Have you been medically and/or financially harmed by anyone providing you with growth hormone, anabolic steroids or anti-aging treatments? Let's talk. Hopefully I can help. -Tom Perls MD, MPH, FACP (see below for my contact information)
The real truth about Growth Hormone for Anti-Aging and Sports. It's Quackery and Hucksterism.
As detailed on this website, human growth hormone (hGH) for many good reasons is illegal for anti-aging, athletic enhancement and age-related diseases, just like anabolic steroids are illegal for body-building and athletic enhancement.
Claims that human growth hormone and substances that stimulate its production work to stop or reverse aging or build strength are unfounded and the marketing of these substances for such purposes constitutes quackery and hucksterism. On the other side of the coin are the risks of arthritis, diabetes and cancer, and actually lower life expectancy.
In the U.S. Congressional report, "Quackery: A $10 Billion Scandal”, a quack is defined as: "...anyone who promotes medical schemes or remidies known to be false or that are unproven for a profit."
See the menu to the left for specific topics ranging from the legal/FDA, medical literature to convicted pharmacies and physicians to deaths
New Developments in the illegal provision of growth hormone for antiaging and bodybuilding. JAMA June 18, 2008
On MSNBC.COM: Call for crackdown on docs who peddle HGH
About The Author: Tom Perls MD, MPH is an Associate Professor of Medicine at Boston University School of Medicine and is a practicing geriatrician at Boston Medical Center. Dr. Perls is the Founder and Director of the New England Centenarian Study. He is board-certified in Internal Medicine (residency: Harbor UCLA Medical Center) and Geriatrics (fellowships: Harvard Medical School and Mount Royal Hospital in Melbourne Australia). He earned his MPH at the Harvard School School of Public Health and he is a Fellow of the American College of Physicians. Dr. Perls became interested in becoming a vocal critic of the anti-aging industry when he noted the pernicious and deceitful picture of older people painted by many anti-aging clinics, websites and hucksters. Such marketing promotes terrible and completely unwarranted biases. Learning more about the most popularized treatment, Dr. Perls realized that the promotion of GH is unquestionably dangerous and illegal quackery.
You can reach Dr. Perls through the contact page on this website (see the bottom of the menu on the left) or by phone at 617-638-6688.
California-based medical guru Ramon Scruggs, who was accused in the Mitchell Report of having prescribed steroids and human growth hormone to several Major League players, pleaded guilty to two federal criminal charges Monday.
Scruggs appeared in a U.S. District Court in San Jose to plead guilty to one count of conspiracy to distribute anabolic steroids and HGH and one count of money laundering. His sentencing is set for Sept. 14.
Once the flamboyant owner of a profitable clinic called the New Hope Health Center in Costa Mesa, Calif., Scruggs preached that steroids and HGH could improve quality of life for his patients, some of whom he never saw personally. Among Scruggs' patients were former Mets pitcher Scott Schoeneweis and Cardinals third baseman Troy Glaus.
The indictment a grand jury issued against Scruggs and his co-defendants in March 2008 said sports agents referred pros to Scruggs for drugs that were "unavailable to the players through lawful medical channels absent the illegal prescriptions provided by Scruggs."
Two of Scruggs' former employees, Allen Danto and Heidi McPherson, were also indicted in the case. Danto pleaded guilty earlier this month to conspiracy to distribute anabolic steroids and HGH. McPherson pleaded not guilty and is set for a trial beginning Sept. 21.
Applied Pharmacy owners Jason R. Kelley (l.) and Samuel Kelley leave the federal courthouse on Thursday in downtown Mobile, Ala.
The owners of an Alabama pharmacy that allegedly sold performance-enhancing drugs to Jose Canseco, John Rocker, Evander Holyfield and other athletes were among the 12 people indicted by a federal grand jury for their role in what court documents describe as a $4 million steroid ring that operated in at least 10 states, including New York and New Jersey.
The superseding indictment was handed down in December but was not unsealed until Thursday, when six of the defendants linked to Applied Pharmacy Services appeared in U.S. District Court in Mobile for a hearing. Applied's owners - Samuel Kelley, Jason R. Kelley and Jodi Silvio - are scheduled to return to court for an arraignment next week.
The indictment does not identify company clients, but Drug Enforcement Administration agents who raided the Mobile compounding pharmacy in 2006 found records that indicated Canseco, Rocker, Holyfield and more than a dozen other athletes had obtained performance-enhancing drugs from Applied.
"Several of the steroids were powerful veterinary steroids [STANOZOLOL] approved for use in animals such as cattle and horses - but not human beings," the indictment said. "Some of the sales of anabolic steroids were to teenagers and young persons under the age of 21. Daily, these defendants put the health and safety of hundreds of people at risk for the sake of millions of dollars."
The 2006 Mobile raid was the first action in what would become known as Operation Which Doctor, the multistate investigation of illegal Internet drug distribution led by Albany County District Attorney David Soares.
Seventeen doctors and wellness center executives pleaded guilty to charges from Operation Which Doctor, and many of them agreed to testify against Signature's operators. But Albany County Judge Stephen W. Herrick threw out the indictment in 2008 and barred prosecutors from bringing the case to a new grand jury, Herrick ripped prosecutors for the way they handled the case, saying the indictment and the instructions to the grand jury considering the case were confusing.
Federal authorities in Alabama describe one of the 12 Applied defendants, an Arizona naturopathic doctor named Jesse Haggard, as a fugitive. Haggard is idenfitied as a steroid dealer in the indictment.
Last year, the Daily News reported that one of the businesses targeted by the Albany probe sent a package containing the anabolic steroid oxymethelone and testosterone cypionate to Haggard's Phoenix-area clinic. The package was addressed to Kevin Schexnider, who was a co-owner of a now-closed Houston-area gym. Schexnider's partner was a trainer named Kelly Blair, a former schoolmate and relative-through-marriage of Andy Pettitte.
Pettitte told congressional investigators last year that he obtained human growth hormone from his father Tom. The News, meanwhile, reported that Tom Pettitte obtained the HGH from Blair. In an interview last year, Haggard acknowledged that Schexnider was a patient but would not talk about the package sent to his clinic.
News Release [print-friendly version] FOR IMMEDIATE RELEASE April 10, 2008 Contact: Casey McEnry Number: 415-436-7994
APR 10 -- SAN JOSE – United States Attorney Joseph P. Russoniello announced that a federal grand jury in San Jose has indicted Dr. Ramon Scruggs, 60, of Tustin, California, Allan Danto, 54, of San Diego, California, and Heidi MacPherson, 39, of Laguna Niguel, California on counts of conspiracy to commit offenses against the United States, conspiracy to commit money laundering, and money laundering. In addition, Dr. Scruggs is also charged with four counts of distribution of anabolic steroids and four counts of misbranding drugs held for sale with intent to defraud and mislead.
The indictment, which was returned under seal on March 6, 2008, was unsealed today. The conspiracy charge against all three defendants alleges that the defendants conspired to: (1) distribute anabolic steroids in a manner which was outside the scope of professional medical practice, and not for a legitimate medical purpose; (2) smuggle human growth hormone into the United States in a manner contrary to law; and (3) misbrand drugs held for sale with intent to defraud and mislead.
According to the indictment, Dr. Scruggs was a physician who operated his medical practice at New Hope Health Center located in Costa Mesa, California. Under the name of New Hope Health Center, Scruggs and two employees in his office, Mr. Danto and Ms. McPherson, conspired to distribute anabolic steroids, human growth hormone (“HGH”) and various other prescription drugs in a manner outside the usual course of practice, for non-legitimate purposes, including performance enhancement, aesthetic body improvement and other non-medical reasons.
The non-legitimate prescriptions written by Dr. Scruggs were forwarded to pharmacies both inside and outside the state of California, including Signature Pharmacy, in Orlando, Florida, and the drugs were subsequently delivered from the pharmacies to Dr. Scruggs’s clients throughout the United States, including the Northern District of California. At other times, syringes were pre-loaded with anabolic steroids and sent directly from the New Hope Health Center to Dr. Scruggs’s clients.
The defendants are not in custody, and their initial appearances have not yet been scheduled.
The maximum statutory penalty for the count of conspiracy to commit offenses against the United States in violation of 18 U.S.C. § 371 and for each count of distribution of anabolic steroids in violation of 21 U.S.C. § 841 is five years imprisonment and a $250,000 fine.
The maximum statutory penalty for each count of misbranding drugs held for sale with intent to defraud and mislead in violation of 21 U.S.C. § 331(k) and 333(b) is three years imprisonment and a $250,000 fine.
The maximum statutory penalty for the count of conspiracy to commit money laundering in violation of 18 U.S.C. § 1956 and the count of money laundering in violation of 18 U.S.C. § 1956 is 20 years imprisonment and a $500,000 fine.
However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.
Matt Parrella, Jeff Nedrow, and Jeff Finigan are the Assistant United States Attorneys who are prosecuting the case with the assistance of Brenda Hodgen and Susan Kreider. The prosecution is the result of a four-year investigation by the Drug Enforcement Administration, the Food and Drug Administration Office of Criminal Investigations, and the Internal Revenue Service Criminal Investigation.
Please note, an indictment contains only allegations against an individual and, as with all defendants, Dr. Scruggs, Mr. Danto, and Ms. McPherson must be presumed innocent unless and until proven guilty.
Further Information:
Case #: 08-00144
A copy of this press release may be found on the U.S. Attorney’s Office’s website at www.usdoj.gov/usao/can.
ScienceDaily (June 18, 2008) — A great deal of attention has been paid to the use of growth hormone (hGH) by elite athletes and a few vocal entertainers. But underlying this tip of the iceberg is a $2 billion dollar a year business, likely involving hundreds of thousands of regular people, and promoted by anti-aging and age-management clinics and compounding pharmacies who aggressively market and sell growth hormone with the claim that it has anti-aging or athletic enhancing properties.
Since their previous article in the Journal of the American Medical Association (JAMA) in 2005 on the clinical and legal aspects of growth hormone for anti-aging, in which researchers from Boston University School of Medicine, Boston Medical Center and the University of Illinois at Chicago alerted the medical community and lay public to the deceptive mass marketing and illegal distribution of growth hormone for anti-aging and athletic enhancement, the authors provide new evidence demonstrating that these deceptive and dangerous activities have grown worse.
Remarks Dr. Thomas Perls, Director of the New England Centenarian Study and an associate professor of Medicine at Boston University School of Medicine, who has monitored the anti-aging industry for over the past ten years, "despite the overwhelming evidence that the risks and dangers of growth hormone far outweigh the clinically demonstrated insignificant benefit in normally aging individuals, the prescribing, distribution and sale of hGH for alleged anti-aging aesthetic and athletic enhancement has dramatically grown over the past few years. Clearly, the coordinated and aggressive marketing campaigns of the anti-aging and age-management industries are highly and most unfortunately effective."
Clinical evidence does support the therapeutic use of hGH for children and adults with appropriate clinical indications. However, these cases are disease specific and rare. Furthermore, any effectiveness that is demonstrated in the rare medical conditions approved for hGH distribution cannot be translated into effectiveness among healthy aging adults, a deceptive assertion often made by proponents of hGH use for a wide range of panacea-like benefits.
In January, 2007, the FDA issued an alert emphasizing that prescribing and distributing hGH for anti-aging and body building is illegal. A number of high-profile government investigations such as Operations Raw Deal, Phony Pharm and Which Doctor have attempted to make a dent in the illegal distribution of hGH and anabolic steroids for unapproved uses such as anti-aging or aesthetic reasons. As stated on the Albany County District Attorney's website, in the case of Operation Which Doctor, numerous governmental agencies are "working together to take down a nationwide distribution ring of anabolic steroids, Human Growth Hormones and other controlled substances, by targeting the ring's dirty doctors, its distributors that pose as clinics, and ultimately the ring's supplier Signature Pharmacy."
Contrary to published claims, neither long-term safety nor health benefits have been demonstrated in normally aging individuals taking hGH. A review of clinical studies among healthy, normally aging individuals found that hGH supplementation does not significantly increase muscle strength or aerobic exercise capacity. However, documented adverse effects include soft tissue edema, arthralgias (joint pains), carpal tunnel-like syndrome, gynecomastia (enlarged breasts) and insulin resistance with an elevated risk of developing diabetes. Increasingly more and more animal and laboratory studies suggest an increased cancer risk.
The authors suggest that several measures need to be taken to address the inappropriate distribution and use of hGH.
Among their recommendations:
The public must be accurately informed by physicians and scientists who do not have a vested interest in hGH, about health risks, fraudulent marketing and illegal distribution of this drug.
Organizations that promote or indirectly profit from the medically inappropriate and illegal distribution of hGH that have been accredited by the Accreditation Council for Continuing Medical Education (ACCME) to offer American Medical Association Physician Recognition Award (PRA) category 1 CME credits or other categories of CME credit should, at a minimum, have their accreditation revoked.
U.S. manufacturers of hGH must be more effective in, and held accountable for, controlling the distribution of the drug to companies providing the drug for illegal uses.
Congressional hearings and media attention surrounding hGH should focus less on athletes and prominent entertainers who are also victims of deceptive marketing and pushing of hGH, and much more on the distributors who are violating federal and state laws by making the drug available for non-approved uses.
Senators Schumer and Grassley and Representative Steven Lynch deserve the public's support of their intention to strengthen and enhance the law regarding the illegal distribution of hGH. 'Strengthening the law' should entail stiffer financial and imprisonment penalties for illegally prescribing and/or distributing growth hormone for purported anti-aging, age management, aesthetic enhancement, and body building uses. Enhancing the law should include the addition of sermorlin (growth hormone releasing hormone [GHRH]) and mecasermin (insulin-like growth factor I [IGF-1]) and their analogues. GHRH (which stimulates the release of endogenous hGH) and IGF-I (which mediates many of the effects of hGH) result in hGH-like effects, and, therefore, the potential for their inappropriate use as purported anti-aging and performance enhancement therapies clearly exists.
Perl adds: "In my capacity as a reviewer of medical records seized from anti-aging clinics by the DEA, I almost never see hGH provided in isolation. It is usually a part of a complex cocktail of one or more anabolic steroids, human chorionic gonadotropin (specifically for men to decrease the obvious signs of steroid abuse such as small testicles and enlarged breasts), thyroid hormone, DHEA and other drugs. Additional drugs such as blood pressure medicines, diuretics and insulin may be given to treat the side effects of the basic cocktail."
Perls is a consultant for the US Department of Justice.
Former Campbell Businessman Indicted For Selling Human Growth Hormone
Saturday, January 17, 2009
SAN JOSE, Calif. -- A federal grand jury in San Jose said a former Campbell businessman illegally sold synthetic human growth hormones, along with other products he falsely claimed contained this hormone.
Stephen Joseph Heuer, 48, formerly of Aptos in Santa Cruz County, was indicted for conspiracy, illegal distribution of a human growth hormone, distribution of misbranded drugs, mail fraud and tax evasion.
According to the indictment, Heuer owned a company, Cocoon Nutrition, which included nutritional supplement stores in Cupertino and Campbell.
The business focused on selling products containing synthetic human growth hormone, or HGH. Doctors prescribe HGH to some children with deficiencies and some preliminary studies indicate it could reduce body fat in adults, according to the Mayo Clinic Web site.
Heuer also operated a Web site to distribute products he claimed contained HGH, U.S. Attorney Joseph P. Russoniello said, and distributed products falsely advertised as containing the hormone.
The company sold HGH to persons without a valid prescription, for use in ways outside "the usual course of professional practice, and not for medical purposes," according to a statement from the Internal Revenue Service's criminal investigation department.
In addition to making medical claims through radio, e-mail and Internet advertising, Heuer sent packages of "bunk HGH" to customers across the country through U.S. mail.
Heuer's associate, Robert Bohen, of Orange County, was also charged. Bohen also helped supply the items supposedly containing HGH.
Additionally, Heuer is charged with failing to report income from selling these products between 2002 and 2004 on federal tax returns. The indictment alleges he used a variety of techniques to conceal this income, including offshore bank accounts and claiming not to be an American citizen.
Heuer was arrested Wednesday in South Carolina and appeared in federal court that same day. He was booked on a $500,000 bail, and has a potential court date on Thursday, Jan. 29 at 9:30 a.m. in San Jose.
Copyright 2009 by KTVU.com and Bay City News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
New Jersey businessman sentenced to 2 years for running steroid, human growth hormone ring
By ERIC TUCKER |Associated Press Writer
7:07 PM EST, January 16, 2009
PROVIDENCE, R.I. (AP) — A businessman who sold steroids and human growth hormone to bodybuilders from around the country was sentenced to two years in federal prison Friday by a judge who called him the ringleader of a far-reaching operation.
Daniel McGlone, who was charged in Rhode Island two years ago as part of a bigger multistate probe into the illegal sale of steroids, apologized to his customers and to his family.
"I know that I let people down, your honor, and I know that it will not happen again," he told U.S. District Judge William Smith.
McGlone, 56, has admitted to recruiting doctors to write fake prescriptions for hundreds of customers between April 2004 and August 2006. He attracted clients by advertising his business, which he ran out of his apartment in North Brunswick, N.J., in magazines geared toward bodybuilders.
When customers contacted McGlone, he advised them on which drugs they should take, then forwarded the requests to doctors who signed prescriptions without meeting or examining the patients. He had the prescriptions filled by large mail-order pharmacies.
Prosecutors have not identified McGlone's clients.
The distribution of human growth hormone is prohibited under federal law, except for specified medical uses. It is not approved for bodybuilding or weight-loss treatments.
"Here we have a drug dealer who made a million dollars dealing drugs to people who have the money to spend," Smith said.
Though McGlone could have received nearly five years in prison under sentencing guidelines, prosecutors recommended a far more lenient punishment based on his cooperation in what they said was an ongoing investigation. They did not elaborate.
McGlone has pleaded guilty to 50 counts, including illegal drug distribution, health care fraud and money laundering. He forfeited more than $730,000 and was ordered to pay more than $19,000 in restitution to Blue Cross & Blue Shield of Rhode Island.
McGlone was ordered to report to prison Feb. 9.
McGlone was charged in February 2007 in Rhode Island along with two doctors from New York, Ana Maria Santi and Victor Mariani. Santi was sentenced to two years in prison and Mariani was given 12 months' home confinement for writing the prescriptions.
Signature Pharmacy, a Florida company whose client lists reportedly include many professional athletes, filled many of the prescriptions written by Santi and Mariani, prosecutors said.
Signature was raided two years ago, but a New York judge last September threw out an indictment against five operators of the pharmacy, saying Albany County county prosecutors had presented the case to a grand jury in a confusing and disjointed way.
Alan Mintz MD, Founder of Cenegenics, Self-Administered Growth Hormone, Dead at Age 64, Due to a Brain Mass (Cancer?)
In our April issue, writer Pat Jordan took an interesting look at a group of doctors who are behind the longevity movement—those guys who pump their patients full of testosterone and human growth hormone and tell them they can live forever. One of the more colorful doctors in Dr. T to the Rescue was Alan Mintz, who ran the Cenegenics Medical Institute near Las Vegas. He was bombastic, overbearing and quite sure of himself, telling Jordan that “Cenegenics is more about aesthetics than longevity. We call it ‘age management.’ Our goal is the highest possible quality of life and sexual function, and then a quick death of a heart attack at 94. We don’t make outrageous claims about longevity.”
Good thing about that last line. Dr. Mintz died last week at the age of 64. We’ll let the irony speak for itself.
Decreased Growth Hormone Lengthens Life Span
Growth Hormone's Link to Starvation May be Clue to Increasing Life Span
Newswise — Researchers at UT Southwestern Medical Center have determined that starvation blocks the effects of growth hormone via a mechanism that may have implications in treating diabetes and extending life span.
“It’s been well-established that growth is blunted during starvation. But our work shows that this is not just from running out of energy. It’s much more sophisticated than that,” said Dr. Steven Kliewer, professor of molecular biology and senior author of a study available online and appearing in today’s issue of the journal Cell Metabolism.
Using genetically altered mice, the researchers found that during fasting, the actions of growth hormone are blocked by a fat-burning hormone called FGF21.
“It’s something that we hadn’t anticipated,” said Dr. Kliewer.
Growth hormone has many functions in the growth and reproduction of cells, such as controlling the length of developing arm and leg bones in children.
Growth hormone has several other functions, however, even in adults. It promotes the breakdown of fats, stimulates creation of protein and increases levels of IGF-1 (insulin-like growth factor-1), a hormone that promotes growth. Too much growth hormone can cause insulin resistance, resulting in diabetes, and lead to other disorders.
In the current study, mice that were genetically altered to produce excess FGF21 grew to be much smaller than ordinary mice, even though they ate more and had more fat in proportion to their size.
Paradoxically, and to the researchers’ surprise, the altered, smaller mice produced much greater amounts of growth hormone than normal.
Why didn’t the altered mice grow larger than normal in response? The researchers found that FGF21 does not block the production of growth hormone; rather, it works to prevent growth hormone from activating the genes it normally controls.
Interfering with the actions of growth hormone has been shown to increase life span in mice, Dr. Kliewer said.
“In addition, intermittent fasting – which increases FGF21 concentrations – also extends life span in mice. This raises the intriguing possibility that FGF21 might be a longevity factor,” Dr. Kliewer said.
“This is something that we’re beginning to test in the lab,” he said. “But our genetically engineered mice have all the classic hallmarks of extended life span: growth hormone resistance, low concentrations of IGF-1, increased insulin sensitivity and small size.”
FGF21 is already being tested in human clinical trials for treatment of obesity and diabetes in adults, but the new findings linking FGF21 to interference with growth hormone might indicate that caution is needed before using it in children or teens, Dr. Kliewer said.
Other UT Southwestern researchers involved in the study were lead author Dr. Takeshi Inagaki, instructor of molecular biology; Dr. Vicky Lin, postdoctoral research fellow in pharmacology; and Dr. David Mangelsdorf, chairman of pharmacology and a Howard Hughes Medical Institute investigator. Dr. Moosa Mohammadi from New York University School of Medicine also participated in the study.
The work was supported by the National Institutes of Health, the Welch Foundation and the Howard Hughes Medical Institute.
The House of Representatives Committee on Oversight and Government Reform’s recent hearing: Myths and Facts about Human Growth Hormone, B12, and Other Substances. February 12, 2008.
Committee Holds Hearing on Myths and Facts about Human Growth Hormone, B12, and Other Substances
Witnesses testify to shed light on controversial substances
By Bryan Hoch / MLB.com
WASHINGTON -- Just 24 hours before Roger Clemens and Brian McNamee were scheduled to occupy the same room on Capitol Hill, four expert witnesses testified to shed additional light on several sometimes-mysterious and often-misconstrued substances at the heart of the Mitchell Report.
The Committee on Oversight and Government Reform held a hearing Tuesday regarding "Myths and Facts about Human Growth Hormone, B-12 and Other Substances," in Room 2154 of the Rayburn House Office Building.
In an opening statement, chairman Henry Waxman (D-Calif.) said that nothing has surprised him more in the committee's ongoing investigations than the public's confusion regarding steroids, human growth hormone, vitamin B-12 and other substances.
"Senator Mitchell's report on the use of performance-enhancing substances in baseball found that the use of human growth hormone by professional baseball players is rising," Waxman said. "Just last week, Sylvester Stallone seemed to be endorsing the use of HGH [in a published interview] to reverse the aging process.
"It is an unfortunate reality that what professional athletes and celebrities do serves as a health guide to millions of Americans. Even worse, there seems to be an almost unlimited number of unscrupulous scam artists ready to exploit this reality."
A cursory glance at several Web sites reveals an easy-to-access array of products that claim to be able to reverse the aging process, enhance physical performance and boost energy. An isolated Google search performed Tuesday for "human growth hormone" yielded more than 7.6 million results, many of them highly dubious sales pitches.
"The committee's three-year, bipartisan investigation of performance-enhancing substance abuse in professional sports uncovered an industry dangerously tolerant of pseudo-science and medical mischief in its locker rooms," Rep. Tom Davis (R-Va.) said. "The Mitchell Report added to that picture, making it clear that while steroid use continues to be a concern, the newest trend is HGH abuse, alleged to speed recovery from injuries and build lean muscle mass."
Key to the discussion was the definition and use of HGH, which will be at the forefront of Wednesday's proceedings. McNamee, Clemens' former personal trainer, has alleged that Clemens -- a seven-time Cy Young Award winner who owns 354 Major League victories -- used the drug along with steroids as part of his training regimen beginning in 1998.
When medically necessary, the panel indicated, HGH can be a safe and effective clinical treatment for children and adults. Legitimate uses for HGH include promoting linear growth in short children, and it has been approved by the United States Food and Drug Administration for conditions such as growth hormone deficiency, chronic kidney disease, Turner syndrome and muscle wasting due to HIV or AIDS.
Such cases are relatively rare. Dr. Alan Rogol, professor of clinical pediatrics at the University of Virginia and the Indiana University School of Medicine, said that cases of growth hormone deficiency, for example, average one in every 4,000 persons, while Turner syndrome averages one in every 2,500 girls.
Certainly, a Major League player like Clemens -- or Andy Pettitte and Chuck Knoblauch, who did not refute their inclusion in the Mitchell Report and provided testimony -- would not qualify under any of those criteria.
For healthy, normally aging individuals, a Stanford University review of 31 clinical studies found the only benefit to be a slight increase in muscle mass. Documented negative side effects included soft tissue swelling, joint pains, carpal tunnel-like syndrome, breast enlargement and diabetes.
The risks increase because, as Dr. Todd Schlifstein of the New York University Medical Center said, HGH users typically do not use the drug alone. Combinations with anabolic steroids are common and allow users to see greater short-term gains -- such as a "ripped," muscular effect -- while also increasing their chances at harmful long-term effects.
"The combined use increases muscle strength, speed and size," Dr. Schlifstein said. "Studies have had mixed results when comparing the performance-enhancing benefits of using HGH and steroids versus using steroids alone."
No long-term clinical studies have been conducted on the effects of HGH use in healthy adults or in anyone at doses exceeding FDA-approved levels. For these reasons and others, Dr. Thomas T. Perls of the Boston University School of Medicine has recommended that HGH be classified as a Schedule III controlled substance in the United States, much like anabolic steroids.
"There are a number of safe and legitimate FDA-approved uses of growth hormone in adults and children," said Dr. Rogol. "The off-label use of growth hormone, which is primarily in the anti-aging and body image or athletic market, comes with increased risks."
Many users are unaware of correct dosage. Higher HGH dosages may achieve levels similar to those found in the endocrine disease acromegaly, which is caused by too much growth hormone in the body. This condition may lead to severe muscle weakness and heart disease. Professional wrestler Andre the Giant is one well-known person who suffered from acromegaly.
"Though there are a number of legitimate reasons to administer human growth hormone, these do not include anti-aging or 'improvement' in athletic performance," Rogol said. "People who misuse this drug run the risk of seriously damaging their health."
Dr. Rogol said that some athletes and others may not even be purchasing or receiving legitimate HGH, leaving them to inject unknown substances into their bodies. Compounds falsely sold as HGH -- which can only be injected, not taken orally, a common misconception -- may also promote the growth of tumors due to unlisted ingredients.
"Best case, gullible people are only being scammed out of their money," Davis said. "Worst case, they are placing their health in the hands of criminals who could be operating beyond the reach of our laws anywhere in the world."
Also central to the topic of drugs in professional sports is the continuing use of the injectable vitamin B-12, notably concerning Clemens, Rafael Palmeiro and Miguel Tejada. When McNamee charged that he injected Clemens on at least 16 occasions with steroids or HGH, Clemens insisted that he had only received injections of B-12 and Lidocaine, a localized short-lasting painkiller, from his personal trainer.
Palmeiro claimed, after testing positive for steroids and being suspended in 2005, that he had only injected himself with B-12, which he said he acquired from Tejada.
While panel experts bristled at the idea of an unlicensed person injecting a client using needles and syringes, would the B-12 even have done Clemens any good, other than as a red, syrupy placebo?
"It seems like a benign drug," Schlifstein said, "but let's remember, it is a drug."
Experts testify that B-12 is useful for those who suffer from pernicious anemia or have difficulty absorbing B-12 from food or tablets. Still, the widely-held belief that B-12 injections increase energy, fight off colds and generally promote good health appears to be a myth.
"All of these are true when persons deficient in vitamin B-12 are treated," said Dr. Susan B. Shurin, deputy director of the National Heart, Lung and Blood Institute. "However, there is no evidence at all of those clinical benefits when the vitamin is given to persons who are not deficient."
Davis expressed hope that hearings like Tuesday's would continue to pave a path toward eradicating harmful substances and confusion regarding these topics from the American public.
"We have to find a way to block transmission of that false incentive and convince young athletes there are no magic pills or wonder drugs that will grease the path to the Hall of Fame," Davis said. "Only hard work, and the most effective antidote to illicit drugs -- the truth -- should fuel the bodies and minds of those seeking athletic excellence at any level."
Bryan Hoch is a reporter for MLB.com. This story was not subject to the approval of Major League Baseball or its clubs.
Performance rose even when athletes mistakenly thought they were taking growth hormone, researchers say
Posted June 17, 2008
By Alan Mozes HealthDay Reporter
TUESDAY, June 17 (HealthDay News) -- When athletes think they are taking a performance-enhancing drug, their performance tends to get better -- even if they never really take the drug.
So concludes a study of recreational athletes, half of whom received human growth hormone supplements while the other half took a placebo.
"This is a very relevant finding of the biology of the mind," said study co-author Dr. Ken Ho, head of the pituitary research unit at the Garvan Institute of Medical Research in Sydney, Australia. "There is a very real placebo effect at play in a sporting context, in which a favorable outcome can be achieved purely on the basis of a belief that one has received something beneficial -- even if one hasn't."
Ho and his colleagues were expected to present their findings Tuesday at the Endocrine Society's annual meeting, in San Francisco.
Human growth hormone (HGH) is produced naturally by the anterior pituitary gland at the base of the brain. It is a key player in the regulation of muscle, skeletal, and organ growth. The hormone also helps process calcium and protein and stimulates the immune system.
As an injectable supplement for the purposes of boosting athletic performance, the use of HGH has been on the rise in recent years. But the World Anti-Doping Agency (WADA) notes that its use has also been linked to an increased risk for heart disease, diabetes, muscle, joint, and bone pain, high blood pressure, and osteoarthritis. WADA has therefore classified HGH as a banned substance both in and out of sports competitions.
The drug made headlines early this year when baseball great Roger Clemens denied using HGH in testimony presented at special Congressional hearings on doping in professional baseball. His former New York Yankees teammate, pitcher Andy Pettitte, has admitted to taking the drug.
Since 2004 a blood test has been in place to screen out those athletes engaged in surreptitious use. At the endocrine meeting, a separate team of researchers from Ohio University and the Aarhus Kommunehospital in Denmark presented evidence -- derived from a mouse study -- that points the way toward a new group of more easily identified biomarkers for HGH, which, theoretically, could lead to improved HGH screening down the road.
But Ho pointed out that "there is actually no firm scientific proof that growth hormone actually does enhance athletic performance, despite a widespread belief in its ability to do so". In fact, a review of the literature on the subject, published in March in the Annals of Internal Medicine, found no evidence that HGH could boost athletic prowess.
Ho and his team wanted to explore whether the physical boost athletes attribute to HGH might be more psychological in nature.
To do so, they focused on 64 healthy recreational athletes, men and women between the ages of 20 and 40, who had been exercising at least two hours per week over the six months prior to the study.
After testing the participants for their athletic ability, the men and women were randomized into two groups. One group got growth hormone for eight weeks, and the second received a dummy substance, or placebo. Neither the researchers nor the athletes knew which group participants were in.
At the end of the two-month trial, all the participants were asked to guess whether they had been taking HGH or a placebo, and whether their sporting performance had changed during the study period. Athletic ability was then re-tested on a range of performance parameters.
Ho and his team found that about half of the participants who received a placebo incorrectly assumed they had been given HGH. Gender played a significant role in such perceptions: the male placebo athletes were much more likely than the female athletes to have mistakenly thought they were in the HGH group.
However, regardless of gender, athletes on placebos who thought they had taken HGH typically believed their performance had improved during the study.
What's more, these "incorrect guessers" actually did improve, albeit minimally, in all measures of performance, including endurance, strength, power, and sprint capacity. In one category -- high-jumping ability -- the improvement was significant.
People in the placebo group who correctly guessed that they had taken a placebo improved their performance by about 1 percent to 2 percent, Ho said. But those who mistakenly thought they had taken HGH showed twice that level of overall improvement -- about 2 percent to 4 percent.
"This proof of the placebo effect would equally apply to any drug, at any event, in any sport, and for any athlete, given whatever their coach is giving them," suggested Ho. "And, of course, it also goes beyond sport. It extends to health in general, and medical treatment in general."
How does this placebo effect stack up against improvements linked to actually taking HGH? Ho said his team is working on that comparison, with data coming at a later date.
Meanwhile, Dr. Michael O'Brien, an attending physician in the division of sports medicine at Children's Hospital Boston, called the finding "intriguing."
"This is one of the more unique sports supplement studies I've heard about," he noted. "Professional and elite athletes have always known that there's a very large psychological component to sports, especially with respect to endurance and recovery from hard training. But this is more evidence that more and more chemicals aren't the answer. Particularly for athletes who have a really balanced psychological approach to training."
March 18, 2008 -- Athletes who risk their careers and reputations by taking human growth hormones may be getting little in return, a new research review suggests.
Combined results from 27 studies did not support the claim that taking human growth hormones boosts athletic performance.
Short-term use of growth hormones was associated with increases in lean body mass, but not improvements in strength.
And there was even some suggestion that human growth hormone worsened exercise performance.
The studies were small and of short duration, with the longest lasting just 84 days.
Larger, longer studies are needed to conclusively determine whether growth hormone improves athletic performance, and if so, at what cost, researcher Hau Liu, MD, MPH, tells WebMD.
"Based on the current literature, we found no evidence that human growth hormones improved exercise capacity or athletic performance," he says.
Human Growth Hormone Studies
Human growth hormone is produced naturally in the body, and is essential for growth and development. A synthetic version, available since 1985, is used to treat growth hormone deficiency and other medical conditions.
Athletes take it in the belief that growth hormones will improve their performance and help them recover more quickly from injury.
But they are acting on faith, because the research doesn't prove these claims, Liu says.
The studies reviewed by Liu and colleagues from California’s Santa Clara Valley Medical Center and Stanford University included 303 physically fit healthy people -- mostly young men -- given growth hormone treatment either by injection or infusion.
The participants were followed for one month to just under three months to determine if the growth hormone affected body composition, strength, metabolism, and exercise capacity.
Although growth hormone use did seem to lead to increases in lean body mass, it did not appear to improve muscle strength.
And Liu says two of three studies examining exercise performance showed growth-hormone-treated patients had higher lactate levels than untreated control subjects, which could be indicative of diminished exercise capacity. Growth-hormone-treated participants also reported more fatigue.
The study appears in the May 20 issue of the Annals of Internal Medicine, but it was released online today.
"More research, including identification and evaluation of the real-world growth hormone doping protocols, is warranted to definitively determine the effects of growth hormone on athletic performance," they write.
Spotlight on Performance-Enhancing Drugs
Like anabolic steroids, growth hormone is banned by the World- and U.S. Anti-Doping Agency, the Olympic Committee, and most major and amateur sports leagues.
While steroid use can be detected though a simple urine test, this is not the case with growth hormones.
As a result, it is not at all clear how widespread growth hormone use is among student and professional athletes.
"The estimates have been from just about everyone to almost nobody," U.S. Anti-Doping Agency senior managing director Larry Bowers, PhD, tells WebMD. "We just don't know."
Mainstream Docs Join Anti-Aging Bandwagon
Brian Alexander MSNBC contributor
POSTED: 9:56 am EDT April 21, 2008
UPDATED: 1:43 pm EDT April 21, 2008
For thousands of years, magicians, alchemists, even a few fringe medical practitioners have fueled an unbounded optimism that we can blunt the ravages of time, stay younger for longer, maybe even defeat death itself. Their pitches have usually hinged on some drug, food or device - everything from electricity to yogurt to surgically installing the gonads of animals into our own bodies - that will slow or reverse the aging process. Every decade or so, "anti-aging" promoters grasp onto news coming out of research labs and trumpet those developments as the answer we have all been awaiting.
Lately, the buzzwords are "nano," which refers to the science of the ultra small (a nanometer is one millionth of a millimeter), and stem cells. One "nano" face cream, for example, promises to stave off wrinkles with "nano-encapsulated technology" into which the makers have "packed microscopic bundles of Prodew, a nourishing skin humectant." A dietary supplement advertised as "The World's FIRST Stem Cell Enhancer," promises to "Rebuild, Renew, Rejuvenate" - giving you more stem cells and keeping your organs healthy - if you take the blue-green algae capsules. The claims are based on wispy science and hype.
But while the cycle remains the same, something new is happening in the world of anti-aging. Mainstream doctors who once wanted nothing to do with the naturopaths, osteopaths and others who first populated modern anti-aging, and whom they often considered glorified carnival barkers, are buying in, signing up for "certification" as anti-aging practitioners and offering patients the promise of youth and rejuvenation through such treatments as human growth hormone, testosterone, special diet and exercise regimens, antioxidants and hundreds of other supplements.
"It is mushrooming," says Dr. Elliot Snyder, an emergency room physician based in Northern California who follows the movement closely by frequently attending anti-aging meetings and talking to friends in the field. He also uses some of its techniques himself. Besides exercising five days a week and following a strict low-fat diet that includes lots of fruits, vegetables and wild salmon but no white flour or red meat, he takes supplements ranging from thiamin and biotin to DHEA, DMAE, colostrum, arginine, carnitine and omega-3 fatty acids - about 50 pills per day. He is 64 but looks a decade younger.
Back in 1994, the annual Las Vegas meeting of the fledgling American Academy For Anti-Aging Medicine was held in a small hotel off the Las Vegas strip. Everyone could fit into a temporary tent-like structure on the pool patio. Last December, at the 15th A4M confab, roughly 2,000 attendees, including business owners, anti-aging promoters and hundreds of doctors - among them obstetricians, ER docs, psychiatrists and internists - filled a cavernous meeting space inside the Venetian Hotel and Resort.
Today, claims Dr. Robert Goldman, A4M's co-founder, there are about 20,000 A4M-certified doctors around the world. A4M's tax returns confirm the boom. The income from fees charged to those seeking board certification from A4M more than doubled from $544,845 in 2005 to $1.2 million in 2006.
A rival organization, Age Management Medicine Group, is growing rapidly, too, says co-founder Rick Merner. He claims the group had more than 400 doctors at its last meeting, sponsored by the nation's single largest "age-management" clinic, Cenegenics. The Cenegenics Foundation also certifies practitioners in age-management medicine (it shuns the term "anti-aging") and claims to have experienced a 100 percent increase in the number of its physician "affiliates" to more than 800.
Mainstream business has recognized the potential. GE Healthcare, for example, sent a team to the recent A4M meeting to market body scanners that cost about $100,000 each and are often used by anti-aging doctors to look at fat deposits inside the body and convince patients of the need to do something about them. (Msnbc.com is a joint venture of Microsoft and NBC Universal, which is a GE company.)
'A life-changing experience' Patients all over the country are buying in. Rebecca Gooden, a 57-year-old Charleston, S.C., real estate agent, first saw an anti-aging doctor in December when she sought help for joint pain, insomnia and lack of energy. "I had felt something was going on but standard testing did not show any of it," she says. "I had been having symptoms but doctors kept telling me there was nothing wrong and I knew there was." Frustrated, when she saw an article about Cenegenics in a magazine, she called for an appointment in hopes of solving her problems. Now, she spends about $1,000 a month on hormones and supplements to treat various hormonal deficiencies and has become an anti-aging convert. "I feel like a new person ... it has been a life-changing experience for me."
All this despite the fact that as far as the American Medical Association or the American Board of Medical Specialties is concerned, there is no such thing as an anti-aging specialty.
Therein lies the often bitter tension between the medical establishment and those physicians and organizations who say they can help us slow or even stop the aging process and the debilitation that comes with it. Goldman and his A4M co-founder, Dr. Klatz, have been accused by respected academics of being snake-oil salesmen. Cenegenics and A4M have both been labeled glorified hormone-pushers.
Anti-aging advocates, on the other hand, argue that they are a persecuted minority of enlightened medical professionals who have the patients' best interests at heart and that the AMA, the mainstream media and the government, especially the Food and Drug Administration, have conspired to keep the truth from the public.
"Certain vested interests would not like to have anti-aging," Klatz argues.
To the ears of Northwestern University bioethics professor Laurie Zoloth, this sounds like an old story. "Whenever one hears these things, that there is a conspiracy against patients, if you come to us we will tell you truth, then one has to ask, 'Why are your statements credible?'"
Has anti-aging 'arrived'? That is precisely the question many consumers are now being asked to answer for themselves. If their M.D. is signing onto anti-aging, does that mean the message is now credible? Does the certificate on his or her wall mean that real anti-aging has, at last, arrived? Or does it simply mean that every patient now has one more reason to live by the Latin phrase caveat emptor - buyer beware?
Dr. Thomas Perls, a Boston University researcher who studies centenarians (people who live at least 100 years), and a vociferous critic of the anti-aging industry, argues that while some anti-aging practitioners "may have their hearts in the right place ... in my mind the whole anti-aging practice has so many problems of ethical and professional misconduct. These practices are selling medicines and substances at great profit with very little in the way of clinical studies to support what they are doing."
The answers to the science questions can be complicated, but the motivations of some doctors to enter the anti-aging world are not. Dr. Arnold Relman, a former editor of The New England Journal of Medicine who is now a professor emeritus of medicine and social medicine at Harvard Medical School, believes "the interest in anti-aging practice is mainly based on economic considerations" by physicians who are looking to boost income.
"Get your piece of the $50 billion anti-aging marketplace!" trumpets a flyer distributed to doctors at A4M's Las Vegas meeting. An article by X and X in "Medical Spas," a magazine that's a member of XX, encourages doctors to open their own medical spas and to have them certified under the World Council for Clinical Accreditation, another A4M organization, because "a single anti-aging patient is estimated to bring $4,000 to $20,000 in annual gross revenue."
The business can be very good, indeed. Doctors can count on regular hours because the patients are not sick. Better yet, patients pay cash because visits and procedures are not generally covered by insurance, which also means there is no upper limit to fees. And since there is no need to deal with insurance companies or HMOs, practices do not require extra staff to handle all that paperwork.
Additionally, anti-aging doctors often sell lines of creams and supplements, such as vitamins, antioxidants and plant extracts, which claim to do everything from strengthening the immune system to boosting libido, directly out of their offices, sometimes with an enormous mark-up. They can also use their own in-office technology, like those GE body scanners, to charge for in-house testing.
Patients generally see anti-aging doctors much more often than regular physicians. That's because in addition to checking on measures like weight and body fat and how patients are feeling overall, the docs are constantly monitoring a large range of sometimes esoteric health indicators with a battery of medical tests, including urinalysis and blood work. They look for levels of everything from testosterone and estrogen to follicle stimulating hormone and dehydroepiandrosterone (a natural steroid known as DHEA). Based on all these results, the doctors may then recommend drugs, hormones, supplements and special diets and fitness regimens - and then set an appointment to see the patient again in several weeks or months for another cash-only check-up.
One doctor, two hats Dr. Andrew Jurow, an ob-gyn in Burlingame, Calif., says he started an anti-aging practice alongside his ongoing traditional practice after becoming a devotee himself. "I am as mainstream as you can get. I am 59 years old, board certified in ob-gyn, as was my father. If you had come to me five, six years ago and talked about anti-aging, I would have said, 'Hogwash!'"
But then Jurow, long an avid exerciser, attended an A4M meeting and came away impressed with what he heard. Five years ago he began visiting an anti-aging doctor himself. Now he sees his regular ob-gyn HMO patients through one door of his building and anti-aging patients through another.
Jurow says he is not getting rich off his anti-aging patients. Rather, his motivation is his own belief that it works. Still, he says, if he sees an anti-aging patient for an hour, he can charge $350, whereas HMOs might reimburse him as little as $50 for a traditional office visit.
Dr. Mickey Barber, a Charleston, S.C., Cenegenics affiliate and Gooden's physician, was an anesthesiologist before turning to "age management" medicine five years ago. She believes that mainstream medicine "at one point in time was lucrative, but it is less so now with health insurance, litigation, and many doctors became discouraged. I think doctors are looking for another way to provide medical care for patients, and if part of that pays the bills, sure."
A typical evaluation of a new patient in Barber's clinic, she says, takes about seven hours and she may order up to 90 laboratory tests. The day costs $3,000.
Johnny Adams, a 58-year-old software consultant in Newport Beach, Calif., has experienced the way some anti-aging doctors bump fees by prescribing and testing. He has spent between $1,400 and $2,000 per year for the last four years on anti-aging, but that represents a big drop in his costs.
When he first began, he says, he tried a number of doctors. "One had me on a very overly aggressive and rather na¯ve program. He had me on everything under the sun. Pretty soon I was taking something like 178 different nutritional supplements, hormones, some prescription drugs I was getting from overseas." Now he focuses on nutrition, exercise and some supplements such as omega-3s, antioxidants and vitamins.
The anti-aging field's emphasis on supplements comes even though there is little evidence that most do anything for people who already eat a healthy diet. "I know it's possible that I'm just giving myself expensive pee," says Snyder, the ER doc, laughing.
Unlike manufacturers of prescription and over-the-counter medications, dietary supplement makers do not have to prove their products are safe or effective before selling them. Some supplements have been shown to be contaminated with lead or other harmful substances. And research has even found that large doses of antioxidants, like beta-carotene, actually increase cancer risks.
Hormones are hot But hormones are the most popular tools in anti-aging's armory. Scientists recognized their potential over 100 years ago, but their use in modern anti-aging traces back to July 1990 when a researcher named Daniel Rudman published a study about the effects of human growth hormone (HGH) on men over 60 in The New England Journal of Medicine.
Though the anti-aging industry existed long before then, Texas entrepreneur Howard Turney, who now calls himself Lazarus Long after an immortal character in a Robert Heinlein novel, created a new version. He was so enthused about Rudman's positive results that he started a resort called El Dorado in Cancun, Mexico, to administer HGH to those seeking rejuvenation. Ronald Klatz, then an osteopath and a consultant at El Dorado, held the A4M's organizing meeting there.
Rudman issued many caveats and cautions about using HGH and never recommended its use to delay aging. In fact, he was horrified his study was being used to support the industry especially since heavy use of growth hormone can have unwanted side effects. Endocrinologists worry that unnecessarily taking HGH could trigger cancers, diabetes and other hormone-related conditions. There are still many unknowns.
Still, HGH, the body's "master hormone," became the hottest thing to hit anti-aging since vitamin C because it was a real drug that appeared to restore youthful vigor.
Klatz wrote a 1996 book, "Grow Young with HGH," summing up the life-extension world's hope that there was finally a fountain of youth in a bottle. He dedicated it to Rudman saying, "His vision and pioneering human research with growth hormone for anti-aging marked the beginning of the end of aging."
Now that sports doping scandals have made HGH, as well as testosterone and other hormones, front-page news, and some anti-aging clinics and compounding pharmacies have been raided by the U.S. Drug Enforcement Agency for being overly liberal with hormone prescriptions, the anti-aging community has toned down its endorsement of hormones, at least in public.
"Less than 10 percent of patients involved in anti-aging are receiving growth hormone," Klatz insists.
That seems a dubious assertion. In fact, hormones remain a key ingredient of anti-aging practice. "Most of my anti-aging patients get hormones," typically growth hormone as well as sex hormones appropriate to each gender, Jurow says.
In his own article in "Medical Spas," Klatz argues that one of the main reasons for an M.D. to partner with a med spa is to "offer patients ... Bio-Identical Hormone Replacement Therapy, which aims to arrest age-related declines in hormone levels such that the natural peaks achieved in youth are maintained throughout life."
Yet there is no evidence that people live longer if they take HGH - lab animals with less growth hormone actually live longer than their normal brethren - or any other hormone. Nor is there any conclusive proof hormones make healthy older people any healthier. Research results are mixed, the picture murky.
The recent death of Cenegenics founder Dr. Alan Mintz, a prime HGH promoter, demonstrates that growth hormone is no panacea. He died last June, at age 69, reportedly during a brain biopsy.
As some enthusiasts admit, anti-aging patients are essentially running a giant uncontrolled experiment on themselves - increasingly at the hands of doctors.
Critics point out that the biggest concern about doctors getting involved is that many patients incorrectly assume that if their trusted physician is recommending hormones and supplements, these treatments must be safe and effective.
The fact is, no drug, treatment or supplement has ever been shown to extend human lifespan.
But Gooden, the Charleston real estate agent, calls her own transformation at the hands of Barber "a miracle."
"For as long as I can remember I have had insomnia," she says. "And increasing pain that doctors said was arthritis." Barber's daylong testing, however, "showed what needed to be dealt with," mainly deficiencies in DHEA, estrogen and testosterone. "My hormonal levels were way out of whack, my cardiac function was not what it should be," Gooden says.
Barber arranged for Gooden to meet with a personal trainer and a nutritionist and prescribed a host of prescription drugs such as testosterone, estrogen and thyroid medication, and the usual array of anti-aging supplements like DHEA and vitamins, most of which she obtains from Barber.
These days, many anti-aging promoters, seeking to shed the flim-flam image, are ratcheting down the rhetoric. They have begun using terms like "age management" and "healthy aging" that imply realistic goals and give important, if commonsense, advice.
Most anti-aging doctors tell patients what we already know: Exercise. Lose weight. Lower our blood pressure. Don't smoke. "I do not see this as the basis for a new practice specialty," argues Relman, the professor emeritus at Harvard.
But a good anti-aging doctor, says Snyder, is more like a devoted personal mountain guide. Rather than cramming sick patients into quickie appointments, he or she will "push you into exercise, get you to join a club, get a personal trainer, a nutritionist to create a full diet to follow and not just for weight loss. They'll direct you to certain supplements, antioxidants, watch the glucose curve to see if you are borderline diabetic. If you go to a regular doctor he will not be as proactive. He'll wait for an event to happen, then treat it. That is what I do in ER medicine."
That kind of preventive care is what Orange County, Calif., entrepreneur and long-time anti-aging advocate David Kekich, 65, says he gets from his anti-aging doctor. Though he did try testosterone therapy for a short time, he was unable to continue because it aggravated pain from a spinal cord injury. Instead, Kekich and his physician have built a program of rigorous exercise; a low-fat diet with abundant fresh fruits and vegetables, little red meat and no sugar or processed flour; regular blood testing; and aggressive supplementation - up to 60 tablets per day.
"I see my doctor about once a year," Kekich reports. "He fine-tunes things. Regular doctors could not even come close. When I have gone to them they tell me I am crazy and should not even look at these things and that I should wait until I have a problem. But to me that is closing the barn door after the horse is gone. Most doctors are mechanics. They fix things. To me, prevention is the name of the game."
Filling a gap Mainstream medicine may look askance at anti-aging practices, but it has adopted its elements. Sterling centers such as Princeton, Stanford, the Cleveland Clinic, Northwestern University, Duke University and others have established "executive health" programs where the wealthy undergo similar day-long evaluations, and testing costing thousands of dollars.
The fact that the wealthy are willing to pay so much, and that doctors are catering to them, is more a comment on the health care system we have built, says Northwestern's Zoloth, than on the validity of anti-aging medicine.
Relman agrees that anti-aging medicine is stepping into the growing gap between the public and faith in the health care system. "It is unfortunate but understandable given the sad facts about the current state of medical care in this country," he says. "Without a strong base of primary care, you cannot have an effective health care system. It breaks down into specialized and unconnected procedures and tests and gets more and more disorganized and unsatisfactory, and that is what is happening in America today."
Though it may fill the gap, much of the anti-aging agenda is still based more on hope than evidence. "We do worry that there could be bad effects 20 or 30 years from now," admits Jurow, referring mainly to hormones.
In the world of anti-aging, though, which sees us all moving closer to death with every passing minute, hope outweighs proof. "We don't have time to wait half a century to find out if something is really going to work!" Klatz says.
With lawmakers grilling Roger Clemens on Capitol Hill this week about using performance-enhancing drugs, human growth hormone (HGH) is back in the spotlight. Hardly a surprise, given the metronome of such news stories since Jose Canseco published Juiced in 2005, a tell-all tale that alleges widespread steroid use among major leaguers.
What is surprising is how widely human growth hormone is used beyond the arena of athletics. Government investigations such as the U.S. attorney's Operation Phony Pharm and the Albany district attorney's Operation Which Doctor are now highlighting the extent of growth hormone's distribution and use for antiaging purposes. The targets of these investigations are clinics and online marketers who persuade middle-aged and elderly Americans to shell out hundreds of dollars each month for the hormone that, according to boosters, does everything from build bone and muscle mass to improve libido, mood, cognitive function, and sleep quality.
One study estimates that tens and perhaps even hundreds of thousands of Americans now use human growth hormone in this way. Organizations such as the American Academy of Anti-Aging Medicine, a group of 11,500 physicians and scientists committed to actively slowing the aging process, give the movement the veneer of scientific credibility, but as Business Weekreports, the antiaging industry remains a magnet for controversy. Distributing prescription human growth hormone "off label" (for purposes other than the few approved indications such as pituitary deficiencies, muscle wasting disease among HIV/AIDS patients, and intestinal failure) for antiaging purposes is technically illegal. However, about a third of human growth hormone prescriptions are used for antiaging or athletic enhancement, a 2005 study published in the Journal of the American Medicine Association estimates. It's also possible to get non-prescription human growth hormone pills and sprays, but the Federal Trade Commission has issued a consumer alert warning that these products are more hype than anything else.
Mainstream medicine certainly doesn't buy in. "Anybody who claims today that human growth hormone can slow, stop, or reverse aging in people is mistaken," says Jay Olshansky, a longevity researcher at the University of Illinois. A recently published study in the Annals of Internal Medicine reviewed the rigorous research on the safety and efficacy of growth hormone in the healthy elderly. Good studies were scarce, but the review found that the hormones do nothing to improve life span, bone mineral density, lipid profiles, insulin resistance, and other markers of health. Moreover, 19 percent of people on growth hormones got carpel tunnel syndrome, compared with 1 percent on placebos; 6 percent of men developed gynecomastia, or enlarged breast tissue, compared with 0 percent on placebos; and 22 percent developed blood sugar level problems compared with 14 percent taking placebos. Swelling was another common side effect.
"The risks of human growth hormone outweigh any possible benefits," says Hau Liu, the Stanford University researcher who led the study, though he points out that it only reviewed selected clinical outcomes. It did not, for example, consider the ability to walk up a flight of stairs or other quality-of-life measures. There was one bright spot for the antiaging industry, though: Lean body mass did increase slightly for older people getting the growth hormone. But, says Liu, they could have done much better by simply working out.
Growth hormone and associated proteins could be responsible for promoting many types of cancer, according to an Australian researcher.
Professor Mike Waters, from the Institute for Molecular Bioscience at The University of Queensland, said that blocking growth hormone action could be a useful avenue for cancer therapy.
He made the comments in a review published in the October 2007 issue of American scientific journal Endocrinology. His review found that many studies have reported a link between growth hormone and cancer, and a recent analysis found that people lacking growth hormone function are resistant to malignancies.
“There is also evidence that blocking growth hormone action can reduce both size and number of tumours,” Professor Waters said.
The review backed up Professor Waters' own research, published in August in the journal Proceedings of the National Academy of Sciences USA, which found growth hormone receptor could induce tumour growth when sent to the cell nucleus.
Growth hormone receptor is the protein that cells use to sense growth hormone, which determines the extent of growth after birth, and regulates metabolism.
Growth hormone receptor works from the surface of the cell, but can also be found in places within the cell, including the nucleus.
“Nuclear-localised growth hormone receptor has been reported in a number of cancers previously,” Professor Waters said. “But no one had analysed the consequences of this until our study.”
Professor Waters and his team found that nuclear localisation of growth hormone receptor is definitely associated with increased cell proliferation and spreading of malignant cells, leading to cancer.
“Cells need to multiply in order for us to grow, and it is growth hormone that triggers this proliferation,” Professor Waters said. “But if the cells multiply too quickly and aggressively, it can be dangerous for the body, and result in disorders such as cancer, so we have an in-built brake that stops the cells from proliferating too much.”
“When we sent growth hormone receptor into the nucleus of cells in mice, we found that this brake stopped working, the cells multiplied at a greater rate and tumours began to appear.”
Professor Waters said the ability of nuclear-localised growth hormone receptor to trigger tumour formation could have important clinical implications.
“Our findings indicate that nuclear growth hormone receptor could be targeted to treat proliferative disorders such as cancer, and strategies aimed at stopping growth hormone receptor from moving to the nucleus could result in useful cancer therapeutics. More generally, blocking growth hormone action in the adult should reduce the spread of cancer within the body without major side effects.” Dr. Perls: See the abstract in the Proceedings National Academy Sciences: Nuclear targeting of the growth hormone receptor results in dysregulation of cell proliferation and tumorigenesis, Becky L. Conway-Campbell et al.
Baby boomers pay for six pack in a syringe
By Philip Sherwell, Sunday Telegraph
Last Updated: 1:00am BST 19/08/2007
With his six-pack stomach, bulging chest and bull-like shoulders, the muscleman in the newspaper advertisement displays the sort of rippling torso that adorns the cover of men's fitness journals.
But there is one difference. From the neck up, Dr Jeffry S Life is a balding 67-year-old physician. His physique is the product not of a computer touch-up but a controversial American "ageing management" technique, that often includes a cocktail of human growth hormones and testosterone.
Some 13,000 clients have so far spent thousands of dollars on a technique known as Cenegenics (from the Greek for "new beginning"). As post-war baby boomers enter their 60s, it promises to boost performance from the office to the gym to the bedroom.
The initial one-day $2,995 evaluation at the Cenegenics Medical Institute (CMI) in Las Vegas, has already attracted a handful of unnamed Britons seeking the secret of Dr Life's remarkable torso.
However, unlike many other health fads, there is one reason why it may not prove popular.
Cenegenics was the brainchild of Alan Mintz, a radiologist, whose own buffed body also used to be the best advertising for his business - until he died in June, aged 69, five years short of the average male American life expectancy.
His death prompted internet speculation that he paid the ultimate price for using human growth hormones. But the CMI has been at pains to assert that Dr Mintz's passing was the result of a brain haemorrhage. His decline was due to an accident in the gym, according to Dr Life, his friend and personal physician, who also works for Cenegenics in Las Vegas.
After the initial evaluation, clients spend up to $13,000 on exercise and diet regimes, supplemented by vitamins and, in most cases, hormone replenishment such as testosterone.
Approximately 20 per cent are also prescribed injections of human growth hormones if they are diagnosed as demonstrating adult growth hormone deficiency (AGHD).
Critics say that it is unproven and potentially dangerous. Tom Perls, a professor of medicine at Boston University, expressed surprise at the number of Cenegenics clients diagnosed with AGHD, as he said the condition normally affects three people in 10,000.
In an interview outlining his philosophy last year, Dr Mintz listed a panoply of positives that he attributed to human growth hormone. They include a decrease in fat and skin wrinkling, an increase in muscle and improved mood.
"Next year does not have to be worse than this year," Dr Mintz said. "How about good sexual activity with your loved one once a week, twice a week, feeling good about it?"
¤
CLAIMS BY ANTI-AGING CLINICS AND DOCTORS STATING THEY ARE LEGALLY TREATING GROWTH HORMONE DEFICIENCY IN ADULTS IS A RUSE.
The Food, Drug, and Cosmetic Act sets very stringent indications for the use of GH (and anabolic steroids). In adults, GH can be given for: -acquired immunodeficiency syndrome (AIDS) wasting syndrome -short bowel syndrome -adult growth hormone deficiency
There is no such thing as legal off-label provision or distribution of GH
Since the details of the law recently received prominent media attention, many antiaging clinics and the like have shifted gears to say that they are no longer giving GH for antiaging, but rather they are providing it for GH deficiency. This is a misleading attempt to provide GH within the confines of the law.
In fact, to meet the legally required diagnostic criteria of adult growth hormone deficiency, the patient must fail a growth hormone stimulation test, ie, his or her anterior pituitary gland must fail to produce a standard minimum amount of GH in response to administration of growth hormone-stimulating hormone, arginine, or less commonly, insulin. Not surprisingly, most antiaging clinics do not perform the test (and Web sites do not require it) because only three in 10,000 adults, including the very old, would fail this test and could legally receive GH.
The other criterion that must be met for providing GH is that a demonstrable pathologic cause for the decreased GH response must be provided. In nearly all cases, the cause is either an anterior pituitary tumor or treatment of the tumor with surgery or radiation therapy or both.
Fountain of youth or a false hope?
Backers, detractors battle over HGH
By Michael Martinez Tribune national correspondent Published May 27, 2007
BEVERLY HILLS, Calif. — At age 48, Ann Hull was tired of being tired. So she came to Beverly Hills, a medical mecca for anti-aging therapy, and her physician put her on human growth hormone—a drug she said made her feel younger.
"Just immediately, I noticed a difference," said Hull, a former model turned aspiring lawyer from Studio City, Calif., who began HGH treatments three months ago. "I feel better, my hair is better, my skin is better, my body fat has gotten down."
Scientists and some prosecutors, however, denounce HGH as a false fountain of youth. Hull was legitimately prescribed HGH injections for a hormone deficiency. Still, the drug is at the center of a growing medical and legal controversy.
Sales are up, anti-aging clinics have gone viral on the Internet, and celebrities including Sylvester Stallone use it. However, abuse has prompted New York authorities to indict more than 20 people, including five physicians in three states, for allegedly running HGH mills over the Internet. A New York congressman now wants stricter federal control over the drug.
Still, HGH has captured the imagination of Baby Boomers dispirited over aging, even though medical experts say growth hormone is a placebo for such uses. Those experts add that the exercise and nutritional regimens of patients are the real sources of rejuvenation.
In a natural state, HGH is a protein produced in the pituitary gland. Synthetic HGH is a prescription drug.
The prescribed uses of HGH are typically for children with short stature or adults with rare hormone deficiencies and AIDS patients, authorities said.
However, the drug has also become an illicit health fad. And one New York district attorney compared the Internet distribution of HGH prescriptions, with patients not even seeing doctors, to "cartels that sell hard-core street drugs."
As advocates assert the revitalizing benefits of HGH—despite scientific refutation—HGH sales have almost doubled in five years, to more than $1 billion last year, according to IMS Health Inc., a health-care information firm.
Much of those sales come from rejuvenation clinics on the Internet portraying aging as if it were "a disease" that HGH can reverse, authorities said. Another popular "off label" use of HGH is for performance enhancement by bodybuilders and athletes because the drug is hard to trace, experts said.
Among its most aggressive advocates, the Chicago-based XXX, with more than 20,000 members, says the drug's popularity is due to Baby Boomers being increasingly diagnosed with hormone deficiency, which HGH remedies by improving mobility, cognitive functions, immune functions, body composition and sleep, among other results, according to group officials.
Speakers at the group's conferences have drawn controversy for their promotion of HGH, which XXX President XXX called "the first medically proven age-reversal therapy" in his 1997 book.
In addition to their claims about reversing aging, XXX and academy XXX have themselves been at the center of scrutiny when the Illinois Department of Financial and Professional Regulation fined each man $5,000 in 2000 for placing "MD" after their names. Neither has ever been a licensed medical doctor in the U.S., but both men have osteopathic degrees and graduated from an MD program in Belize.
XXX disputes critics' charges that the drug is being abused. Growth hormone "is utilized by only less than 10 percent of the total anti-aging patient population for properly diagnosed adult growth hormone deficiency syndrome," XXX said in an e-mailed statement through a spokeswoman.
Officials: Claims overblown
Pitchmen, however, make grand promises, authorities charge.
"It's the next carbohydrate diet. It's the new South Beach diet. It's the new fountain of youth," said Albany County, N.Y., District Atty. P. David Soares, who's leading an investigation against an Internet ring of rejuvenation clinics, doctors and a drugmaking pharmacy in which physicians allegedly wrote prescriptions without even seeing the patients.
That's illegal in New York state, he said.
"We have not had the legitimate need for human growth hormone that would be on pace with what you're seeing in prescription sales," Soares said. "What was traditionally a product that could be acquired in back alleys or at the HIV treatment centers is now being exchanged freely over the World Wide Web."
At the Rejuvalife Vitality Institute, the Beverly Hills clinic where Hull is being treated, the president, Dr. Andre Berger, said his practice doesn't portray HGH as a miracle cure-all and added that he conducts clinical exams along with tests to determine whether HGH is necessary. His Web site advertises "non-surgical cosmetic & anti-aging treatments," including "the dramatic, positive effects of ... human growth hormone."
"This is not a supermarket where a patient can get it off the shelf," Berger said in his office. "They have to have a diagnosis."
Berger described critics' accusations against clinics like his as "ridiculous."
"It's not a fountain of youth. It's an important hormone. If deficient and replaced, it can help health span, vitality and well-being, which is the essence of what people are looking for. It's not a clinical disease because aging is not a disease, but it helps to treat the symptoms, signs and negative aspects of aging. It's not a panacea," he said.
Legislating HGH
In the wake of Soares' inquiry, Sen. Charles Schumer (D-N.Y.) has introduced legislation that would make HGH, now a regular prescription, a schedule III controlled substance, which would tighten restrictions on its dispensing, allow tougher penalties for trafficking and ensure federal monitoring of the drug. It would also make selling prescriptions a federal crime; currently, it is not. An unlawful prescription would occur when a doctor acts in bad faith.
But advocates of anti-aging medical practices say the legislation is unneeded as the vast majority of doctors administer HGH legally. These practices exploded after Dr. Daniel Rudman of the Medical College of Wisconsin wrote a 1990 article in the New England Journal of Medicine stating HGH injections to a dozen men over age 60 produced lean muscle mass, denser bones, thicker skin and less fat. That article has been disputed by many scientists.
"You can't justifiably smear the anti-aging paradigm because of the actions of a few Internet-based rogue physicians," said Fintan Dunne, editor of MyLongLife.com and an advocate of anti-aging medicine.
But Dr. Stanley Korenman, professor of medicine at UCLA and associate dean of ethics, said no evidence exists that HGH prolongs life.
"And even in the people who need it, like the ones I treat who have proved to have growth hormone deficiency, it's very hard to prove benefits. Everyone feels better, but it may be a placebo effect and in fact I know it is a placebo effect," Korenman said. "The question is, how good is it really?"
Disagreement even exists within the anti-aging community about HGH injections versus over-the-counter products promoting natural HGH. For example, nurse Lisa Wells of Van Nuys has a Web site selling homeopathic products she says stimulate the body to produce natural HGH, but anti-aging doctors often dismiss such products as a waste of money.
Meanwhile, Hull, the patient from Studio City who began HGH injections this year, says that renewed health helped her graduate from law school last weekend. She's even off medicine for high blood pressure and allergies. She spends $500 a month on HGH and supplements, she said.
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In our April issue, writer Pat Jordan took an interesting look at a group of doctors who are behind the longevity movement—those guys who pump their patients full of testosterone and human growth hormone and tell them they can live forever. One of the more colorful doctors in Dr. T to the Rescue was Alan Mintz, who ran the Cenegenics Medical Institute near Las Vegas. He was bombastic, overbearing and quite sure of himself, telling Jordan that “Cenegenics is more about aesthetics than longevity. We call it ‘age management.’ Our goal is the highest possible quality of life and sexual function, and then a quick death of a heart attack at 94. We don’t make outrageous claims about longevity.”
