A judge has halted the e-mail operation of a firm selling purported weight-loss and anti-aging products.
Grant Gross, IDG News Service
Sunday, August 26, 2007 5:00 AM PDT
A U.S. district judge has ordered a company to stop sending unsolicited e-mail marketing weight-loss and anti-aging products that allegedly did not work, the U.S. Federal Trade Commission (FTC) announced last week.
The operation sent unwanted e-mail messages in violation of the Controlling the Assault of Non-Solicited Pornography and Marketing Act, or CAN-SPAM Act, of 2003, the FTC said. The company's Web sites sold pills that allegedly caused significant weight loss and contained the plant hoodia gordonii under names such as HoodiaHerbal and Hoodia Maximum Strength.
The sites also sold allegedly natural products that were supposed to elevate a user's human growth hormone (HGH) level and thereby dramatically reverse the aging process under names such as Perfect HGH and Dr-HGH.
The claims made about the products were false or unsubstantiated, the FTC said in its complaint. The defendants falsely claimed that their supposed hoodia products cause rapid, permanent and substantial weight loss, as much as 40 pounds a month, the FTC said.
The defendants also falsely claimed that their supposed HGH products would cause a clinically meaningful increase in a consumer's growth hormone levels, the FTC said. The defendants falsely claimed that their HGH products would turn back or reverse the aging process, including lowering blood pressure, reducing cellulite, improving vision, causing new hair growth and improving sleep.
The FTC's spam database has received over 85,000 e-mail messages sent on behalf of the operation, the FTC said. Many of these e-mail messages were sent using Web form hijacking, in which the spammer injects the spam message into form fields on an innocent, third-party Web site, the agency said. The message appears to come from the victim Web site operator's mail server.
This is the first time the FTC has filed a case against spammers using this tactic.
The FTC accused the company of violating CAN-SPAM by sending commercial e-mail messages that contained materially false and misleading header information; contained deceptive subject headings; failed to provide clear and conspicuous opt-out links; and failed to include a physical postal address.
The judge has also ordered the company's assets to be frozen. A hearing scheduled for Monday will determine whether to extend the restraining order and the asset freeze, the FTC said.
Tuesday, April 24, 2007
When Drug Dealers Go Online
Anyone with an e-mail account likely knows that Viagra is readily available over the Internet. Less recognized until Tuesday's simultaneous raids of internet pharmacies in Florida and Texas — which grabbed headlines because of the promise of celebrity customers to be revealed — is the extent to which illegal prescription drug trafficking, like other forward-looking businesses, has gone online. "The Internet changes everything. It changed the music industry. It changed travel. And it particularly advantages those enterprises that benefit from clandestine activity," says Dr. Robert Forman, psychology professor on leave from the University of Pennsylvania who studies the Internet drug trade. "Prescription opiate abuse has gone up like a rocket since about the same time heavy use of the Internet has gone up."
Like other industries searching for the formula for online success, the illegal drug trade encompasses a variety of Web, brick-and-mortar, domestic and global configurations. In the latest criminal case, District Attorney David Soares of Albany County, N. Y., claims to have broken up what he calls a national online drug trafficking ring which sold, to New Yorkers alone, $10 million worth of illegal anabolic steroids, human growth hormone and other controlled drugs. In a press release, Soares alleged that Signature Compounding Pharmacy — with two multi-million-dollar office buildings in Orlando, Fla. — repeatedly filled prescriptions from doctors, some unlicensed, which the company knew had never seen the patients, a violation of state law. Agents also shut down Cellular Nucleonic Advantage of Sugar Land, Texas, raided offices of Palm Beach Rejuvenation Center in Jupiter, Fla. and are looking at six other businesses in Florida, Alabama and New York. A lawyer for Signature offered no comment on the charges, only saying that the company's website had reopened for business. Cellular Nucleonic offered no comment as well. Meanwhile, the Houston Chronicle reported that Sugar Land's office was locked and the company's sign taken down. Sugar Land has no phone number on record.
A source within the investigation confirmed to TIME that major sports figures who allegedly patronized the businesses — but who are not targeted for prosecution — include former heavyweight champ Evander Holyfield; Los Angeles Angels outfielder Gary Matthews Jr.; former major league pitcher Jason Grimsley; former major league slugger Jose Canseco; and Pittsburgh Steelers associate team physician Richard A. Rydze. The list first appeared in the Albany Times Union. Holyfield has denied using steroids. Matthews offered no comment as did representatives of Grimsley. Canseco?s lawyer said it was unlikely his client bought steroids off the internet. The Steelers organization told the Times Union that Rydze did not provide or prescribe steroids to any of its players.
Signature co-owner Stan Loomis — who was arrested and faces extradition to New York along with his wife, his brother and another business partner — has freely credited sales of human growth hormone for the company's rapid growth, telling the Orlando Business Journal in 2005 that annual gross sales reached $21 million in five years due largely to doctors prescribing the drugs to baby boomers 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," Loomis told the Business Journal in 2005. The Loomises and their partner have declined comment and are currently being held in an Orlando jail pending extradition to New York.
The overwhelming obstacle presented by the Internet for law enforcement is that illegal drugs deals — which once upon a time might have required risking a meeting with unsavory characters in a shady part of town — are now just a Google away from the privacy of home. Such was the case in Kentucky where a postal inspector discovered that one out of every two overnight packages delivered to the town of Whitesburg contained drugs from out-of-state pharmacies. Forman said he has found that customers of illegal internet drug businesses often are affluent and high-profile. "They have a lot to lose by getting caught at a place drugs are sold or being blackmailed by the drug dealer. The Internet charges a premium for the drugs, but if you have the wherewithal, you pay it," he said.
A quick investigation with any search engine shows any number of dealer websites advertising no-prescription-needed or directing customers to doctors who will prescribe without a physical examination. Forman said it wouldn't be unusual for a trafficker to host a website in Russia, use a postal address in Mexico, ship drugs from India, deposit payments in the Cayman Islands, and maintain the ability to switch locales overnight. He's monitored marijuana dealers who open secure e-mail accounts through free encryption services such as hush mail, sell off a crop and close the e-mail account within two weeks. "Law enforcement's challenge has just multiplied exponentially," Forman says. "They can only get the dumb guy at this point. With a $300 billion illicit worldwide drug trade, you can imagine there are one or two IT guys working for them."
Published 12:00 am PDT Sunday, May 13, 2007 Story appeared in SCENE section, Page L8
Q: My mother is 72 and recently started taking growth hormone shots every day. They are very expensive, and I'm wondering if there is any benefit to this. Also, are there risks associated with growth hormone?
A: Great question. Growth hormone is produced by the pituitary gland in the brain, and blood levels of this hormone do tend to drop as we get older, as do many other hormones, including estrogen, testosterone and DHEA.
The field of anti-aging medicine has become popular in the United States over the past two decades, especially since a small study done in the 1980s suggested that GH injections in healthy older men might improve muscle mass and energy levels.
The anti-aging industry has since exploded, and organizations such as the American xxx xxx promote the use of many such supplements and hormones, touting them as fountains of youth. It's important to note that the use of growth hormone to prevent aging has not been approved by the FDA, and it is currently illegal to distribute growth hormone as an anti-aging substance in the U.S.
Is there any good science behind all of this? In otherwise-healthy adults, the benefits of growth hormone use are not clear-cut. A recent article in the Annals of Internal Medicine reviewed what was felt to be the best of the studies on the use of GH in healthy older adults. The people in these studies were treated for about 27 weeks; they lost on average 4.5 pounds of fat and gained about 4.5 pounds of muscle. There was no significant change in serum cholesterol levels or bone density.
People getting growth hormone had a significantly higher risk of soft- tissue swelling, joint pain and carpal tunnel syndrome. They were also more likely to develop elevated blood sugar and diabetes. There is also some concern that inappropriate use of growth hormone may increase the risk of certain cancers. Other studies have found no improvement in muscle strength, endurance, or thinking ability in people getting growth hormone.
Are there other side effects to growth hormone use? It definitely has a negative effect on one's wallet, as do many of these expensive alternative treatments. Growth hormone must be injected daily to work (although the human pituitary gland secretes GH every 90 minutes or so, so one injection a day doesn't really mimic what our bodies normally do). The average daily dose is approximately 1 unit; the cost can range from $8 to $18 or more per unit, setting you back up to $10,000 or more per year, especially if you have to pay a physician to provide it for you.
And, contrary to popular notions, currently available GH supplements cannot be absorbed from the GI tract; in fact, many "growth hormone" pills contain no growth hormone at all.
So is there any fountain of youth out there? Aging is inevitable, but you can do your best to maximize your GH function in your golden years.
Get enough sleep; growth hormone is secreted primarily at night while we sleep, and sleep deprivation reduces this. Take steps to reduce stress in your life; chronic stress also reduces GH secretion. Be sure you get enough healthy protein in your diet; this may also stimulate GH release. And be sure to get weight-bearing exercise; this will build up muscle just as well as GH. All for a lot less money than a hormone supplement.
Risks for Users of Human Growth Hormone
In the latest frenzy to prolong life, aging baby-boomers seem to have latched onto another supposed magic cure for anti-aging: Human Growth Hormone (HGH). On an episode of CNN: Chasing Life today, CNN writer Caleb Hellerman wrote about several people in Kansas City, KS, who have tried this banned substance, HGH, with the hope that their symptoms of normal aging could be reversed. A couple in Kansas claim to have felt much less tired and a lot better since taking daily doses of HGH; they stated that this drug is not for everyone, but it worked for them. A Dr. Jackie Springer of the Green Rock Clinic is one of the proponents of this drug which is supposed to increase muscle mass and bone density, and reduce fat. Springer who had been prescribing Human Growth Hormone, lost her license as a result. HGH is a worthwhile drug, for certain patients such as those suffering from stunted growth, but they are illegal if prescribed for anti-aging purposes.
Dr. Thomas Perls, who spoke out against this latest panacea, is warning people of the dangers associated with taking this hormone, stating that there is no evidence that it actually works. He believes it could bring on cancer, among other problems like diabetes, joint pain and many other ailments.
"Growth hormone is secreted in our body to promote cell growth, and cancer is unbridled cell growth," says gerontologist Dr. Thomas Perls, who campaigns vehemently against the use of HGH."
Endocrinologists tell us that the endocrine system works in such a way that all hormones have to be delicately balanced for the human body to function properly; when one hormone spikes, the others all go wonky - think of puberty, menopause ... Yet in spite of the dangers of this unproven drug, HGH sites flourish like crazy on the internet. No doubt some people will continue to experiment with anything that promises a longer or better life but Doctors warn of trouble in the future (similarly as the problems brought on by excessive use of steriods by athletes).
Photo credit: CNN: Ed and Beth Lothamer believe taking human growth hormone has improved their health. "It's not for everybody, but we think it works, so we do it," says Ed Lothamer.
Posted by Evelyn Dreiling on 04/22/2007 at 01:24 PM in Health|Permalink
April 27, 2007
More enterprise spammers uncovered Filed under: Security
Researchers at Support Intelligence continue to find spam sources they say are located within some of the world's largest businesses.
After outing spam distribution centers in companies including Aflac and Bank of America in recent weeks, the network security company has identified unusual e-mail traffic emanating from well-known enterprises including media conglomerate Clear Channel, book-seller Borders Group, and outsourcing specialists Affiliated Computer Services (ACS).
According to the Support Intelligence blog, Clear Channel, which owns scads of television and radio stations, began sending out significant volumes of spam in March. Most of the spam initially advertised low-price pharmaceuticals, Viagra and HGH, and came from multiple IP addresses within the firm, researchers said.
Spam traffic coming from Clear Channel spiked in late March and carried on through April as the mail being sent out shifted toward advertisements for cheap IT products, including those made by Adobe and Microsoft.
For Borders -- which the security company said does a "fairly good job" containing spam issues -- the problem consisted of a pharma-oriented spam run that pumped out mail at high volumes from March 29-April 3rd. Support Intelligence said that the spam was likely generated by a botnet-controlled device, and utilized resources in six different countries to power itself.
In the case of ACS, Support Intelligence said it specifically tracked a load of spam coming from several sources in the firm between late March and mid-April. Messages delivered from IP addresses controlled by the company included content advertising everything from pharmaceutical products and male sexual enhancement drugs to pump-and-dump stock schemes, before the torrent of e-mail slowed down, according to the security firm.
After I wrote a story about Support Intelligence's observations of Aflac-driven spam, representatives at the company gave me additional information on the situation. According to the PR officials, Aflac was not "hijacked" by spammers nor were any of its Web servers compromised, as I had originally reported.
In reality, company officials said the incident was "the result of a user's home machine that was attacked by a virus which generated roughly 80mbs of spam."
The company also denied the report that the campaign involved messages related to a pharming attack.
The firm said that the e-mails generated by the machine did not consist of "a spam campaign," as I'd reported, but rather "nothing more than spam selling a pharmaceutical product as a result of a virus infected PC."
I think I'm missing something in there, unless Aflac thinks it's OK for outsiders to usurp control of its employees' machines to distribute spam e-mail (and make money) from its IP addresses, that is.
COSMETIC interest in the controversial anti-ageing growth hormone has swelled by 20 per cent since Rocky star Sylvester Stallone was allegedly caught with the chemical at Sydney airport.
The Cosmetic Physicians Society of Australasia says its members have fielded an unprecedented number of inquiries about human growth hormone, particularly from men in their 50s and 60s, in the past month.
The specialists say demand was fuelled by publicity arising from Stallone's February visit to promote his latest film, Rocky Balboa, when he was charged with trying to import 48 vials of the hormone – a so-called "anti-ageing" elixir – into Australia.
The hormone is produced naturally by the pituitary gland to promote healthy growth, but many claim it enhances movement, sight, hair and general wellbeing when taken in its synthetic form.
It is also claimed to turn fat into muscle and is most well-known for its popularity among body-builders and Chinese swimmers, but scientific studies have yet to firmly establish any of these benefits.
Australian cosmetic surgeons who gathered in Melbourne for their national conference this week say there has been a 15 to 20 per cent increase in inquiries about hormone products in the past month.
Society president Glenn Murray said more people had been taking up the products, primarily to "boost up" levels of the hormone that had dropped off with age.
Both men and women, typically aged in their 50s and 60s, were signing up for the hormone despite there being few long-term studies showing benefits or side-effects, Dr Murray said.
"They're feeling tired and like they're looking their age and just want to slow things down," he said.
"When they're older and wanting to get a great last 20 years then they're willing to try it and take some risks for the chance of a better quality of life."
Dr Michael Zacharia, president of the Australasian Academy of Anti-Ageing Medicine, said a regular, low dose could "extend youthfulness".
"It's not that you're going to live longer as such but you can prevent a lot of diseases, like cardiovascular disease, from coming along," Dr Zacharia said.
"An 80-year-old who's on an anti-ageing regime will look better, feel better and be just as active as he was when he was 60."
But this is disputed by most in the academic scientific field who say there is a lack of hard science to prove the $500-a-month treatment actually works.
Australian laws prohibit the import of natural and manufactured growth hormones without a permit.
Stallone is required to enter a plea on his case's next scheduled court date, April 24, but he is excused from attending court if legally represented.
Sylvester Stallone brought GH, a banned import, into Australia
STALLONE PLEADS GUILTY TO GH IMPORTATION
BEIJING, May 15 -- Hollywood star Sylvester Stallone has pleaded guilty to bringing vials of human growth hormone into Australia.
Sydney's Downing Centre Local Court has been told Stallone admitted two charges of importing a prohibited import when he arrived at Sydney airport from the U.S. in February.
The Australian Customs Service alleged Stallone, 60, imported 48 vials of human growth hormone in five boxes when he came to Australia to promote his latest film "Rocky Balboa."
The star of the "Rocky" and "Rambo" films was due to enter a plea last month, but the court heard that "medical material" sent by Stallone to Australia needed to be analysed by Customs first.
Customs alleged that officers found the boxes of human growth hormone when Stallone alighted from Qantas flight QF8 from the United States on February 16.
Documents previously tendered to the court alleged Stallone ticked the "no" box when asked to declare whether he was bringing in restricted or prohibited goods, "such as medicines, steroids, firearms or any kind of illicit drugs."
The documents alleged the active ingredient in the substance, going under the brand name Jintropin, was the human growth hormone somatropin.
The court documents revealed that the court attendance notice was issued on Feb. 19, the same day that Customs officials raided his room at the Park Hyatt hotel.
When questioned by reporters, Stallone would not identify the substance but said "it's something that I've taken for years", and "it's not dangerous".
The maximum fine for the offence is 110,000 Australian dollars, but Stallone faces a maximum penalty of 22,000 Australian dollars because the charge is being dealt with in a local court.
What Anna Nicole Smith Was Shooting
The dead starlet's autopsy revealed that she was injecting human growth hormone to counter the effects of aging and promote weight loss. Does that work? Inside the HGH boom—and the backlash.
March 28, 2007 - When the Broward County, Fla., medical examiner performed an autopsy on Anna Nicole Smith's body, he zeroed in on her left buttock. There, he found evidence of repeated needle injections that had produced a "deep-seated" abscess filled with yellow-green pus. It was likely, he wrote in his report, that bacteria from that infection entered her bloodstream, sending her temperature soaring to 105 degrees and prompting her to respond with an overdose of medication. What was Smith injecting herself with? According to the medical examiner, it was a cocktail of anti-aging drugs including human growth hormone, or HGH. Smith's "repeated intramuscular injections," he wrote, were "self-treatment for longevity and weight control."
That revelation shines a spotlight on the hot—and sometimes murky—market for HGH. Touted as a wonder drug that builds muscle, sheds fat and restores youth, HGH has grown into a multibillion-dollar worldwide business, by some estimates. The only problem is, it's not always a legal one. Though growth hormone has certain uses approved by the Food and Drug Administration, these don't include anti-aging therapy, bodybuilding or athletic enhancement. Just last month, Sylvester Stallone was charged by Australian authorities with illegally importing 48 vials of the stuff. (Stallone's lawyers are expected to enter a plea on his behalf on April 24.) And the district attorney in Albany County, N.Y., recently disclosed an ongoing, multistate investigation that has allegedly uncovered an illegal drug ring involving, among other things, HGH. "Millions of dollars are spent on it by people in their 40s and 50s, and there's no indication I can think of that's legal for [them]," says Dr. Tom Perls, an associate professor at Boston University School of Medicine.
The body naturally makes human growth hormone. A product of the pituitary—a small pea-sized gland at the base of the brain—HGH is critical for normal childhood development. But by the time people reach their 30s, their bodies begin to produce progressively less of it. A man in his 70s, for instance, may generate only one third to one half of the HGH he used to generate in his 20s. Doctors may prescribe growth hormone injections for patients with abnormally low HGH levels, like people who suffer from dwarfism or chronic wasting disease. But for the most part, declining HGH production is simply a part of aging—and not necessarily a bad thing, medical experts say.
The current boom in HGH use traces its roots to a 1990 article in the New England Journal of Medicine. In it, researchers presented the results of a study in which 12 men over the age of 60 received regular HGH injections and demonstrated increases in lean body mass and bone density. The authors didn't claim that the treatment reversed the aging process, and an editorial note warned against widespread use of growth hormone. Yet, the study helped spawn a bevy of anti-aging clinics and a surge in HGH sales. According to a 2005 study in the Journal of the American Medical Association, between 20,000 and 30,000 people used growth hormone as an anti-aging therapy in 2004—a tenfold increase from the mid-1990s. Another researcher, Dr. Mary Lee Vance of the University of Virginia, has estimated that 30 percent of growth hormone prescriptions in the U.S. are for reasons not approved by the FDA. The price tag for such treatment is hefty: often more than $1,000 per month.
One of the many companies profiting from the anti-aging trend is Las Vegas-based Cenegenics Medical Institute, which has been featured on "60 Minutes" and in the pages of GQ. The clinic administers HGH and other hormone supplements as part of what it calls "a proven age-management medical system with predictable results." It treats around 2,000 HGH-"deficient" patients with the growth hormone, according to Cenegenics CEO Dr. Alan Mintz. "We do very careful evaluations first," he says. "Used appropriately, there is actually no risk associated with this. It actually reduces risk of heart disease. … The side effects are minor, dose-related and totally reversible."
But many medical experts challenge such claims. Some studies have demonstrated that HGH increases muscle mass, but not necessarily muscle strength or function. Moreover, some researchers have detected worrisome side effects, like diabetes, arthritis and hypertension. "Ironically, people who take [HGH] for vanity may find it hurts their looks because people with high levels of growth hormone … can become disfigured," says Perls. He notes that there's even evidence that it could reduce life span. All of which led him to start a Web site, antiagingquackery.com, to challenge what he claims are dangerous myths about the drug.
Law enforcement is evidently concerned as well. As part of the Albany County D.A.'s investigation, authorities have arrested doctors, pharmacists and clinic operators in New York and Florida—all part of what prosecutors describe as an elaborate network to sell HGH and steroids illegally on the Internet. The investigation, which is still ongoing, will likely gain more attention when the D.A. reveals the names of professional athletes and celebrities who were alleged customers (HGH is popular among some athletes because it's hard to detect in drug tests). In response, New York Sen. Charles Schumer is proposing a bill that would make HGH a controlled substance and give the federal government the power—which it doesn't currently have—to prosecute the illegal sale of prescriptions. "Certainly what's happened with Anna Nicole Smith will help" authorities crack down on unauthorized HGH use, says Perls. "The more attention, the more pressure will be brought to do something about this."
A statement by the medical examiner also indicates that Anna Nicole Smith appears to have abused Human Growth Hormone, together with Vitamin B12. HGH is often abused by bodybuilders to increase muscle mass, and is also illegally prescribed together with B12 and other vitamins and hormones, in an attempt to stop aging.
Olympic Booster Tied to Clinic in Drug Inquiry
Marc Serota for The New York Times
The Palm Beach Rejuvenation Center is under investigation for the distribution of performance-enhancing drugs.
JUPITER, Fla., March 6 — A businessman and wrestling booster who has sponsored Olympic and school-age athletes is under investigation by state and federal authorities examining the distribution of steroids and human growth hormone, according to a law enforcement official familiar with the case.
The booster, Joseph L. Raich, is the vice president of Palm Beach Rejuvenation Center, a business here offering hormone and antiaging treatments. The center was described as a nexus of illegal drug activity in charges filed Monday against the company’s president and medical director.
Mr. Raich was not charged, but the authorities seized steroid and human growth hormone supplies from his desk last week, according to a Florida Department of Law Enforcement document. And he continues to be under investigation over possible involvement with bogus prescriptions or illegal distribution, the law enforcement official said Tuesday. He added that Mr. Raich had been talking with investigators.
Mr. Raich, 44, is well known here for having sponsored the 2004 United States Olympic freestyle wrestling team, allowing members to stay at his home and to use local training facilities during a week that June, two months before the Athens Olympics. The 9,000-square-foot home has a pool and personal chef.
Mr. Raich is also active in youth wrestling. Last year, Jupiter Christian School became the smallest school in Florida history to win a state team championship in the sport. Three members of the team, including two individual state champions, came from the Raich family. The Raiches also sponsor an annual wrestling tournament at the school.
Mr. Raich and Jupiter Christian school officials declined to comment Tuesday. No one has accused any of the wrestlers for the school or the Olympic squad of using performance-enhancing drugs.
Kevin Jackson, the national freestyle wrestling coach, said in a telephone interview that the team’s trip to Florida, including its placement in Mr. Raich’s home, was arranged by the Palm Beach County Community Olympic Development Program. That program was recognized by the United States Olympic Committee but is now defunct.
“We knew that he was involved in some kind of medical center or rehabilitation center,” Mr. Jackson said. “But we had no idea that he may have been doing some of the things that have just been made public.”
Darryl Seibel, a spokesman for the U.S.O.C., said, “Without prejudging anyone’s guilt or innocence, we had no knowledge at all about any business activities Mr. Raich may have been involved in.”
In a telephone interview, Gary Abbott, the director of communications for USA Wrestling, which is partly financed and affiliated with the U.S.O.C., said of Mr. Raich, “To be honest with you, I think we only know him as a wrestling leader in Florida, and we are not aware of his business dealings.”
The Olympic practice sessions were held in the John Raich Wrestling Room at Cardinal Newman High School. The room was named after Joseph Raich’s brother John, a 1983 Florida state wrestling champion who, according to USA Wrestling’s Web site, was killed in a boating accident after his senior year of high school.
Joseph Raich is also a real estate developer and an investor in addition to working at the center. He had offices there until it closed after a raid by law enforcement authorities Feb. 27. (A satellite clinic in Palm Beach Gardens remained open.) The investigation, led in part by the Albany County district attorney because of tough drug laws in New York, is focusing on distributors of the drugs and the doctors who falsify prescriptions, not on users. So far, 13 people have been charged.
Authorities, acting under a sealed search warrant, seized steroids, growth hormone, syringes and business records, including Mr. Raich’s tax records, during the search of the rejuvenation center offices, according to a receipt of the items seized in the search that was filed with the court.
From Mr. Raich’s desk specifically, they reported seizing 13 Genotropin MiniQuicks, a growth hormone in a cartridge designed for easy attachment to needles to inject; one Norditropin growth hormone product made by Norvo Nordisk that advertises the ability to remain potent without being refrigerated; and one full bottle of Ultratest 250, a combination of anabolic steroids.
Mr. Raich’s office had also been used as headquarters of the Wrestling Club of the Palm Beaches Inc., a nonprofit group that promotes youth wrestling. Mr. Raich was a co-founder of the club with high school coaches and others in March 2003. It is listed on the Florida Amateur Wrestling Association’s Web site as a chartered club of USA Wrestling. The wrestling association describes itself as the official organization representing USA Wrestling in Florida.
Robert Kamperman, an association board member, said that Mr. Raich had not been involved with the group for more than two years. “There were differences in opinions between Raich and the board over the direction of the association,” he said. “Raich and a group of others put forward a proposal to assume total responsibility for all our Florida national teams. But the offer was turned down by the board.”
Mr. Raich listed his e-mail address as joe@hghtest.com in a listing for the Wrestling Club of the Palm Beaches on a Web directory kept by the Florida Amateur Wrestling Association. He identified himself as the head coach of the wrestling club.
Also part of the same complex of offices is a company called RXHGH Inc., which was founded in April 2003 by Mr. Raich along with Glen Stefanos, who is also the president of the rejuvenation center. (His name was spelled Stefanos in criminal filings but Stephanos in business filings.)
Mr. Stefanos; his brother George Stefanos; and the center’s medical director, Dr. Robert Carlson, were charged Monday in Albany County with seven counts of criminal sale of prescriptions and controlled substances. They all pleaded not guilty.
Dr. Carlson’s criminal defense lawyer, Charles R. Holloman of Ocala, Fla., said Dr. Carlson did nothing intentionally wrong and had been advised that his prescribing practices were legal.
Other tenants in the office building said the rejuvenation center was raided by federal agents about one year ago, but reopened the next day.
Steroids and human growth hormone are widely used by body builders and other athletes seeking a chemical boost in strength and power. Their side effects may include joint pain, diabetes and increased risk of cancer. They are illegal without a prescription. The drugs are also increasingly promoted as a cure for a host of age-related ills, although distributing or prescribing them that way is illegal.
A posting on Craigslist in Miami on Feb. 16 had a title of “Human Growth Hormone — The Fountain of Youth Is Available to You,” and a listing of Brianna Raich. She included her e-mail address and identified herself as an assistant sales representative for Palm Beach Rejuvenation Center. It is unclear what her relationship is to Joseph Raich.
“We are one of the leading suppliers of Human Growth Hormone, which has been called ‘The Fountain of Youth,’ ” Brianna Raich wrote. “The effects of using HGH are remarkable and unfortunately I cannot list them all on this page. A few to name are increased muscle mass, decrease in fat percentage, women say bye to cellulite, increased energy, stamina, improvement in skin, etc. etc.”
Brianna Raich, 20, did not respond to e-mail and telephone messages.
Commentary: Steroids and Growth Hormone problems are years away
Nancy Armour/Associated Press Saturday, March 3, 2007
Check out one of the gazillion Web sites peddling steroids and human growth hormone, and it's a wonder everybody isn't on the stuff.
Lose weight and build muscle - in some cases, without even exercising. Erase those ugly wrinkles and look younger. Get more energy. Maybe even sleep better.
Or so they say.
When abused or used for purposes for which they weren't intended, there's no telling what can happen. The worst part is, it'll be years, maybe even decades, before we know all the surprises that are in store.
"Ten, 20 years from now, we could have a whole population of bizarre medical problems we never thought of because we've been playing with people's hormones," said Dr. Todd Schlifstein, an assistant professor at NYU's School of Medicine.
"We're going to have a whole population with huge heads and huge hands and feet because their joints are overgrown."
Authorities in upstate New York and Rhode Island are targeting distribution networks they say might be responsible for steroid and human growth hormone sales nationwide. Nine people already have been arrested, and at least two dozen could face charges by the time the investigations end.
Some high-profile athletes, including Los Angeles Angels outfielder Gary Matthews Jr. and boxer Evander Holyfield, have been linked to the inquiry through drug shipment records. But this isn't the latest BALCO, an ongoing case that required Barry Bonds, Marion Jones, Jason Giambi and others to testify before a federal grand jury.
Prosecutors in the latest case don't really care who's putting what in their bodies. They're after the pushers, the lab-coated equivalents of the coke dealers hanging out at the end of the block.
Lest anyone think differently, there's not much difference.
Performance-enhancing drugs are just that. Drugs.
"The abuse of performance-enhancing drugs is really an extension of the broader concept of drug abuse," said Dr. Gary Wadler, a member of the World Anti-Doping Agency. "We don't give it that cachet, but that's what it is."
Just as LSD and cocaine can fry your brains, HGH and steroids might destroy your body, too.
Lyle Alzado was a beast in his playing days, a fearsome, snarling 6-foot-3 and 270 pounds. By the time he died in 1992 at 43, brain cancer had eaten away all that muscle, leaving little more than a shell. Steroids were to blame, Alzado said. He started taking them in 1969 and spent as much as $30,000 a year on them. He also said he took human growth hormone.
"My last wish?" Alzado said before he died. "That no one else ever dies this way."
Or endures the living hell that mark the days of some East German athletes.
East German officials were determined to step out of the Soviet Union's Cold War shadow, using sport to prove their country's might. They began a systematic doping plan in the 1970s. Some 10,000 athletes were doped - most having no idea the drugs they were being given were harmful. Many were still-developing teenagers.
It wasn't until livers failed or spines twisted or, worst, children were born with birth defects, that the East German athletes realized the full horror of what had been done to them - numb limbs, gynecological problems, miscarriages, breasts in men (at least one female athlete had a sex change).
Sure, the science behind performance-enhancing drugs is evolving and is more sophisticated than it was 30 years ago. For many, the tradeoff is worth it.
But remember there is a price for everything, even if it isn't paid right away.
"Nothing," Schlifstein said, "is cost free and risk free."
Sunday, March 4, 2007 Story last updated at 5:30 p.m. on Sunday, March 4, 2007
New York congressman pushes law targeting steroids
By AMY WESTFELDT Associated Press Writer
NEW YORK - America's "culture of competitiveness" is helping fuel the demand for illegal, performance-enhancing steroids, said a prosecutor overseeing a widespread investigation of online steroid sales.
Albany County District Attorney P. David Soares appeared in New York on Sunday with U.S. Sen. Charles Schumer, who said he would introduce federal legislation barring the sale of prescriptions for illegal drugs. The proposed law would also tighten restrictions on one steroid, human growth hormone, by placing it on a list of federally regulated controlled substances.
Nine people in three states have been arrested in the investigation and two Orlando, Fla., pharmacies were raided last week. As many as 24 could face felony charges.
Soares said Sunday that the country's sports culture, starting with high school students, parents and coaches driven to win, and extending to multimillionaire professional athletes, has led to dangerous use of performance-enhancing drugs.
"We've created a culture of competitiveness. ... An industry can only thrive like that if you have a willing consumer base," Soares said. "You want to make varsity. You want to go to this college."
Soares refused to discuss specifics of the ongoing investigation Sunday. He has said his focus is on shutting down drug distributors and physicians writing illicit prescriptions instead of buyers.
S chumer said Sunday that "the odds are high" that professional athletes would be among the buyers for the steroids. The Times Union of Albany reported last week that former baseball star Jose Canseco, former heavyweight champion Evander Holyfield and Los Angeles Angels outfielder Gary Matthews Jr. were among the network's customers.
Schumer, D-N.Y., said he would introduce legislation that would outlaw the bad-faith sale of prescriptions by doctors who have never met their patients. The physicians who are hired by the online distributors "have become no more than drug dealers," he said.
He said the legislation would also make human growth hormone, one of the most popular new steroids, a federally regulated substance. Unlawful sale would be punishable by five years in prison.
The Drugs
Posted: Tuesday March 6, 2007 10:36AM; Updated: Tuesday March 6, 2007 10:36AM
Courtesy of Bureau of Narcotic Enforcement
By David Epstein
Clomiphene Citrate: A prescription drug typically used for the treatment of female infertility, it is taken by male athletes to negate the effects of increased estrogen, a result of anabolic steroid abuse.
Human Chorionic Gonadotropin (HCG): A hormone produced naturally during pregnancy, HCG is taken by anabolic steroid users to stimulate the production of testosterone, which is suppressed as a result of steroid use.
Human Growth Hormone (HGH): The primary purpose of the naturally occurring growth hormone is the maintenance of normal bone growth from birth to adulthood. Synthetic HGH is typically used by physicians to treat growth disorders, but athletes often abuse the drug to build muscle and decrease fat, usually in conjunction with anabolic steroids. The generic name for synthetically produced HGH is somatropin; brand names include Genotropin and Saizen.
Nandrolone: This synthetic anabolic steroid has been used to treat anemia, osteoporosis and breast carcinoma. It builds muscle and increases red-blood-cell count.
Stanozolol: This synthetic anabolic steroid is typically used to treat a rare immune disease in humans and to increase appetite, muscle mass and energy in animals -- often horses recovering from illness or injury. It might be preferred by athletes who value speed because it doesn't build muscle quickly. Also, some abusers claim that stanozolol, unlike some other steroids, doesn't cause water retention. Winstrol is a brand name.
Trenbolone: A synthetic anabolic steroid that some claim is a more potent muscle builder than testosterone, it promotes red-blood-cell production and increases the rate of glycogen replenishment, both of which aid in postworkout recovery.
GROWTH HORMONE INCREASES CANCER RISK IN ADULTHOOD
The decline in growth hormone levels is likely a very good thing. Multiple studies show that growth hormone increases cancer risk, especially in mice (along with the fact that growth hormone shortens life span, it does not increase it). Therefore, as we age, were we to maintian the growth hormone levels of when we were in our twenties, we would likely develop cancer and die much sooner. Thus the drop in GH with age is likely an evolutionary adaptive response to allow us to live longer in good health.
SI's Luis Fernando Llosa and L. Jon Wertheim, on the scene for the Florida raids, continue to report on the ongoing investigation that promises to rock sports
By Luis Fernando Llosa and L. Jon Wertheim
The Palm Beach Rejuvenation Center is decidedly less exotic than its name might suggest. Wedged between a lawyer's office and a brokerage firm on the third floor of a dreary Jupiter, Fla., office building, it is a glorified boiler room, "basically a call center," as one employee explains. Yet investigators contend that the Palm Beach Rejuvenation Center (PBRC) -- and dozens of so-called antiaging or wellness centers like it -- is a vital component in a massive illegal distribution network that enabled customers to place orders over the Internet for performance-enhancing drugs, including steroids and human growth hormone (HGH).
"This is the newest frontier," says Christopher Baynes, a prosecutor in New York's Albany County, whose office initiated the investigation three years ago. "The guy with the black bag at the gym now has his own website."
On Feb. 27, SI accompanied investigators from multiple law-enforcement agencies (box right) on a raid of PBRC. Simultaneously, agents in Orlando were raiding Signature Pharmacy, a compounding pharmacy that last year did more than $40 million in sales, much of it with PBRC. On Monday, PBRC co-owner Glen Stefano and 10 others pleaded not guilty to multiple charges during arraignment proceedings in Albany. Stefano was charged with illegally selling steroids and hormones. Earlier, Signature owners Robert Loomis and his wife, Naomi, were charged with criminal diversion of prescription medications, criminal sale of a controlled substance and insurance fraud.
It will take weeks, months perhaps, for authorities to sift through the client lists, hard drives, invoices and trash from Dumpsters that were seized in the raids -- more than a ton of documents was confiscated. And when they're through, investigators believe they'll unearth the names of hundreds, even thousands of clients who have received a wide array of drugs; and that list is likely to include prominent athletes.
Just consider the fruits of a similar Drug Enforcement Administration (DEA) raid last year, code-named Operation Netroids. On Aug. 29, agents converged on Applied Pharmacy Services, a compounding pharmacy in Mobile. (A compounding pharmacy makes its own drugs generically.) Seized client records revealed the names of more than 20 athletes in a variety of sports who received drugs from Applied Pharmacy. A 37-page classified intelligence report reviewed by SI alleges that, among athletes:
• Outfielder Gary Matthews Jr., whose career year with the Texas Rangers in 2006 earned him a five-year, $50 million free-agent deal with the Los Angeles Angels, was sent Genotropin in 2004. The prescription was written by a doctor at a now-defunct antiaging clinic in Florida. (Through his agent, Matthews declined comment, but the lawyer who represents the outfielder said last Saturday that Matthews has not broken any laws and would cooperate with the investigation.)
• Kurt Angle, a 1996 Olympic gold-medal-winning freestyle wrestler and now a star professional wrestler, received two prescriptions for trenbolone and one for nandrolone between October 2004 and February '05. (Angle did not return messages left with his spokesman.)
• Rangers outfielder Jerry Hairston Jr. received Genotropin, human chorionic gonadotropin (HCG) and Clomiphene Citrate in 2004. One of Hairston's prescriptions was written by "A. Almarashi." Investigators believe Almarashi is an alias for a Queens, N.Y., doctor stripped of her medical license in 1999. She is awaiting trial on multiple charges after allegedly writing bogus prescriptions for thousands of online customers she never examined. (Hairston, a third-generation major leaguer, emphatically denied any connection. "Not one time have I taken steroids or anything like that," he said last Thursday. "I would never do anything like that to jeopardize my career or my family's name.")
• In June 2004 a patient named Evan Fields picked up three vials of testosterone and related injection supplies from a Columbus, Ga., doctor, traced through Applied. Later that month Fields also obtained five vials of Saizen and three months later returned for treatment of hypogonadism, a condition whereby sex glands produce little or no hormones. Investigators noted that Fields shares both the birth date and home address of former heavyweight champion Evander Holyfield. What's more, when SI called a phone number on a Post-It note attached to the Fields patient file, Holyfield answered. (Holyfield, who at 44 continues to fight professionally, told SI that he knew nothing of the drugs. Through Main Events, the promotional company that represents him, he released a statement denying any steroid use.)
• David Bell, a veteran of a dozen major league seasons, received six packages of HCG at a Philadelphia address last April, when he played for the Phillies. The cost was $128.80, and the drug was prescribed in conjunction with an Arizona antiaging facility. Bell acknowledges receiving the shipment but tells SI the drug was prescribed to him "for a medical condition," which he declined to disclose, citing his right to privacy.
• Jose Canseco, the retired major leaguer and an admitted steroid user, received somatropin, testosterone, stanozolol and HCG, as well as 340 syringes, in 2004. The shipment to his California residence was arranged through the same defunct antiaging clinic that Matthews allegedly patronized. (Canseco did not return calls seeking comment.)
• No birth date was indicated on the prescriptions, but according to the Applied database, former Atlanta Braves reliever John Rocker received two prescriptions for somatropin between April and July 2003. (Through his spokeswoman, Rocker denied any knowledge of the prescription and denied ever receiving a banned substance.)
Sources tell SI that the clients appearing on invoices and customer lists are unlikely to face prosecution, because the targets of the raids and investigations are the members of the network of suppliers. "Our focus here is to shut down distribution channels," says Albany County district attorney David Soares, one of the leaders of the investigation. And because the reports only allege receipt (and in some cases, purchase) of the banned drugs -- not usage -- the athletes are unlikely to face disciplinary action from their respective leagues or governing bodies. (Major League Baseball didn't add HGH to its list of banned substances until 2005.) Still, the information offers a clear and chilling glimpse into just how easily banned substances, including steroids and HGH, can be obtained by anyone, of any age, who possesses Internet access and a credit card.
The origins of this wide-scale, multi-agency investigation can be traced to upstate New York. In the fall of 2004 state narcotics investigators based in Albany noticed that a local doctor, David Stephenson, was running a website, docstat.com, and was purchasing massive quantities of a variety of drugs, including narcotics and steroids. According to authorities, Applied was his chief supplier. After receiving the drugs at his residence, Stephenson repackaged them and resold them to "patients" who had visited his website. One investigator placed an order through docstat.com, claiming to be an overweight pilot with a heroin addiction and a drinking problem. As part of a questionnaire offered when registering on the site, clients were asked the reason they were seeking particular drugs. The investigator responded that he needed prescriptions for hydrocodone, methadone, nandrolone, Ritalin and testosterone because "I want to get high to fly." Within days the drugs arrived by way of express mail.
In the summer of 2005 Stephenson pleaded guilty to felony criminal sale of a controlled substance; he is serving a six-year jail sentence. The Stephenson case, however, stood for much more than a rogue doctor abusing his license. Studying the chain of supply, agents from Albany County were able to lay bare a drug pipeline that marries the power of the Internet with spurious antiaging centers, board-certified compounding pharmacies and venal doctors. Soon, the agents shared their findings with federal and state authorities across the country.
As Mark Haskins, a senior investigator for New York State's Bureau of Narcotic Enforcement, explains it, "Basically you have an antiaging clinicwith an Internet presence. [Clinic operators] put the product on the Internet. The customer finds them online, fills out a brief questionnaire and requests steroids, hormone therapy, whatever. Someone from the clinic contacts the customer and then develops a prescription for the steroid treatment or hormone treatment. Then [the clinic] sends or e-mails the prescription to a doctor, who is often not even in the same state. He'll sign it [because] he's being paid by the clinic, usually $20 to $50 for every signature. The signed prescriptions get faxed to the compounding pharmacies, which know from the very beginning that there is no doctor-patient relationship. The pharmacy then sends the product to the customer."
Last spring, during a raid on his Scottsdale, Ariz., home, Jason Grimsley, then a pitcher for the Arizona Diamondbacks, admitted to using HGH, steroids and amphetamines. In an affidavit he explained to investigators that another major leaguer, later identified as former first baseman David Segui, "told [me] of a doctor in Florida that he was using at a 'wellness center' to obtain human growth hormone."
"It makes total sense for athletes to do it this way," says agent Alex Wright of Florida's Metropolitan Bureau of Investigation. "If they get caught, they can say, 'I sent my blood work to the clinic like [it] asked me, and the doctor said my [testosterone] levels are low.' This is the best way they can get stuff. They have the comfort of anonymity because there is no face-to-face. They are just a name and a credit card."
In addition to exposing the architecture of the distribution ring, the ongoing investigations appear to confirm what doping experts have suspected for years: HGH is a popular drug among athletes. A synthetic hormone, HGH is thought by some to accelerate recovery times, speed healing, decrease body fat and, particularly when combined with steroids, increase muscle mass and therefore strength.
HGH can be prescribed by doctors for legitimate medical purposes. Historically, this has meant combating rare pituitary disease and treating patients with progressively debilitating conditions resulting from AIDS and some forms of cancer. Yet lately some doctors have ascribed a liberal definition to "legitimate medical purposes," contending that aging is, in effect, a progressively debilitating disease and that any patients with diminishing hormone levels are eligible for the drug. The xxxx Medicine, a Chicago-based group that supports using HGH to replace growth hormone as its levels decline with age, counts more than 10,000 health-care practitioners among its members. This "off-label," or unorthodox, use of HGH is the source of significant controversy in the medical community. "It's a ruse," says Dr. Thomas Perls, an associate professor at Boston University School of Medicine, who maintains the website antiagingquackery.com. "The public has equated hormones with youth, and HGH is the drug of choice for these hucksters to push." (Through a spokesman the academy said in a statement to SI that Perls's comment "is on the level of that of a 'flat earth society' uninformed person.")
The risks of HGH use are abundant, including diabetes, muscle and joint pain, hypertension, carpal tunnel syndrome, abnormal enlargement of organs and advancement of cardiovascular diseases. Some researchers believe HGH can accelerate cancer. "The issue is pretty straightforward," says Mark Schutta, a University of Pennsylvania endocrinologist. "You're giving people a hormone that can potentially increase the growth of abnormal cells." Schutta also notes that the American College of Endocrinology does not recommend using HGH to treat adults except in the exceedingly rare instance that a patient produces no growth hormone naturally.
Regardless, HGH has found favor among athletes. "Of all the things out there, certainly synthetic human growth hormone is way at the top of the list," says Dr. Gary Wadler, a New York University associate professor of medicine and a World Anti-Doping Agency member. "What athletes have [tried to do] is make muscles bigger with HGH and then make those big muscles stronger by adding steroids to the mix."
Another factor contributing to HGH's popularity: Leagues that ban it don't test for it. There is only one effective test for HGH detection, and it involves a blood sample. Unions in most major sports have been unwilling to subject their players to blood work, deeming it a physical intrusion. As NFL Players Association executive director Gene Upshaw recently put it, "I'm still not willing to have our players stuck like a pin cushion."
In perhaps the biggest doping scandal in NFL history, a South Carolina doctor, James Shortt, distributed HGH and steroids to members of the Carolina Panthers' 2003 Super Bowl team, including three of the five starting offensive linemen. (Shortt admitted guilt and is serving a 366-day sentence.) Last fall, on the HBO show Costas Now, former NFL defensive tackle Dana Stubblefield said he believes 30% of the league's players use HGH. NFL officials have often expressed concern about HGH, and the league recently pledged $500,000 to help develop a reliable HGH test.
That is why investigators were particularly curious when they noticed that a University of Pittsburgh Medical Center- affiliated internist, Richard Rydze, had used a credit card from his private practice to purchase more than $150,000 worth of HGH from Signature Pharmacy. Since the mid-1980s Rydze has been an associate team physician for the Pittsburgh Steelers. Questioned by SI, Rydze did not deny making the purchases, but he asserted that he uses the HGH to treat elderly patients who are "deficient in growth hormone" and require tendon repair. "[It's] not for athletes -- never," says Rydze. "I don't give it to people who want to come in here and look pretty and look young and build up their muscles. I will not do that."
According to Rydze, he dispenses HGH to "35 or 40" patients referred to him by other physicians, including the Steelers' orthopedist. (The orthopedist declined comment.) Rydze says that he treats these patients, including retired football players, early in the morning -- "mainly in my spare time" -- and that these patients tend to "cycle through" every three or four months. "We monitor their levels, and then they're gone, back to their own doctors," says Rydze, 56, who won the silver medal in platform diving at the 1972 Olympics. He also says that he ordered the HGH through Signature to save money. (In the wake of this revelation, the University of Pittsburgh Medical Center says it is conducting an internal investigation of Rydze.)
One might assert that at the very least, it shows questionable judgment for an NFL team doctor to purchase $150,000 of HGH -- approximate street value: as much as $1 million -- at a time when drug issues are in the league's crosshairs and the Shortt scandal remains a public relations scar. Rydze, however, asserts he has his team's full support. "The Rooneys [the Steelers' owners] are aware that I do this," he says. "I mean, they have my trust that I would never do this with an athlete." (Steelers president Art Rooney II declined to address Rydze's specific characterization, but he released a statement that read in part, "There is no evidence Dr. Rydze prescribed or provided any hormone treatments to any of our players [and he] has assured me that this has never happened and will never happen.")
If the list of implicated sports stars and teams has already turned the investigation into a cause célèbre, investigators are haunted by how many "nonfamous" athletes have been implicated in the sweeps. In the coming weeks authorities will seek answers to why, for instance, Signature sold performance-enhancing drugs to a teenage in-line skating champion. Or why facilities offering antiaging treatment are servicing so many clients born in the 1990s, some of them still in puberty. "Kids are watching ESPN or reading Sports Illustrated and making every effort to gain a competitive edge," says Soares, the Albany County DA. "That we have steroids and human growth hormone so readily available presents a clear and present danger."
At last week's raid of the Palm Beach Rejuvenation Center, a string of strikingly muscular, strikingly young employees filed out, somber expressions etched on their faces. Inside, authorities questioned executives, including Joseph Raich, listed on a government document as a company director. Raich, 44, is well-known in the South Florida youth wrestling community. He has provided financial assistance to aspiring Olympians, and before the Athens Games in the summer of 2004, he sponsored a training camp in South Florida for the U.S. Olympic wrestling team. The Florida Amateur Wrestling Association website even lists Raich (who did not return repeated messages seeking comment) as the contact for the Wrestling Club of the Palm Beaches. The listing also provides his e-mail address: Joehghtest.com.
No Proof That Growth Hormone Therapy Makes You Live Longer
Surveyors of anti-aging elixirs tout human growth hormone as a remedy for all things sagging - from skin to libidos - and claim it can even prevent or reverse aging. But researchers at the Stanford University School of Medicine say there's no evidence to suggest that this purported fountain of youth has any more effect than a trickle of tap water when it comes to fending off Father Time.
"There is certainly no data out there to suggest that giving growth hormone to an otherwise healthy person will make him or her live longer," said Hau Liu, MD, a research fellow in the division of endocrinology and in the Center for Primary Care and Outcomes Research, and first author of a review study to be published in the Jan. 16 issue of Annals of Internal Medicine. "We did find, however, that there was substantial potential for adverse side effects."
Those negative side effects included joint swelling and pain, carpal tunnel syndrome and a trend toward increased new diagnoses of diabetes or pre-diabetes. "You're paying a lot of money for a therapy that may have minimal or no benefit and yet has a potential for some serious side effects," Liu said. "You've got to really think about what this drug is doing for you."
Growth hormone is widely promoted on the Internet and its use as a purported anti-aging drug has caught the attention of the popular media, ranging from the "Today Show" to Business Week.
Between 20,000 and 30,000 people in the United States used growth hormone as an anti-aging therapy in 2004, a tenfold increase since the mid-1990s, according to the authors of an unrelated study published in the Journal of the American Medical Association in 2005. This increase comes despite both the high cost of such therapy - often more than $1,000 a month - and the illegality of distributing growth hormone for anti-aging therapy in this country. Those numbers prompted Liu and some colleagues to see if the medical literature provided any support for such therapy.
Growth hormone is naturally produced by the pituitary gland, a pea-sized organ at the base of the brain. Production is highest during childhood and the hormone-drenched adolescent years, then typically starts tapering off around age 30, continuing to decline into old age. Growth hormone is critical to proper development in children, particularly their height, and injections of growth hormone are considered a legitimate treatment for short children and for adults whose pituitary glands don't produce enough growth hormone to maintain normal metabolism. But most promoters of growth hormone as an anti-aging therapy target the healthy elderly.
Liu's team undertook a systematic review and analysis of published studies, excluding any that looked at diseases for which growth hormone is an accepted therapy. They focused solely on studies using growth hormone to treat the elderly, specifically those whose main maladies were nothing worse than age and being mildly to moderately overweight. They also included only studies that evaluated the use of the hormone in randomized, controlled clinical trials.
Of all the papers contained in two of the largest databases of medical literature in the world, only 31 met the team's criteria. The 31 studies had a combined total of slightly more than 500 participants, and the average duration of therapy was about a half-year, said Liu, adding that he was surprised at the limited amount of data in the literature.
"These studies were designed to look at what happens when you give growth hormone to a healthy elderly person," said Liu. "For example, what happens to their bone density, to their exercise levels and to their exercise capacity."
The researchers found that growth hormone had a modest effect on body composition, increasing lean body mass, or muscle, by slightly more than 2 kilograms and decreasing body fat by roughly the same amount.
But, Liu said, "It did not change other clinically important outcomes, such as bone density measurements, cholesterol and lipid measurements, and maximal oxygen consumption." In short, the studies provided no real evidence that the therapy resulted in increased fitness.
"From our review, there's no data to suggest that growth hormone prolongs life, and none of the studies makes that claim," said Liu.
That finding, according to Liu, highlights one of the fundamental problems in the whole debate over the use of growth hormone to combat the effects of aging-misinterpretation of the data.
The promotion of growth hormone as an anti-aging treatment took off in 1990 when a paper published in the New England Journal of Medicine presented results of a small study in which 12 men over the age of 60 were injected with growth hormone three times a week for six months. At the end of treatment, they had statistically significant increases in lean body mass and bone mineral, unlike a group of nine men who had received no treatment.
The authors of that study made no claims that the treatment had reversed the aging process and stated that many questions remained unanswered, but they did note that the increase in muscle and decrease in fat were "equivalent in magnitude to the changes incurred during 10 to 20 years of aging."
That statement triggered a wave of misinterpretation-inadvertent or otherwise-that persists to this day, despite repeated efforts by the journal to play down the sensational claims now made for growth hormone or growth hormone "releasing agents" widely sold on the Internet. The original study was accompanied by an editorial warning against the general use of growth hormone as a therapy in adults.
In 2003 another NEJM editorial specifically addressed the issue again, as the 1990 paper was receiving as many online "hits" in a week as other 1990 articles got in a year, owing largely to promoters of growth hormone citing it as supporting evidence.
###
The researchers participating in this study were supported by grants from the U.S. Agency for Healthcare Research and Quality, the U.S. Department of Veterans Affairs and the National Institute of Aging.
Other Stanford researchers participating in the study were Dena Bravata, MD, senior research scientist in medicine; Ingram Olkin, PhD, professor emeritus of statistics and of education; Smita Nayak, MD, who is now an assistant professor of medicine at the University of Pittsburgh; Brian Roberts, MD, research fellow in the division of endocrinology; Alan Garber, MD, PhD, the Henry J. Kaiser Jr. Professor, and Andrew Hoffman, MD, professor of medicine.
Stanford University Medical Center integrates research, medical education and patient care at its three institutions - Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu/.
Fountain of Youth with just a shot in the arm?
Critics warn anti-aging aids are pricey ripoff
By Penni Crabtree STAFF WRITERJuly 25, 2004
CRISSY PASCUAL / Union-Tribune
The market for anti-aging remedies like these from the California Healthspan Institute in Encinitas could exceed $40 billion by 2006.
Want to live to a spry 125?
At the California Healthspan Institute, the middle-aged and aged can pay thousands of dollars a month for injections, pills and creams the clinic says can help turn back the clock – or stop it.
"Aging can now be delayed and even reversed. . . . We can now expect to live to the age of 125 in excellent health," the Encinitas anti-aging medical clinic's Web site says in touting one therapy, human growth hormone replacement.
But many mainstream scientists say such assertions by the fast-growing but controversial anti-aging medicine industry have more to do with marketing than medicine.
Claims that human growth hormone, known as HGH, or any other product marketed as an anti-aging remedy can delay or reverse aging are unfounded at best, critics say, and at worst are sheer hucksterism.
Far from being aging "cures," some treatments – such as various hormone replacement therapies – may offer little or no benefit while posing potentially serious long-term health risks, many scientists say.
Other products, including scores of vitamin, mineral and herbal supplements sold in stores or over the Internet, are ineffective as anti-aging fixes and are often fraudulent, the scientists say.
Yet Americans continue to spend hundreds of millions of dollars each year in their search for the Fountain of Youth. By 2006, the market for drugs, treatments and cosmetic procedures intended to make people feel and look younger could exceed $40 billion, according to one study touted by the XXX Anti-Aging Medicine, a Chicago organization that is a leading advocate for the industry.
But as the market for anti-aging therapies grows, so do concerns that the hype is far outpacing any science to support it. Some anti-aging medicine industry claims have become so grandiosethat theJournal of Gerontology, a leading publication for scientists in the field of aging, devoted back-to-back issues this month and last month to debunking them.
For researchers such as Dr. S. Jay Olshansky, a professor at the University of Illinois School of Public Health, it is nothing less than war.
"As scientists in the field, we've decided the time has come to stop it," said Olshansky, an anti-aging medicine critic and guest editor for the journal issues. "A lot of people are still buying into this anti-aging quackery; it's a growing industry, and it's a dangerous industry."
Dr. Ron Rothenberg, a local physician who founded the California Healthspan Institute in 1998, counters that those who criticize anti-aging medicine suffer from an advanced case of hardening of the mind.
"It's a fear of something new, it's conservatism of medicine," he said. "But the claims aren't that outrageous: You are going to die, what's the journey going to be like, can this improve the journey?
"That's all we are trying to do," Rothenberg added. "It's not snake oil – though snake oil contains a lot of omega-3s and is probably very beneficial."
Getting old fast
Caught in the crossfire between feuding scientists and anti-aging medicine practitioners are some 76 million baby boomers who are turning 50 at the rate of one every seven seconds.
As joints turn achy, libidos flag, hairlines recede and Botox beckons, many Americans approaching a certain age are turning to everything from herbal remedies to hormone replacement as a way to stave off aging.
They are being met with a bewildering array of medical studies. To add to the confusion, some of those studies are held up by both sides as evidence to support their arguments that a product is either unproven and potentially harmful, or safe and beneficial.
Much of the debate centers on hormone replacement therapies, particularly HGH, a genetically engineered prescription drug that is mainly used to treat children and adults with stunted growth.
HGH is not approved by the Food and Drug Administration as an anti-aging fix, but the agency takes a hands-off approach to regulating it. Under a practice known as off-label use, doctors are given enormous leeway to prescribe drugs for purposes other than those approved by the federal agency.
In its natural form, HGH is made by the pituitary gland, located at the base of the brain. HGH reaches peak levels in youth, working in concert with testosterone and estrogen in the development of tissues and organs. But as people grow older, their levels of HGH drop off.
Anti-aging medicine practitioners have seized on HGH as a kind of master hormonal switch to rejuvenate aging bodies. Clinics and physicians – many of them clustered in anti-aging medicine industry hotbeds such as Southern California, Arizona, Florida and Nevada – charge patients as much as $1,000 a month for daily HGH injections.
Yet most scientists say there is no proof that HGH has any effect on aging. More importantly, the interaction of hormones in the human body is complex and little understood, so monkeying with hormone levels when it is not medically necessary could prove risky, they say.
Clinical studies have found that HGH reduces fat and increases muscle in healthy older men and women. But the effect is largely cosmetic – there are no changes in strength, endurance or bone density to suggest more meaningful benefits, researchers say.
On the other hand, some studies suggest that HGH can cause side effects such as temporary diabetes, carpal tunnel syndrome and fluid retention that over time could lead to high blood pressure and heart problems. HGH also elevates the levels of insulin-like Growth Factor-1, which researchers say is associated with higher incidences of breast and prostate cancer.
"In terms of real function – carrying a bag of groceries up the stairs – we have no evidence at all that growth hormone facilitates that, let alone that it actually extends life span," said Dr. S. Mitchell Harman, director of the Kronos Longevity Research Institute in Phoenix and co-author of a National Institute on Aging study in 2002 that examined HGH use. "In fact, animal tests suggest growth hormone is a pro-aging hormone; animals with low growth hormones live longer then animals with high growth hormone levels.
"All in all, I think that giving older people growth hormone willy-nilly is a very bad idea."
Scientists are particularly concerned about the long-term use of HGH and another hormone, testosterone, as anti-aging remedies for younger boomers in their 40s or 50s. A decade down the road, some researchers caution, they risk developing unexpected health problems related to their anti-aging hormone replacement regimens.
As with HGH, testosterone replacement therapy has shown some benefits in clinical studies, including improvements in muscle mass, memory and mood. But testosterone has also been linked to prostate cancer and an increased risk of stroke.
In 2002, about 1.75 million prescriptions for testosterone therapy were written, a 30 percent increase from 2001 and a 170 percent jump from 1999, according to the Institute of Medicine.
"If a person is 70 years old, with a life expectancy of 10 years, maybe the worstthing they are doing is wasting their money, because prostate and other issues take time to develop," said Dr. Frank Bellino, a spokesman for the National Institute on Aging. "But if you are in your 40s and 50s, you are playing Russian roulette with your health when you get on these things."
Worth the risk?
Some anti-aging medicine patients say it is a risk they don't mind taking.
Scott Jones, owner of San Diego's Ace Parking Co. and a patient at the California Healthspan Institute, said he considers the $2,000 to $3,000 he spends each month on HGH injections, testosterone cream, vitamins and supplements as "preventive" health care.
Jones, 55, whose father died in 1995 of Alzheimer's disease and Parkinson's disease, said he first turned to anti-aging medicine after his personal trainer told him about possible links between diminishing hormone levels and age-related diseases.
After 18 months on the California Healthspan Institute regimen, which includes practices that few scientists would dispute, such as maintaining a healthy diet and regular exercise, Jones said he lost about 25 pounds and now has "more energy than 10 horses."
"I don't want to sit back and do nothing," Jones said. "I know there are risks with some things because there have not been a series of studies over time that have been conclusive. But I feel the risks are worth it."
Advocates of anti-aging medicine point to clinical studies they say offer tantalizing scientific clues that, while not proof, indicate they are on the right track.
For instance, a study published in January found that older men with higher levels of testosterone in their bloodstreams may be less likely to develop Alzheimer's.
Last year, the Institute of Medicine sifted through the available scientific data on testosterone therapy and recommended that narrow studies be done to determine its benefits and risks.
Yet in making the recommendation, the institute noted that use of testosterone therapy to counter the effects of aging isn't supported by the scientific evidence, and advised against it.
Anti-aging medicine advocates counter that older people can't afford to wait for yet another study.
"Do you want to wait 30 or 40 years before we figure this out?" said Robert Goldman, an osteopath who co-founded the Academy of Anti-Aging Medicine, or A4M, which claims more than 12,000 anti-aging medicine health practitioners and scientists in 70 countries. "Rational people realize that the choice is grow old and die – tough, nothing we can do about it – or let's do something about it."
Scientists say such arguments are disingenuous, motivated more by the desire to cash in on the fears of aging Americans than to advance the cause of medicine.
'Silver Fleece' award
Critics take particular aim at X, which was founded in 1993 by X and fellow osteopath XX, for its role in fostering the anti-aging medicine industry.
X offers anti-aging "board certification" to doctors who pay $3,440 and complete written and oral exams, but the certification is not recognized by the American Board of Medical Specialties, an umbrella organization for 24 medical specialty boards that certify physicians based on established educational standards.
In March, researchers attending a scientific conference on aging awarded a tongue-in-cheek "Silver Fleece" award to anti-aging products created by X and X and sold by Market America.
The award, a bottle of vegetable oil labeled "Snake Oil," was aimed at a collection of over-the-counter anti-aging supplements, including a product that claims to "naturally increase the secretion of human growth hormone."
Such products highlight another aspect of the anti-aging medicine industry that troubles many scientists. As with the multibillion-dollar market for weight-loss and "alternative" herbal medicines, anti-aging remedies have firmly taken root in the largely unregulated dietary supplement industry.
Since the 1994 passage of the Dietary Supplement Health and Education Act, companies can market supplements without any proof that they work or are safe.
The dietary supplement industry's interest in anti-aging medicine was apparent this year when advocates persuaded a congressional committee to exclude the hormone DHEA from a bill now in Congress that would restrict use of more than 40 steroid-like substances.
DHEA, or dehydroepiandrosterone, is promoted for everything from building muscle to boosting memory and libido. The hormone was banned by the FDA in 1985 but allowed back on the market as a dietary supplement after passage of the dietary supplement law.
With about $50 million in annual sales, it is one of the most popular anti-aging products on the market. Yet many scientists say it is ineffective at best, and possibly harmful.
A number of local health practitioners market DHEA and other dietary supplements as anti-aging remedies, including Kurt Donsbach, who operates an "alternative" medicine cancer clinic south of Tijuana in Rosarito Beach.
The Bonita chiropractor, who was convicted in 1996 of federal tax evasion and smuggling illegal medicines across the border, also has a major stake in a Chula Vista public company called Alpha Nutraceuticals.
Along with DHEA, Alpha markets Donsbach's formulas, including a "Homeopathic Growth Hormone Spray" that promises to "return growth hormone . . . to levels similar to mid-normal for someone 10 to 15 years younger."
Alpha Nutraceuticals did not respond to telephone and e-mail messages requesting an interview.
Scientists say claims that supplements that are swallowed or sprayed have hormone-like activity, or promote the production of hormones in the body, are false.
"HGH is a protein. It doesn't get absorbed, so if it isn't injectable, it isn't effective," said Harman, of the Kronos Longevity Research Institute. "But these products probably aren't doing anyone any harm, either – unless you consider the financial loss."
Critics say much of their frustration with the unproven or fraudulent remedies touted by the anti-aging medicine industry is the shadow they cast over the legitimate study of aging.
"For the first time, we have credible tools of science and technology to explore the question of whether we can delay the onset of age-related diseases at the basic level of cells and genes," said Dan Perry, executive director of the Washington, D.C.-based Alliance for Aging Research. "But at the same time, we have these people that have been with us since time immemorial who say, 'I've got the cure, if you just buy this pill.'
"It tars the whole field of aging research and casts a whiff of charlatanism," Perry said.
X dismisses critics of X and anti-aging medicines as hidebound supporters of a "multibillion-dollar gerontological machine."
"Under the guise of good science and the illusion of righteousness, they continue to criticize this," GX said. "But the bottom line is every year we grow." Union-Tribune library researcher Danielle Cervantes contributed to this report.
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In the latest frenzy to prolong life, aging baby-boomers seem to have latched onto another supposed magic cure for anti-aging: Human Growth Hormone (HGH). On an episode of CNN: Chasing Life today, CNN writer Caleb Hellerman wrote about several people in Kansas City, KS, who have tried this banned substance, HGH, with the hope that their symptoms of normal aging could be reversed. A couple in Kansas claim to have felt much less tired and a lot better since taking daily doses of HGH; they stated that this drug is not for everyone, but it worked for them. A Dr. Jackie Springer of the Green Rock Clinic is one of the proponents of this drug which is supposed to increase muscle mass and bone density, and reduce fat. Springer who had been prescribing Human Growth Hormone, lost her license as a result. HGH is a worthwhile drug, for certain patients such as those suffering from stunted growth, but they are illegal if prescribed for anti-aging purposes.
Union-Tribune library researcher Danielle Cervantes contributed to this report.
