctors prescribe exercise routines, vitamins and "hormone optimization" — the institute's most controversial practice.
After lifestyle options are exhausted, and based on lab results, doctors at Cenegenics may prescribe human growth hormone, or HGH.
The body naturally makes HGH to fuel growth during childhood and maintain organs throughout life, but about mid-life, the pituitary gland begins decreasing the amount it makes.
HGH can only be prescribed for adults who are deficient, according to the Food and Drug Administration.
Life was found to be deficient about five years ago, and his regimen includes supplementing the hormone, he said
About 12 percent of patients are prescribed HGH, Barber said. "We won't treat them (with HGH) if they're not deficient," she said.
Dr. Jerry Back, director for the Advanced Centers for Hypertension, Diabetes and Cholesterol Disorders, and affiliated with Trident Health System, said that there's not mainline literature to support the use of HGH for anti-aging purposes.
"There's very little literature to back it up," he said.
The chief of Geriatrics and Extended Care at the Ralph H. Johnson Veterans Affairs Medical Center, Dr. Don Courtney, said that about 1 in 10,000 children are deficient in HGH, but once you reach a certain age, there are no symptoms.
HGH will boost muscle size, he said, but not necessarily strength.
"Yes, it reverses some things, but it does not prevent fractures and falls," he said. Also, the effect can be a higher oxygen demand and more strain on the heart, Courtney said.
Life, in addition to his HGH therapy, lifts weights, practices tae kwon do, eats well and in five small portions a day, sleeps well, takes vitamins and avoids alcohol, he said.
Two Men Headed to Jail After Trying to Illegally Distribute HGH
Boca Raton personal trainer Patrick Bronder and Michael Manno, a former chiropractor living in Lodi, New Jersey were sentenced for their participation in a scheme to illegally distribute human growth hormone and other pharmaceuticals, and to commit tax evasion.
Yesterday, U.S. District Court Judge Donald M. Middlebrooks sentenced Bronder to 87 months imprisonment, 3 years of supervised release, and forfeiture of $325,913 in illegal proceeds. Judge Middlebrooks sentenced Manno to 38 months imprisonment, 3 years supervised release, a $10,000 fine and forfeiture of $128,533 in illegal proceeds.
As previously outlined in documents filed with the Court, from April 2001 through June 2002, Bronder purchased prescription drugs, including human growth hormone and drugs for the treatment of cancer, high cholesterol and other medical conditions from Manno. Manno purchased these drugs from individuals who acquired the drugs, directly and indirectly, from patients who had obtained the drugs through clinics in New York City through Medicaid.
During that same time period, Bronder and Manno sold the drugs to a pharmaceutical wholesaler located in Boca Raton for more than $6.8 million. At the same time, Bronder received additional compensation of $325,000 from the same pharmaceutical wholesaler for the sale of prescription drugs.
Bronder directed that more than $3.3 million of the money received from the pharmaceutical wholesaler be wired into bank accounts in the Bahamas established by him and another co-conspirator, Michael Sherman. Bronder caused most of that money to be repatriated into the United States through more than 3,000 withdrawals from automatic teller machines in southern Florida. Sherman has pleaded guilty to conspiracy to defraud the IRS by allowing Bronder to use his Bahamian accounts and is scheduled to be sentenced by Judge William J. Zloch on August 25, 2008.
Eventually, the prescription drugs that Bronder and Manno sold to the pharmaceutical wholesaler were acquired by pharmacies. The pharmacies dispensed the drugs to patients who were unaware that the drugs had been previously prescribed to other patients and sold on the streets of New York City.
Three men affiliated with a Florida anti-aging clinic at the heart of Major League Baseball's steroid scandal pleaded guilty Thursday to drug-related charges in Albany County (N.Y.) District Court.
Glen Stephanos, the co-owner of the Palm Beach Rejuvenation Center, pleaded guilty to one count of criminal sale of a controlled substance, a felony. Under the terms of his plea bargain, Stephanos faces five years' probation, must forfeit $350,000 and will testify against the remaining defendants arrested in Albany District Attorney David Soares' "Operation Which Doctor."
His brother, PBRC marketing director George Stephanos, and PBRC employee Ryan Dumas pleaded guilty to conspiracy, a misdemeanor. Both men agreed to pay a $1,000 fine and testify against other defendants.
According to the Mitchell Report on doping in baseball, the Palm Beach Rejuvenation Center supplied human growth hormone and steroids to several baseball players, including Cleveland Indians pitcher Paul Byrd, who bought nearly $25,000 worth of HGH in 13 transactions between August 2002 and January 2005.
The Muscle Men
Inside the "Rejuvenation Centers" at the heart of the nation's largest illegal steroid and HGH operation
Rick Ankiel was the best story in baseball in 2007. Then steroids-scandal reports linked him to a Palm Beach Gardens rejuvenation center and Signature Pharmacy.
c. stiles
The Palm Beach Rejuvenation Center in Palm Beach Gardens is still open for business and still advertising HGH on its website.
Grass doesn't get any greener than on major-league baseball's spring training fields. It's the annual dawn of each season, when vivacious young hopefuls play catch with millionaire all-stars. That was the scene on a February morning at Roger Dean Stadium in Jupiter, spring training home of the St. Louis Cardinals. Dozens of players who likely will never play an inning of a meaningful game in the big leagues struggled to impress assistant coaches in fielding drills and batting practice — perhaps their only chance to wear the famed Cardinal red. Fans relaxed in the spring air. Parents and grandparents ate hot dogs and sipped beer as children in ball caps clung to the chain-link fence, begging for fragments of broken bats or old balls, calling their heroes by name: "There's Troy Glaus!" "Hey, Pujols! Albert Pujols!"
When Pujols — the most popular Cardinal — was done taking batting practice, fans wanted to know where the second most popular player was. He was the best story in sports in 2007, the man people compared to Robert Redford's character in The Natural. Where was Rick Ankiel?
Still, there were enough sights and smells to satiate even the most curious children and autograph seekers. There was even a tiny St. Louis fan who played a resident of Munchkinland in The Wizard of Oz telling stories by the bleachers.
One year ago, this citadel of major-league baseball wasn't so serene. Investigators contend that South Florida is not just a popular spring training destination but also the epicenter of a nationwide network distributing illicit prescription steroids and human growth hormones.
Officers were assembling in a parking lot a few miles away in the commercial area of this wealthy retirement and golfing town. Federal agents brought a battering ram when they raided the quiet third-floor offices. They hauled out computers, file cabinets, bins of papers. The sign in front of the building said "Anti-aging clinic," but the name of the business was Palm Beach Rejuvenation Center. A line of employees — mostly muscular young men — exited the building while PBRC owners spoke with agents inside. Officers also carried out packages of stanozolol, a synthetic anabolic steroid; and cartridges of Genotropin, the brand name for synthetically produced human growth hormone.
The raids were a result of a joint investigation initiated by the Albany County District Attorney's Office in New York state. Deemed "Operation Which Doctor," it included the Drug Enforcement Administration, the Food and Drug Administration, the IRS, the Florida Department of Law Enforcement, and the New York State Bureau of Investigation. Albany D.A. David Soares was, at that very moment, at a simultaneous raid of Signature Pharmacy in Orlando. More agents were raiding Infinity Rejuvenation in Deerfield Beach and Oasis Longevity & Rejuvenation in Delray Beach, along with other "anti-aging clinics" in Texas and New York. The raids brought about more than a dozen arrests and seizures of truckloads of customer records.
Former Sen. George Mitchell (D-Maine) released a report to Bud Selig, commissioner of major-league baseball, last December detailing the illegal use of steroids and other performance-enhancing drugs by players. The Mitchell Report, which followed more than a year and a half of investigation and cost $60 million to produce, said rejuvenation centers like PBRC "troll the internet for customers, corrupt physicians who write prescriptions for patients they have not seen, and compounding pharmacies [which make drugs from raw ingredients] that fill these dubious prescriptions and deliver performance enhancing substances to end users by mail." The report describes allegations about Roger Clemens and the widespread steroid dealings of former New York Mets batboy Kirk Radomski but says, "As serious as Kirk Radomski's illegal distribution network was before it was shut down by federal agents, the threat to baseball posed by illegal sales of performance enhancing substances over the internet is greater."
District Attorney Soares' office claims these businesses were no more than boiler rooms or call centers set up to streamline illegal drug sales over the internet by connecting — through cyberspace only — crooked doctors with the most desperate players in the game. Star players like Clemens and Barry Bonds have personal trainers to procure their drugs (allegedly), but patrons of these rejuvenation centers are young athletes striving to make it onto a major-league roster or journeyman veterans willing to do anything to extend their careers another year. They're pro athletes, but most are far from household names: Paul Byrd, Jay Gibbons, Jose Guillen, Darren Holmes, Ismael Valdez, Steve Woodward, and Jupiter's own Rick Ankiel, all of whom, the report claims, purchased HGH and prescription drugs from South Florida rejuvenation centers.
At a time when the steroids issue so pervades sports and prescription drugs inundate our culture, many see an operation like this and shake their heads. Fans want to see men with bigger chests and arms hit baseballs harder and farther. They want to see towering pitchers well into their 40s burn fastballs past men half their age. Ticket prices are up. Attendance is up (except at Marlins games). Television revenues are up.
Athletes make personal sacrifices, but even if they don't get paid millions of dollars, they get to play a game for a living.
So desensitized are we to steroid talk and hearings that new news seems like old news. Many fans would rather not hear about the latest players linked to clinics or dirty clubhouse assistants. These fans wonder, "Who's the victim?"
The first time he got the package in the mail, he wasn't sure what to do with it. "There were a bunch of little bottles of liquid and syringes," he says. "Each stack had six or seven different things in it. Growth hormone, testosterone, muscle builder, stuff to balance it all out. It was more complicated than I expected."
He is a minor-league baseball player we'll call J. He is exactly the kind of client the rejuvenation centers were built for, according to investigators. He received drugs from Signature Pharmacy at least three times. His name appears on records seized from Signature during the raid but has not been disclosed publicly or, to his knowledge, to his team. Last month, at his apartment in Palm Beach County, he agreed to discuss his steroid use on the condition of anonymity.
J says he paid about $1,000 per stack. A "stack" is a combination of steroids and HGH that comes as a package. It's generally used for a one-month workout cycle. When his first stack arrived, he says, he called a number he had for Palm Beach Rejuvenation Center to figure out how to use it. "I didn't want to inject the wrong thing — this into that or in the wrong order or whatever, and have something bad happen." The conversation was awkward initially, but he got the information he needed.
Near the television in his apartment, J has a photo of himself and two friends posing in a weight room. He was a late-round draft pick out of high school only a few years ago. The signing bonus offered to him was less than $100,000, but it was enough for him to decide to forgo college (and scholarship eligibility) and move straight into rookie-league ball, the bottom of the minor leagues. He had mild success his first season but got hurt halfway through. He was injured again early into his second season.
"That's when I started thinking of ways to heal faster," J said. "By then, everyone was talking about how HGH can get you healthy and strong again fast."
He says he didn't want to risk bringing up the topic of buying the substances around the clubhouse — "too risky if someone doesn't like you or something," he says. Instead, he went to his computer to Google. He typed in H-G-H. There, near the top of the sites Google found, was a link to Palm Beach Rejuvenation Center. The site advertised more muscle mass, less fat, more strength, more stamina, more (and better) sex, and no unwanted side effects. J filled out a page saying he wanted more information about the uses of human growth hormone. He entered his phone number.
A representative from PBRC called him the next day, J says. "He talked a little about how safe it was and how it can fight off aging." He says he told the man he wanted to heal quickly and get stronger. "He said something about better sex, like trying to tell me that was the right thing to call it." J says he read his credit-card number over the phone. The representative told him he would need to have blood work sent in. He went to a doctor the next day and said he needed work done for a physical.
Within two weeks of his first visit to the website, J was opening up his first stack. He says he doesn't remember the name of the prescribing doctor on the label, but "I had never heard the guy's name before."
Each stack came with several vials of liquid and syringes. The liquids were synthetic human growth hormone protein and stanozolol, an anabolic steroid that sometimes goes by the brand name Winstrol, along with other testosterone boosters. The packages also came with two bottles of pills: clomiphene citrate, a female infertility drug steroid users employ to counteract estrogen buildup, and anastrozole, a breast-cancer drug that blocks water retention.
Doctors believe that the combination of HGH and steroids is so popular among athletes because HGH helps the muscles get bigger and the anabolic steroids then make the bigger muscles stronger. "Guys would sometimes talk about HGH being a last resort because it actually makes your body grow," J said. "It's not like a monster or anything or like the head-swelling stuff you hear about Barry Bonds. It's just noticing your glove is a little tight, so it's just time to buy a new glove."
Odd growth is just one of the side effects of HGH on FDA lists. Long-term dangers include nerve pain, elevated cholesterol and glucose levels, and an increased risk of cancer — growth hormone makes everything on the body grow, the logic goes, especially tumors. Side effects of steroid use can include testicular atrophy, back acne, and psychological instability.
Even if J had met with a physician, a better sex life is still not one of the FDA-approved reasons to prescribe HGH. In a 2004 import alert, the FDA detailed the dangers of HGH, specifically the unregulated raw HGH coming in illegally from China. This cheaper product is especially popular, the alert says, among compounding pharmacies. The FDA says the only acceptable conditions for which HGH should be prescribed are exceedingly rare: hormone deficiency in children that causes short stature, short stature associated with Turner's syndrome, adult deficiency due to rare pituitary tumors, and muscle wasting associated with HIV/AIDS. Not bad sex. Not bigger muscles. Not baseball injuries.
Albany prosecutors say the type of operation PBRC was running appeals to tech-savvy young athletes who might not even know the damage they're doing to their bodies.
J says he believed he was making an investment in his future. He says he was desperate to maintain his lifestyle. Even if it was a poor existence as a minor-leaguer, it was all he knew.
"I've never had a real job that wasn't playing ball," he said. "If I decide I'm done with this, I might as well start working on a boat somewhere or mowing lawns."
Before she was the first physician to plead guilty in the Albany investigation, Dr. Ana Maria Santi was a popular doctor. A native of Poland, Santi, who is 69, survived the Holocaust there. Her father resisted Hitler's soldiers, hiding guns in the girl's bed to escape detection during Nazi searches. From Poland, she moved to Argentina and attended medical school. From there, she moved to the United States, settling in Queens, New York, and working as an anesthesiologist.
In New York, her life began to spin out of control. In 1990, her medical license was suspended for one year and she was sent to rehab after she admitted practicing medicine under the influence of alcohol. In 1999, her license was permanently revoked for the same thing. Records show that witnesses saw her consume alcohol while working. After losing her license, she continued to work in a doctor's office, though not as a physician.
By 2005, records show that Santi, who has described herself in court as an alcoholic, had discovered a new source of income. Working out of her home and from local copy stores, Santi began signing prescriptions sent to her from Oasis Longevity & Rejuvenation Center in Delray Beach. Despite the fact that her license and DEA number had been revoked, prosecutors say Santi wrote more than $150,000 worth of prescriptions for Oasis between January 2005 and September 2006 without ever seeing a patient face to face. She was paid $25 per prescription.
Instead of signing her own name and using her defunct DEA number, Santi assumed the identity (and DEA number) of Dr. Abdul Almarashi, a former colleague. She signed prescriptions: "A. Almarashi." Santi was signing off on thousands of prescriptions being filled by both Signature and Applied Pharmacy, another compounding pharmacy under investigation in Alabama. She made $7,500 a week, authorities say. During that time Almarashi lived in a nursing home in San Diego.
Even after Applied was raided in 2006 and investigators confronted her with evidence of her crimes, Santi did not stop signing bogus prescriptions. When she was arraigned last year, the Times Union in Albany reported Santi was asleep in her jail jumpsuit, curled up on a bench in the courthouse.
Santi pleaded guilty to criminal diversion of prescription medications, a class D felony. When she was sentenced in January, she told Albany County Judge Stephen Herrick that she was sorry for everything she had done. He cited the audacity of her prescription approval even after being confronted by authorities. She was sentenced to three to six years in prison.
The investigation that snared Santi began four years earlier as a combination of happenstance and good detective work, says Albany County District Attorney spokeswoman Heather Orth. "New York State has one of the best prescription screening processes in the country. [New York's Bureau of Narcotic Enforcement investigators] started noticing a doctor, David Stephenson, signing off on way too many scripts, and most of them were for steroids." Stephenson ran a website selling narcotics and steroids out of his upstate New York home. "It became clear that the number of prescriptions he was signing was more than the number of patients he saw," Orth said, "and signing a prescription without a face-to-face meeting is illegal in New York."
In 2004, an investigator placed an order through Stephenson's website, www.docstat.com, requesting methadone, hydrocodone, Ritalin, and testosterone. The investigator said he was an overweight pilot addicted to alcohol and heroin and needed the prescriptions because "I want to get high to fly." The drugs arrived in the mail a few days later.
Stephenson pleaded guilty to criminal sale of a controlled substance, but prosecutors say they realized they had just pricked the surface of a network more complicated than the infield-fly rule. Stephenson was a small player in what investigators learned was an internet-based black market making steroids and human growth hormone available to everyone from wily geriatrics looking for better sex to teenaged athletes with credit cards who heard their favorite pros talking about the healing effects.
"It became clear that there was a network — doctors, so-called rejuvenation clinics, pharmacies — and they were making controlled substances available illegally; that's what it all boils down to," Orth said. "Doctors have made a conscious effort to part ways with their oaths."
Mark Haskins, a senior investigator with the New York Bureau of Narcotic Enforcement, wanted to know more about where the prescriptions were coming from. In 2006, he went undercover in cyberspace. When informed of the operation, the Florida Department of Health provided Haskins a medical license and drug-prescribing number. Haskins created a bogus résumé full of degrees and fished it out over the internet. He created a website and company name — NuLife HRT, which he said was based in Albany. He used the address of a county office building.
Soon, he had a bite with Oasis Longevity. In court documents, Haskins says he negotiated a price of $50 per prescription, twice what Santi was getting. Offers from other clinics were being faxed to the number Haskins provided, which led to the prosecutor's office. Then Oasis began mailing him prewritten prescriptions they expected him to sign, all of them for steroids.
The investigation also netted other doctors. One was a dentist in Florida whose license had been revoked for incompetence. Another was Dr. Claire Godfrey, an obstetrician and former beauty queen from Florida in her mid-30s. Godfrey pleaded guilty to the same felony charge as Santi and was sentenced to five years of probation. She was involved with Infinity Rejuvenation in Deerfield Beach, and her name appeared on about $1.3 million worth of prescriptions in the six months before her arrest, most of which were filled by Signature. Prosecutors say Godfrey was recorded during surveillance of Signature asking if she would be paid all the money owed to her. She was concerned some scripts may have been stamped with her name without her knowing — and she wanted to make sure she would be paid for all of them. In the two years before her arrest, Godfrey was paid more than $200,000 for her prescription signing.
Dr. Robert Carlson of Sarasota had a successful practice before prosecutors say he got involved with Signature. A heart surgeon, Carlson was featured on local news shows because of his cutting-edge surgical techniques. An Eagle Scout, Carlson is an incredibly young-looking 51. The mansion he shares with his third wife, Julie, is valued at nearly $3 million, and he has a stable of horses on his property.
In 2002, Carlson was preaching the miracles of treatments using "bioidentical hormones" or "hormone balancing." On his website and in lectures, Carlson, who did not respond to repeated phone messages from New Times, told prospective patients how human growth hormone can fight the effects of aging. He said it can help you lose weight, get stronger, build muscle definition, and enhance your sex life, and he was living proof: a youthful, energetic, attractive, two-time Ironman.
By the end of that year, Carlson bought into a business with Julie's brother, Joseph Raich. Glenn Stephanos, an acquaintance of Raich's, was the third partner, and Glenn's older brother, George, was the marketing director. They chose a name that sounded tropical, soothing. They decided on Palm Beach Rejuvenation Center.
The idea, prosecutors allege, was to create a profitable pipeline for steroids and human growth hormone. Carlson could take advantage of his good name and stamp the prescriptions, for which he would be paid $5,000 a week. Signature could take advantage of a U.S. Supreme Court ruling and make the drugs themselves, often from raw ingredients originating in China and not approved by the FDA. Then Raich and the Stephanos brothers needed only to drum up potential HGH consumers, taking advantage of the most powerful (black-)marketing tool ever: the cavernous anonymity of the world wide web.
Palm Beach Rejuvenation Center started advertising by the end of 2002, not long after Signature Pharmacy went into business. Earlier that year, the Supreme Court ruled that it was legal for compounding pharmacies to advertise.Compounding pharmacies manufacture prescription drugs from raw ingredients in their own labs instead of reselling FDA-approved substances. The ruling legalized businesses like Signature and created what is now an estimated $2 billion industry. As the court saw it, compounding pharmacies were necessary to fill specific prescriptions larger pharmacies couldn't, for patients with particular allergies, for example.
The Mitchell Report mentions that Signature owned a lypholizer, a vacuum freeze dryer that can convert a single gram of raw HGH into thousands of doses — the way an internet business can turn a few drug purchasers into thousands or a few dollars into millions. In 2002, Signature did about $500,000 worth of business. In 2006, prosecutors say, the pharmacy made an estimated $40 million.
The Stephanos brothers grew up in Beverly, Massachusetts. Glenn, 52, married and moved to Palm Beach when he was young. George, 59, lived in New York and New Jersey much of his adult life. According to the Gloucester Times, George was on Beverly High's undefeated football team in 1964, and Glenn was captain of the basketball team when he graduated in 1974.
Glenn married the daughter of Otto DiVosta, a wealthy home builder. George ran a nightclub in Manhattan called Rascals. In 1992, he was sued by an insurance company after they accused him of beating a man at the club. Both brothers are tall, with Tarzan builds, strong chins, and long, flowing hair.
Joseph Raich, a muscular 45-year-old, is from a family that has lived in Palm Beach for several generations. He is known as a youth wrestling booster who has donated tens of thousands of dollars to the sport.
They went into business in office space on Indiantown Road in Jupiter, a mile or so from the beach. All three men own property near the light-green building. It was this space that, authorities say, became the call center that dealt with customers like J.
PBRC began canvassing the internet and placing ads in bodybuilding publications. Like thousands of other new businesses storming the internet in the early part of the decade, they advertised the wonders of hormones. Broad-shouldered spokesmen appeared on television singing the praises of the drugs. The real-life fountain of youth, they called it: lean looks, happy feelings, and they never failed to mention the potential for better sex. The implication was clear: The drugs make everything grow. They called themselves anti-aging clinics, and, prosecutors say, they existed solely as an online marketplace.
A single HGH dose might cost a consumer $150 or more. That same dose, investigators say, cost PBRC about $18 and cost Signature about $4.
They were successful businessmen, all with large houses within minutes of the office. Glenn lives in a country club community, between the ocean and a golf course. Raich owns a peach-colored mansion down the road, with wide double doors in the front and an immaculate balcony overlooking a large pool. Raich has another property in Palm Beach, with a professional chef and an indoor gym.
In 2004, the U.S. Olympic wrestling team stayed at Raich's house. They reportedly threw down mats and practiced in his gym. The U.S. Olympic Committee did not return phone calls regarding Raich, but last year, Gary Abbott, director of communications for USA Wrestling, told the New York Times, "We only know him as a wrestling leader in Florida, and we are not aware of his business dealings." Raich also did not return calls.
When the Jupiter office was raided, Raich's wrestling connections became a problem. The Florida High School Athletic Association began investigating Jupiter Christian's wrestling program, which in 2006 became the smallest school to win a state wrestling championship. Raich had been a longtime booster of Jupiter Christian's and reportedly had wrestlers living at his house at some point. Chris Ruh, son of Jupiter Christian wrestling coach Robin Ruh, was an employee of PBRC. Agents found HGH and steroids in Chris Ruh's desk as well as Raich's. Robin Ruh resigned four months later.
Raich told the Palm Beach Post, "Absolutely, positively, never, ever was any student at Jupiter Christian or any other high school anywhere given any performance-enhancing substance by me or anyone associated with me."
The FHSAA did not find evidence of students using HGH or steroids from PBRC. Jupiter Christian agreed to distance itself from Raich. Raich also sold his portion of PBRC to Glenn Stephanos, a deal the Stephanos defense teams says was in the works before the raid.
In July, a woman named Sara Jiminez of Palm Beach Gardens filed a sexual-harassment suit against Raich and Glenn Stephanos. The suit alleges that both men made unwanted sexual advances while she worked at PBRC and that when Jiminez questioned the legality of PBRC's business, she was fired.
Less than a week after the suit was filed, Raich pleaded guilty in Albany to one count of conspiracy in the fourth degree, a class E felony. He was ordered to pay $200,000 to the Albany County D.A. and agreed to testify against the Stephanos brothers and the Signature owners. He was also sentenced to four years of probation.
A source close to Raich's family says he was dealing with personal problems at the time of the plea and didn't want to deal with the Albany case hanging over his head any longer. Three weeks after Raich pleaded, Carlson, his brother-in-law, followed suit.
When Carlson was arraigned in Albany the week of the raids, his attorney, Charles R. Holloman of Ocala, began the defense in the media by telling anyone who would listen that his client received bad legal advice. Carlson had been led astray, they said, and they even had the name of the culprit — Rick Collins, a New York attorney, former amateur bodybuilder, and author of a book about steroids called Legal Muscle. His client was shocked by the charges, Holloman told the Palm Beach Post. "It was like walking down a street and a safe falls out of the third floor of a building on your head," he said after Carlson was charged with seven felony counts. "It's a screw-up of galactic proportions. By greed or neglect or sloppy record-keeping or all of those."
Carlson and the owners of Signature had been told, defense attorneys claimed, that if patients had blood work done and sent to the approving doctor, the prescriptions would be legal, even without the face-to-face meeting.
Collins then sent an open letter to the editor of the Times Union defending himself and his legal advice. "My firm has always made clear to our clients that the current law does not permit anabolic steroids to be prescribed for other than a legitimate medical purpose and within the usual course of professional practice in a valid physician-patient relationship," he wrote. "My stance has been critical of certain laws regarding anabolic steroid use by mature adults under the supervision of knowledgeable physicians. I have condemned steroid abuse by teenagers... [and] by cheating competitive athletes."
Signature defense attorneys in Florida and New York told the press that it was not the responsibility of the pharmacy to make sure the doctor had the required proper relationship with the patients.
In August, Carlson pleaded guilty to one count of insurance fraud, a class E felony. He agreed to testify against Signature owners and anyone involved with PBRC who doesn't plead guilty. Under the agreement, Carlson must pay $300,000 to the District Attorney's Office and will probably be able to continue practicing in Florida.
"Carlson could have gotten some bad legal advice the second time," said David Holland, a New York-based attorney defending the Stephanos brothers. Neither Glenn nor George Stephanos returned phone calls. "He didn't have to plea," Holland said. "As this case unfolds, we'll see this is more about the cutting edge of medicine and technology — if it ever goes to trial, which it honestly might not because there are so many holes in the prosecution's case."
The prosecution says establishments like PBRC are operations that began without ever intending to provide legal services. Both Stephanos brothers, along with the heads of Signature — owners Robert Stan Loomis and his wife, Naomi, and Robert's brother Kenneth Michael Loomis — are charged with enterprise corruption, a class B felony. "It's the state's version of federal racketeering charges," Orth says.
"Enterprise corruption means they're saying there was never even any intention of a legal business," Holland says. "That's just totally false."
Holland says that the PBRC case, which could go to trial by this summer, is an issue of technology and that laws haven't kept up. "What this case is really about is telemedicine," he says. "A new age of technology and doctor-patient relationships. Technology allows doctors to meet with patients over things like teleconference. This could be a landmark case in the field."
There is no evidence to suggest Carlson — or any other doctor charged in relation to Signature — met with patients via teleconference. Surveillance tapes of Signature do show that during one 60-day period in 2006, Carlson approved 3,100 prescriptions sent to the pharmacy, all of which came from PBRC. They were almost all for testosterone or HGH.
The fact that patient blood work was done for at least some patients — it's not clear what percentage — constitutes at least some relationship, the defense contends. "New York, as a state, has shown that they care about issues like telemedicine and that they are in favor of advancing the field. It's just that the laws might not have caught up to the technology," Holland claims.
Besides, Holland says, the law in New York isn't as clear as the prosecution has made it out to be. "The reputation is that New York has much stricter prescription laws, but nobody has shown us the law that specifically states a doctor must see a patient in person, face to face, every time." When asked about the specific code or what the exact wording of the law in New York is, the D.A.'s spokeswoman said she would get back to New Times but did not by presstime.
The clientele were also not the bodybuilders and pro athletes the prosecution makes them out to be, Holland says. Rather, most were men in their late 40s and 50s, often with erectile dysfunction. They were seeking confidential treatments for personal issues. (Dallas Cowboys quarterbacks coach Wade Wilson has said he purchased HGH from PBRC for this reason. The NFL suspended him for five games.) And while the prosecution has suggested that upward of 10 percent of PBRC's customers were residents of New York, Holland says he thinks the number is less than 1 percent. He says prosecutors have not been forthcoming with evidence.
It's also odd, the defense says, that in a criminal enterprise case, the PBRC corporation was not indicted. And during the raids, four search warrants were issued, but only three were served. Holland says that's because authorities reported seeing what looked like "legitimate medical practices" at the fourth location, a PBRC clinic on Military Trail in Palm Beach Gardens. That facility, which is still open and operating, provides Botox cosmetics, laser hair removal, microdermabrasion, and other anti-aging treatments. Holland says as far as he knows, neither PBRC location (the clinic on Military Trail or the offices that were raided) were ever the call centers Soares likes to depict. "The Albany D.A. is raiding offices in Florida," Holland said. "He had reporters and camera crews with him. He certainly doesn't shy away from publicity."
Soares is not commenting on Operation Which Doctor right now because it is an ongoing investigation, Orth says. In September, Soares told the Times Union: "Our intention from the beginning was not to delve into this professional sports realm. It's distracting us. We want to keep the focus on the dangers presented by these internet pharmacies. We're not just talking about steroids; we're talking about other prescribed and controlled medications.
"The idea that an individual no longer has to travel to neighborhoods to purchase narcotics and can get them delivered to their door because of the computer that sits in their office or bedroom is a frightening thought."
No story was more emotional for fans than that of Rick Ankiel. In 1997, while still at Port St. Lucie High School, Ankiel was USA Today's High School Player of the Year. A hard pitcher with a deadly curveball, he was a minor-league all-star in his first season. At 20 years old, he was a big-league starter with St. Louis. He was second in the league in strikeouts per nine innings.
But in the 2000 playoffs, Ankiel lost control. He started the first game of the National League Division Series against the Atlanta Braves. The Cardinals scored six runs in the first inning, but Ankiel struggled. He escaped bad situations in the first and second innings but in the third didn't fare as well.
It was as bad as it gets in the pros: He allowed four runs on two hits, walking four batters and throwing five wild pitches before being removed with two outs. There were no physical ailments; Ankiel just couldn't throw the ball straight anymore. He was the first person since 1890 to have five wild pitches in an inning. In game two, Ankiel was pulled after only 20 pitches, five of which went past the catcher. It was an unprecedented mental breakdown.
Ankiel refused to answer questions about his problem. He slipped down the ranks of baseball until he got to the Rookie League. Eventually, he seemed to regain his control, working back up through the minors as a relief pitcher. In 2004, he was called back up to the Cardinals, where he seemed to have everything together. But that offseason, Ankiel's troubles returned. Before the 2005 season, he announced he was retiring as a pitcher and would try to make it as an outfielder.
The switch beckoned comparisons to Babe Ruth, who also began his career as a pitcher. Through that year, Ankiel batted his way up the ranks of the minors for a third time. In August 2007, like a baseball fairytale, Ankiel got another call-up to the Cardinals.
In his first at bat, he received a standing ovation from the St. Louis crowd. In the seventh inning, Ankiel hit a three-run home run that helped seal the win. Over the next month, he batted .358, with nine home runs and 29 RBI. On the night before the New York Daily News reported Ankiel was linked to a rejuvenation center in Palm Beach Gardens and had received HGH from Signature, he hit two home runs and had seven RBI. It was the single best hitting day of his career.
The report detailed HGH purchases from 2004. He told reporters at the time: "All and any medications that I have received in my career has [sic] always been under a doctor's care, a licensed physician."
The Mitchell Report chronicles the revelations. It was game seven of the American League Championship Series when news broke that Cleveland Indians pitcher (and possible starter that night) Paul Byrd purchased $25,000 worth of HGH from PBRC. Byrd had played for several teams at that point. He later told reporters he had been prescribed the drug for a pituitary tumor. Baltimore Orioles outfielder Jay Gibbons received six shipments of HGH from Signature between October 2003 and July 2005. His prescriptions were signed by "A. Almarashi." Journeyman pitcher Ismael Valdez ordered $2,500 worth of HGH and had it shipped to the Texas Rangers ballpark in Arlington.
Back at the spring training fields in Jupiter, fans were discussing New York Yankees pitcher Andy Pettitte, whose news conference to discuss his use of HGH had been playing around the clock on ESPN. "Do I think I'm a cheater? I don't," Pettitte told a swarm of cameras and media members. "Because from the bottom of my heart, and God knows my heart, I know why I was doing this. Was it stupid? Yeah, it was stupid. Was I desperate? Yeah, I was probably desperate."
A warm breeze blew across the practice field as a man in the bleachers mumbled, "So many of 'em are on juice. You can't even think about it when you watch 'em."
"There should be a designated steroids-free player like they have the designated hitter," joked a man who'd brought his son to see spring training.
As for the PBRC crew, the Stephanos brothers remain out on bail. There is still no trial date set in New York; there are motions to dismiss the charges on filing technicalities pending, and a patients' rights to privacy ruling in Florida is still up in the air. The defense remains confident that if it goes to trial, this case will be a landmark in the field of telemedicine.
District Attorney Soares' office continues to pursue what it says is a vast criminal enterprise. On the D.A.'s website, www.albanycountyda.com, visitors can view a Mafia-style flow chart of Operation Which Doctor targets with headshots of the charged participants. At the top is Palm Beach Rejuvenation, and in the center is Signature Pharmacy. Over some of the pictures, like Carlson's and Raich's, are diagonal red stamps that say "Pled Guilty."
Meanwhile, Signature and PBRC are both still open for business. Though the office prosecutors say was the call center on Indiantown Road is now empty, the clinic on Military Trail in Palm Beach Gardens is still bustling, and the parking lot is full of luxury cars. The PBRC website, www.pbrcenter.com, is also still up and still implores visitors to call for a free consultation to learn more about human growth hormone.
Rick Ankiel declined New Times interview requests. In an email response, Ankiel wrote, "I would rather look forward to the upcoming season then[sic] look back. I appreciate your email and support. Rick."
At Roger Dean Stadium, as Ankiel neared the batting practice field, the calls began. "Hey, Ricky!" "Good luck this year, Rick." Ankiel gave a quick wave of acknowledgment. He stepped into the batter's box. He took four or five pitches batting lefty, then five more from the other side of the plate. Then Ankiel switched back to batting left-handed. He connected on his first pitch and zapped a line drive deep into right field. The kids gripping the fence gave him a smattering of applause.
On January 18, Ankiel signed a one-year contract with the Cardinals that will pay him $900,000. With performance-based incentives, it could be worth $1 million (still less than half of his first pitching contract). He is projected to be the starting center fielder.
By late February, J was still at his apartment — and not at spring training. He wasn't invited this year, he says, though he believes he still has some options to continue playing, "possibly outside the U.S." In the meantime, he says, he will keep working out on his own.
Asked if he still uses steroids, he said, "I'd like to say I don't."
NEW YORK TIMES
August 20, 2006
PHYS ED; Raging Hormones
By GRETCHEN REYNOLDS
Six years ago, Dr. Paul Savage was a pudgy mess. A 38-year-old emergency-room director in Waukegan, Ill., he weighed 267 pounds, suffered from high blood pressure and shortness of breath and had sallow skin that drooped in wattles around his chin. Today, at 44, he's a new, unrecognizable man. Almost 100 pounds lighter, he boasts 12 percent body fat, a superhero jaw line and skin tone that seems almost incandescent. Savage says he owes much of his transformation to the self-administration of human growth hormone (H.G.H.). ''I worked with a personal trainer and a nutritionist first,'' he says. ''I actually gained three pounds. Then I started growth hormone, and the weight dropped away.''
Like a freshly hatched evangelist, Savage quit emergency-room medicine and in 2004 co-established a clinic in Chicago dedicated to hormone therapy, with an emphasis on H.G.H. His franchise, which operates under the name BodyLogicMD, serves about 1,500 people nationwide, many of whom pay upward of $15,000 for a yearly cycle of growth-hormone injections. The patient count rises by almost 100 each month.
According to a 2005 article in The Journal of the American Medical Association, human growth hormone is being prescribed to tens of thousands of people each year at anti-aging or ''age management'' facilities like Savage's. Those who take H.G.H. -- including many doctors -- say it can restore sagging physiques, flagging endurance and wilting libidos as well as cure depression and sharpen mental acuity. ''I can't believe everybody isn't taking this,'' says Dr. Darren Clair, 53, the founder of Vibrance Health Services, an age-management clinic in Beverly Hills, Calif., and himself a dedicated H.G.H. user. No one has yet claimed that H.G.H. reduces foot odor and freshens breath, though that could be coming.
Growth hormone has also become popular with athletes who believe it builds muscle and improves speed. ''It's definitely the drug du jour,'' says Chuck Kimmel, the president of the National Athletic Trainers' Association. The catch is that it's illegal. The Food and Drug Administration has banned H.G.H. for all but a few specific medical conditions (see ''The Outlaw Drug,'' next page), and it has been banned by most professional sports leagues in the United States and by the International Olympic Committee. In June, the house of Jason Grimsley, a pitcher for the Arizona Diamondbacks, was searched on the suspicion that he received H.G.H. In Europe, bags of growth hormone were reportedly seized as evidence in a recent Tour de France doping scandal. And in July, James Shortt, a physician in South Carolina, was sentenced in federal court for his role in providing growth hormone and steroids to, among other patients, several players on the Carolina Panthers football team. As he told the former Panthers tight end Wesley Walls in a tape-recorded consultation, ''Everybody is using it.''
Aside from the nettlesome illegality of H.G.H., there's another concern: not much research has been conducted on the effects of the drug on healthy people, though there are indications that H.G.H. can do some serious physical damage. Still, it's tempting: the possibility of a firmer, faster, younger body. H.G.H. does seem to deliver on its promise, and for many people, that makes it more than worth the risk.
Most of us produce plenty of growth hormone when we're young. Our pituitary glands steadily pump it out, helping our bones to extend, our muscles to bulk and our skin collagen to stretch.
As with most hormones (notably testosterone and estrogen), the production of H.G.H. drops with age. ''There's approximately a 1 to 2 percent reduction a year'' after puberty, Savage claims, adding that over time, that results in ''decreasing muscle mass and increasing fat mass, especially around the midsection; thinning of the skin; weaker, less-dense bones.''
An unsightly affront, yes, but for athletes it could also mean a drop in performance. ''Growth hormone is the engine of bodily repair,'' Clair says. ''It tells muscles and bones to rebuild themselves.'' With less of it, even minor injuries can linger. A strained muscle that might have bothered you for a day or two when you were 20 can twinge for weeks when you're 35, in part because of decreased levels of H.G.H.
There's some scientific evidence that increasing your H.G.H. may indeed speed healing. In a recent study conducted at several hospitals worldwide, patients who had broken tibiae were given daily injections of H.G.H. for up to 16 weeks. (Growth hormone is degraded by stomach acid and can't be taken in pill form.) The injections brought their levels up above those considered normal for teenagers. The treatment, the researchers found, ''accelerated healing significantly.''
Few clinical studies have looked at what happens when healthy people supplement their H.G.H. levels for sustained periods of time, but advocates point to one report in particular, from The New England Journal of Medicine in 1990. Twelve men in their 60's and older were given injections of H.G.H. for six months. They received high doses, about double those given to adult patients with growth-hormone deficiency. At the end of the study, the men had a 14 percent decrease in body fat, an 8.8 percent increase in lean body mass and a 1.6 percent increase in the bone density of their spine, equivalent in magnitude, the authors concluded, ''to the change incurred during 10 to 20 years of aging.''
This study almost single-handedly started the H.G.H. industry. But the doctors who recommend growth hormone tend to ignore an editorial that ran in the same issue of The Journal and that warned about the use of H.G.H. by healthy people. The editorial noted that H.G.H. can alter the body's ability to metabolize carbohydrates, leading to blood-sugar imbalances and, in some cases, diabetes. It can cause bones to thicken, contributing to joint pain and severe arthritis. Amounts of H.G.H. even slightly beyond the normal range can result in high blood pressure, edema and, in the worst cases, congestive heart failure. In a later editorial, which cited a more recent study, The Journal added that healthy people who took extra doses of H.G.H. gained muscle mass, but they didn't get stronger. Only those who lifted weights did.
Doctors worry about another possible danger of H.G.H. ''Growth hormone is a trigger for unbridled cell growth,'' says Dr. Thomas Perls, an associate professor at Boston University School of Medicine and the director of the ongoing New England Centenarian Study, which looks at the genetics and lifestyle habits of people who live to be 100. ''That's its role in the body. That is also the mechanism behind cancer.'' Several studies have linked high production levels of growth hormone to the development of prostate tumors and invasive breast cancer.
''My mother wanted to be healthy,'' says Erick Schenkhuizen, a financial planner in San Diego, whose mother, Hanneke Hops, an avid tennis player and runner, began taking almost daily injections of H.G.H. in 2003, at 56. Her prescribed dose, like those for most patients at anti-aging clinics, was designed to raise the hormone level back to where it had been years earlier. She lost 16 pounds in two months and raved in The San Francisco Chronicle that the drug ''makes me feel good.'' Seven weeks later, she was diagnosed with multiple inoperable tumors in her liver, pancreas and ovaries, and seven weeks after that, she was dead. Was there a connection between the hormone injections and the cancer? ''I don't suppose we'll ever know,'' Schenkhuizen says. ''But my mother questioned it. I question it.''
As does Perls. ''It may be that the decline in growth hormone with age is a protective measure by the body to reduce the risk of cancer,'' he says. ''My fear is that using growth hormone could be like throwing gasoline on the fire of cell growth. It could cause cancers to grow and metastasize rapidly and be untreatable by the time they're detected.''
At the heart of the H.G.H. debate is a philosophical question about what it means to grow older. ''Is aging a disease?'' asks Dr. Susan G. Nayfield, the chief of the geriatrics branch at the National Institute on Aging. Should you fight it by dosing yourself with hormones until your blood runs with levels similar to those you had in college? ''People tried that with hormone-replacement therapy'' for menopausal women, Nayfield says. ''We know how that turned out.'' (The Women's Health Initiative's long-range national study of the effects of supplementing declining estrogen and progesterone levels in menopausal women was halted in 2002. Against all expectations, the extra doses of hormones significantly increased the risks of breast cancer, heart disease, stroke and mental impairment.)
''Maybe the body knows what it's doing when it tells you to slow down a little over time,'' Nayfield concludes. ''Maybe we should listen.''
But that advice can gall those of us who once were faster, once were slimmer, once were superbly fit. ''Athletes hate to think they're a step slower than they used to be or that they're one step slower than that guy over there,'' says Chuck Kimmel of the trainers' association. ''They want a magic bullet.''
For the moment, those who use H.G.H. are convinced they've found it. ''I subscribe to the theory that hormone balance gives a person the optimal rate of health,'' Paul Savage says. ''It has certainly been true for me.''
THE OUTLAW DRUG: DESPITE ITS POPULARITY, MOST H.G.H. USE IS ILLEGAL
UNLIKE MOST DRUGS, H.G.H. can be prescribed only to treat illnesses for which it has been specifically approved by the Food and Drug Administration: primarily growth-hormone deficiency in children and adults and wasting syndrome in people who have AIDS. By law, an adult is hormone-deficient only if the diagnosis has been confirmed by laboratory tests in which the pituitary gland is stimulated and H.G.H. production measured. The hormone cannot be prescribed to improve athletic performance or to stave off aging. And it can't be used without a doctor's supervision, so virtually all online sales of the hormone are illegal.
In the past few years, the F.D.A. has accelerated its campaign against the use of H.G.H. for unapproved purposes, sending letters of warning to clinics and companies that promote the drug as an anti-aging treatment. But no one expects the crackdown to have much effect. ''There are too many clinics and too little manpower,'' says Dr. Thomas Perls, an associate professor at Boston University School of Medicine. At many anti-aging clinics, doctors claim that patients have clinical hormone deficiency, which afflicts about one in 10,000 adults. ''But the doctors don't do the stimulation test,'' Perls says. So the diagnosis isn't legally valid.
If you've been beguiled by reports about the wonders of H.G.H., ''see an endocrinologist,'' Perls urges, and get a full hormonal work-up. What you do after that is between you and your lawyer.
Posted on: Wednesday, 11 April 2007, 06:00 CDT
Anti-Aging Clinics Proliferate in Florida
FORT LAUDERDALE, Fla. _ Oasis Longevity & Rejuvenation topped its Internet pages with a photo of a well-muscled man to help sell its human growth hormone shots. The Boca Raton, Fla., clinic is now shut down, its principals charged last month with selling the drugs illegally. But the business of selling hormones claiming they build hard muscle, burn flab and reverse the effects of aging has been a lucrative _ and controversial _ staple for years in South Florida. Dozens of clinics make millions yearly selling hormones, often venturing into gray areas of medicine and the law, prosecutors and physicians say. Among the sellers are a former cocaine dealer and a former merchant of illegal steroids."It's a huge business because people want the fountain of youth," said Dr. Paul Jellinger, an advisor to the American Association of Clinical Endocrinologists. "They're just disregarding the fact that there's no proof that it works. (Also,) this stuff can hurt you."Two sets of arrests this year showed the underside of the business. In February, 14 people running seven Internet pharmacies in South Florida were indicted by a federal grand jury, accused of selling drugs without the patients visiting a doctor. In Florida and many states, it's illegal to prescribe or sell a drug unless the doctor first sees the patient in person. Then, last month, officials from Albany, N.Y., arrested 15 people, including eight in South Florida, suspected of selling hormones and steroids to buyers _ a few of them pro athletes _ without a doctor visit. The ring centered on Signature Pharmacy in Orlando, which was charged in the case and sold $40 million of the drugs last year, said Christopher Baynes, an assistant district attorney in Albany. Signature's top source of customers: Palm Beach Rejuvenation Center, an anti-aging clinic in Palm BeachGardens that accounted for $15 million of the business, said Baynes. Officials arrested two of the clinic owners and its doctor, plus six others at Oasis and online site medxlife.com, which each accounted for millions of the revenue. The principals at Signature and the clinics have pleaded not guilty and declined to comment. Signature sold to at least two dozen South Florida clinics. Said Baynes: "There are more out there involved with Signature. I don't know whether more will be charged."Among the names to surface in connection to the case: Palm Beach Life Extension in Palm BeachGardens. An Albany agent said in a document the clinic is separate but "under the control" of Palm Beach Rejuvenation and sold drugs illegally. The Health and RejuvenationCenter in Palm BeachGardens. At least one co-owner used to work at Palm Beach Rejuvenation, attorneys and other clinic operators said. Infinity Rejuvenation in Deerfield Beach. A doctor was arrested in Albany on charges she signed illegal prescriptions from the clinic. Metragen Pharmaceuticals in Deerfield Beach. In documents, Albany agents said some of Signature's illegal prescriptions came from Metragen. The company's founding principal started it after his former pharmacy, Powermedica, was shut down in 2005 for illegally selling steroids. The owners of those four businesses have not been charged. Officials or attorneys for the four declined to comment or could not be reached with calls to their offices. Hormone sellers said Signature was the biggest single supplier in South Florida and aggressively recruited clinics that sent them the customers. "Signature solicited everyone, from the small sites to the big sites to the individual doctors," said Mark White, director at Anti-Aging Group Health in Aventura who said he did not use Signature. In affidavits, agents said clinics in the Albany case used Web sites and ads to attract patients who filled out medical forms and got blood tests, but never saw a doctor. A clinic doctor wrote a prescription, which was filled by Signature and shipped to the patient. The Oasis marketing director, Aaron J. Peterson, told a judge when he pleaded guilty March 28 that the clinic paid Signature $10,000 for finding a doctor who signed prescriptions without seeing patients. Owners of another South Florida clinic also paid Signature to line up a doctor, and paid the doctor thousands per month for signing prescriptions, said the clinic's attorney, John Contini. He spoke on the condition his clients not be named. "These physicians were abdicating their duty to the patient," Contini said. Contini said Signature also sent his clients to an attorney who, for $1,500, assured them the operation was legal. South Florida "anti-aging" clinics have been selling human growth hormones, or HGH, since the 1990s. The owners grasped onto a few small studies suggesting that symptoms of aging declined after shots of HGH, which is made by the pituitary gland to control metabolism. Clinics began claiming that taking HGH or testosterone can erase fatigue, body fat, muscle loss, low sex drive, even gray hair. Muscle-builders craved it. "It's hormone replacement therapy, to make people feel better," said Jeffrey George, owner of SouthBeach Rejuvenation in West Palm Beach. "Females have menopause and no one complains about them getting hormones. Men have `andropause' and we prescribe hormones for them." The cost: Up to $1,000 a month. Specialists and federal officials say it's medically correct to use HGH for patients who no longer produce it, which normally is caused by trauma or pituitary tumors. But there's no proof shots help when HGH declines naturally, experts said. "Hormone levels go down as we get older. That's somehow how nature figured out how to do it," said Dr. Michael Karl, a specialist at the University of Miami medical school. What's more, doctors said studies show that having too much HGH for one's age can cause heart disease, high blood pressure, diabetes and muscle and joint pain, and possibly spur cancer cells. Some HGH proponents contend that most older patients need shots because they have low levels in their blood. But physician experts said a low level means little because HGH fluctuates and drops near zero daily. Albany prosecutor Baynes said clinics in his case sold HGH to patients with normal test results. Brian Cotugno, who used to be a consultant to HGH clinics, said many would not stop selling to patients with normal lab tests because they would lose millions in sales to those using it for non-medical reasons."A lot of their business was (from customers) who just wanted to call and order substances over the phone," Cotugno said. Cotugno said he got into the business a few years ago, after a 10-year sentence for cocaine trafficking, which he called a mistake at age 22. He started his own clinic, Maxim Rejuvenation in West Palm Beach, Fla. Maxim was one of eight entities dropped last month from a list of approved online pharmacies by the accreditation group Pharmacy Checker, said its vice president, Gabriel Levitt. After the Albany arrests, the nonprofit group no longer accredits online pharmacies that sell or promote HGH, he said. "It's not safe," Levitt said, "to get prescriptions online for controlled substances or growth hormones."___ MORE ABOUT STEROIDS, HGH AND SUPPLEMENTS Testosterone: An anabolic steroid, the male sex hormone promotes tissue growth. Doctors prescribe it when the body fails to make it. No large-scale research shows whether it can combat age-related changes. Excess amounts can cause sterility, spur prostate cancer and worsen sleep apnea. Hormone pills, sprays: Some sellers offer HGH as a pill or an oral or nasal spray instead of as an injection. Less is known about the possible benefits compared with injectable HGH. Natural supplements: Some sellers promote nonprescription protein supplements, amino acids and other substances they contend will spark the body to produce more hormones. No one regulates these, and there's little data whether they work or are harmful. Sources: American Association of Clinical Endocrinologists, American Academy of Anti-Aging Medicine, HarvardMedicalSchool, WebMD.com
____WHAT IS HGH? "Anti-aging" clinics and doctors promote many hormone products they contend will eradicate fatigue, muscle loss, flab, declining sex drive and other symptoms of aging: Human growth hormone: The pituitary gland makes HGH (somatropin) to govern muscle and bone growth. Doctors prescribe synthetic HGH shots if the body fails to make it. No large-scale research shows if it can combat age-related changes. Some body-builders seek it to add muscle. Excess amounts can cause heart disease, diabetes and possibly promote cancer.___ (c) 2007 South Florida Sun-Sentinel. Visit the Sun-Sentinel on the World Wide Web at http://www.sun-sentinel.com/ Source: South Florida Sun-Sentinel
4/8/07 - Busts over anti-aging drug sales may be tip of the iceberg in S. Florida
South Florida Sun-Sentinel (KRT) via NewsEdge Corporation :
Apr. 8--Oasis Longevity & Rejuvenation topped its Internet pages with a photo of a well-muscled man to help sell its human growth hormone shots.
The Boca Raton clinic is now shut down, its principals charged last month with selling the drugs illegally. But the business of selling hormones claiming they build hard muscle, burn flab and reverse the effects of aging has been a lucrative -- and controversial -- staple for years in South Florida.
Dozens of clinics make millions yearly selling hormones, often venturing into gray areas of medicine and the law, prosecutors and physicians say. Among the sellers are a former cocaine dealer and a former merchant of illegal steroids.
"It's a huge business because people want the fountain of youth," said Dr. Paul Jellinger of Hollywood, an advisor to the American Association of Clinical Endocrinologists. "They're just disregarding the fact that there's no proof that it works. [Also,] this stuff can hurt you."
Two sets of arrests this year showed the underside of the business.
In February, 14 people running seven Internet pharmacies in South Florida were indicted by a federal grand jury, accused of selling drugs without the patients visiting a doctor. In Florida and many states, it's illegal to prescribe or sell a drug unless the doctor first sees the patient in person.
Then, last month, officials from Albany, N.Y., arrested 15 people including eight in South Florida suspected of selling hormones and steroids to buyers -- a few of them pro athletes -- without a doctor visit. The ring centered on Signature Pharmacy in Orlando, which was charged in the case and sold $40 million of the drugs last year, said Christopher Baynes, an assistant district attorney in Albany.
Signature's top source of customers: Palm Beach Rejuvenation Center, an anti-aging clinic in Palm Beach Gardens that accounted for $15 million of the business, said Baynes. Officials arrested two of the clinic owners and its doctor, plus six others at Oasis and online site medxlife.com, which each accounted for millions of the revenue.
The principals at Signature and the clinics have pleaded not guilty and declined to comment.
Signature sold to at least two dozen South Florida clinics. Said Baynes: "There are more out there involved with Signature. I don't know whether more will be charged."
Among the names to surface in connection to the case:
Palm Beach Life Extension in Palm Beach Gardens. An Albany agent said in a document the clinic is separate but "under the control" of Palm Beach Rejuvenation and sold drugs illegally.
The Health and Rejuvenation Center in Palm Beach Gardens. At least one co-owner used to work at Palm Beach Rejuvenation, attorneys and other clinic operators said.
Infinity Rejuvenation in Deerfield Beach. A doctor was arrested in Albany on charges she signed illegal prescriptions from the clinic.
Metragen Pharmaceuticals in Deerfield Beach. In documents, Albany agents said some of Signature's illegal prescriptions came from Metragen. The company's founding principal started it after his former pharmacy, Powermedica, was shut down in 2005 for illegally selling steroids.
The owners of those four businesses have not been charged. Officials or attorneys for the four declined to comment or could not be reached with calls to their offices.
Hormone sellers said Signature was the biggest single supplier in South Florida and aggressively recruited clinics that sent them the customers.
"Signature solicited everyone, from the small sites to the big sites to the individual doctors," said Mark White, director at Anti-Aging Group Health in Aventura who said he did not use Signature.
In affidavits, agents said clinics in the Albany case used Web sites and ads to attract patients who filled out medical forms and got blood tests, but never saw a doctor. A clinic doctor wrote a prescription, which was filled by Signature and shipped to the patient.
The Oasis marketing director, Aaron J. Peterson, told a judge when he pleaded guilty March 28 that the clinic paid Signature $10,000 for finding a doctor who signed prescriptions without seeing patients.
Owners of another South Florida clinic also paid Signature to line up a doctor, and paid the doctor thousands per month for signing prescriptions, said the clinic's attorney, John Contini. He spoke on the condition his clients not be named.
"These physicians were abdicating their duty to the patient," Contini said.
Contini said Signature also sent his clients to an attorney who, for $1,500, assured them the operation was legal.
South Florida "anti-aging" clinics have been selling human growth hormones, or HGH, since the 1990s. The owners grasped onto a few small studies suggesting that symptoms of aging declined after shots of HGH, which is made by the pituitary gland to control metabolism.
Clinics began claiming that taking HGH or testosterone can erase fatigue, body fat, muscle loss, low sex drive, even gray hair. Muscle-builders craved it.
"It's hormone replacement therapy, to make people feel better," said Jeffrey George, owner of South Beach Rejuvenation in West Palm Beach. "Females have menopause and no one complains about them getting hormones. Men have 'andropause' and we prescribe hormones for them."
The cost: Up to $1,000 a month.
Specialists and federal officials say it's medically correct to use HGH for patients who no longer produce it, which normally is caused by trauma or pituitary tumors. But there's no proof shots help when HGH declines naturally, experts said.
"Hormone levels go down as we get older. That's somehow how nature figured out how to do it," said Dr. Michael Karl, a specialist at the University of Miami medical school.
What's more, doctors said studies show that having too much HGH for one's age can cause heart disease, high blood pressure, diabetes and muscle and joint pain, and possibly spur cancer cells.
Some HGH proponents contend that most older patients need shots because they have low levels in their blood. But physician experts said a low level means little because HGH fluctuates and drops near zero daily. Albany prosecutor Baynes said clinics in his case sold HGH to patients with normal test results.
Brian Cotugno, who used to be a consultant to HGH clinics, said many would not stop selling to patients with normal lab tests because they would lose millions in sales to those using it for non-medical reasons.
"A lot of their business was [from customers] who just wanted to call and order substances over the phone," Cotugno said.
Cotugno said he got into the business a few years ago, after a 10-year sentence for cocaine trafficking, which he called a mistake at age 22. He started his own clinic, Maxim Rejuvenation in West Palm Beach.
Maxim was one of eight entities -- four in Florida -- dropped last month from a list of approved online pharmacies by the accreditation group Pharmacy Checker, said its vice president, Gabriel Levitt.
After the Albany arrests, the nonprofit group no longer accredits online pharmacies that sell or promote HGH, he said.
"It's not safe," Levitt said, "to get prescriptions online for controlled substances or growth hormones."
Bob LaMendola can be reached at blamendola@sun-sentinel.com or 954-356-4526 or 561-243-6600, ext. 4526.
Agents Arrest 124 in Drug Raids
By Amy Shipley/The Washington Post WASHINGTON — Federal agents raided more than four dozen underground drug labs and arrested 124 people in 27 states during an 18-month crackdown on Chinese steroids, human growth hormone and other performance-enhancing drugs
Article Launched: 09/24/2007 12:00:00 AM MDT
The operation, which agents described as the largest anti-steroid action by law enforcement ever, involved cooperation among 10 nations and involved raids and arrests in Mexico, Canada, Australia, Belgium, Denmark, Germany, Sweden and Thailand, U.S. officials said.
Under pressure from Olympic and world anti-doping officials to address China's reputation as the main global supplier of illicit performance-enhancing drugs with the 2008 Summer Games in Beijing just 11 months away, Chinese authorities cooperated with the probe, DEA officials said. The Chinese agreed to accept information packets from U.S. and international law enforcement agencies in the coming weeks to address further the problem within their borders, the officials said.
News conferences to announce details of the busts were scheduled for Sunday in New York, San Diego, Houston, Kansas City, Mo., and Providence, R.I. While some of the individual busts over the last 18 months have been reported, the scope of the action has not been made public until now. Officials withheld announcements on the various raids to ensure the safety of agents as the last round of raids took place this weekend, officials said.
The action targeted underground labs that peddled steroids, human growth hormone and other drugs to customers through Web sites and message boards. It is not yet known whether high-profile Olympic or professional athletes were clients of any of the labs, DEA spokesman Dan Simmons said.
Officials from major sport anti-doping bodies including the World Anti-Doping Agency and U.S. Anti-Doping Agency assisted throughout, offering expertise and support, Simmons said. WADA Chairman Dick Pound is scheduled to arrive in Beijing on Tuesday, where he is expected to follow up on issues surrounding the manufacture and supply of steroids and other drugs from China, which he raised during meetings last fall with Chinese Olympic and government officials as among threats to the legitimacy of competition at the Olympics next August.
China already has taken action against at least one of its companies, Simmons said.
"Chinese authorities were willing partners," he said. "They said they would in fact make efforts to arrest and prosecute violators there in China."
The massive probe could have unusual and unnerving repercussions for the clientele of the labs, as the DEA has begun compiling a database of names of those who ordered or participated in illicit performance-enhancing drug activities through the labs for the use of all law enforcement bodies in the United States, Simmons said.
Simmons declined to elaborate on the intended use or makeup of the database, which he said is being assembled from hundreds of thousands of e-mails and Internet exchanges. He said it would be up to the individual U.S. attorney's offices prosecuting the cases — at least five, including the southern districts of New York and California, are involved — to decide how to handle information that arises regarding well-known athletes.
He added that the probe has no connection to the Signature Pharmacy investigation out of Albany, N.Y., a probe into illegal prescriptions of performance-enhancing and other drugs that has implicated a number of major league baseball and NFL players, coaches and doctors.
Since its inception early in 2006, what has been called Operation Raw Deal resulted in the seizure of at least 242 kilograms of raw steroid powder from China and 11.4 million dosage units of steroids or other chemicals, along with $6.5 million in cash, 25 vehicles and 71 weapons, according to Rusty Payne, a spokesman at DEA headquarters in Alexandria, Va. Fifty-six labs have been seized.
Approximately 70 percent of the enforcement action has occurred since Thursday, Payne said. Specific details of the actions taken overseas were not available as of Sunday, but China was considered the source of the "vast majority" of the illicit drugs, Simmons said.
U.S. law enforcement considered indicting the Chinese companies that supplied the illicit drugs, but decided that a partnership with the Chinese authorities would be more productive, Simmons said. Several agents flew to China this February to discuss the investigation.
The probe targeted raw material manufacturers and suppliers primarily in China and underground drug laboratories in the United States, Canada and Mexico.
It further looked at U.S.-based Web sites that market "conversion kits" that allow for the at-home processing of steroid powders, as well as Internet bodybuilding discussion boards that facilitate and instruct on the illegal use and production of performance-enhancing drugs.
"Operation Raw Deal uncovered a clandestine web of international drug dealers who lurk on the Internet for young adults craving the artificial advantage of anabolic steroids," DEA Administrator Karen P. Tandy said in a statement. "Today we reveal the truth behind the underground steroid market: dangerous drugs cooked up all too often in filthy conditions with no regard to safety, giving Americans who purchase them the ultimate raw deal."
Recent raids turned up anabolic steroids, human growth hormone, insulin growth factor and other drugs and chemicals including ketamine, fentanyl, ephedrine, pseudoephedrine, and GHB, Payne said.
The operation grew out of a massive bust in Mexico in 2005 known as Gear Grinder, which took down eight Mexican steroid producers credited with supplying more than 80 percent of the illicit steroids in the United States. That bust, Simmons said, pushed virtually all of the remaining U.S. steroid business to China.
Simmons said the labs taken down in the various busts showed no adherence to any standards for safety or sanitation, with drugs being mixed in basements or bathtubs before being shipped out to consumers.
Steroids and other performance-enhancing drugs are banned by the Olympic movement and most major sports leagues. Side effects of anabolic steroids, which increase muscle mass, include increased body hair, a deepening of the voice, enlargement of the breasts in men and a shrinking of the testicles.
Human growth hormone, believed to build strength and help muscles recover better from injury, can cause an enlargement of the jaw, forehead and hands and feet.
Human growth hormone (hGH), made by the pituita ry gland, promotes the normal development and maintenance of tissues and organs by triggering the release of insulin-like growth factors and inducing other beneficial physiological and metabolic effects. Synthetic hGH was made through genetic engineering and became widely available after 1985. hGH replacement therapy is approved for a limited number of medical conditions, including treatment of children and adults with scientifically proven growth hormone deficiency whose bodies produce insufficient or ineffective levels of the hormone. In addition, hGH is approved to treat muscle wasting in people with AIDS. A physician must prescribe the growth hormone. The dose is individualized for each person and is taken by injection.
6-16 Office of Criminal Investigations Fiscal Year 2005 ________________________________________________________________________
Illegal Sale of hGH _________________
This case was initiated based on information that injectable hGH was being imported into the U.S. from China by Mark Niehold, Phoenix, Arizona. Niehold had attempted to import injectable hGH into the U.S. in the past. Representative samples were taken from the shipment of hGH, which tested positive for the presence of hGH.
On October 28, 2003, a shipment of injectable hGH intended for Niehold was intercepted by the Department of Homeland Security’s (DHS) Bureau of Customs and Border Protection (CBP) in California. The shipment contained 60 vials of injectable hGH, and laboratory analysis revealed that it tested positive for the presence of hGH.
On December 17, 2003, a delivery of hGH was sent to Niehold at his residence. Niehold stated that he was an employee of the Federal government.
Niehold operated the website
www.thelowestcosthgh.com, and advertised the sale of hGH and other prescription drugs. Investigators learned that individuals who purchased hGH from Niehold over the Internet confirmed that they purchased hGH from an individual named "Mark," whom they met at the Internet web site.
On March 1, 2004, an analysis of Niehold’s government-issued laptop computer revealed that Niehold continued to distribute hGH over the Internet by using his government-issued computer after he was notified that it was illegal. E-mail correspondence recovered from Niehold’s computer revealed that Niehold directed the importation of hGH from China to be labeled on CBP importation documents as "Ceramic Figures."
On April 14, 2004, a search warrant was conducted at Niehold’s residence in Arizona. Two computers were seized in the search warrant for analysis. Also seized were miscellaneous documents implicating Niehold in the distribution of hGH. Analysis of Niehold’s computers revealed additional evidence of the illegal distribution of hGH.
On December 23, 2004, Niehold was convicted of violating Arizona Revised Statute 13 § 3406 - Possession, Use, Administration, Acquisition, Sale, Manufacture or Transportation of Prescription Only Drugs.
On December 31, 2004, Niehold was sentenced to 3 months of supervised probation and a $1,000 fine.
Defendant, a Federal Government Employee, Used Government Computer to Sell hGH
6-17 Office of Criminal Investigations Fiscal Year 2005 ________________________________________________________________________
Illegal Sale of Serostim (hGH) ___________________________
In October 2002, FDA’s OCI was contacted by the FBI, Honolulu, Hawaii, regarding the illegal sale of Serostim (hGH) in Honolulu, Hawaii, for use in bodybuilding. The investigation revealed that Eddie Gaviran (a Honolulu, Hawaii Firefighter) and Eddie Belluomini (a Honolulu, Hawaii Police Officer) were selling Serostim to body builders (an unapproved use) for $400 to $650 per box, substantially under wholesale prices ($800 to $1,400).
Some of Serostim (thought to be counterfeit) was forwarded to FDA for analysis. The packaging, labeling, and product were found to be consistent with authentic Serostim.
On February 26, 2004, Belluomini was convicted of violating 21 U.S.C. § 333(e) - Distribution/Possession of hGH.
On July 6, 2004, Gaviran was convicted of violating 21 U.S.C. § 333(e)(1) – Illegal Sale of hGH and sentenced to 6 months probation. Gaviran was removed from serving as a Honolulu, Hawaii firefighter.
On December 8, 2004, Belluomini was sentenced to 3 years probation, and ordered to serve 60 days of home detention with electronic monitoring. Belluomini was removed from his duties as a Honolulu, Hawaii police officer.
Customs Finds hGH at New York Mail Facility _________________________________________
On July 20, 2004, OCI was notified by FDA's New York District Office that a shipment containing 252 - 10 IU vials of hGH had been discovered. The package was found that day during a routine inspection by Immigration and Customs Enforcement (ICE) personnel at the New York mail facility. It had been shipped from China and was destined for Albert Milano in New Middletown, Ohio.
Milano was interviewed and admitted to importing hGH without a prescription for himself and three or four friends. Milano also showed U.S. Postal Inspectors where he had hidden an additional 113- 10 IU vials of hGH.
Serostim Sold for Use in Body Building - an Illegal Use
hGH Discovered During Routine Inspection by Immigration and Customs Enforcement
6-18 Office of Criminal Investigations Fiscal Year 2005 ________________________________________________________________________
The investigation disclosed numerous e-mails between Milano and Chinese hGH suppliers in which Milano claimed to have been purchasing 3000 – 5000 IU hGH per month. Milano also discussed with his suppliers various methods to avoid detection of the hGH by ICE personnel as it entered the country.
Milano was convicted of 21 U.S.C. § 333(e) – Possession with intent to distribute Human Growth Hormone. On October 25, 2005, Milano was sentenced to 3 years probation, 100 hours community service in U.S. District Court for the Northern District of Ohio, Eastern Division.
This case was investigated by OCI, the U.S. Postal Inspection Service and New Middletown Police Department.
Kickbacks Offered for Prescriptions for Human Growth Hormone (hGH) _________________________________________________________
This investigation was initiated in November 2000, based upon complaints alleging Serono Labs sold Serostim® (a human growth hormone) outside of its approved label indication for the treatment of AIDS wasting, which is an unintentional loss of at least 10% of body weight. A complaint also alleged that clinical research data was falsified and submitted to FDA, that prescriptions for the drug were falsified by sales representatives upon direction of Serono management, and kickbacks were given to doctors, patients, and pharmacies.
Although the allegations of falsified clinical research data were not proven, the investigation did result in several allegations being corroborated, including Serono's off-label promotion of Serostim.
While Health and Human Service’s Office of Inspector General (HHS/OIG) and FBI agents focused on the kickbacks and Medicare fraud allegations, OCI agents discovered that the off-labeling allegation referred to a complex scheme to broaden the indication from AIDS wasting through the use of bioelectrical impedance analysis (BIA) tests on patients in order to justify prescriptions of Serostim®. OCI also learned that Serono marketed Serostim® for lipodystrophy, which is unrelated to AIDS wasting, but may have similar signs and symptoms.
FDA cleared the BIA machine only for use in healthy individuals. The investigation revealed that RJL Systems, the manufacturer of the BIA machine used by Serono, had changed the algorithms in the BIA software but did not submit these changes to FDA and, therefore, was marketing a device that had not been approved.
U.S. Attorney General Announced $704 Million Settlement in Serono Case
6-19 Office of Criminal Investigations Fiscal Year 2005 ________________________________________________________________________
FDA learned that Serono worked with Rudy Liedtke, the owner of RJL Systems, to create the "Somascan" software specifically for Serono. This software was used by Serono sales representatives in tests on AIDS patients to show loss of lean body mass and body cell mass. Serono persuaded doctors to use this as a criteria to determine AIDS wasting and persuaded third-party payers to use this measure as a justification for reimbursement.
On December 21, 2004, Adam Stupak, a former Serono Regional Director of Sales, was convicted of three counts of 42 U.S.C. § 1320A-7(b)(2)(A) - Offering to pay illegal remunerations; and 18 U.S.C. § 2 - Aiding and abetting, for his part in offering three doctors in the New York City area all-expenses paid trips to a medical conference in Cannes, France, in exchange for writing thirty Serostim® scripts.
On April 19, 2005, Rudy Liedtke, the owner of RJL Systems, was convicted of 18 U.S.C. § 371 - Conspiracy to commit an offense against the U.S.
In April, 2005, Serono executives Mary Stewart
, former Vice President of Sales; John Bruens, former Vice President of Marketing; Melissa Vaughn, former Regional Sales Director; and Marc Sirockman, former Regional Sales Director, were indicted in the District of Massachusetts on charges relating to offering kickbacks to doctors in the form of a trip to a medical conference in Cannes, France, in exchange for writing additional prescriptions of Serostim®.
Vaughn was charged with one count of 18 U.S.C. § 371 - Conspiracy; and two counts of 42 U.S.C. § 1320a-7(b) - Offering to pay illegal remunerations for causing the offers to two doctors in Florida.
Sirockman was charged with one count of 18 U.S.C. § 371 – Conspiracy; and two counts of 42 U.S.C. § 1320a-7(b) - Offering to pay illegal remunerations, for offering the trip to a doctor in New Jersey and causing the offer to be made to another doctor in New Jersey. On October 17, 2005, Serono was convicted of 18 U.S.C. § 371 - Conspiracy to introduce into interstate commerce, with intent to defraud or mislead, adulterated medical devices; and one count of 18 U.S.C. § 371 - Conspiracy to offer and pay illegal remuneration. Serono was ordered to pay a $136,935,000 criminal fine and to repay $567,065,000 to the government to settle civil liabilities in connection with fraud upon the Medicare and Medicaid systems.
On the day of Serono’s conviction, Attorney General Alberto Gonzales and U.S. Attorney for the District of Massachusetts Michael Sullivan announced the investigation's findings, as well as the $704 million settlement, at a press conference in Washington, DC.
6-20 Office of Criminal Investigations Fiscal Year 2005 ________________________________________________________________________
Smuggling, Selling, and Distributing hGH _____________________________________
This investigation was initiated in October 2002, based on information received by the Department of Homeland Security's Immigration and Customs Enforcement (ICE), Blaine, Washington. During the course of its investigation, FDA learned that Darrellene Lowery and her associate, Lawrence Neri, were involved in purchasing and distributing hGH at the Bellingham Health and Fitness Gym, Bellingham, Washington, and David Thomas of Seattle, Washington, was illegally supplying hGH.
On June 27, 2003, Lowery was arrested in Ferndale, Washington. She admitted that she used steroids and hGH and that she had gone to Mexico on several occasions for the purpose of smuggling steroids into the U.S.
On July 7, 2003, Thomas was arrested in Seattle, Washington. During a search of his vehicle, hypodermic needles, steroid price list sheets, one vial of Cynomel, one vial of Deposterona, one vial of Norandren-200, and one bottle of Reforvit Simple were seized. The vials all bore Spanish labels and indicated they originated from Mexico.
FDA learned that Robert Sutton supplied drugs. Further inquiries revealed that Sutton and his associate Melanie Meo used a P.O. Box in Lynwood, Washington, to conduct their illegal drug business. Assistance was received from the Drug Enforcement Administration, Blaine, Washington, and U.S. Postal Service (USPS), Seattle, Washington. USPS learned that Sutton and Meo received many foreign and unusual packages at that mailing address.
On September 23, 2003, Thomas was convicted of violating 1 count of 21 U.S.C. § 331 (e)(1) and 18 U.S.C. § 371 - Conspiracy to Distribute hGH. Both Neri and Thomas were convicted of violating 1 count of 21 U.S.C. § 352 - Sale of a Misbranded Drug.
On December 18, 2003, Neri was sentenced to 15 days incarceration. Lowery was sentenced to time served and 3 years probation.
On December 29, 2003, Thomas was sentenced to 30 days incarceration.
On February 6, 2004, a package destined for Meo was opened pursuant to a federal search warrant. The package contained a large quantity of veterinary medicine and unapproved steroid drugs from Mexico. The street value of these drugs was estimated at approximately $60,000 to $80,000.
Extensive Investigation Resulted in Conviction of 6 Individuals
6-21 Office of Criminal Investigations Fiscal Year 2005 ________________________________________________________________________
Sutton admitted that he was the largest anabolic steroid and hGH dealer on the West Coast. Sutton admitted to selling approximately 1,500 boxes of hGH, including counterfeit hGH, to individuals throughout the U.S. Sutton received the prescription medicines, veterinary medicines, hGH, and anabolic steroids from Mexico, India, China, Iran, Pakistan, and Europe.
On February 9, 2004, Meo was arrested after she arrived at her residence in Washington. Meo admitted that she assisted Sutton in delivering hGH and anabolic steroids.
FDA learned that Adolfo Torres (in Mexico) supplied drugs. On March 5, 2004, Torres was arrested subsequent to the issuance of an arrest warrant at George Bush International Airport in Houston, Texas, after he entered the U.S. (in transit) bound for Spain.
I had my first prescription for HGH filled at College Pharmacy in Colorado Springs, Colorado. I only live two miles away from College Pharmacy, but most of College Pharmacy's business is by mail order. In the past, they have some very good prices on Genotropin and Saizen, but the price increases in the past three years have pushed their prices somewhat above some other sources such as Drugstore.com, -- except for the Norditropin Pen, for which College Pharmacy has one of the best available prices for any HGH product within the United States.
The best price that I currently know of at a licensed pharmacy within the United States on any of the major-label brands of HGH is $268.04 for 5.8 mg. Genotropin cartridges at Drugstore.com (as of January 31, 2007), however they usually don't keep this item in stock. That price is $15.40 per unit for purchases of 3 or more cartridges. (I have seen lower prices listed on other pharmacy web sites on one or two occasions, but telephone calls revealed that the product was not actually available.) Even at Drugstore.com, their web site often shows a price that is out-of-date. College Pharmacy's Norditropin Pen is a very close second to Genotropin from Drugstore.com. As of May 22, 2007, College Pharmacy was selling the 5 mg. (15 unit) Norditropin Pen for $240. Prices are continually changing, so by the time you read this, the situation may have changed.
If you are member of Costco, you may find good prices on HGH there.
I have often bought Genotropin from Drugstore.com. Most of the pharmacists at Drugstore.com are not very familiar with HGH, though. With all of the different brands of HGH and different packaging of each brand, it may take several phone calls between them and your physician and you to get everything set up just right. One time that I ordered Genotropin from Drugstore.com, I got the bare cartridges when I wanted the assembled Intra-Mix cartridges. I know of other people that have had this happen to them at other pharmacies. If (like me) you already have Intra-Mix cartridges, you can just unscrew the external Genotropin Mixer from the Intra-Mix cartridges and use them on the bare Genotropin cartridges. (This is a good reason for always saving a couple of your old empty Intra-Mix cartridges.) Otherwise, you'll have to get the Genotropin Mixer, which is an external plastic device that screws onto the bare Genotropin cartridges. The Genotropin Mixer is something that your pharmacy can obtain, but it may take several days.
College Pharmacy is the most hassle-free place to buy HGH. They have fairly good prices, and they nearly always have at least one major brand in stock at a very good price. They are very familiar with the use of HGH as a medicine by HGH-deficient adults against the manifestations of aging, and with the process of obtaining the HGH prescriptions from your physician, and with shipping the HGH in refrigerated packages. (HGH is usually shipped in a special styrofoam container with special gel packs that retain the cold temperature to keep the package contents at refrigerator temperatures during the shipping process.)
There are also a few other large compounding pharmacies in the United States which are good pharmacies for purchasing HGH.
With mail-order HGH, you will always have an overnight shipping charge. This usually amounts to about $17 for up to a six-month supply shipped anywhere in the U.S. It makes sense to order a three to six month supply to minimize shipping costs. Most pharmacies also have discounts for larger purchases.
Local pharmacy in steroid case feuded with California doctor
Friday, March 09, 2007
By EDDIE CURRAN
Staff Reporter
On the Web site of the New Hope Health Center, California doctor Ramon Scruggs promoted what he claimed to be the anti-aging benefits of steroids and human growth hormone and provided a means for people to become his patients and receive those drugs.
Scruggs no longer operates the site. Records show he was placed on 35 months probation last year and ordered by the Medical Board of California to cease practicing medicine over the Internet.
During a five-month period in 2002, Mobile-based Applied Pharmacy Services Inc. mailed Scruggs about $50,000 worth of anabolic steroids and human growth hormone, according to a lawsuit that was filed in Mobile County Circuit Court and claimed Scruggs failed to pay for the drugs.
Applied Pharmacy won a judgment when Scruggs failed to respond to the lawsuit, but these days, the company on International Drive near Colonial Mall Bel Air is winning little besides terrible publicity.
Enter the company's name in Google news, which serves up recently published news stories, and you get about 600 hits.
According to many of those reports -- including an exhaustive story in Sports Illustrated -- Applied Pharmacy and two of its owners, Alston S. "Sam" Kelley and Jason R. Kelley, played a central role in what prosecutors have described as a nationwide scheme to distribute steroids and HGH to people, including top professional athletes, who had no legitimate need for the medications.
About a dozen people have been charged in the case, including individuals in New York and Florida. No one associated with Applied Pharmacy has been charged.
The company, though, has hired Mobile criminal lawyer Arthur Madden and another attorney in Albany, N.Y., where the probe originated, Madden said.
Athletes named
Among the current and former professional athletes identified as having been sent steroids and HGH produced by Applied Pharmacy: former heavyweight champion boxer Evander Holyfield; Olympic gold medal wrestler Kurt Angle; former Atlanta Braves pitcher John Rocker; retired home run champion and admitted steroid user Jose Canseco; and current major leaguers Gary Matthews Jr. and Jerry Hairston.
On Thursday, it was reported that officials with Major League Baseball had traveled to Albany to meet with Albany County District Attorney David Soares, whose office initiated the investigation.
National Football League officials have also pledged to meet with Soares, following reports that a team doctor for the Pittsburgh Steelers received steroids and HGH from an Orlando pharmacy that, like Applied, that has been identified as a source of performance-enhancing drugs.
Applied Pharmacy is what's known as a compounding pharmacy. Such companies order the raw materials for prescription medications, then produce the drugs, much in the way pharmacies operated decades ago, before the advent of the major pharmaceutical companies.
'Customized'
According to its Web site, Applied Pharmacy "is a licensed mail-order compounding pharmacy, dedicated to hard-to-find medications and customized delivery systems for physicians and patients."
Products listed on the company's Web site include treatments for baldness, pain management, wrinkles and male sexual dysfunction, as well as hormonal medications.
According to media reports, the probe began in 2004, when Albany-based New York state narcotics officers began an investigation of an area doctor, David Stephenson, who operated a Web site called docstat.com.
Sports Illustrated reported that Stephenson was buying "massive quantities" of drugs, including steroids, and Applied Pharmacy was his main supplier.
The probe expanded to include a host of agencies, including the Drug Enforcement Administration, the Internal Revenue Service and the U.S. Justice Department.
In August, the investigation moved into high gear, as DEA agents raided Applied Pharmacy's Mobile offices as part of an operation code-named Operation Netroids. According to media reports, the names of many pro athletes were found in the company's records as having received prescriptions for anabolic steroids and HGH.
Other court records reflect that Mobile-based federal prosecutors have been looking at Applied Pharmacy since at least September 2005.
That month, the U.S. Attorney's Office in Mobile asked a federal magistrate judge for permission to review the federal tax records of Applied Pharmacy, a related company called Gulf South Pharmaceutical Lab, and four individuals, including Sam and Jason Kelley (not the same Jason Kelley who coached girls basketball at McGill-Toolen Catholic High School).
Also sought were the tax records of a Florida man, Ronald Wade Welch, and Jodi Carl Silvio, a local pharmacist who owns and operates two Medicap Pharmacy locations, one in Mobile's Midtown area, the other in Fairhope.
Documents associated with the case were sealed, and there is no indication of whether the judge granted the prosecutors' request.
Just because someone is listed as an interested party does not mean that he or she is the target of a criminal probe, authorities said. More than a dozen people have been charged, including individuals in New York and Florida, but none in Alabama.
Ongoing investigation
An investigation into Applied Pharmacy remains ongoing, Assistant U.S. Attorney Gloria Bedwell, the prosecutor working the case, said Wednesday.
Bedwell, though, declined to comment further or to say if the investigation is related to the one based in Albany.
Silvio said Thursday that he is a minority owner in Applied Pharmacy but works full-time at his own pharmacies and is not involved in Applied's day-to-day operations.
"I haven't been contacted by any law enforcement people," Silvio said.
He said he's aware of the media reports about the company but doesn't know if they're true.
Many people, such as those with AIDS, have legitimate needs for steroids, he said. Applied Pharmacy relies on written prescriptions by doctors and counts on physicians to make correct diagnoses before ordering the medications made by the pharmacy, he said.
Officials with the Alabama State Board of Pharmacy said this week that the state agency is also investigating Applied Pharmacy, but board officials otherwise declined comment.
The Kelleys have repeatedly declined to comment about the news reports and have referred questions to Madden.
The Mobile lawyer cautioned that people should not be too swayed by media reports about Applied Pharmacy. Steroids and HGH are banned by professional sports leagues, but that's not the same as them being illegal, he said.
"It's not like these drugs are illegal," he said. "There is a real variety of approved medical uses for them, and physicians use them in the treatment of all kinds of conditions." [DR PERLS COMMENT: The allowed indications for steroids or HGH in adults are extremely narrow and clearly defined. None of these indications could legally justify HGH for athletic-related uses or anything associated with aging]
(Staff Reporter Brendan Kirby contributed to this report.)
3 at Springs pharmacy indicted over unapproved hormone Contact: Jeff Dorschner of the Office of United States Attorney Troy Eid, District of Colorado, +1-303-454-0243
DENVER, Aug. 29 /PRNewswire-USNewswire/ -- College Pharmacy, a Colorado Springs based pharmacy, its owner, a sales representative, and a sales representative from a company in Houston, Texas, have been indicted by a federal grand jury in Denver for the illegal importation and distribution of hGH, human growth hormone, from China, United States Attorney Troy A. Eid announced. Thomas Bader, age 63, who owned and operated the pharmacy, and Kevin Henry, age 56, a College Pharmacy sales representative, were arrested yesterday without incident by Special Agents of the Food and Drug Administration's Office of Criminal Investigations, as well as agents from U.S. Immigration and Customs Enforcement (ICE), the Drug Enforcement Administration (DEA), and the Federal Bureau of Investigation (FBI). Also charged was Bradley Blum, age 36, of Houston, Texas. Blum was a sales representative for a company facilitating the illegal importation of hGH from China. Bader and Henry made their initial appearance in U.S. District Court today.
According to the indictment, the defendants allegedly bought, received and distributed Chinese manufactured human growth hormone (hGH), which had not been approved by the FDA. Once the growth hormone was received in the United States, the defendants allegedly repackaged the product and sold it to physicians and their patients throughout the country. The indictment also alleges that the defendants were aware that the Chinese manufactured hGH was misbranded and unapproved for distribution and use in the United States.
The FDA through provisions of the Federal Food, Drug and Cosmetic Act (FDCA) limits the use of Human growth hormone (hGH), also known as somatropin, to the treatment of a disease or other recognized medical condition that has been authorized by the Secretary of Health and Human Services (HHS). In addition, the FDA has never approved the distribution or use of any hGH manufactured in or imported from China.
Bader was a licensed pharmacist in the State of Colorado, and was the owner, operator and officer of College Pharmacy, located in Colorado Springs, Colorado. Bader employed Henry, who functioned as a sales representative for the pharmacy. Henry was responsible for finding sources of drugs, including hGH, and also for selling and marketing products distributed by College Pharmacy.
According to the indictment, among the drugs distributed by Bader through College Pharmacy was hGH. The indictment alleges that both defendants knowingly bought the hGH from companies that manufacture genetically derived hGH in China, including GeneScience.
After the drug was imported into the United States, Bader allegedly directed his employees to repackage the Chinese hGH into vials labeled College Pharmacy, including boxes and information. The indictment states that between September 2004 and March 2007, Bader advertised and marketed hGH and distributed the product by delivering it using various interstate carriers.
Bader is charged with one count of conspiracy, ten counts of mail fraud, four counts of distribution of human growth hormone, one count of sale or facilitating the sale of smuggled goods, and one count of asset forfeiture.
Henry is charged with one count of conspiracy, ten counts of mail fraud, four counts of distribution of human growth hormone, and one count of asset forfeiture.
Blum is charged with four counts of distribution of human growth hormone, one count of sale of facilitating the sale of smuggled goods, and one count of asset forfeiture.
The corporation College Pharmacy is also charged in all eighteen counts of the indictment.
The penalty for conspiracy as well as the penalty for the distribution of human growth hormone is not more than 5 years in federal prison, and up to a $250,000 fine. The penalty for mail fraud as well as receiving smuggled goods and facilitating the sale of smuggled goods is not more than 20 years in federal prison, and up to a $250,000 fine.
The indictment also includes an asset forfeiture count. Among the assets that are the subject of the forfeiture count are approximately $4,100,000 in cash, and real property, including the pharmacy, a property in Iowa, properties in North Carolina, several properties in Florida, as well as properties in Manitou Springs, Colorado Springs, Castle Rock, and Denver.
"Our drug-trafficking prosecutions here in Colorado are increasingly international, especially when illicit pharmaceuticals are involved," said U.S. Attorney Troy Eid. "Asia is an especially attractive source for drug smugglers. These can be complex and expensive investigations, but cases like College Pharmacy show we won't hesitate to meet this new challenge."
"The FDA Office of Criminal Investigations takes very seriously the investigation and ultimate prosecution of those who endanger the public by selling unapproved and illegal drugs. The safety of these drugs is questionable at best, and the defendants placed profits ahead of public safety by selling potentially harmful substances," said Larry Sperl, Special Agent in Charge of the FDA Office of Criminal Investigations Kansas City Field Office. "The FDA Office of Criminal Investigations would like to thank the US Attorney's Office for their diligence and support in pursuing this case."
This case was investigated by the FDA's Office of Criminal Investigations, the U.S. Immigration and Customs Enforcement (ICE), the Drug Enforcement Administration (DEA), and the Federal Bureau of Investigation (FBI).
The case is being prosecuted by Assistant United States Attorneys Jaime Pena and Gregory Rhodes. The Asset Forfeiture issues are being coordinated by Assistant United States Attorney James Russell.
The charges are only allegations, and the defendants are presumed innocent unless and until proven guilty.
SOURCE U.S. Department of Justice
Prosecutor takes over steroids [hGH] probe
Mercer County officers allegedly bought drugs
Saturday, August 25, 2007
BY KEVIN SHEA
The Mercer County Prosecutor's Office has taken over the investigation into a group of Mercer County police officers that is accused of illegally buying human growth hormone, known as HGH, for personal use, the office confirmed yesterday.
And the case may be heating up, multiple law enforcement sources tell The Times. The probe, which came to light in May of last year, started as a federal investigation by the U.S. Attorney's Office in Camden after federal investigators forwarded them information from a case in Ohio concerning a Florida dentist who was dealing with HGH.
The dentist, Jeffrey M. Weiser, of Lake Worth, Fla., is a former New Jersey resident who in 2005 pleaded guilty in federal court in Cincinnati to selling HGH and other controlled substances over the Internet.
As part of that investigation, Weiser's records and e-mail correspondence were seized and law enforcement sources have said those records led to a group of mainly Trenton police officers and at least one Mercer County Sheriff's officer.
Sources say federal prosecutors ultimately handed over the investigation to the New Jersey Attorney General's office, and they in turn handed it over to Mercer prosecutors.
Casey DeBlasio, spokeswoman for the prosecutor's office, would only confirm the office has the investigation and refused to answer any other questions about the case.
Law enforcement sources, however, say there has been recent activity on the case including discussions between prosecutors and the Trenton Police Department. Trenton police spokesman Sgt. Pedro Medina also refused to answer questions about the probe.
Weiser, who once lived in Marlton in Burlington County, retired in May 2001, federal authorities have said, and moved to Florida, where he opened a personal fitness consulting business.
His business maintained a presence on a number of Internet Web sites promoting personal fitness, body building and the use of anabolic steroids and human growth hormone.
In 2001, authorities say, Weiser began prescribing testosterone and other anabolic steroids such as Nandrolone, Oxandrolone, Stanozolol, as well as prescription HGH for what officials say were hundreds of his personal fitness customers throughout the United States. They say he also began prescribing drugs to offset the side effects of anabolic steroid abuse for these same customers.
HGH can be legally prescribed to promote bone and tissue growth for specific ailments.
But Weiser prescribed the drugs without ever meeting his clients, who officials say came to him through referrals or the Internet.
The federal investigation of Weiser shows that customers e-mailed their requests to Weiser, who then faxed the prescriptions to various pharmacies throughout the country. The customers then paid the pharmacies for the drugs and paid Weiser a fee for each prescription, authorities said.
Although he pleaded guilty in 2005, Weiser's federal sentencing has been delayed because of his "substantial assistance" to authorities in jurisdictions outside Ohio.
Weiser's Florida lawyer said yesterday the sentencing is scheduled for October.
Kevin Shea can be reached at (609) 989-5705 or kshea@njtimes.com.
PROPONENT: Dr. Eli Hammer is a proponent of the use of human growth hormone as part of anti-aging treatment. He is also under investigation by federal officials.
August 5, 2007
Raids trigger debate on growth hormone anti-aging therapy
Dr. Eli Hammer was talking with a patient in the conference room of his north Scottsdale office when seven federal drug agents wearing bulletproof vests walked in and handed him a search warrant.
Ten hours later, they left with Hammer’s patient files, copies of computer hard drives, 19 stacks of documents and about 200 vials of human growth hormone.
“They picked the wrong office,” Hammer said. “The DEA investigation was completely off base.” The May 1 Drug Enforcement Administration raid sparked an investigation by the Arizona Medical Board that threatens Hammer’s medical career and intensifies debate about the lucrative anti-aging industry and its legions of well-heeled baby boomers willing to do whatever it takes to look and feel younger.
The doctor agreed to talk about his case and the debate over the medical use of growth hormone in an exclusive interview with the Tribune.
At issue is whether growth hormone does more harm than good, when it should be legal to prescribe for aging adults and who should decide.
“It gives me energy and clarity of mind,” said Jim Dougherty, the 65-year-old founder of PetSmart. “I feel great.”
Diagnosed years ago at the Mayo Clinic with hypogonadism, or abnormally low levels of testosterone, he said it wasn’t until he started seeing Hammer five years ago that he found the right chemical balance.
Dougherty injects himself six times a week with growth hormone and once a week with testosterone, plus takes vitamin supplements. Hammer checks his blood every three months and adjusts dosages as needed.
Sales of growth hormone reportedly top $600 million a year in the U.S. and an estimated 30,000 Americans have taken the drug, including celebrities like Sylvester Stallone and Nick Nolte.
So there’s much at stake as it comes under increasing scrutiny from federal and state law enforcement, with arrests this year of more than 20 people in connection with prescribing and dispensing growth hormone, including doctors and pharmacists in Florida, New York and Texas.
“We’re not looking at the users,” said Ramona Sanchez, special agent with the DEA in Phoenix. “We’re looking at those doctors that distribute and dispense it absent (certain) medical conditions.”
Sanchez won’t say why Hammer’s growth hormone prescribing practices were targeted or whether his case is connected to recent local search warrants that linked Mesa, Chandler and Phoenix police and firefighters to steroid use. No arrests have been made.
“We’re scratching the surface right now,” she said. “We’ll let the evidence take this wherever it goes.”
Growth hormone is illegal under federal law except to treat childhood growth disorders, AIDS wasting, pituitary tumors and adult hormone deficiency, typically due to a pituitary tumor or trauma. Unlike most drugs, the law forbids prescribing it “off-label” to counter the effects of advancing age or improve athletic performance.
Studies, including the 1990 research that spawned hundreds of anti-aging clinics, show dramatic cosmetic improvements in subjects treated with high doses over relatively short periods.
But they’ve also shown troubling side effects, including edema, diabetes, joint pain and abnormal growth of bones or internal organs.
“There’s absolutely no proof that giving growth hormone helps anybody in any way,” said Dr. Thomas Perls, associate professor of geriatrics at Boston University School of Medicine who runs the Web site www.antiagingquackery.com. “I think anybody who is selling growth hormone for anti-aging is a quack,” Perls said.
But Hammer and others, led by two Chicago osteopathic physicians who started an anti-aging academy that now claims some 17,000 members, believe a blood test can diagnose older men and women as being hormone deficient and thus legal candidates for treatment.
“There’s no law saying I can’t treat them for adult growth hormone deficiency, and that’s what I do,” Hammer said. “I don’t see how the government should get involved with a doctor-patient relationship.”
The Arizona Medical Board suspended Hammer’s license last month because he refused to submit to a board-ordered substance abuse evaluation, but a judge suspended the board’s action pending an administrative hearing.
Timothy Miller, executive director of the board, which regulates Arizona physicians, said its investigation stemmed from the DEA raid on Hammer’s office and took another turn after the doctor tested positive for the anti-anxiety drug Xanax and lacked a prescription for it.
Hammer and his attorneys say he took the drug before an international flight and was not impaired. The board’s action was unwarranted, they say, and has done irreparable damage to his medical practice.
Regarding the growth hormone allegations, Miller wouldn’t say whether the board has access to patient files seized by the DEA. But, typically, those charts would be reviewed to see if prescriptions fit patient diagnoses, and how the diagnoses were made.
“It’s really an issue of looking at a particular case and seeing if it was appropriate for that patient,” Miller said. “It’s not always black and white.”
Since growth hormone naturally declines with aging, and levels vary widely throughout the day, Perls and other doctors argue that it’s impossible to diagnose hormone deficiency with just a blood test.
Dr. S. Mitchell Harman, director and president of the Kronos Longevity Research Institute in Phoenix, said potential side effects of anti-aging growth hormone use outweigh any short-term benefit.
Harman co-authored a 2002 follow-up to the 1990 anti-aging study, giving Milwaukee veterans high levels of growth hormone over a six-month period to see if there were functional improvements.
Just like the subjects in 1990, they lost body fat and gained lean muscle mass, even without exercise or changes in their diet. But nearly half of them suffered serious side effects: diabetes, swollen tissue and aching joints.
Anti-aging practitioners argue that lowering the dosage will solve those problems. But Harman says the evidence just isn’t there to say the stuff is safe, much less effective.
“These doctors who are out there prescribing growth hormone for otherwise healthy people, they don’t have a scientific leg to stand on,” he said.
He calls the XXX XXX XXX Anti-Aging Medicine “a bunch of fakes” and its members “physicians who have opted out of mainstream medical practice.”
“I think some of them are quite sincere. We tend to believe things that are in our own self-interest,” Harman said. “I think there’s an element of self-delusion.”
The academy’s certificate hangs on the wall in Hammer’s office. Though it’s not recognized as a specialty by the American Medical Association and Hammer distances himself from the group’s controversial founders, he’s proud to say that he walked away from mainstream medicine because it only allowed him to dispense pills, not practice prevention.
Tall, fit and trim, Hammer sits behind a teak desk in his office and talks about discovering growth hormone as an overweight, unhappy family physician.
It changed his life. He abandoned his practice and started the Hammer Institute for Anti-Aging Medicine in 2000, where he recommends a regimen of diet, exercise, vitamin supplements and growth hormone.
Hammer says it was a fluke that he had 200 vials of growth hormone in his office the day DEA burst in. Food and Drug Administration pressure on compounding pharmacies squeezed local supply. The Mesa pharmacy he had been using ran out, so he ordered from a Southern California pharmacy that shipped it to his office.
For the most part, growth hormone investigations have involved athletes, bodybuilders and illegal Internet trafficking, where doctors write prescriptions without even seeing the patient.
“My assumption is the DEA will say, ‘You’re not what we were looking for. This is not the practice we’re looking for.’”
What is growth hormone? Growth hormone is produced in the pituitary — a tiny gland at the base of the brain — and stimulates growth and cell reproduction. Growth hormone production slows as you age, beginning in your 40s.
Human growth hormone is made synthetically through recombinant DNA technology, in which bacteria or animal cells are given the gene that directs them to make growth hormone.
FDA-approved uses
• Hormonal deficiency that causes short stature in children
• Long-term treatment of short stature associated with Turner syndrome
• Adult short bowel syndrome
• Muscle-wasting disease associated with HIV/AIDS
• Adult hormone deficiency due to pituitary disease, surgery, radiation or trauma
Growth hormone shots can: • Increase bone density
• Increase muscle mass
• Decrease body fat
• Improve mood, motivation and libido
• Increase exercise capacity
Side effects can include: • Swelling in arms and legs
"Age-management specialist" ordered to curb advertising. From Stephen Barrett MD, www.Quackwatch.com, August 21, 2007
Philip S. Czekaj, M.D. and the Texas State Board of Medicine have entered into an agreed order under which Czekaj was assessed an administrative penalty of $500.
Czekaj operates the Genesis Medical Spa in San Antonio, Texas, which, in 2006, advertised that in addition to being board certified. Czekaj was trained and certified by the Cenegenics Institute in the field of age management medicine. (The site also defined age management medicine as "a proactive approach that utilizes hormone modulation and nutritional supplementation to help prevent disease and minimize the effects of aging.") The board became concerned that prospective patients might conclude that Czekaj was certified in "cenegenics" or "age management medicine" instead of emergency or preventive medicine in which he is actually certified. Cenegenics and age-management medicine are not medically recognized specialties
Texas Medical Board Disciplins Doctors For Advertising That He Is Board Certified in Anti-Aging Medicine
PILISZEK, THEODORE S., M.D., HOUSTON, TX, Lic. #G1149 On April 13, 2007, the Board and Dr. Piliszek entered into an Administrative Agreed Order assessing an administrative penalty of $250. The action was based on allegations that Dr. Piliszek advertised that he is board certified in anti-aging medicine and nutrition, an area that is not certified by a member board of the American Board of Medical Specialties.
LE CONEY, RICHARD HUCHET, M.D., KEMAH, TX, Lic. #F0243 On August 25, 2006, the Board and Dr. Le Coney entered into an Agreed Order assessing an administrative penalty of $250. The action was based on allegations that Dr. Le Coney advertised he was board certified in anti-aging medicine although he was not.
Steelers drop longtime MD
Internist was linked to purchase of $150,000 in steroids, HGH
Friday, June 15, 2007
By Ed Bouchette, Pittsburgh Post-Gazette
The Steelers have removed Dr. Richard Rydze from their medical staff roster, an apparent reaction to the revelation in March that he had purchased $150,000 in testosterone and human growth hormone with his own credit card.
Rydze was interviewed by investigators from Albany County, N.Y., in February, but never accused by them of any wrongdoing. Nevertheless, his employers at the University of Pittsburgh Medical Center began their own investigation after his name surfaced in the New York case.
More than three months later, UPMC officials are not ready to comment about their investigation, said Susan Manko of the hospital's news bureau.
Steelers President Art Rooney II declined comment yesterday on the team's dropping Dr. Rydze, an internist, after 21 years of working mostly on game days for them. Previously, Rooney said, "There is no evidence that Dr. Rydze prescribed or provided any hormone treatments to any of our players. Dr. Rydze has assured me that this has never happened and will never happen."
Nevertheless, having a doctor on their staff connected to steroids purchases apparently was not something the Steelers believed they could tolerate.
The NFL bans the use of any kind of steroids or human growth hormone. Dr. Rydze previously told Sports Illustrated he uses the HGH to treat older patients. He is medical director of the Little Sisters of the Poor Nursing Facility, according to his bio on a UPMC Web site.
Rydze's name surfaced during an investigation by an Albany, N.Y., prosecutor into an illicit steroids distribution network that led authorities to raid two facilities in Orlando, Fla., and arrest four company officials in February.
According to the Times-Union of Albany, N.Y., a New York investigator flew to Pittsburgh to interview Rydze about why he used his credit card to purchase about $150,000 in testosterone and human growth hormone in 2006.
Although never a target, Rydze told the New York Times that investigators had urged him to stop using a Florida pharmacy under their scrutiny and that he complied. UPMC officials also wanted some answers.
Dr. Rydze, a 1972 Olympics silver medalist in platform diving who is enshrined in the Western Pennsylvania Sports Hall of Fame, could not be reached for comment.
If Dr. James Shortt (above in a 2005 file photo) does not pursue further appeal, he will be assigned to a correctional facility by the U.S. Bureau of Prisons.
The U.S. Court of Appeals for the 4th Circuit has upheld the one-year, one-day sentence of Dr. James Shortt for illegally distributing steroids and human growth hormone to Carolina Panthers players and other patients.
In an opinion published today, 4th Circuit Judge Paul V. Niemeyer wrote on behalf of a three-judge panel that "Shortt's conspiracy subverted professional sports as an institution and the roles that professional athletes play in this country."
Shortt's attorney, assistant federal public defender Allen Burnside, had argued that the sentence handed down by U.S. Circuit Court Judge Joe Anderson in July more than doubled the recommended sentencing range of zero to six months, based on federal guidelines.
Prosecutors had asked Anderson to give Shortt a longer sentence than the recommendation, partly because the guidelines didn't address the distribution of HGH for performance-enhancing purposes.
The appeals court, based in Richmond, Va., strongly sided with Anderson, saying newer guidelines than were applicable in Shortt's case now would give the doctor a sentencing range of 15 to 21 months and still not take into account the illegal HGH distribution.
"Professional athletes have extraordinary influence on admiring and aspiring young athletes," Judge Niemeyer wrote. "Shortt's destructive influence on our national games is a social consideration which is both important to the sentencing determination and unaccounted for in the sentencing guidelines."
Court records showed Shortt provided steroids and HGH to at least seven Panthers players from 2002 to 2004, including during the team's 2003 Super Bowl season. Discoveries in the case led the NFL to strengthen its testing and disciplinary program for banned substances.
Shortt, formerly of West Columbia, S.C., has two options for further appeal, according to a 4th Circuit spokesperson. He has 14 days to file a petition for a rehearing before all 12 4th Circuit judges, or 90 days to appeal to the U.S. Supreme Court.
If Shortt does not pursue further appeal, he will be assigned to a correctional facility by the U.S. Bureau of Prisons. Burnside has asked that Shortt be assigned near his new home in California.
Barbara Brewitt, Ph.D. has been fined $415,000 for falsely claiming to be a medical doctor and illegally Biomed Comm, Inc. http://www.biomedcomm.com/ The health law judge's order manufacturing and selling homeopathic "healthy aging" drugs through her Seattle-based company http://www.casewatch.org/ag/wa/brewitt/order.pdf concluded:
**Brewitt and Biomed Comm were not licensed to manufacture or sell drugs.
**Over a 5-year period, Brewitt falsely represented herself as a medical doctor more than 20 times to a Seattle-based pharmacy in order to obtain Norditropin, a growth hormone drug used in Biomed Comm's manufacturing process.
**Brewitt's products were promoted for treating Alzheimer's disease, autism, cancer, menopausal symptoms, attention deficit hyperactivity disorder (ADHD), and HIV/AIDS and about 50 other conditions. Many callers to her company were advised about what to take for their conditions.
**Inspections of her manufacturing facility revealed multiple law violations. On one occasion, Brewitt hid materials in her car that she did not want the inspector to see. http://www.casewatch.org/ag/wa/brewitt/inspection.pdf
Concluding that Brewitt had "systematically avoided compliance with laws regulating the manufacture and sale of drugs," the judge ordered the maximum $1000-per-day penalty for (a) 315 days of unlicensed drug sales, (b) 37 days of unlicensed manufacturing, and (c) 63 days of unlicensed practice of medicine.
In a parallel action, another health law judge denied Biomed Comm's application for a license to manufacture drugs and prohibited it from reapplying for a 10-year period. The judge's order concluded that Brewer had engaged in dishonesty, misrepresentation, and unprofessional conduct. http://www.casewatch.org/ag/wa/brewitt/license_denial.pdf
The Department of Health's investigation was triggered by a complaint from a former employee who stated that Brewitt herself mixed many of the products in her own kitchen as she chanted over a crystal bowl. The department obtained a temporary restraining order in February 2006. http://www.casewatch.org/ag/wa/brewitt/tro.shtml
A former researcher at the National Institutes of Health, Barbara Brewitt knows growth, as in human growth hormones. Her company's hGH-based formulas purport to treat everything from menopause to fatigue. Whether or not they work, they're generating growth of another sort, thanks to Costco.com, drugstore.com, GNC, and, as of December 2003, Amazon.com.
2004 FAST 50 WINNER
Barbara Brewitt, Ph.D.
CEO and CSO, Biomed Comm Inc. Seattle - WA US
From Barbara's original entry:
Tell us what you do (or what your team or organization does) and the specific challenge you faced.
In a world where pharmaceutical companies dominate medicine and natural supplements offer quick fixes for health, Dr. Barbara Brewitt is bucking the system. As a former researcher with the National Institutes of Health (NIH) - and with nine (9) International and US patents to her name - she discovered that when it comes to the human body, less is more. She is internationally recognized for her double blind, placebo-controlled clinical studies on human growth hormone and growth factors. Through these studies, she discovered that by simply enhancing the body's ability to communicate with itself on a cellular level, the body achieves optimal immune, nervous and hormonal health. The catch - while many people want you to believe that you need large doses of drugs to "cure" yourself, Dr. Brewitt has proven the opposite. By observing the body's natural responses, she created a system of cell-signal enhancers that utilize diluted doses of a her patented Human Growth Hormone (hGH) to provide effective health solutions at affordable prices that are accessible to the masses. Dr. Brewitt's research flies in the face of both the pharmaceutical and natural product industries that believe external solutions can be found for internal problems.
What was your moment of truth?
As a researcher at the NIH, Dr. Brewitt studied the effects of several medications on cataracts and the eye lens. While most researchers around her were providing the lens with increasingly higher doses of medications - and things were getting worse - she took the opposite approach and continually lowered the dose of growth factors, and it worked. She observed that increasingly high doses of foreign substances could shock the body and shut biological processes down completely. She observed that the body releases low-level "pulses" of hormones to stay in balance and combat disease, rather than releasing hormones in a steady stream. The body takes breaks. This simple discovery shaped all of her subsequent research and is the cornerstone of her product line. She approaches disease as the body would; with low doses of medication administered in a sporadic but predictable pattern. Her solutions integrate practical safety of natural medicines with the rigorous scientific control of modern medicine, at a low-cost that makes optimum health accessible on a worldwide level. As such, Dr. Brewitt provides a sustainable worldwide medical option to an industry and people in need of a healthier future.
What were the results?
In 1996, Dr. Brewitt founded Biomed Comm Inc., which provides a complete line of hGH based cell-signal enhancers available over the counter. Biomed's medicines are uniquely positioned to take advantage of a multi-billion dollar market as they address a variety of issues ranging from PMS and stress to human-immunodeficiency syndrome and autism. Biomed has experienced nearly 300% growth in the mass markets over the past 2 years, leveraging sales relationships with major brick and mortar retailers such as GNC, and Wild Oats, as well as branded e-commerce players such as Costco.com, Drugstore.com, among others. Her groundbreaking approach has resulted in her being a frequent guest speaker and author of numerous articles on subjects ranging from child development to healthy aging, and applications of human growth hormone (hGH) to combinations of CSE(R) growth factors for HIV and autism.
Paper: Houston Chronicle Date: Wed 03/07/2007 Section: B Page: 3 Edition: 3 STAR
`Main doctor' led authorities to local firm / Investigators say steroid scheme revealed through undercover work
By CINDY GEORGE, ROBERT CROWE Staff, Albany Times Union, Associated Press
A nationwide probe that accused a Sugar Land company in a scheme to illegally sell steroids over the Internet made contact with the business by having an undercover New York health investigator pose as an unscrupulous doctor, narcotics investigators said.
The phony doctor - who agreed to write prescriptions without even meeting patients - was introduced to Cellular Nucleonic Advantage by a Manhattan physician who cooperated with agents after being identified as "the main doctor" in the multimillion-dollar illicit drug ring, investigators said.
The founder of CNA and two employees are among those now facing felony charges in New York state, which has some of the nation's strictest drug laws.
In addition, U.S. Sen. Chuck Schumer, D-N.Y., said this week that he will propose legislation to make sales of illegal online prescriptions a federal crime.
Investigators in the wide-ranging probe, dubbed "Operation Which Doctor," say the Sugar Land company distributed anabolic steroids, human growth hormone and other prescription drugs through an illegal online enterprise. The yearlong probe was made public last week after a task force raided an Orlando, Fla., pharmacy.
Bidding war
CNA was among a number of "anti-aging" companies in at least four states that were engaged in a bidding war for physicians, some of whom were unlicensed, prosecutors allege. CNA is accused of directing clients to fill mail-order prescriptions with the Orlando company, Signature Compounding Pharmacy.
The Houston-area suspects are Benjamin Eugene Bolton Jr., 39, of Bay City; Monday Ann Miller, 38, of Sugar Land; and Sweta Patel, 24, of Sugar Land, also known as Sally Patel. They face New York state drug charges in a 32-count indictment. As many as 24 people, including physicians and pharmacists, could face similar charges.
Albany County, N.Y., District Attorney P. David Soares organized the probe, which involved New York and federal agents. His prosecutors said they began realizing the scope of the illegal Internet drug trade two years ago after arresting a physician for selling steroids online from his New York home. That doctor is serving a six-year prison sentence.
The physician credited with introducing the task force's phony doctor to CNA is Ahmed Halima, a Manhattan spine specialist whom investigators call "the main doctor" in the operation. They say he wrote more than 800 prescriptions for CNA during a four-month period last year, sometimes without meeting patients. Halima has not been charged because he suffered a debilitating stroke, the lead narcotics agent on the case said.
Evidence collected
The Sugar Land company was one of several businesses that bid for the phony doctor's services by appealing to a fake company called Nu-Life Hormone Replacement Therapy in Albany, investigators said.
Through those connections, the New York State Bureau of Narcotic Enforcement collected evidence through wiretaps from a number of companies, including CNA's office suite on Dairy Ashford in Sugar Land, agents said. That office was raided late last year, resulting in the arrests of Bolton and Miller. Patel went to New York and turned herself in.
Bolton, who attended Lamar University in Beaumont and Stephen F. Austin State University in Nacogdoches, founded CNA in 2004. Public records show he has started many small businesses, including a publishing company, a laser hair therapy center and various fitness and health companies.
Bolton, a 6-foot-7-inch former semipro football player, could not be reached for comment. Miller declined to comment.
Patel was CNA's receptionist by the time investigators were monitoring the company, said her lawyer, Phillip Steck of Albany. He said she was an unsuspecting college student who got caught up in something that looked legitimate.
OREGON BOARD OF MEDICAL EXAMINERS
THOMASHEFSKY, ALLEN JAN, MD; MD08126; ASHLAND, OR
01/11/2007 Voluntary Limitation Licensee entered into a Voluntary Limitation with the Board on January 11, 2007. In this Order, Licensee agreed to not prescribe or administer HGH (human growth hormone) for non-FDA approved indications. If Licensee treats any patient with HGH for an FDA approved condition, Licensee will document the medical indications that support treatment and will obtain and document a consultation with an endocrinologist, approved by the Board's Medical Director, who concurs with the use of HGH. This Order is not a disciplinary action. View Order 10/13/2006 Interim Stipulated Order Licensee entered into an Interim Stipulated Order with the Board on October 13, 2006. In this Order, Licensee agreed not to prescribe Human Growth Hormone until the Board's investigation is complete. View Order
DIAZ, THOMAS EDWARD, M.D., IRVING, TX, Lic. #H4284
On October 7, 2005, the Board and Dr. Diaz entered into an Agreed Order assessing an administrative penalty of $5,000. The action was based on allegations that Dr. Diaz failed to practice medicine in an acceptable professional manner by selling vitamins and supplements to five patients for prevention and longevity health treatments at a profit and prescribing human growth hormone to one female patient for anti-aging effects.
WANTED BY THE FBI
Wanted for selling HGH
HEALTH CARE / MEDICAL FRAUD; CAUSING INTRODUCTION OF MISBRANDED DRUGS INTO INTERSTATE COMMERCE; MISBRANDING MEDICATION; FALSE STATEMENTS TO THE GOVERNMENT; OBTAINING CONTROLLED SUBSTANCES BY MISREPRESENTATION
STEVEN GABRIEL MOOS
Aliases:
Steven Moos, M.D., Dr. Steven Gabriel Moos, M.D.
DESCRIPTION
Date of Birth Used:
July 22, 1969
Hair:
Brown
Place of Birth:
Indiana
Eyes:
Brown
Height:
6'3"
Sex:
Male
Weight:
185 pounds
Race:
White
NCIC:
W895984763
Nationality:
American
Occupation:
General practice physician specializing in "lifestyle" medicine
Scars and Marks:
None known
Remarks:
Moos is a known user of narcotics. He may have ties to Mexico City, Mexico and China.
CAUTION
Steven Gabriel Moos is wanted for his alleged participation in medical fraud. Moos was a general practice physician who specialized in the area of "lifestyle" medicine in Tigard, Oregon. He used his practice for the sale of treatments through the Internet, mail orders, and via his office. Between July 1, 2002, and July 10, 2002, the United States Customs Service in San Francisco, California, intercepted and seized a total of five packages sent from China and addressed to Moos. Among the contents of the packages was a chemical active ingredient which was a misbranded and adulterated drug, as well as an unapproved new drug as defined by the Food Drug and Cosmetic Act. Additionally, the packages did not contain the required health and safety warnings, nor adequate instructions for use.
A federal arrest warrant charging Moos with four counts related to medical fraud was issued on June 3, 2004, in the United States District Court, District of Oregon, Portland, Oregon. On July 9, 2004, the Oregon Board of Medical Examiners revoked Moos' medical license.
In what's believed to be a first in Oregon, the attorney general has filed a civil lawsuit against two physicians asserting they unlawfully advertised and sold prescription drugs over the Internet.
The lawsuit comes after disciplinary action by the Oregon Board of Medical Examiners wasn't enough to change the physicians' behaviors, said Jan Margosian, spokeswoman for the Oregon Dept. of Justice.
"The board of medical examiners did what they could do, and that did not stop them," she said.
The lawsuit, filed in Washington County Circuit Court, accuses general physician Steven Gabriel Moos, MD, and dermatologist Thomas Alfred Holeman, MD, of, without examining or seeing patients, selling the "female arousal cream" "Viaglide" over an Internet Web page that claims it has the "same active ingredient found in Viagra." The lawsuit also accuses the physicians of unlawfully selling free drug samples and of falsely advertising and selling human growth hormone as something that can "reverse the effects of aging."
Drs. Moos and Holeman could not be reached for comment.
This is not the state's first attempt to stop Dr. Moos from selling prescriptions over the Internet. In 2000, the Oregon Board of Medical Examiners put Dr. Moos on probation for 10 years, with an agreement that he would "not associate in any manner with any Internet Web site that renders or purports to render medical services to patients or prescribe medication." And after a hearing earlier this year, the board suspended Dr. Moos' license after it found that he was again selling prescription drugs over the Internet.
Posted on Thu, Apr. 12, 2007 Anti-aging clinics proliferate in Florida
By Bob LaMendola
South Florida Sun-Sentinel
(MCT)
FORT LAUDERDALE, Fla. - Oasis Longevity & Rejuvenation topped its Internet pages with a photo of a well-muscled man to help sell its human growth hormone shots.
The Boca Raton, Fla., clinic is now shut down, its principals charged last month with selling the drugs illegally. But the business of selling hormones claiming they build hard muscle, burn flab and reverse the effects of aging has been a lucrative - and controversial - staple for years in South Florida.
Dozens of clinics make millions yearly selling hormones, often venturing into gray areas of medicine and the law, prosecutors and physicians say. Among the sellers are a former cocaine dealer and a former merchant of illegal steroids.
"It's a huge business because people want the fountain of youth," said Dr. Paul Jellinger, an advisor to the American Association of Clinical Endocrinologists. "They're just disregarding the fact that there's no proof that it works. (Also,) this stuff can hurt you."
Two sets of arrests this year showed the underside of the business.
In February, 14 people running seven Internet pharmacies in South Florida were indicted by a federal grand jury, accused of selling drugs without the patients visiting a doctor. In Florida and many states, it's illegal to prescribe or sell a drug unless the doctor first sees the patient in person.
Then, last month, officials from Albany, N.Y., arrested 15 people, including eight in South Florida, suspected of selling hormones and steroids to buyers - a few of them pro athletes - without a doctor visit. The ring centered on Signature Pharmacy in Orlando, which was charged in the case and sold $40 million of the drugs last year, said Christopher Baynes, an assistant district attorney in Albany.
Signature's top source of customers: Palm Beach Rejuvenation Center, an anti-aging clinic in Palm Beach Gardens that accounted for $15 million of the business, said Baynes. Officials arrested two of the clinic owners and its doctor, plus six others at Oasis and online site medxlife.com, which each accounted for millions of the revenue.
The principals at Signature and the clinics have pleaded not guilty and declined to comment.
Signature sold to at least two dozen South Florida clinics. Said Baynes: "There are more out there involved with Signature. I don't know whether more will be charged."
Among the names to surface in connection to the case:
Palm Beach Life Extension in Palm Beach Gardens. An Albany agent said in a document the clinic is separate but "under the control" of Palm Beach Rejuvenation and sold drugs illegally.
The Health and Rejuvenation Center in Palm Beach Gardens. At least one co-owner used to work at Palm Beach Rejuvenation, attorneys and other clinic operators said.
Infinity Rejuvenation in Deerfield Beach. A doctor was arrested in Albany on charges she signed illegal prescriptions from the clinic.
Metragen Pharmaceuticals in Deerfield Beach. In documents, Albany agents said some of Signature's illegal prescriptions came from Metragen. The company's founding principal started it after his former pharmacy, Powermedica, was shut down in 2005 for illegally selling steroids.
The owners of those four businesses have not been charged. Officials or attorneys for the four declined to comment or could not be reached with calls to their offices.
Hormone sellers said Signature was the biggest single supplier in South Florida and aggressively recruited clinics that sent them the customers.
"Signature solicited everyone, from the small sites to the big sites to the individual doctors," said Mark White, director at Anti-Aging Group Health in Aventura who said he did not use Signature.
In affidavits, agents said clinics in the Albany case used Web sites and ads to attract patients who filled out medical forms and got blood tests, but never saw a doctor. A clinic doctor wrote a prescription, which was filled by Signature and shipped to the patient.
The Oasis marketing director, Aaron J. Peterson, told a judge when he pleaded guilty March 28 that the clinic paid Signature $10,000 for finding a doctor who signed prescriptions without seeing patients.
Owners of another South Florida clinic also paid Signature to line up a doctor, and paid the doctor thousands per month for signing prescriptions, said the clinic's attorney, John Contini. He spoke on the condition his clients not be named.
"These physicians were abdicating their duty to the patient," Contini said.
Contini said Signature also sent his clients to an attorney who, for $1,500, assured them the operation was legal.
South Florida "anti-aging" clinics have been selling human growth hormones, or HGH, since the 1990s. The owners grasped onto a few small studies suggesting that symptoms of aging declined after shots of HGH, which is made by the pituitary gland to control metabolism.
Clinics began claiming that taking HGH or testosterone can erase fatigue, body fat, muscle loss, low sex drive, even gray hair. Muscle-builders craved it.
"It's hormone replacement therapy, to make people feel better," said Jeffrey George, owner of South Beach Rejuvenation in West Palm Beach. "Females have menopause and no one complains about them getting hormones. Men have `andropause' and we prescribe hormones for them."
The cost: Up to $1,000 a month.
Specialists and federal officials say it's medically correct to use HGH for patients who no longer produce it, which normally is caused by trauma or pituitary tumors. But there's no proof shots help when HGH declines naturally, experts said.
"Hormone levels go down as we get older. That's somehow how nature figured out how to do it," said Dr. Michael Karl, a specialist at the University of Miami medical school.
What's more, doctors said studies show that having too much HGH for one's age can cause heart disease, high blood pressure, diabetes and muscle and joint pain, and possibly spur cancer cells.
Some HGH proponents contend that most older patients need shots because they have low levels in their blood. But physician experts said a low level means little because HGH fluctuates and drops near zero daily. Albany prosecutor Baynes said clinics in his case sold HGH to patients with normal test results.
Brian Cotugno, who used to be a consultant to HGH clinics, said many would not stop selling to patients with normal lab tests because they would lose millions in sales to those using it for non-medical reasons.
"A lot of their business was (from customers) who just wanted to call and order substances over the phone," Cotugno said.
Cotugno said he got into the business a few years ago, after a 10-year sentence for cocaine trafficking, which he called a mistake at age 22. He started his own clinic, Maxim Rejuvenation in West Palm Beach, Fla.
Maxim was one of eight entities dropped last month from a list of approved online pharmacies by the accreditation group Pharmacy Checker, said its vice president, Gabriel Levitt.
After the Albany arrests, the nonprofit group no longer accredits online pharmacies that sell or promote HGH, he said.
"It's not safe," Levitt said, "to get prescriptions online for controlled substances or growth hormones."
---
MORE ABOUT STEROIDS, HGH AND SUPPLEMENTS
Testosterone: An anabolic steroid, the male sex hormone promotes tissue growth. Doctors prescribe it when the body fails to make it. No large-scale research shows whether it can combat age-related changes. Excess amounts can cause sterility, spur prostate cancer and worsen sleep apnea.
Hormone pills, sprays: Some sellers offer HGH as a pill or an oral or nasal spray instead of as an injection. Less is known about the possible benefits compared with injectable HGH.
Natural supplements: Some sellers promote nonprescription protein supplements, amino acids and other substances they contend will spark the body to produce more hormones. No one regulates these, and there's little data whether they work or are harmful.
Sources: American Association of Clinical Endocrinologists, American Academy of Anti-Aging Medicine, Harvard Medical School, WebMD.com
---
WHAT IS HGH?
"Anti-aging" clinics and doctors promote many hormone products they contend will eradicate fatigue, muscle loss, flab, declining sex drive and other symptoms of aging:
Human growth hormone: The pituitary gland makes HGH (somatropin) to govern muscle and bone growth. Doctors prescribe synthetic HGH shots if the body fails to make it. No large-scale research shows if it can combat age-related changes. Some body-builders seek it to add muscle. Excess amounts can cause heart disease, diabetes and possibly promote cancer.
Distributed by McClatchy-Tribune Information Services.
Valley doctor tied to steroid {and GH} ring
Non-practicing physician caught up in federal inquiry
Ken Alltucker The Arizona Republic Mar. 24, 2007 12:00 AM
Nearly a year after federal investigators intercepted a shipment of human growth hormone at the Scottsdale home of a former Arizona Diamondbacks pitcher, a Valley doctor has been linked to the federal investigation into the use and sale of performance-enhancing drugs.
Court documents indicate that Dr. David Wilbirt, who had a small practice in Scottsdale, was part of a nationwide steroid distribution ring that supplied bodybuilders and professional wrestlers with steroids and human growth hormone.
Wilbirt follows former Diamondbacks reliever Jason Grimsley as a major Valley name to be linked to the investigation. Law enforcement agencies from New York to Florida to Arizona and elsewhere are conducting multiple investigations into the sale and distribution of performance-enhancing drugs.
Prosecutors describe a ring that links anti-aging clinics, rogue doctors and athletes and others seeking prescriptions via the Internet.
While high-profile athletes such as former boxing champ Evander Holyfield, Los Angeles Angels of Anaheim outfielder Gary Matthews Jr. and retired slugger Jose Canseco have brought significant attention to the investigation, law enforcement and prosecutors insist the purpose of the investigation is to break up the drug distribution channels.
Wilbirt has not been charged with any crimes, but federal drug investigators in Phoenix say he remains under investigation.
Drug Enforcement Administration agents raided his Tempe home in 2005 and seized patient files, suspected drugs, cash and nearly $30,000 in gold and silver coins.
It's unclear what federal investigators are doing with the information gathered during the raid.
Ramona Sanchez, a DEA spokeswoman in Phoenix, said the investigation is ongoing.
The U.S. Attorney's Office in Phoenix, as a matter of policy, does not comment or confirm ongoing investigations, spokesman Wyn Hornbuckle said.
Wilbirt could not be reached. Candace Toler, who lives with Wilbirt in Tempe, said he is still recovering from a stroke he suffered two years ago.
Wilbirt's lawyer said he doesn't know whether the feds plan to pursue charges against his client.
"There are a lot of issues involved in this case that involve continuing investigations," said Dave Derickson, who represents Wilbert. "I am not totally sure about the status of the investigation. I know it is not a good idea to comment on continuing investigations. My client is not indicted and I prefer keeping it that way."
Last week, Sports Illustrated reported that Wilbirt has been linked to supplying steroids to big-time pro wrestlers, including Olympic gold medalist turned wrestler Kurt Angle; Oscar Gutierrez, who wrestles under the name Rey Mysterio; and Eddie Guerrero, a former Scottsdale resident who died in November 2005 in a Minneapolis hotel room.
The magazine reports on its Web site that Wilbirt was billed for the hormone hCG and the steroid stanozolol, performance-enhancing drugs shipped to Guerrero.
Guerrero, known as "Latino Heat" on the World Wrestling Entertainment tour, died of heart disease, compounded by an enlarged heart because of a history of steroid use.
The federal government investigated Wilbirt from 2001 through 2005, alleging that he wrote nearly 3,900 inappropriate prescriptions during one six-month period alone.
The medical board initiated an investigation in March 2005 after receiving a tip that he prescribed drugs through an out-of-state pharmacy to customers of a company called Bodybuilders.
Among the drugs prescribed were steroids such as oxandrolone, stanozolol and winstrol, as well as growth hormones.
The state board suspended his license in September 2005 after he declined to appear for an investigative interview. A formal license revocation hearing is pending, a medical board spokesman said. The case has been referred to the Arizona Attorney General's Office for a formal license revocation hearing, but no date has been set.
Toler said Wilbirt no longer practices medicine and has no intention of returning to his practice of three decades.
It's not the first time Wilbirt faced the scrutiny of the state medical board. In 2003, a pharmacist reported to the board that the doctor prescribed excess amounts of pain relievers Norco and OxyContin. In 1998, the state board issued Wilbirt a letter of reprimand for improperly prescribing weight-loss medication to non-obese patients.
Suspected steroid ring to stars busted in US
Authorities broke up a suspected steroid ring in Florida on Tuesday that is accused of distributing anti-aging treatments to celebrities and muscle-building drugs to professional athletes.
At least eight people were arrested in Florida, New York and Texas and up to 24 people face felony arrests following a year-long investigation led by the district attorney of Albany County, New York, officials said.
"There are celebrities involved in the case as consumers," Albany District Attorney David Soares told reporters in Orlando.
Officials also confirmed a report in Albany Times Union that the investigation could expose steroid use by current and former Major League Baseball players, National Football League players, bodybuilders and college and high school athletes.
Soares alleges the network prescribed anabolic steroids, human growth hormone and other substances over the Internet and without face-to-face examinations, supplying a large portion of the national market for illegal online steroid sales.
The company at the heart of the investigation is Orlando-based Signature Pharmacy, which has reported booming sales of hormones as an anti-aging treatment.
The case follows stepped up federal efforts against steroid distribution in recent years including the BALCO case in California, which tarnished the reputation of top athletes in baseball, football and track and field.
Several people served prison time in the case, and baseball star Barry Bonds remains under investigation over whether he lied about steroid use to a federal grand jury investigating the case.
'Need to find competitive edge'
"The recent steroid raid in Florida doesn't surprise me at all. People from all walks of life now are using performance enhancing substances," Victor Conte, the head of the BALCO lab who served jail time on steroid distribution charges, told Reuters. "From athletes to movie stars, there seems to be an ever-growing need to find a competitive edge."
The Albany newspaper named one Major League Baseball player as a customer and said the team doctor of one NFL team was interviewed by investigators after purchasing $150,000 worth of testosterone and human growth hormone.
Asked if the report was accurate, Soared nodded yes. Another law enforcement source who asked to remain anonymous also confirmed the report.
Albany prosecutors were involved in the Florida arrests because they allege at least $250,000 worth of illegal and controlled substances were sold and shipped to Albany County.
The probe began looking at an Albany doctor who was arrested last year.
Soares said that led him to Signature Pharmacy, run by Stan Loomis and his wife Naomi Loomis. Those two, Loomis's brother Mike Loomis and marketing director Kirk Calvert were arrested.
"We focus primarily on age management products and services. That relates primarily to hormones for both men and women. We work with the physician to tailor a dose and a specific product for a patient," Stan Loomis said in a marketing video posted on www.worldhealth.net.
In a 2005 company profile published in the Orlando Business Journal, Loomis attributed Signature's rapid growth -- from $550,000 in sales in 2000 to $21 million in 2005 -- to sales of injected human growth hormones prescribed by doctors as an anti-aging remedy.
"Traditional medicine is a big part of our business -- but it doesn't give the financial reward that customized medicine does," says Loomis told the business journal in 2005.
Source: Reuters
Attorney Defends Suspects Arrested In Orlando Pharmacy Raid
POSTED: 5:10 pm EST March 9, 2007
UPDATED: 5:29 pm EST March 9, 2007
ORLANDO, Fla. -- The local pharmacists, busted in a steroid scandal, defended themselves, Friday, through their attorney. Signature Pharmacy was raided last week in connection with an investigation out of Albany, New York that allegedly includes professional athletes.
The attorney would not let any of the accused owners at Signature Pharmacy speak to the media and even the attorney refused to answer any Eyewitness News questions, but she did reveal a bit of their strategy, to put the blame on the doctors who signed off on all of the prescriptions.
Stan, Naomi and Mike Loomis walked out of their million-dollar pharmacy business flanked by employees and friends. Their attorney wanted to fire back at what she calls misinformation coming from the New York district attorney.
"The characterization of Signature Pharmacy as a drug dealer is absurd," said defense attorney Amy Tingley.
All are charged with the criminal sale of a controlled substance after agents raided their offices and hauled off boxes of files and prescription information. They're accused of being one of the largest suppliers of steroids and anti-aging hormones in the country, prescribed by doctors who never examined patients in person.
The attorney said those doctors are not employees or agents of Signature Pharmacy, which has no doctors on staff.
"It is the responsibility of the physician to ensure that any medication containing a controlled substance is prescribed for a legitimate medical reason," Tingley said.
Federal authorities believe customers would contact anti-aging clinics over the Internet and request the drugs. The order would go to Signature Pharmacy in Orlando, who would pay willing doctors to sign off. Then Signature would ship the drugs to the patient.
"They have done nothing wrong," Tingley said. "We intend to aggressively and vigorously defend against these baseless accusations."
But sources close to the investigation are left wondering, if the suspects weren't doing anything wrong, why had they drawn up a document called a `raid card' with the attorney's contact info to keep handy in case police showed up?
Local investigators said there will likely be more arrests in connection with the pharmacy still to come.
ATTORNEY GENERAL FILES LAWSUIT AGAINST TWO OREGON MEDICAL DOCTORS
October 23, 2003
Attorney General Hardy Myers today filed a lawsuit in Washington County Circuit Court against two Oregon medical doctors alleging violations of state consumer protection laws in the unlawful sale and advertising of prescription drugs on the Internet and from a clinic in Tigard. Named in the lawsuit are Dr. Steven Gabriel Moos (pronounced Moss)of Tigard, a medical doctor of "lifestyle" medicine doing business in Oregon as Frontier Medical Clinic of Tigard and the Center for Men’s Health, LLC and Dr. Thomas Holeman of Milwaukie, a current employee of Moos at the Tigard clinic. Dr. Moos also has a clinic in Grants Pass.
The case was initially referred to the Oregon Department of Justice by the Oregon Board of Medical Examiners (BME), who in 2000 placed Dr. Moos on ten years of probation for problems associated with advertising and selling prescription drugs over the Internet. The BME subsequently became aware of additional misconduct by Moos as a result of his criminal indictment in Multnomah County for unlawful drug use and a criminal investigation in California related to practicing medicine without a license. Moos’ medical license was suspended by the BME on an emergency basis in January 2003. The emergency suspension was confirmed as a final order in April 2003.
The Oregon Department of Justice received significant assistance from the Food and Drug Administration’s Office of Criminal Investigation with the investigation leading up to this lawsuit. Oregon and the FDA and other state and federal agencies are members of the International Interagency Health Products Fraud Steering Committee that promotes multi-agency cooperation in the prosecution of health fraud.
In the course of the investigation, the Department of Justice learned that the FDA had a parallel investigation of the defendants. The two agencies then collaborated in a joint investigation that determined the defendants unlawfully promoted Human Growth Hormone (HGH), illegally sold free samples of prescription drugs, and made misrepresentations concerning a gel marketed and sold on the Internet which they claimed contained the same active ingredient as Viagra.
"Oregonians must be able to trust their doctors when it comes to the health and safety of themselves and their families," Myers said. "The defendants’ alleged conduct exploits the trust of their patients to turn a profit peddling prescription drugs that could, in some circumstances, endanger their health."
"Today’s court action shows that Oregon’s Department of Justice and FDA’s Office of Criminal Investigation can effectively strike at medical professionals who violate the public trust and endanger the public health," said FDA Commissioner Mark B. McClellan, M.D., Ph.D.
As a result of the joint investigation, today’s lawsuit, alleges that defendants violated state and federal laws by advertising and selling "Viaglide," a female arousal cream, over the Internet claiming it contained the same active ingredient found in Viagra when, in fact, it did not. Defendants sold "Viaglide" without a prescription and without examining or taking a medical history from the user. The defendants sold numerous tubes of "Viaglide," at one point averaging 100 tubes per month at $19.99 per tube, but total sales are not known.
The lawsuit also alleges that defendants prescribed, promoted and sold Human Growth Hormone (HGH) by misrepresenting it to consumers as a harmless panacea for the effects of aging when, in fact, the FDA has not found it to be safe and effective for that purpose.
Lastly, the lawsuit alleges that defendants sold prescription drugs to their patients that had been provided to the defendants by the drug manufacturers as free samples and could not be lawfully sold. Federal law prohibits the sale of prescription drug samples with a maximum penalty of ten years in jail and a $250,000 fine.
The lawsuit seeks full restitution to any consumer who purchased "Viaglide," HGH, or drug samples from the defendants, civil penalties of up to $25,000 for each violation of law, reasonable attorney fees and a permanent injunction prohibiting the defendants from individually or in any business capacity from promoting or selling drugs, nutritional supplements and any other product claimed as useful in the cure, treatment or prevention of disease in humans.
Consumers wanting information concerning this case and health fraud in general may call the Attorney General’s consumer hotline at (503) 378-4320 (Salem area only), (503) 229-5576 (Portland area only) or toll-free at 1-877-877-9392. Justice is online at www.doj.state.or.us.
CONTACT: Jan Margosian, (503) 947-4333 (media line only) jan.margosian@doj.state.or.us| FDA Public Affairs, (301) 827-6242 |
Mikhail Drachev in custody in Canada.
Suspect in 2001 slaying arrested in Canada
Lindsey Collom The Arizona Republic Apr. 22, 2007 12:00 AM
A suspect in the slaying of a Russian immigrant turned Phoenix police informer has been arrested after more than five years on the lam.
Authorities in Toronto arrested Mikhail Drachev, 24, late Friday in a homicide case that drew headlines because it grew out of a botched heist of nearly $1 million in human growth hormone from a pharmacy on West Bell Road.
A then-student at Arizona State University was one of two men convicted in the murder, but Drachev eluded capture by leaving the area.
"I knew the day would come," Phoenix police Detective Tom Britt said Saturday.
Police say Drachev was one of three men who kidnapped and murdered Konstantin Simberg, 21, in December 2001. Britt said Drachev has been living in Toronto under an alias. His undoing began about two weeks ago, when he confessed his real name to a woman he wanted to marry. She ran an Internet search and came up with the America's Most Wanted Web site. At the time, she didn't alert police.
It took a domestic-violence incident for her to tell police about Drachev, officials said. They went to his apartment and arrested him without incident.
Britt was on the phone with Simberg when he was kidnapped. Britt described hearing the sound of a struggle and a scream before the call ended.
A day later, two hunters found Simberg's body in Yavapai County. He had been stabbed, soaked with gasoline, set on fire and buried alive.
Britt believes Simberg was killed over his agreement to testify against Troy Langdon, 29, and Sean Southland, 34, in the September 2001 attempted theft of nearly $1 million in human growth hormone. The pair recruited Simberg for $25,000 to help transfer the goods from a Federal Express truck into a U-Haul with a crew of his choice. But something went wrong and the crew, composed of mostly high school boys, scattered. Simberg was arrested after one of the boys implicated him in the attempted robbery, and that's when he agreed to testify.
Langdon and Southland were tried and sentenced in the robbery.
Christopher Gabriel Andrews, 24, a former ASU student, is serving a life sentence, and Dennis Tsoukanov, 26, is also serving a sentence.
U.S. Department of Justice
United States Attorney Southern District of Florida 99 N.E. 4 Street Miami, FL 33132 (305) 961-9000
March 30, 2007
NEWS RELEASE:
TDD (202) 514-1888
FORMER CONGRESSIONAL AIDE SENTENCED FOR COMMITTING HEALTH CARE FRAUD
R. Alexander Acosta, United States Attorney for the Southern District of Florida, Jonathan I. Solomon, Special Agent in Charge, Federal Bureau of Investigation, and Kimberly McKinley, Special Agent in Charge, Office of Personnel Management - Office of Inspector General, announced today that defendant Enrique A. Pollack, a/k/a Henry A. Pollack, was sentenced to serve a six-month term of imprisonment for committing health care fraud, in violation of Title 18, United States Code, Section 1347. Upon release, Pollack was ordered to serve a three-year term of supervised release. Pollack was further ordered to pay restitution in the amount of $68,305.
Pollack had been employed as an aide by the Congress of the United States, U. S. House of Representatives since December 16, 1993. As a federal employee, the defendant was eligible to participate in The Federal Employees Health Benefits Program (FEHBP), a health care benefit program created to provide health benefits to federal employees. The United States Office of Personnel Management of the federal government contracts with various insurance companies to offer these benefits.
Pollack previously pleaded guilty to Counts 33 through 36 of an Indictment, which charged the defendant with filling prescriptions and refills for a human growth hormone in 2005, and causing the submission of claims to the FEHBP for reimbursement of the drugs. During his plea colloquy, Pollack admitted to having misrepresented and having caused others to misrepresent information relating to his medical condition and history in order to have the prescriptions approved for insurance coverage.
U.S. Attorney Acosta stated, "Public servants, at all levels of government, have a duty to those whom they serve to follow the law. This prosecution makes clear that no one is above the law, and that we will vigorously prosecute these cases."
Mr. Acosta commended the investigative efforts of the FBI and the Office of Personnel Management - Office of Inspector General. This case was prosecuted by Assistant United States Attorney Eloisa D. Fernandez.
A copy of all press releases may be found on the website of the United States Attorney's Office for the Southern District of Florida at www.usdoj.gov/usao/fls <http://www.usdoj.gov/usao/fls/ >. Related court documents and information may be found on the website of the District Court for the Southern District of Florida atwww.flsd.uscourts.gov <http://www.flsd.uscourts.gov/ > or on <http://pacer.flsd.uscourts.gov > <http://pacer.flsd.uscourts.gov/ >.
FDA Warning Letters Regarding Use of HGH for Anti-Aging
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
February 18, 2004
Ref: 2004-DAL-WL-12
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Tony Stires Global Internet Alliance 4541 West End Corpus Christi, Texas 78411
Dear Mr. Stires:
This letter concerns T-10 HGH, Human Growth Hormone, marketed by your firm as shown on your Internet site www.ezsuoer.com. According to information on this site, T-10 HGH is being sold as an anti-aging treatment regimen. Ordering instructions for the drug are provided on the site.
The T-10 HGH formula is described on your web site as, “ Sublingual T-10 HGH is sprayed directly into the mouth three times a day and is absorbed directly into the mucus membrane.” and as, “T-10 HGH - Real Recombinant Growth Hormone - 30 ml (1 fl. oz) - one month supply per bottle. . . . 600 nanograms per milliliter!”
The intended anti-aging treatment and disease treatment claims for T-10 HGH are conveyed on your Internet site. These include statements such as, “• HGH restores muscle mass• HGH decreases body fat • HGH increases sexual function• HGH thickens the skin, reducing wrinkles • HGH restores lost hair . . . • HGH improves cholesterol profile • HGH Improves vision• HGH improves memory • HGH elevates mood and improves sleep • HGH normalizes blood pressure • HGH increases cardiac output and stamina. . . .” The web site has a graph that reflects the benefits of using HGH to obtain positive effects on cholesterol levels.
T-10 HGH cannot be a dietary supplement because it is not intended for ingestion since it is absorbed directly through the cells of the oral mucosa, thus avoiding inactivation and destruction by the digestive system. The Federal Food, Drug and Cosmetic Act defines the term, “dietary supplement” in 21 U.S.C. 321(ff)(2)(A)(i) to mean a product that is “ . . . intended for ingestion . . . ” Consequently, a product that is not intended for ingestion cannot meet the definition of a dietary supplement.
The Food and Drug Administration (FDA) approved growth hormone as a new drug in 1940. Growth hormone was not marketed as a dietary supplement, nor as a food, before its approval as a drug. Therefore, growth hormone is excluded from the definition of a dietary supplement under 21 U.S.C. 321 (ff)(3)(6) because growth hormone is an article approved as a new drug under 21 U.S.C. 355.
Based on the claims cited above, T-10 HGH is a “drug” as defined by 21 U.S.C. 321(g). Moreover, the T-10 HGH is a “new drug” as defined by 21 U.S.C. 321(p) because there is no evidence that it is generally recognized as safe and effective for these intended uses. Under 21 U.S.C. 355(a), a “new drug” may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug. The continued distribution of this product without an approved NDA violates 21 U.S.C. 355.
In addition, your T-10 HGH is misbranded under 21 U.S.C. 352(f)(1) because its labeling fails to bear adequate directions for the uses for which it is being offered and it is not exempt from this requirement under 21 CFR section 201.115 since it is an unapproved new drug.
Distribution of your T-10 HGH product also violates 21 U.S.C. 333(e)(1). Your growth hormone is being promoted and distributed on your web site for an unapproved use. There are no recombinant human growth hormone (somatotropin) products that are approved by the FDA for anti-aging treatment. 21 U.S.C. 333(e)(1) states that, “ . . .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 21 U.S.C. 355 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, United States Code, or both.”
This letter is not intended to be an all-inclusive review of your Internet sites, and the products your firm may market. The violations of the Act described above are not intended to be an all-inclusive list of the deficiencies of you and your firm. It is your responsibility to ensure that all drug products manufactured and distributed by your firm are in compliance with Federal laws and regulations.
Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Possible actions include seizure, injunction, and/or prosecution.
We request that you reply in writing within fifteen (15) days of your receipt of this letter stating the action your firm will take to discontinue marketing this drug product. Your response should be directed to Reynaldo R. Rodriguez, Jr, Director, Compliance Branch, at the U.S. Food and Drug Administration, Dallas District, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204.
Sincerely,
/s/
Michael A. Chappell District Director Dallas District Office
Department of Health and Human Services Public Health Service
Food and Drug Administration 555 Winderley Pl., Ste. 200 Maitland, FL 32751
VIA FEDERAL EXPRESS WARNING LETTER FLA-02-54 June 29, 2002
Darin Grey GHMedical.com 1250 E. Hallandale Beach Blvd. Penthouse A and 442 Sunset Drive Hallandale, FL 33009
Dear Mr. Grey:
This letter concerns Saizen 5 mg., 15 IU. [somatropin (rDNA origin) for injection] also known as recombinant human growth hormone (HGH) which is currently marketed by your firm as shown on your Internet site www.ghmedical.com. According to information on this site, Saizen is being promoted as part of an anti-aging treatment regimen. Ordering instructions for the drug are provided on the site.
The intended anti-aging treatment use for Saizen is conveyed through claims on your Internet site. These include statements such as ". . . Saizen . . . Looking and feeling younger.. Saizen may also be used for hormone rejuvenation therapy.. .Benefits gradually occur over a six to twelve month period.. .Benefits of HGH.. . include.. . 15% average decrease in fat.. . 8% average increase in muscle and lean body structure.. improved skin texture.. . decrease skin wrinkles.. . greater bone density.. . increased time for healing. . . increased immunity and resistance to infection.. . increased libido.. . increase in both energy and strength.. . improvement of sleep pattern.. . increase of cardiac output and kidney function.. . HGH is known to 1many as the one and only hormone replacement with the capabilities of reversing the biological age. _ ."
Saizen is a "drug" as defined by 21 U.S.C. 321(g). Saizen has a new drug application (N019-764) approved by FDA. Saizen is approved for one indication only, namely for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. The conditions recommended or suggested for the Saizen sold through your web site such as hormone rejuvenation therapy and reversing the biological age, among others, render it a "new drug" as defined by 21 U.S.C. 321 (p).
Under 21 U.S.C. 355(a), a "new drug" may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for such drug. The continued distribution of this product without an approved NDA violates 21 U.S.C. 355.
In addition, your Saizen is misbranded under 21 U.S.C. 352(f)(l) because its labeling fails to bear adequate directions for the uses for which it is being offered and it is not exempt from this requirement under 21 CFR section 201.115 since it is an unapproved new drug.
Finally, distribution of your HGH product violates 21 U.S.C. 333(f). Saizen is being promoted and distributed on your web site for an unapproved use. There are no recombinant HGH products that are approved by the Food and Drug Administration (FDA) for anti-aging treatment. 21 U.S.C. 333(e) states that ". . .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 21 U.S.C. 355 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, United States Code, or both."
This letter is not intended to be an all-inclusive review of your Internet sites, and the products your firm may market. The violations of the Act described above are not intended to be an all-inclusive list of the deficiencies of you and your firm. It is your responsibility to ensure that all drug products manufactured and distributed by your firm are in compliance with Federal laws and regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Possible actions include seizure, injunction, and/or prosecution.
We request that you reply in writing within fifteen (15) days of your receipt of this letter stating the action your firm will take to discontinue marketing of this drug product. Your response should be directed to Martin E. Katz, Compliance Officer, at the U.S. Food and Drug Administration, Florida District, 555 Winderley Place, Suite 200, Maitland, FL 32751, telephone number 407-475-4729.
FBI raid, ethics questions swirl around Tigard cosmetic physician
06:27 PM PST on Wednesday, January 5, 2005
By ABE ESTIMADA, kgw.com Staff
A local cosmetics physician who bought a medical practice from another doctor on the run from the law is not only under investigation by the Federal Bureau of Investigation but could be selling medical credentials he doesn’t have, kgw.com has learned.
KGW
Dr. Jerome Lentini delivers a botox shot.
The Tigard and Salem offices of “A Younger You Medical Center,” an anti-aging medical practice owned by Dr. Jerome Nicholas Lentini, were searched Wednesday by FBI agents.
Calls to a phone number provided by the A Younger You web site and to the U.S. Attorney’s Office in Portland were not immediately returned on Wednesday.
FBI spokesperson Beth Anne Steele would only confirm that search warrants were served at Lentini’s Tigard office on 9600 SW Oak St. but declined to give details about the nature of the investigation. Salem police referred questions about the search of Lentini’s clinic on 2290 Commercial St. SE in Salem to the Portland FBI office.
All federal court documents relating to the search warrants were under seal on Wednesday.
While a review of state records shows that no complaints or disciplinary actions have ever been taken against Lentini or his practice by the Oregon Board of Medical Examiners or the Oregon Attorney General's Office, kgw.com has learned that the physician may be violating state statutes for advertising a medical board certification that he no longer holds.
Lentini claims on his business’ web site that he is “board certified by the American Board of Anti-Aging Medicine.” But the American Academy of Anti-Aging Medicine, which issues the certification, said the Tigard doctor hasn’t been licensed with them since 2003. The Chicago-based academy has certified about 11,500 doctors in the U.S.
KGW
FBI agents exit Dr. Jerome Lentini's office on Wednesday.
Lentini was certified by the academy between 2002 and 2003 but failed to renew his certification, said Victor Martinez, a client services executive with the academy.
Records from the academy also show that Lentini took and passed a written examination in 2003 to renew his license but did not take an oral exam to complete his certification, Martinez said. To also maintain standing with the academy, Lentini also had to show proof he had completed seminars and classes that accrue required credits.
The academy sent two notices – one by e-mail and one by fax – to Lentini to inform him he needed to renew. But the physician did not respond to those queries or pay his dues, Martinez said.
“Obviously, that’s just not good,” said Martinez when he learned that Lentini was advertising on his Web site that he was certified by the academy.
“He cannot claim he’s affiliated with us or an active member,” Martinez continued. “He cannot do that. It’s just false.”
It’s not just ethics that may have been compromised.
Lentini’s claim on his web site could be considered “unprofessional conduct” as defined by Oregon state statute and could be grounds for some sort of disciplinary action, said Oregon Board of Medical Examiners investigator Mike Sherman.
“This is certainly outside the ethics to falsely advertise your credentials,” Sherman said.
But the board cannot investigate Lentini until a written complaint is filed with the agency, he said. Nor can the agency disclose what complaints have been lodged against Lentini until the board rules on a punishment.
“Until we get to the point where the board takes formal action, complaints against physicians are confidential by law,” Lentini said. “We just can’t disclose it to anybody.”
Depending on the severity of the infraction, the board could choose not to act against Lentini or mete out a maximum punishment of revoking his Oregon medical license. Lentini is a registered physician and surgeon in the state, according to records from the Oregon Board of Medical Examiners. His license was issued on Jan. 20, 1995 and is set to expire on Jan. 20 of this year.
KGW
Former offices of Dr. Steven Moos.
According to the Oregon AG's office, Lentini bought the medical practice and clinic from Dr. Steven Gabriel Moos.
Kgw.com in January 2003 first reported that Moos' medical license was pulled after police seized what they believe to be drugs from his house. Moos had been on probation after the state medical board found in 2000 that he was selling prescription drugs over the Internet.
Moos is also under federal indictment for illegally importing human growth hormone, falsifying information to the U.S. Drug Enforcement Administration and illegally obtaining controlled substances.
Moos and his family left their $1.1 million home on Bull Mountain sometime in spring 2004 without informing anybody of his whereabouts. Washington County authorities later issued an arrest warrant for him.
According to the business’ web site, A Younger You provides a variety of anti-aging treatments, including Botox injections.
The web site also says that Lentini “specializes in hormone replacement and cosmetic medicine.”
“Because the world today is full of fast-paced movers, it is important to keep up with those around you and maintain your sense of youth and well-being,” the web site said.
Lentini said on his web site that he operated “Total Face Care Center” in Boca Raton, Florida. A search of records with the Florida Department of Health showed that Lentini voluntarily relinquished his license to practice in that state, allowing it to expire on Jan. 31, 1998. Florida also had no record of complaints filed against Lentini.
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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.
In our April issue, writer Pat Jordan took an interesting look at a group of doctors who are behind the longevity movement—those guys who pump their patients full of testosterone and human growth hormone and tell them they can live forever. One of the more colorful doctors in Dr. T to the Rescue was Alan Mintz, who ran the Cenegenics Medical Institute near Las Vegas. He was bombastic, overbearing and quite sure of himself, telling Jordan that “Cenegenics is more about aesthetics than longevity. We call it ‘age management.’ Our goal is the highest possible quality of life and sexual function, and then a quick death of a heart attack at 94. We don’t make outrageous claims about longevity.”
Department of Health and Human Services
Department of Health and Human Services Public Health Service 
