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."
Edmund Chein, M.D. Revocation of DEA Registration and Denial of Application for Exporter’s Registration, 72 Fed. Reg. 6580 (February 12, 2007) (He also loses his medical license)
Edmund Chein of the Palm Springs Life Extension Institute
In a consolidated proceeding (Practitioner’s and Exporter’s Registrations), on November 7, 2001, DEA issued an Order to Show Cause and Notice of Immediate Suspension to Respondent on the ground that continued registration threatened the public health and safety. DEA issued another Order to Show Cause on May 24, 2002, which proposed to deny Respondent’s application for an exporter’s registration on the ground that registration would be inconsistent with the public interest. Respondent requested a hearing, conducted in three stages between January 28 and December 11, 2003. On July 28, 2005, the Administrative Law Judge recommended that DEA revoke Respondent’s practitioner’s registration and deny his application for an exporter’s registration.
The 2001 Order alleged that Respondent purchased controlled substances from illegitimate sources and re-distributed them without a legitimate medical purpose. Undercover operations revealed that Respondent prescribed human growth hormones and testosterone to patients before obtaining the results of necessary blood tests. Execution of a search warrant discovered that Respondent was in possession of numerous controlled substances without the appropriate purchase, use, and inventory records.
On June 29, 1998, the Medical Board of California initiated proceedings against Respondent that resulted in revocation of his state medical license. Once the Board revoked his license, Respondent sold the clinic to his sister, who held a valid registration. Despite the transfer in ownership, Respondent, without a state license, continued to run the clinic and direct employees in the handling and shipping of controlled substances. Respondent’s history of distributing controlled substances in violation of the Controlled Substances Act and inadequate recordkeeping constituted conduct that threatened public health and safety. Consequently, DEA revoked Respondent’s registration because continued registration was inconsistent with the public interest. 21 U.S.C. §§ 823(f) and 824(a)(4).
The 2002 Order proposed to deny Respondent’s application for an exporter’s license because he had already engaged in exporting behavior illegally. On May 7, 2001, Respondent submitted an application for an exporter’s registration. The "application was not accepted for filing" and the filing fee was refunded. Respondent submitted a second application, which triggered an administrative inspection and investigation.
Respondent’s records indicated that he exported over 300 controlled substances to at least eleven countries without an exporter’s registration. Furthermore, some of the foreign shipments of controlled substances Respondent made violated international treaties. Respondent continued to export controlled substances after DEA notified him that it was illegal and even after receiving the Notice of Immediate Suspension. Respondent also imported two controlled substances from a Mexico pharmacy without an importer’s registration, in violation of 21 U.S.C. 957(a).
Respondent’s history of exporting controlled substances without the appropriate registration and his participation in the diversion of controlled substances constituted conduct that threatened public health and safety. Consequently, DEA denied Respondent’s application for an exporter’s registration as inconsistent with the public interest. 21 U.S.C. § 958(d).
Respondent claimed the DEA proceeding should be dismissed because the Office of Chief Counsel engaged in misconduct during the proceeding that required replacement with private counsel. Respondent alleged that a DEA employee committed perjury by certifying that she was the Acting Unit Chief of the Registration Unit although she no longer held that position on the day she signed the affidavit regarding the failure to process Respondent’s application. The position of the employee on the date of the declaration is immaterial because she conducted the investigation leading to the non-acceptance of the application and did not have the intent to deceive.
Respondent further alleged that the employee committed perjury by asserting that the first application was not accepted "for an unexplained reason." The first application was refunded because the office mistakenly believed he already had a DEA registration number. There is no mandatory duty to register an applicant and Respondent’s violations of federal law, revealed during investigation for the second application, support a finding that his first application would have been denied. Furthermore, Respondent did not demonstrate that he relied on any act or statement by DEA that would establish the materiality of the allegedly perjurious assertion. Both of Respondent’s challenges were without merit.
Greeley doctors implicated in illegal steroid ring
Sharon Dunn, (Bio)sdunn@greeleytribune.com January 26, 2008 Three Greeley doctors have been implicated in a nationwide steroid ring, and one pleaded guilty this week in an Alabama court.
Dr. Scott Corliss, a physician with the Greeley Medical Clinic, pleaded guilty Thursday in U.S. District Court in the Southern District of Alabama to dispensing illegal steroids. As a part of his plea agreement, he agreed to turn over $12,000 he had received in proceeds from 2005-06. He faces up to three years in prison and a fine of up to $250,000.
His plea agreement implicates Family Physicians Dr. Kenneth Olds and Dr. Kelly Tucker, who also faces a charge of sexual assault against a patient in a separate case. That charge was made in Weld District Court.
Olds refused to comment.
Officials at Greeley Medical Clinic would not comment about the case, but Dr. Dan Zenk, the center's president, e-mailed a prepared statement:
"The Greeley Medical Clinic learned today that Dr. Scott Corliss, a physician affiliated with our clinic, accepted a plea bargain concerning certain unlawful activities. The Greeley Medical Clinic emphasizes to the community that any illegal activity that involved Dr. Corliss occurred without the Greeley Medical Clinic's knowledge or approval, and was completely unauthorized in nature. Any type of illegal conduct is contrary to the Greeley Medical Clinic's values, mission and professional obligations to the health and well-being or our patients. We are investigating this matter further."
According to court documents, the doctors worked with Brett Branch, owner of Infinite Health in Eaton, and a sales representative for Applied Pharmacy Services Inc., a compounding pharmacy in Mobile, Ala., which court records state manufactured and sold anabolic steroids, HGH, and other drugs. A compounding pharmacy can custom-make prescriptions for individual patients.
Applied Pharmacy Services also was one of the pharmacies named in the recent Mitchell Report, in which former Sen. George Mitchell investigated rampant steroid use in Major League Baseball.
Contacted Friday, Branch said based on his attorney's advice, he could not comment about if he'd been charged or about his involvement in the case.
Tucker vehemently rejected his inclusion in the record of Corliss' guilty plea in Alabama. "That's false," he said.
"If Scott Corliss did something, that's not me," he said. When asked if he knew Branch, he paused, then he hung up the phone.
Court documents stated Branch "recruited customers at various gyms and sports clubs," and he received a percentage payment from Applied Pharmacy for each of the drugs dispensed to his customers. Branch approached the doctors in March or April 2005, court documents state, and he paid for Corliss and Tucker to attend the American Academy of XX XX XX conference in May 2005 in Las Vegas.
Court documents stated Branch, who is not a doctor, would fax pre-printed prescription orders to Drs. Olds, Tucker and Corliss, along with his customers' blood test results. The customers would then see the doctors, who would then sign the prescription orders, court documents state. The prescriptions were for steroids such as Trenbolone, a bovine/equine steroid not approved for human use, and Human Growth Hormone. Court documents stated Branch would pay the doctors $100 for each prescription.
In September 2005, Branch asked Corliss and Tucker to become part owners of Infinite Health, an offer that only Tucker accepted, court documents state. A month later, court documents state, Corliss read an article that stated the growth hormone he and the others had been prescribing was illegal and brought it to Branch's and Tucker's attention. Court documents state that Tucker and Branch replied, "Because the physicians saw the patients and reviewed their blood work, the practice was legal."
Corliss' participation decreased then, but court documents state when Tucker became sick in February 2006, Branch asked Corliss to see patients normally referred to Tucker. Corliss agreed, court records state, detailing 11 incidents in which Corliss prescribed illegal steroids from February 2006 to May 9, 2006.
In September 2006, Corliss spoke with Drug Enforcement Agents. Court documents stated, "although the initial customers sent to him by Branch requested the anabolic steroids and HGH for 'anti-aging' treatment, Corliss began to doubt the legitimacy of the anti-aging justification."
Soon thereafter, Corliss sent a letter to Branch, ending his association with Infinite Health, court records state, then notified his partners and his employer of his conduct. Court records state he also turned himself in to the Colorado Board of Medical Examiners, which then admonished him.
According to the admonishment issued by the Board on May 18, 2007, Corliss saw 32 patients referred from Branch, and he prescribed steroids to at least 18 patients complaining about excess body fat. Corliss' license is still active, according to state records, but the Board threatened to suspend it if there were more complaints about him prescribing the drugs.
Corliss completed a three-day course on "Prescribing Controlled Drugs: Critical Issues and Common Pitfalls of Mis-Prescribing," the court records state.
Corliss joined the Greeley Medical Clinic in 1996 after serving for five years as associate director of the North Colorado Family Medicine residency in Greeley, and he has "special interests" in weight management and anti-aging concerns, according to the Greeley Medical Clinic's Web site.
It is not known at this time if Tucker, Olds or Branch also have been charged with wrongdoing. Officials with the U.S. District Attorney's office in the Southern District of Alabama did not return calls Friday.
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.
Skin doctor’s license placed on probation
01:00 AM EST on Thursday, December 6, 2007
By Felice J. Freyer
Journal Medical Writer Providence Journal - Providence,RI,USA
The Health Department has put on probation the medical license of Dr. Nomate Toate Kpea, a dermatologist with five practices around the state, and has required Kpea to undergo a competency evaluation.
The state Board of Medical Licensure and Discipline found that Kpea misdiagnosed benign lesions as cancer and performed needless surgery, failed to completely remove a skin cancer, failed to properly train and supervise his advanced practice clinicians (nurse practitioners and physician assistants), advertised “with a tendency to deceive,” and prescribed human growth hormone without adequate evaluation of the patients.
In one case, the board found, an advanced practice clinician in Kpea’s office misidentified a skin lesion that was later found to be malignant melanoma, a form of skin cancer that can be deadly if not diagnosed early.
Probation is a level of discipline that is stronger than a reprimand but less severe than a license suspension. Kpea can continue to practice, but he has agreed not to perform a method of skin-cancer removal known as Mohs surgery until he has completed his competency evaluation and undergone any training the evaluators recommend.
Kpea’s practice, called Skin Medicine USA or Skin Medicine and Cosmetic Surgery Centers, included offices in Warwick, Providence, North Smithfield, Newport and Narragansett, as well as several out of state. Kpea, 54, is well known in the community. According to a recent news report, he is also the “paramount chief” of a town in Nigeria that was founded and ruled by his family.
Dr. Robert S. Crausman, the medical board’s chief administrative officer, said that the board had complaints against Kpea dating to 2000, but only the more recent ones clearly violated medical standards.
Many of the findings focused on his use of the Mohs precision cutting tool, which allows surgeons to remove skin cancer without harming healthy tissue. In one case, Kpea misdiagnosed squamous cell carcinoma and performed Mohs surgery on a patient. The patient actually had a benign skin lesion called an actinic keratosis. In another case, nonmalignant lesions were misdiagnosed as cancer. Having needless surgery can leave a patient with unnecessary scars, Crausman said.
In another instance mentioned in the board’s report, Kpea “performed an incomplete excision and missed an obvious tumor at the lowest level excised.”
In two other cases, Kpea prescribed human growth hormone to a patient diagnosed with a deficiency of the hormone and to another with short stature. The board concluded that Kpea “was not using this medication for its purported anti-aging effect,” which would have been a violation of Food and Drug Administration regulations. But it did find that he did not adequately evaluate the patients before prescribing.
Additionally, the board found, Kpea too frequently used frozen biopsies to quickly diagnose a condition and proceed immediately to Mohs surgery; it is better practice in most instances to send samples to a laboratory and wait for a diagnosis from a pathologist, Crausman said.
His advertisements had a “tendency to deceive,” Crausman said, because they led patients to believe they would be seen by a doctor, only to discover after they arrived that a physician assistant or nurse practitioner would do the exam.
Kpea has agreed to undergo a skills and competency evaluation by the Colorado Center for Personalized Education for Physicians, and complete any additional training and evaluation that the board recommends based on the Colorado findings. Meanwhile, he must not practice Mohs surgery.
Kpea also must now have all biopsy specimens read by a board-certified pathologist or dermatopathologist.
Additionally, the board has required that all advanced practice clinicians at his offices be supervised at least a half day a week by Kpea or an appropriately trained physician, meet weekly with a physician to review cases, and meet monthly for training.
Kpea must also pay an administrative fee of $2,500.
Neither Kpea nor his lawyer returned phone calls yesterday.
'Grandmotherly' Santi wrote thousands of prescriptions
By Dan Connolly |Sun reporter
November 3, 2007
PROVIDENCE, R.I. - Short and stout, with gray ringlets of hair framing a round, bespectacled face, Ana Maria Santi looks the part of a doting grandmother.
Instead, the 68-year-old disgraced doctor from Queens, N.Y., has become the most unlikely face of a national steroid ring that reportedly involved Orioles outfielder Jay Gibbons, among others.
Yesterday, in federal court here, Santi received a two-year jail sentence, plus one year of house confinement and two additional years of supervised probation for issuing thousands of prescriptions for human growth hormone and other illegal steroids to clients she never examined. She also has to forfeit $24,340 she made from a New Jersey company as part of the scam and repay $19,205 to Blue Cross and Blue Shield of Rhode Island, which had reimbursed customers who received the illegal drugs.
"She may have a grandmotherly face, but her actions certainly were not grandmotherly," said Adi Goldstein, the assistant U.S. attorney prosecuting the case. "She committed the serious crimes of writing prescriptions for steroids and hGH. She had customers, not patients."
Santi, dressed in a blue prison jumpsuit, sat quietly in the courtroom but occasionally turned to her two adult sons, waved and smiled. When asked by U.S. District Court Judge William E. Smith whether she wanted to make a comment for the record, she said: "No, your honor. Thank you very much, and I am sorry for what I did."
According to a federal investigation in Rhode Island of Internet drug operations - which is separate but similar to the ongoing state investigation in Albany, N.Y. - Santi admitted using the name and prescription number of a dying former co-worker for at least five years. She did so despite having her medical license revoked in 1999 and "without ever meeting, diagnosing, speaking to or observing" her clients, Goldstein told the court yesterday.
From 2005 to 2006, Goldstein said Santi earned $125,000 for the forged signatures.
"She committed this offense with a stroke of a pen and a push of a fax button from her home," Goldstein said.
Furthermore, she said Santi recruited fellow New York City doctor Victor Mariani, a former medical school classmate of Santi's in Argentina, to participate in the scam. Mariani, 73, was sentenced yesterday to one year of home confinement, two additional years of supervised probation, a $6,000 fine and forfeiture of $34,485 in earnings. Unlike Santi, who had a history of previous insurance fraud, Mariani was a first-time offender and was considered "not as culpable" as Santi, Goldstein said.
Mariani said at the sentencing hearing that he believed someone was examining and diagnosing patients - presumably Santi - but admitted to never seeing them himself.
He and Santi signed the majority of their prescriptions for American Pharmaceutical Group, which was run by co-defendant Daniel McGlone out of his kitchen and home office in North New Brunswick, N.J.
McGlone, according to court documents, found prospective clients through various methods, including magazine advertisements that targeted bodybuilders. He paid doctors $25 for each steroid/hGH prescription, then had the prescriptions filled by compound pharmacies, such as the federally raided Signature Pharmacy in Orlando, Fla. According to court documents, McGlone made approximately $860,000 in profit from individual clients and pharmacies. He is awaiting sentencing in Rhode Island federal court in February.
Santi and the principal ownership of Signature are among those charged by the Albany County District Attorney's office, which made headlines earlier this year with a series of steroids raids in Florida. Santi has pleaded guilty in Albany and is awaiting sentencing, while the Signature group is awaiting trial there.
Santi and Mariani were facing harsher penalties under federal sentencing guidelines yesterday, but Judge Smith took into consideration the defendants' age and health. Yet Smith said it was important to "send a message to the medical community that ... this is a very serious offense, and the court values it as such."
Goldstein, the federal prosecutor, said it's important to expose the steroid rings as much wider in scope than athletes looking for an edge. In Rhode Island, she said, the investigation uncovered at least 20 individuals who had ordered a total of 4,000 units of hGH.
"This extends beyond professional athletes and goes beyond the doors of gyms as well," she said. "People are using this for anti-aging, for weight loss. Not just as performance enhancers."
Because doctors such as Santi and Mariani did not know the previous medical or psychological histories of those receiving the drugs, some recipients possessed significant risk factors, including a man who later was charged with the brutal beating of a Rhode Island state trooper, she said.
As for athletes, Goldstein would not confirm whether any NFL or Major League Baseball players received drugs prescribed by yesterday's defendants.
"That's not something I am willing to comment about," she said. "And I probably wouldn't know it if they were."
However, SI.com previously reported that Gibbons received shipments of hGH and anabolic steroids from South Beach Rejuvenation Center in Miami Beach - and filled by Signature Pharmacy - from 2003 to 2005. According to SI.com, one of the prescribing physicians in the Gibbons case was "A. Almarashi," the alias used by Santi.
"A. Almarashi," the name of a now-deceased former co-worker of Santi's, also was the signature on prescriptions for Genotropin allegedly sent to Jerry Hairston Jr., a Texas Rangers infielder-outfielder, by an Alabama-based compound pharmacy in 2004, according to SI.com.
Hairston and Gibbons were Orioles teammates from 2001 to 2004. Hairston has denied that he received or used illegal performance enhancers. Gibbons has refused comment on the story since it was reported in September, except to say that he has cooperated with MLB in its investigation of the matter.
Santi, an anesthesiologist, first had her medical license suspended in 1994 after problems with alcohol. She had it revoked in 1999, the same year she was involved with a liposuction case that resulted in the death of the patient.
She also had at least one prior conviction for insurance fraud, said Edward C. Roy, her attorney in Rhode Island.
"What has befallen her is alcohol," Roy said. "When she is not drinking, she is a great person."
As a child, Roy said his client was "smuggled out of Poland" to England during World War II, and her family later relocated to Argentina. There, he said, she went to medical school and became a doctor, a difficult task for a woman of her era.
Eventually she was forced out of her profession and turned to the prescription scam to survive financially.
"She is remorseful, I'll tell you that," Roy said. "The fact is she is such a brilliant person and achieved a lot in her life and then lost all of those achievements because of alcoholism."
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.
James Forsyth MD
The Trials and Tribulations for homeopathic doctor
Century Wellness Clinic
Jury acquits doctor in Reno HGH trial
SCOTT SONNER ASSOCIATED PRESS WRITER Posted: 11/1/2007 Modified: 11/1/2007 STORYCHAT(read or post comments)
A federal jury acquitted a Reno doctor on Thursday of charges he trafficked in a human growth hormone.
Dr. James Forsythe said the charges had robbed him of his practice and he was eager to return to his work.
His attorneys said that while he was the target of an undercover sting operation in 2004 he twice prescribed the drug to a Food and Drug Administration agent to treat a legitimate health condition.
“I’m ecstatic,” attorney Kevin Mirch said. “I’m glad we persuaded the jury that the doctor is innocent.”
Federal prosecutors argued that Forsythe — with a patient list that includes top casino executives and Nevada first lady Dawn Gibbons — sold the drugs illegally for anti-aging purposes, falsifying the diagnosis of a growth hormone deficiency to cover his tracks.
The 12-member jury deliberated for about two hours in U.S. District Court in Reno Wednesday afternoon and returned its verdict at midmorning on Thursday after hearing closing arguments and listening again to secret tape recordings the undercover agent made of Forsythe, who is married to former Nevada Republican Party Chairwoman Earlene Forsythe.
Senior Judge Howard McKibben on Tuesday dismissed one of two counts the Justice Department brought against Forsythe, saying there was no evidence he introduced the drugs into interstate commerce from Israel without required approval. The remaining charge accused him of distributing Bio-Tropin as an unapproved anti-aging treatment. If convicted, he faced up to five years in prison and a $250,000 fine.
Mirch said FDA agents launched the investigation based on the mistaken understanding the drug had not been approved by the federal agency.
Mirch said when they learned it was simply a new name for a previously approved growth hormone, prosecutors changed their strategy to argue that the drug could be prescribed for adults only in special circumstances, including treatment of hormone deficiency and AIDs wasting.
Mirch said the agency exerted “too much power” in a rush to indict Forsythe in 2005. “He is a good man,” Mirch said. “He has lived since 2004 with absolutely the most horrible cloud over his head, his family’s head and his colleagues’ heads.
“They wanted to get him. They wanted to embarrass the people on this (patient) list and they did. They should have apologized and let this man who is 69 years old attend to his patients like he has for 40 years.”
Assistant U.S. Attorney James Keller said Forsythe didn’t do many of the tests experts said are necessary to determine whether someone suffers from a hormone deficiency.
“This case is not about whether the defendant is a good doctor or whether he practices good medicine,” Keller said.
“You are simply here to determine whether he followed the law and whether he distributed the drug for unauthorized purposes,” he said.
Keller brushed out of the courtroom on Thursday, ignoring a reporter’s request for comment.
On the tape recording, the undercover agent tells Forsythe a man he knows from the gym referred him to Forsythe. He said he had searched on the Internet and been reading about human growth hormones.
Forsythe responded, “So you’re mainly interested in HGH for energy purposes, getting back into shape?” He then told the agent they provide such treatment at his clinic.
Keller said the doctor made a reference to a book entitled “Feel Good with HGH” and handed out a pamphlet “Healthy Aging, Passport to a Better Life.”
“Doesn’t it show he’s doing it for anti-aging purposes?” Keller asked the jury. “He prescribed it for anti-aging, lack of energy — those things for which we want to make us feel younger.”
“There were no questions about the pituitary gland or trauma to the head,” Keller said, which experts testified can cause such a condition.
“Doesn’t that seem like a cover?” Keller asked. He also questioned why Forsythe didn’t write the agent a prescription to take to a pharmacy.
“Why distribute it out of his office? What’s being hidden here?” he said.
Mirch said the government used snippets of the tape out of context “to somehow state that Dr. Forsythe does not have the capacity to tell if someone has a growth hormone deficiency.”
“The government tried to tell you if Dr. Forsythe didn’t do what they consider proper tests, that is a crime. It is not,” he said. “He can prescribe it and give it to that patient if he believes that (diagnosis). It is an allowed use.”
Mirch said the defense team was able to determine that the agent once suffered a stroke, which he compared to head trauma, something the agent had kept from the FDA and Justice Department prosecutors.
“You don’t let an unqualified sick person make the decision to indict a doctor who has a sterling reputation for years and years and years,” he said.
James Forsythe, Dan Bogden, Gibbons, RGJ...
Thu Nov 01, 2007 10:46 pm
First, I agree with the comment posted by Waldwick--couldn't have said it better. I further add that we won't have to hear/read Mirch's (who is also under indictment) ridiculous statements about his client's "reputation" and the government's politically motivated attack on his client.
Second, I also agree (in part) with the comment NVMojo posted regarding Bogen and Gibbons. However, I would like to point out that the current article regarding Forsythe was written by Associated Press.
The beautiful thing about living in a "free society" is, among many things, that a person has the right to choose whichever newspaper he/she wishes to read. Since we (you, me, and the other guy) are posting comments to this website, I guess it is safe to assume that we have each elected to read this newspaper.
shoddy reporting from the RGJ again
Thu Nov 01, 2007 8:38 pm
What happened to the subpoena for fired US Attorney Daniel Bogden? Why do you people cover up for Gibbons all the time? Pathetic. No wonder your revenue is shrinking.
Disappointing verdict with positive results
Thu Nov 01, 2007 3:31 pm
While it's hard to believe that Forsythe was acquitted despite his obvious misconduct and incompetence, at least we won't have to hear him or other anti-aging doc's talk any more about prescribing HGH to combat aging. After all, if Forsythe had admitted that he does give HGH to people to make them feel younger, he would never have gotten off. It will be interesting to see if he repeats the defense he used at trial in his long-scheduled presentation on HGH at the 15th Annual Congress on Anti-Aging Medicine in Las Vegas on December 14, 2007.
Also, to people who are inclined to see this as a victory, I have to say that Forsythe's successful defense--"I may be incompetent, but I'm not a criminal--is hardly cause for celebration.
Federal trial resumes for homeopathic doctor JACLYN O'MALLEY RENO GAZETTE-JOURNAL Posted: 10/23/2007 STORYCHAT(read or post comments) The federal trial of Dr. James W. Forsythe, a Reno homeopathic physician accused of trafficking illegal human growth hormone to patients for anti-aging purposes, resumes today with testimony from the undercover agent who posed as his patient.
During Monday's opening arguments, Assistant U.S. Attorney Brian Sullivan said the case is an unusual form of drug trafficking.
"This isn't the normal case you see in an alley or motel room but (trafficking) of a drug used by Dr. Forsythe in his medical practice," he said. "He caused the introduction of this drug into commerce with the intent to defraud and mislead patients by not telling them it was not approved by the FDA or that it was not for sale in the United States."
Forsythe, 69, is accused of twice selling vials of Bio-Tropin, an illegal human growth hormone sold in Israel, to an undercover Food and Drug Administration investigator in 2004. Special Agent John Zalinsky told Forsythe he was referred to him by a friend at his gym whom he was treating with HGH for anti-aging purposes.
Forsythe also is charged with dispensing the drug for unapproved treatment. Sullivan said using HGH as a medical treatment is limited to illnesses mostly in children, dwarves and sometimes in AIDS patients.
"You can't use HGH for anti-aging. We all get old and know we're going to die," he said.
But Forsythe's lawyer, Kevin Mirch, told jurors the case is about Zalinsky, a former 14-year FBI agent, wanting to "prove a point" and "catch a doctor." He said the government is upset about how Forsythe runs his practice, which includes alternative medicine.
Mirch said Bio-Tropin, according to a book issued by the FDA, is approved and safe.
Agents found records at Forsythe's home and medical clinic of purchases he made of Bio-Tropin through Pharmacy International in Carson City. The business in 2005 was searched by Immigration and Customs Enforcement officials, but no charges were filed against company officials.
Sullivan said Bio-Tropin was FDA-approved between 1995 and 2002, but the manufacturer changed the formula and its name. He said FDA doctors and chemists will testify as to why it's currently not an approved drug.
The trial is expected to last five days.
On Wednesday, Mirch must appear in Washoe District Court to face charges of insurance fraud, theft and subornation of perjury. He faces a January trial and was referred to the Nevada State Bar Association for disbarment by the Nevada Supreme Court. Forsythe told U.S. District Judge Howard McKibben that he was aware of Mirch's situation.
The trial also will stop Friday in observance of Nevada Day and resume next week.
On Sept. 14, 2004, Zalinsky went to Forsythe's office, Century Wellness Clinic, and complained of a post-surgery cough and lack of energy and ability to return to good physical condition.
Forsythe told Zalinsky he was going to give him Bio-Tropin, that it was from Israel and was "highly recommended through quality control," according to a tape recording made of Zalinsky's visit that was played in court.
Zalinsky bought a vial of Bio-Tropin for $238 at Forsythe's clinic and bought another the following month. During that return visit, Forsythe also suggested a certain blood test, which the investigator said his insurance would not pay for, court documents show. But Forsythe allegedly said if he diagnosed him with "hypopituitarism," insurance would pay for it.
According to the insurance company, Forsythe had diagnosed the investigator during that visit with having a serious stroke, hypertension and hypopituitarism, a pituitary gland problem. But doctors consulted by the FDA told the investigator that based on his medical history and symptoms, it was unreasonable for Forsythe to make that diagnosis.
Forsythe is licensed in Nevada as a homeopathic and medical doctor, specializing in internal medicine, anti-aging and oncology. The Nevada Board of Medical Examiners disciplined him for billing problems more then 10 years ago.
After his indictment, Anthem Blue Cross and Blue Shield dropped Forsythe as a preferred physician provider. His medical and homeopathic licenses are intact and he has maintained his practice.
An undercover investigator with the Food and Drug Administration in September 2004 asked a Reno cancer doctor who was known for alternative therapies if he could help him feel young again.
Federal authorities say Dr. James W. Forsythe twice gave the investigator a vial of human growth hormone from Israel to inject into himself that was not approved for use or distribution in the United States. The label said it was for “anti-aging.”
Forsythe told him it would reverse the effects of aging, restore his sleep quality, improve weight control, enhance libido and improve immune function, according to recently unsealed court affidavits in U.S. District Court in Reno.
On Thursday, Forsythe, 68, of Reno, pleaded not guilty to a federal grand jury indictment handed up Wednesday. It charged him with introducing the drug, Bio-Tropin, into Nevada from Israel without approval of the U.S. secretary of Health and Human Services and distributing Bio-Tropin for a purpose other than treating disease. The indictment said others in Forsythe’s clinic helped distribute the hormones between June 2003 and February 2005.
Forsythe surrendered to authorities Thursday morning. He was released on his own recognizance.
“I am confident we will prevail,” Forsythe said after a court appearance Thursday, declining to comment further.
Human growth hormone is secreted by the anterior pituitary gland, and some children don’t produce enough, causing stunted growth.
In the 1980s, the FDA granted approval for a form of HGH that currently is limited to brands of drugs that are sold and used for treatment of limited medical conditions. Bio-Tropin is not approved for use or sale in the United States.
HGH is marketed as an anti-aging miracle that causes weight loss and increases athletic performance. The hormone is part of a federal inquiry into drugs used in professional sports. The Cancer Prevention Coalition in Chicago said that HGH medications increase risks of colon, prostate and breast cancers.
Investigators also say that Forsythe uses a treatment called Poly-MVA, an intravenous treatment he claims is an unconventional therapy that brings “death” to cancer cells. It also is not an FDA-approved drug.
The treatment is featured on a newsletter on his Web site, www.drforsythe.com/cstc.php, and Forsythe claims it is a dietary food supplement.
He also has numerous people identified as patients on his Web site who give testimonials about his treatments.
Forsythe is also accused in court records, but not charged, of receiving the hormone in the mail from smugglers, insurance fraud by fabricating diagnosis to obtain insurance reimbursement for unnecessary tests and treatments and giving patients misbranded vials with inadequate directions.
The U.S. Attorney’s Office said it is still investigating Forsythe and his practice, and more charges are possible.
Forsythe is the owner and medical director of Century Wellness Clinic in Reno. His wife, Earlene, is a partner in the clinic and a registered nurse. The pair have strong ties to the Republican Party and served as delegates to the Republican National Convention. Earlene Forsythe is the former chairwoman of the Nevada GOP. She also declined to comment.
The FDA had been investigating Forsythe since February 2005, when agents searched his home in connection with a Carson City drug supplier investigated for selling Bio-Tropin.
The Nevada Board of Medical Examiners also has been investigating Forsythe, who is certified in homeopathy, internal medicine and oncology.
“Forsythe represents one of the five most serious physician offenders known in the state of Nevada,” according to an affidavit quoting BME investigator Pamela Castagnola.
The board in 1995 charged him in a 44-count complaint with making “unreasonable additional charges for tests in a laboratory, radiological services or other services performed outside of his office.”
This was related to more than 20 investigations for bad conduct, including excessive billing, according to court records.
Forsythe pleaded no contest to one count and agreed to pay $1,000 as a fine and another $44,000 to make up for improper billing.
Castagnola said that since the 1995 discipline, Forsythe has been under investigation.
In 1996, six investigations looked into allegations of excessive billings and bad medical practices. From 1997 to 2004, at least 12 investigations were opened. But, none of the investigations resulted in discipline and most are closed, she said.
The FDA investigator on Sept. 14, 2004, had an appointment with Forsythe at his clinic. He told the doctor he had a large invasive tumor previously removed from his lungs. He said he was 45 and found it difficult to get back into physical shape.
The investigator told him he saw advertisements for the HGH treatment at the doctor’s office and asked if he could help. He told Forsythe that a friend of his at a gym had received the treatment from Forsythe and recommended him. The doctor charged him $422 for the first visit “” $238 was for the one-month supply of hormones, according to court papers.
On Oct. 27, 2004, the investigator returned, and Forsythe sold him another vial of HGH, according to court papers. The doctor also suggested he take a certain blood test, which the investigator said his insurance would not pay for, documents show. But Forsythe allegedly said if he diagnosed him with “hypopituitarism,” insurance would pay for it.
According to the insurance company, Forsythe had diagnosed the investigator during that visit with having a serious stroke, hypertension and hypopituitarism, a pituitary gland problem.
Doctors consulted by the FDA told the investigator that based on his medical history and symptoms, it was unreasonable for Forsythe to make the diagnosis.
Also, they said the initial blood test Forsythe insisted he take was not necessary.
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Click here to read the search warrant issued for Dr. Forsythe’s Century Wellness Clinic, including list of seized items.
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The original article from the Reno Gazette Journal can be viewed here.
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.
MED BIGS JAB STEROID DOC
By MELISSA KLEIN
October 14, 2007 -- An Upper East Side doctor caught writing steroid and growth-hormone prescriptions for patients of a Florida clinic linked to a baseball slugger has had her license suspended.
Dr. Barbara Nichols apparently never met the 11 patients for whom she prescribed human growth hormone, testosterone and other drugs in 2002. They were patients of an Internet business called Modern Therapy based in Miami Beach, according to state documents.
Modern Therapy, also known as South Beach Rejuvenation Center, allegedly hooked up Baltimore Orioles outfielder Jay Gibbons with human growth hormone and steroids, according to recent published reports.
Pat Courtney, a spokesman for Major League Baseball, told The Post that MLB has an ongoing investigation into Gibbons and his association with Modern Therapy.
HGH and testosterone are considered performance-enhancing drugs and are banned in baseball and other sports.
Nichols, 57, reviewed records provided by Modern Therapy and prescribed the drugs. She failed to adequately evaluate and treat the patients and prescribed the drugs without medical need, according to the charges against her by the state Board for Professional Medical Conduct.
The board accused Nichols of 68 acts of misconduct.
She signed a consent agreement with the board, which requires her to pay a $10,000 fine and to stop practicing medicine for three months. She can no longer prescribe controlled substances and hormones.
Nichols did not return calls seeking comment.
Nichols worked for the city Sanitation Department for the last 10 years, earning $105 an hour to do pre-employment and other exams for the department, but did not treat workers or write prescriptions, said Kathy Dawkins, a department spokeswoman. She gave notice in mid-September that she would be quitting, Dawkins said.
Nichols, who lives on East 90th Street, has been in trouble before. She pleaded guilty in 1993 in federal court to willful failure to file income-tax returns. She also filed for bankruptcy protection twice in the 1990s.
Improperly taking HGH - which is legitimately prescribed to help short children grow - can cause the organs to enlarge, and its use is linked to diabetes and high blood pressure.
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.
PROVIDENCE, R.I. -- A former doctor will plead guilty to illegally prescribing anabolic steroids and human growth hormone to patients she never met or examined, her lawyer said Monday.
Ana Maria Santi reached an agreement with prosecutors and plans to plead guilty June 1 to 29 counts of health care fraud, conspiracy and illegal drug distribution in federal court in Providence, said her attorney, Edward C. Roy.
"It's in her best interests," Roy said.
Prosecutors say Santi and other doctors were enlisted by Daniel McGlone, the president of New Jersey-based American Pharmaceutical Group, to write prescriptions for bodybuilders and other customers from April 2004 until August 2006.
Santi, who was stripped of her New York medical license in 1999, forged the signature of a doctor living in a California nursing home on the prescriptions she wrote, prosecutors said. She is suspected of earning $25 for each prescription.
The plea agreement says Santi wrote prescriptions on behalf of at least three companies besides American Pharmaceutical Group.
Prosecutors have agreed to recommend a reduced sentence for Santi, but Roy said he did not know what that would be. Santi also is awaiting sentencing in New York in a state case involving similar allegations.
The maximum prison sentence for all 29 counts is 155 years.
Tom Connell, a spokesman for the U.S. attorney's office in Rhode Island, declined to comment on the plea agreement.
McGlone is charged with advertising steroids and human growth hormone to bodybuilders and other customers and then paying doctors to write medically unnecessary prescriptions. He has pleaded not guilty.
Another doctor, Victor Mariani, pleaded guilty in March for his role.
Prosecutors say that once McGlone received the prescriptions from Santi and Mariani, he would send them to be filled by other pharmacies, including Orlando, Fla.-based Signature Pharmacy.
While Signature Pharmacy is not charged in the Rhode Island case, two of its owners have been indicted in a case brought by prosecutors in Albany, N.Y.
Linked to that case, in various reports, are a number of sports stars, including baseball's Gary Matthews Jr., former heavyweight champion Evander Holyfield and 1996 Olympic wrestling gold medalist Kurt Angle.
The use or distribution of human growth hormone is restricted under federal law to specified medical uses, such as wasting disease associated with AIDS. It is not approved for bodybuilding or weight-loss treatments.
United States Department of Justice, Nevada Office
News Release for Immediate Release Thursday, September 28, 2006
PRESS CONTACTS: Natalie Collins, Public Affairs Specialist
Reno Doctor Charged With Introducing And Distributing Human Growth Hormone
RENO — A Reno doctor has been indicted by the Federal Grand Jury on charges that he caused the introduction of human growth hormone into the Reno area from Israel and distributed human growth hormone for a purpose other than the treatment of a disease or other recognized medical condition, announced Daniel G. Bogden, United States Attorney for the District of Nevada.
James W. Forsythe, aka “Dr. Forsythe,” age 68, owner and Medical Director of the Century Wellness Clinic located at 521 Hammill Lane, Reno, Nevada, was indicted on Wednesday, September 27, 2006, and charged with one count of Causing Introduction Into Interstate Commerce Unapproved New Drugs, one count of Distribution of Human Growth Hormone, and Aiding and Abetting. If convicted, Dr. Forsythe faces up to three years in prison and a $250,000 fine on the causing introduction count and up to five years in prison and a $250,000 fine on the distribution count.
According to the Indictment, on multiple occasions from about June 2003 to February 2005, James W. Forsythe, as aided and abetted by others in the Century Wellness Clinic, Inc., did, with the intent to defraud and mislead, cause the introduction into interstate commerce from Israel to Nevada, a new drug, known as Bio-Tropin, a form of human growth hormone, without the required approval of the U.S. Department of Health and Human Services. Further, on multiple occasions during the same time period, James W. Forsythe, as aided and abetted by others in the Century Wellness Clinic, Inc., did knowingly distribute Bio-Tropin for a purpose other than the treatment of a disease or other recognized medical condition.
Dr. Forsythe is scheduled to make an initial appearance before a United States Magistrate Judge at 3:00 p.m. today. The case was investigated by the FDA and U.S. Immigration and Customs Enforcement and prosecuted by Assistant United States Attorney Robert Don Gifford.
The public is reminded that an indictment contains only charges and is not evidence of guilt. The defendants is presumed innocent and entitled to a fair trial at which the government has the burden of proving guilt beyond a reasonable doubt.
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.
BRANDON — While law enforcement silently pursued him in Palm Beach County, a heart doctor now charged with peddling steroids and growth hormones on the Internet tried to pump up business in this Tampa suburb by teaming with a former professional wrestler called Cyborg.
Dr. Robert G. Carlson and partner Kevin Donofrio of Brandon formed Florida Rejuvenation Institute in September, state corporation records show. Six months later, Carlson was arrested for his role at Palm Beach Rejuvenation Center, an alleged prescription mill in Jupiter that prosecutors say made millions prescribing steroids, testosterone and other potentially dangerous hormones through its Internet site without face-to-face examinations of patients.
Donofrio said Florida Rejuvenation Institute was founded in hopes of repeating the Jupiter company's success. He said he had no idea Carlson was being investigated. But six or eight weeks after the company was formed, Donofrio said he backed away from their enterprise.
"I realized he didn't really want to see patients face to face," Donofrio said. "They were into this Internet medicine business."
Carlson was arrested in February after a three-year national investigation of prescription drug sales on the Internet. Fourteen Floridians have been charged, plus seven more in Texas and New York.
Carlson, a 50-year-old former Eagle Scout, has pleaded not guilty to seven counts of selling controlled substances. He has refused comment. His attorney, Thomas J. O'Hern of Albany, N.Y., would not answer written questions faxed to his Albany office. Carlson's former attorney has said more prescriptions were written with Carlson's name that the doctor had signed.
A professional wrestler for seven years, 44-year-old Donofrio now operates Partners in Wellness, a string of health clubs and clinics providing primary care, physical rehabilitation and pain management. He touts himself as a five-time All-American in Greco-Roman and freestyle wrestling and a Coastal USA Body Building Champion. He also has coached high school wrestlers.
It was through wrestling that Donofrio met Carlson's brother-in-law, Joseph Raich, a longtime booster of amateur wrestling, as well as the wrestling team at Jupiter Christian School, and vice president of Palm Beach Rejuvenation. When investigators raided the company's headquarters in February, Chris Ruh, son of the high school's wrestling coach, was working there, court records show.
Ruh has not been charged, nor have authorities publicly stated that he is under investigation. Raich has not been charged, but prosecutors call him an unindicted co-conspirator. He has hired a criminal defense lawyer.
Their connections to the company and the wrestling team prompted the Florida High School Athletic Association to open an inquiry into the wrestling program. A year ago, Jupiter Christian became the smallest school ever to win a state wrestling title in Florida.
"My main reason was I heard they were the number one company in the world," Donofrio said of his interest in Palm Beach Rejuvenation. "I'd always known success leaves clues. I figured if they're the No. 1 company in the world, in terms of producing volume, they must do it right, you would think. Like the number one football team, they must have the best players, right?"
Because Donofrio already had medical facilities in Brandon, he said he started the company with about $20,000, some of it spent on advertising. They launched Florida Rejuvenation with a couple of public seminars featuring Carlson, a trim-and-fit heart surgeon who hails the benefits of hormones in combating the common effects of aging: weight gain and the loss of sexual libido and energy.
The two seminars drew 230 prospects, Donofrio said, with 40 later meeting face to face with Carlson. But after that, Donofrio said, Carlson told him he didn't want to see patients. He said the doctor, whose practice and home are an hour's drive away in Sarasota, wanted patients' laboratory test results faxed or e-mailed to him rather than having him personally examine patients seeking prescriptions. Carlson insisted it was legal, Donofrio claims.
"That was kind of when a red light went off and I said, 'Nah, I'm not doing that. I'm not getting into that kind of business,'''' Donofrio said.
The law in New York, where Carlson was charged, prohibits doctors from writing prescriptions without face-to-face visits. Florida law has a similar prohibition, with a few exceptions for emergencies and other circumstances.
Doctors at Donofrio's other medical clinics, he said, spend 11/2 hours with each patient, followed by a nutritionist spending an hour with the patient. Only then, he said, are prescriptions written.
"Carlson is a brilliant doctor," Donofrio said. "He's no dummy. The guy is well-educated, but I can't feel good about having my customers, whom I've worked 20 years for, faxing their labs to Sarasota or to Palm Beach for review and not having face-to-face contact with the physician."
A lack of face-to-face contact is central to the charges brought in New York against Carlson and Palm Beach Rejuvenation employees Glenn and George Stephanos, brothers who also have pleaded not guilty to drug charges.
"It's sad," Donofio said. "These guys, they're out there making millions, but I don't know what'll happen to them. But I can sleep at night."
While awaiting trial, Carlson continues his cardiac practice from a third-floor suite in Sarasota. Tacked on the door along with his name is a sign for Palm Beach Rejuvenation of Sarasota, a business he formed six weeks before opening Florida Rejuvenation Institute with Donofrio. Carlson's pitch on his Sarasota company's Web site: "You need hormone replacement for a better quality of life."Donofrio said that, to his knowledge, Carlson never wrote prescriptions for Florida Rejuvenation Institute patients without a face-to-face examination. He said the company was dissolved in late 2006, right after his falling out with Carlson. Told that state records show the company remained in active status, Donofrio produced the copy of a check to the state as well as a state form he signed to dissolve the company. The check was dated March 29, the same day he was interviewed about the company by The Palm Beach Post.
"It was an oversight," he said, when asked why the form and fee weren't filed earlier.
Sitting in his second-floor office at The Athletic Club, his newly renovated health club in Brandon, Donofrio was surrounded by reminders of his days as Cyborg: dozens of photos, from Hulk Hogan to an autographed picture of Dwayne "The Rock" Johnson, a former University of Miami football player who became a wrestler and now stars in action films.
There's also a picture of Eddie Guerrero, a wrestling star who died young. The death certificate for Guerrero, who was 38 when he died in 2005, listed an enlarged heart caused by steroid use as a contributing factor.
The picture is a reminder of why Donofrio says he won't help anyone seeking steroids or human growth hormone to boost athletic performance. Donofrio recalled the parents of an athlete who had shoulder surgery asking for human growth hormone to speed up the healing.
"I said, 'Absolutely not. The guy's 16 years old. He's got plenty of hormones,'''' Donofrio said. "I make it very clear to people: We're not in business for athletic performance. We're in business to give people therapy that need it."
Donofrio has remained involved in youth athletics by volunteering as an assistant coach and fund-raiser for the Brandon High School wrestling team, whose winning dynasty is among the greatest in the nation. The Eagles have a 34-year winning streak of 439 dual matches and have won 18 state championships, including the past seven. Because of its size, the school doesn't compete in the same classification as Jupiter Christian.
"I needed somebody to work with my heavyweights, and so I took him on," Brandon coach Russ Cozart said of Donofrio. "He worked with my heavyweights for three years and did a great job. He was always there for the kids."
Demands of his businesses caused him to miss this past season at Brandon High, but Donofrio said he hopes to return soon.Donofrio added to his business interests in November, forming Infinite Vitality of Brandon, part of a chain of hormone replacement clinics with offices in Tampa and Beverly Hills, Calif. Carlson is not involved, he said.
"We have been led to believe that the changes that occur to our bodies with age are inevitable," Infinite Vitality says on its Web site. "In fact, many of these changes can be minimized or prevented by recent advances in the field of Age Management Medicine."
Infinite Vitality is a "very reputable" hormone-replacement firm, Donofrio said, that requires face-to-face examinations with its physicians. "We're not going to get rich, but we're going to help people and I'm going to continue to help people in the health and fitness industry," Donofrio said. "That's what I got in it for."
Staff researcher Sammy Alzofon contributed to this story.
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.
RENO DOC IN TROUBLE AGAIN
On Thursday, Dr. Forsythe, 68, of Reno, pleaded not guilty to a federal grand jury indictment handed up Wednesday. It charged him with introducing the drug, Bio-Tropin, into Nevada from Israel without approval of the U.S. secretary of Health and Human Services and distributing Bio-Tropin for a purpose other than treating disease. The indictment said others in Forsythe’s clinic helped distribute the hormones between June 2003 and February 2005.
Forsythe surrendered to authorities Thursday morning. He was released on his own recognizance.
“I am confident we will prevail,” Forsythe said after a court appearance Thursday, declining to comment further.
Human growth hormone is secreted by the anterior pituitary gland, and some children don’t produce enough, causing stunted growth.
In the 1980s, the FDA granted approval for a form of HGH that currently is limited to brands of drugs that are sold and used for treatment of limited medical conditions. Bio-Tropin is not approved for use or sale in the United States.
HGH is marketed as an anti-aging miracle that causes weight loss and increases athletic performance. The hormone is part of a federal inquiry into drugs used in professional sports. The Cancer Prevention Coalition in Chicago said that HGH medications increase risks of colon, prostate and breast cancers.
Investigators also say that Forsythe uses a treatment called Poly-MVA, an intravenous treatment he claims is an unconventional therapy that brings “death” to cancer cells. It also is not an FDA-approved drug.
The treatment is featured on a newsletter on his Web site, www.drforsythe.com/cstc.php, and Forsythe claims it is a dietary food supplement.
He also has numerous people identified as patients on his Web site who give testimonials about his treatments.
Forsythe is also accused in court records, but not charged, of receiving the hormone in the mail from smugglers, insurance fraud by fabricating diagnosis to obtain insurance reimbursement for unnecessary tests and treatments and giving patients misbranded vials with inadequate directions.
The U.S. Attorney’s Office said it is still investigating Forsythe and his practice, and more charges are possible.
Forsythe is the owner and medical director of Century Wellness Clinic in Reno. His wife, Earlene, is a partner in the clinic and a registered nurse. The pair have strong ties to the Republican Party and served as delegates to the Republican National Convention. Earlene Forsythe is the former chairwoman of the Nevada GOP. She also declined to comment.
The FDA had been investigating Forsythe since February 2005, when agents searched his home in connection with a Carson City drug supplier investigated for selling Bio-Tropin.
The Nevada Board of Medical Examiners also has been investigating Forsythe, who is certified in homeopathy, internal medicine and oncology.
“Forsythe represents one of the five most serious physician offenders known in the state of Nevada,” according to an affidavit quoting BME investigator Pamela Castagnola.
The board in 1995 charged him in a 44-count complaint with making “unreasonable additional charges for tests in a laboratory, radiological services or other services performed outside of his office.”
This was related to more than 20 investigations for bad conduct, including excessive billing, according to court records.
Forsythe pleaded no contest to one count and agreed to pay $1,000 as a fine and another $44,000 to make up for improper billing.
Castagnola said that since the 1995 discipline, Forsythe has been under investigation.
In 1996, six investigations looked into allegations of excessive billings and bad medical practices. From 1997 to 2004, at least 12 investigations were opened. But, none of the investigations resulted in discipline and most are closed, she said.
The FDA investigator on Sept. 14, 2004, had an appointment with Forsythe at his clinic. He told the doctor he had a large invasive tumor previously removed from his lungs. He said he was 45 and found it difficult to get back into physical shape.
The investigator told him he saw advertisements for the HGH treatment at the doctor’s office and asked if he could help. He told Forsythe that a friend of his at a gym had received the treatment from Forsythe and recommended him. The doctor charged him $422 for the first visit “” $238 was for the one-month supply of hormones, according to court papers.
On Oct. 27, 2004, the investigator returned, and Forsythe sold him another vial of HGH, according to court papers. The doctor also suggested he take a certain blood test, which the investigator said his insurance would not pay for, documents show. But Forsythe allegedly said if he diagnosed him with “hypopituitarism,” insurance would pay for it.
According to the insurance company, Forsythe had diagnosed the investigator during that visit with having a serious stroke, hypertension and hypopituitarism, a pituitary gland problem.
Doctors consulted by the FDA told the investigator that based on his medical history and symptoms, it was unreasonable for Forsythe to make the diagnosis.
Also, they said the initial blood test Forsythe insisted he take was not necessary.
*****************
Click here to read the search warrant issued for Dr. Forsythe’s Century Wellness Clinic, including list of seized items.
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.
Department of Health and Human Services Public Health Service
Food and Drug Administration San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700
Via FEDEX WARNING LETTER March 7, 2003
Steven Heuer Cocoon Nutrition 990 West Fremont Avenue Suite K Sunnyvale, CA 94087
Dear Mr. Heuer,
This letter concerns Cocoon GH-Liquid Spray Growth-600 ng [somatotropin], also known as recombinant human growth hormone.
Your Internet site www.cocoonnutrition.org from which you can order this product, includes claims such as "very powerful Anti-aging benefits of injectable GH.. . is now available in an orally-absorbable form-without a prescription and at a fraction of the cost. . .rejuvenation of the skin and bones and regeneration of the heart, liver, lungs, and kidneys, bringing back organ and tissue function to more youthful levels. GH revitalizes the immune system, lowers the risk factors of heart attack and stroke improves oxygen uptake, and helps prevent osteoporosis. It is a powerful anti-obesity hormone and acts to naturally enhance sexual function. For many it acts like a natural cosmetic, restoring skin elasticity, smoothing wrinkles, and rejuvenating hair and nails.. . Cocoon GH is actual Growth Hormone. It rebuilds cells, regenerates organs, and has many long term benefits.. it can regenerate the size and function of the adrenal glands, sex organs, brain, liver, and all the other glands and tissues of the body." Testimonials included on your web site also convey the intended drug status of your product. Examples of these claims include but are not limited to; the improvement or cure of osteoarthritis, back injury, kidney failure, repetitive stress injury, tendonitis, serious hip joint pain, irregular heart beat and diabetic blood sugar levels.
On your Internet site, you state "GH is now available in an orally-absorbable form -without a prescription and at a fraction of the cost. In the Directions For Use section of your web page, it states that the product sprayed "directly onto the inner cheek and hold for 90 seconds. . . " Cocoon GH is intended to bypass the alimentary canal by direct absorption through the oral mucosa, and is therefore not a dietary supplement because it is not intended for ingestion. 21 U.S.C. 321(ff)(2)(A)(I) defines the term, "dietary supplement" to mean a product that is "intended for ingestion." Consequently, a product that is not intended for ingestion for ingestion cannot be a "dietary supplement."
Further, "growth hormone" was not marketed as a dietary supplement, or as food prior to 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)(B) because growth hormone is an article approved as a new drug under 21 U.S.C. 355.
Based on the claims made for this product, Cocoon GH is a "drug" as defined in 21 U.S.C. 321(g). Moreover, Cocoon GH" is a "new drug" as defined in 21 U.S.C. 321(p) because this product is not generally recognized as safe and effective for its intended uses. Since this product is a new drug, it may not be marketed in the United States Food without an approved new drug application (NDA) [21 U.S.C. 355(a)]. In addition, Cocoon GH 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 offered.
Since you promote and distribute the Cocoon GH product for health related claims that are not the subject of an FDA approved NDA, you are also in violation of 21 U.S.C. 333(e). This section 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 firms may market. The violations of the Act described above are not intended to be 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 make 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, or criminal prosecution pursuant to 21 U.S.C. 333(e).
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 Russell A. Campbell, Compliance Officer, at the U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502.
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.
Department of Health and Human Services Public Health Service
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
Telephone: 781-596-7700
Facsimile: 781-596-7899
WARNING LETTER
NWE-25-02W
July 30, 2002
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Alan Blair
Affordable HGH.com
Top Management Co.
5 River Road, #105
Wilton, CT 06897 and
51 Mayflower Dr
Wilton, CT 06897
Dear Mr. Blair,
This letter concerns somatotropin (rDNA origin) with cyanocobalamine and pyridoxine for injection compounded by your firm. Somatotropin is also known as recombinant human growth hormone (hGH) and is currently marketed by your firm as shown on your Internet sites www.affordablehgh.com and www.buyhghdirect.com.
According to information on these sites, your compounded hGH product is being promoted as part of an anti-aging treatment regimen. This activity is in violation of 21 U.S.C. 333(f).
The intended anti-aging treatment regimen use for your compounded hGH product is conveyed through claims on both of your Internet sites. These include statements such as " ...fountain of youth flows from needle...Human growth hormone (hGH) replacement therapy is one of the most promising of all the anti-aging treatments...six months of hGH replacement therapy can reverse several bio-markers of aging by ten to twenty, years.. .effects of human growth hormone therapy include: decreased body fat, increased lean mass, increased bone density, increased energy levels, improved skin tone and texture, improved immune system function, and a greater sense of well-being...hGH (preferably bio-engineered, recombinant hGH) called "Somatotropin" produces measurable health, anti-aging, and rejuvenation benefits….lowered blood pressure and cholesterol...improved sleep patterns... enhanced sexual drive and performance...regeneration of heart, liver and kidney...improved skin tone and removed wrinkles…". Ordering instructions are contained on your web sites and your sites will automatically refill the prescription, and bill and ship the compounded hGH product on a monthly basis, until the purchaser logs in and suspends or cancels the subscription to the prescription.
Distribution of your hGH product violates 21 U.S.C. 333(f). Your hGH product is being promoted and distributed 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(f) 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 Mark Lookabaugh, Compliance Officer, at the U.S. Food and Drug Administration, One Montvale Ave., 4th Floor, Stoneham, MA 02180.
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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.
Department of Health and Human Services
Department of Health and Human Services Public Health Service 
