The provision of growth hormone and anabolic steroids (testosterone and others) for anti-aging is not only illegal, it is a scam. The homones and the drugs used to treat their side effects end up being hormonal toxic soups that can cause great harm that far outweighs any long term benefit.
Let me know how I can help you. -Tom Perls MD, MPH, FACP (see below for my contact information)
The real truth about Growth Hormone and testosterone for Anti-Aging and Sports: It's Quackery and Hucksterism.
How both sad and ironic it is that growth hormone does the opposite of the claims of members of the anti-aging industry. It very likely accelerates aging and increases the risk for age-related diseases. As shown below, scientific evidence shows that antagonists of growth hormone and animals that have decreased responses to growth hormone are associated with living LONGER and DECREASED rates of cancer.
If there is all this current and mounting evidence that hGH is bad for adults, why did/does the antiaging industry sieze upon it as the next panacia? Because it is all a marketing scam. Growth hormone is simply a great name.. gullible people equate it with youth and the anti-aging industry simply says more growth hormone means being younger. Never mind the deaths, the cancer, the diabetes, the strokes... sell sell sell... scam scam scam.
As for testosterone, it was recently reported in the New England Journal of Medicine to markedly increase the risk for heart attack and other heart conditions.
As detailed on this website, human growth hormone (hGH) and testosterone (an anabolic steroid) for many good reasons are illegal by Federal law, for anti-aging 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
SOME KEY RESOURCES
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
More Information on HGH for anti-aging and age-related problems:
Steroid Nation (TM) is an online journal looking at the use of anabolic steroids (and performance enhancing drugs PEDs, HGH, doping) in sports, youth, and society. By Gary Gaffney, M.D., from the University of Iowa, College of Medicine.
Quackwatch (SM) Is an Excellent Guide to Quackery, Health Fraud, and Intelligent Decisions Operated by Stephen Barrett, M.D.
About The Author:Tom Perls MD, MPH is a 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.
This undated booking photo provided by the Miami-Dade Police Department shows Anthony Bosch.
Anthony Bosch’s clinic, now the focus of a widening steroid investigation, was hidden in plain sight, next to a bank in an office complex on South Dixie Highway across from the University of Miami. Yet it was beyond the reach of state health regulators.
The clinic, BioGenesis of America, fell into a gray area of Florida healthcare law that has allowed many “anti-aging” or “rejuvenation” clinics to proliferate across the state with little government oversight.
Exploiting the same legal loopholes that made South Florida the top source of black-market prescription painkillers, these clinics have helped make the region one of the top markets in the United States for illegal steroids and growth hormones — feeding potentially dangerous medications not just to athletes and bodybuilders, but also to aging men hoping to fend off Father Time.
“How these anti-aging clinics are getting by the law is beyond me,” said Dr. Gary Wadler, a New York physician who works with the World Anti-Doping Agency.
Bosch is now under criminal investigation from the U.S. Drug Enforcement Administration over allegations that he supplied steroids and human growth hormones to several Major League Baseball players, including New York Yankees slugger Alex Rodriguez. Bosch’s ties to the ballplayers were first reported by the Miami New Times, which received copies of what the newspaper says are Bosch’s handwritten ledgers from his Coral Gables clinic, which opened last March but now sits vacant.
In 2009, the DEA also investigated whether Bosch supplied banned substances to All-Star Manny Ramirez of the Los Angeles Dodgers. No charges were filed. Bosch, 49, could not be reached for comment, and his lawyer did not return messages.
While Bosch’s name may be familiar to the DEA or baseball’s doping investigators, he’s an unknown to Florida health regulators.
Bosch is suspected of prescribing and administering medications, yet he is not a doctor or licensed healthcare professional regulated by the state’s Department of Health. The Health Department does investigate people suspected of prescribing drugs without a license, but the department would not say whether Bosch was the target of an investigation.
Bosch is described as “Dr.” in papers filed in 2009 for a now-defunct corporation, state records show. He is listed as having a Ph.D. on the BioGenesis Facebook page.
Bosch’s clinic — advertised as a “spa” on its Facebook page — was also unregulated, state health officials said. Most medical clinics in Florida are monitored by the state Agency for Health Care Administration; however, AHCA only inspects clinics that accept insurance — and many “anti-aging” clinics do not take insurance.
Avoiding spotlight
The Department of Health monitors clinics owned by doctors. But many anti-aging clinics are owned by non-doctors who then hire physicians to work for them — avoiding the scrutiny of regulators.
This is the same gap in the law that allowed scores of pain clinics to sell powerful painkillers across South Florida with almost no oversight, once making Broward County the national pipeline of black-market oxycodone and other dangerous pills. The Legislature finally forced pain clinics to register with the state and increased monitoring in 2009.
“Anti-aging” has become a popular marketing slogan for medical practices specializing in cosmetic procedures. But it has also become something of a code word for steroids and growth hormones, particularly among bodybuilders and pro athletes.
The Mitchell Report, a 2007 examination of steroid use in Major League Baseball by former U.S. Sen. George Mitchell, highlighted the popularity of Florida “anti-aging” clinics as a source of illicit steroids and performance-enhancing drugs for ballplayers.
“Some businesses that describe themselves as anti-aging or rejuvenation centers sell steroids or human growth hormone and arrange for buyers to obtain prescriptions for those substances from corrupt or suspended physicians, or even, in some cases, a dentist,” the report said.
Among the clinics cited in the Mitchell Report was South Beach Rejuvenation, a West Palm Beach clinic that marketed steroids through Internet ads and in fitness and bodybuilding magazines. The clinic was founded by Jeffrey George, who, along with his brother, headed a $40 million pill-mill empire built on illegal steroids and prescription painkillers.
George, who is not a doctor, pleaded guilty to trafficking charges in 2011, and he was sentenced to 15½ years in prison. George also pleaded guilty to murder for the overdose death of a patient at one of his pain clinics.
Federal law prohibits the use of steroids for muscle-building, and human growth hormone (hGH) has been approved by the Food and Drug Administration for use by adults only in rare circumstances. “The law is very specific in what you can use it for,” Wadler said.
Nevertheless, an increasing number of South Florida clinics offer treatment with human growth hormone to combat the effects of aging.
For example, the Anti-Aging Group of Miami, an Aventura clinic, offers human growth hormone therapy to treat patients suffering from low energy, increased fat or a slowing sex drive.
“No Energy? Lost Your Libido? Low Hormone Levels May Be the Reason Why,” the company’s website says.
The clinic’s medical director, Dr. Fikri Victor Shabanah, was identified by Sports Illustrated as having supplied steroids to a hurdler on Jamaica’s 2008 Olympic team. Shabanah did not respond to a request for comment.
The ‘silver bullet’
Another local clinic, BioFit Miamioff Brickell Avenue, describes human growth hormone as the “Silver Bullet of Life Extension” on its website.
But hGH has never been approved by the FDA as an “anti-aging” treatment. The DEA has described the use of hGH for anti-aging therapy as “illicit.”
“There’s no evidence that growth hormone extends life at all,” said Jay Olshansky, an epidemiology professor at the University of Illinois in Chicago, and an expert on aging. “It’s kind of amazing what you can put out there without the FDA coming after you.”
Growth hormones may be prescribed only for people suffering from unusual hormone losses — usually as a result of brain trauma — not to prevent the natural decline of these hormones from aging, said Dr. Alejandro Ayala, an endocrinologist at the University of Miami’s Miller School of Medicine.
“They actually pitch it to the consumer, so the consumer will ask for the hormone. Then it becomes a legalized business,” Ayala said. “This is unethical, and I would say it’s unsafe until science proves otherwise.”
“Miami is particularly known for this type of thing,” he added.
Ayala said many doctors wrongly diagnose patients as having “hGH deficiency” by simply comparing a patient’s current hormone levels with those of a younger person — a method that would not indicate a specific condition requiring hormone treatment. “Most patients they treat are not hormone deficient,” he said.
Steroids and hormones could also be dangerous for patients, increasing the risk of tumors, diabetes or other illnesses, Ayala said.
“They’re basically conducting a biological experiment on their own patients,” Olshansky said.
Another danger: synthetic or counterfeit steroids and hormones from other countries. Because the manufacture of hGH in particular is tightly controlled, black-market sellers have sought out the drugs from overseas, which may be adulterated.
In 2007, for example, the owners of a Colorado pharmacy were indicted for smuggling in hGH from China and shipping it to physicians around the U.S. — including a doctor at a Fort Lauderdale clinic, court records show.
Though doctors can be disciplined for improperly prescribing steroids, punishment in Florida is rare. Of the 81 doctors disciplined by the state for violating prescription rules since 2010, only four were punished for steroid or growth-hormone violations, records show.
But federal investigators have taken notice of the problem.
In 2010, four men were indicted for trafficking human growth hormone through Powermedica, a Deerfield Beach pharmacy. A year later, the DEA arrested 13 people in a steroid trafficking ring centered on a rogue pharmacy in Jensen Beach, in Martin County, which shipped 10,000 steroid prescriptions to patients around the country in a six-month period, records show.
Three doctors were among those arrested as part of the Jensen Beach probe, including two from Broward County. State health officials said the doctors filled out prescriptions for steroids and human growth hormone without ever examining the patients receiving the drugs.
Dr. Steven Pearlstein of Coral Springs and Dr. Alan Lefkin of Parklandboth pleaded guilty to conspiracy charges last fall, and both are now awaiting sentencing in federal court.
A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.
The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.
But since then, Big Pharma has been satisfying the steady desires of U.S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.
From 2005 to 2011, inflation-adjusted sales of HGH were up 69 percent, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12 percent in that same period.
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EDITOR'S NOTE — Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the second of a two-part series.
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Unlike other prescription drugs, HGH may be prescribed only for specific uses. U.S. sales are limited by law to treat a rare growth defect in children and a handful of uncommon conditions like short bowel syndrome or Prader-Willi syndrome, a congenital disease that causes reduced muscle tone and a lack of hormones in sex glands.
The AP analysis, supplemented by interviews with experts, shows too many sales and too many prescriptions for the number of people known to be suffering from those ailments. At least half of last year's sales likely went to patients not legally allowed to get the drug. And U.S. pharmacies processed nearly double the expected number of prescriptions.
Peddled as an elixir of life capable of turning middle-aged bodies into lean machines, HGH — a synthesized form of the growth hormone made naturally by the human pituitary gland — winds up in the eager hands of affluent, aging users who hope to slow or even reverse the aging process.
Experts say these folks don't need the drug, and may be harmed by it. The supposed fountain-of-youth medicine can cause enlargement of breast tissue, carpal tunnel syndrome and swelling of hands and feet. Ironically, it also can contribute to aging ailments like heart disease and Type 2 diabetes.
Others in the medical establishment also are taking a fat piece of the profits — doctors who fudge prescriptions, as well as pharmacists and distributors who are content to look the other way. HGH also is sold directly without prescriptions, as new-age snake oil, to patients at anti-aging clinics that operate more like automated drug mills.
Years of raids, sports scandals and media attention haven't stopped major drugmakers from selling a whopping $1.4 billion worth of HGH in the U.S. last year. That's more than industry-wide annual gross sales for penicillin or prescription allergy medicine. Anti-aging HGH regimens vary greatly, with a yearly cost typically ranging from $6,000 to $12,000 for three to six self-injections per week.
Across the U.S., the medication is often dispensed through prescriptions based on improper diagnoses, carefully crafted to exploit wiggle room in the law restricting use of HGH, the AP found.
HGH is often promoted on the Internet with the same kind of before-and-after photos found in miracle diet ads, along with wildly hyped claims of rapid muscle growth, loss of fat, greater vigor, and other exaggerated benefits to adults far beyond their physical prime. Sales also are driven by the personal endorsement of celebrities such as actress Suzanne Somers.
Pharmacies that once risked prosecution for using unauthorized, foreign HGH — improperly labeled as raw pharmaceutical ingredients and smuggled across the border — now simply dispense name brands, often for the same banned uses. And usually with impunity.
Eight companies have been granted permission to market HGH by the U.S. Food and Drug Administration, which reviews the benefits and risks of new drug products. By contrast, three companies are approved for the diabetes drug insulin.
The No. 1 maker, Roche subsidiary Genentech, had nearly $400 million in HGH sales in the U.S. last year, up an inflation-adjusted two-thirds from 2005. Pfizer and Eli Lilly were second and third with $300 million and $220 million in sales, respectively, according to IMS Health. Pfizer now gets more revenue from its HGH brand, Genotropin, than from Zoloft, its well-known depression medicine that lost patent protection.
On their face, the numbers make no sense to the recognized hormone doctors known as endocrinologists who provide legitimate HGH treatment to a small number of patients.
Endocrinologists estimate there are fewer than 45,000 U.S. patients who might legitimately take HGH. They would be expected to use roughly 180,000 prescriptions or refills each year, given that typical patients get three months' worth of HGH at a time, according to doctors and distributors.
Yet U.S. pharmacies last year supplied almost twice that much HGH — 340,000 orders — according to AP's analysis of IMS Health data.
While doctors say more than 90 percent of legitimate patients are children with stunted growth, 40 percent of 442 U.S. side-effect cases tied to HGH over the last year involved people age 18 or older, according to an AP analysis of FDA data. The average adult's age in those cases was 53, far beyond the prime age for sports. The oldest patients were in their 80s.
Some of these medical records even give explicit hints of use to combat aging, justifying treatment with reasons like fatigue, bone thinning and "off-label," which means treatment of an unapproved condition
Even Medicare, the government health program for older Americans, allowed 22,169 HGH prescriptions in 2010, a five-year increase of 78 percent, according to data released by the Centers for Medicare and Medicaid Services in response to an AP public records request.
"There's no question: a lot gets out," said hormone specialist Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to legitimate patients.
And those figures don't include HGH sold directly by doctors without prescriptions at scores of anti-aging medical practices and clinics around the country. Those numbers could only be tallied by drug makers, who have declined to say how many patients they supply and for what conditions.
First marketed in 1985 for children with stunted growth, HGH was soon misappropriated by adults intent on exploiting its modest muscle- and bone-building qualities. Congress limited HGH distribution to the handful of rare conditions in an extraordinary 1990 law, overriding the generally unrestricted right of doctors to prescribe medicines as they see fit.
Despite the law, illicit HGH spread around the sports world in the 1990s, making deep inroads into bodybuilding, college athletics, and professional leagues from baseball to cycling. The even larger banned market among older adults has flourished more recently.
FDA regulations ban the sale of HGH as an anti-aging drug. In fact, since 1990, prescribing it for things like weight loss and strength conditioning has been punishable by 5 to 10 years in prison.
Steve Kleppe, of Scottsdale, Ariz., a restaurant entrepreneur who has taken HGH for almost 15 years to keep feeling young, said he noticed a price jump of about 25 percent after the block on imports. He now buys HGH directly from a doctor at an annual cost of about $8,000 for himself and the same amount for his wife.
Many older patients go for HGH treatment to scores of anti-aging practices and clinics heavily concentrated in retirement states like Florida, Nevada, Arizona and California.
These sites are affiliated with hundreds of doctors who are rarely endocrinologists. Instead, many tout certification by the American Board of Anti-Aging and Regenerative Medicine, though the medical establishment does not recognize the group's bona fides.
The clinics offer personalized programs of "age management" to business executives, affluent retirees, and other patients of means, sometimes coupled with the amenities of a vacation resort. The operations insist there are few, if any, side effects from HGH. Mainstream medical authorities say otherwise.
A 2007 review of 31 medical studies showed swelling in half of HGH patients, with joint pain or diabetes in more than a fifth. A French study of about 7,000 people who took HGH as children found a 30 percent higher risk of death from causes like bone tumors and stroke, stirring a health advisory from U.S. authorities.
For proof that the drug works, marketers turn to images like the memorable one of pot-bellied septuagenarian Dr. Jeffry Life, supposedly transformed into a ripped hulk of himself by his own program available at the upscale Las Vegas-based Cenegenics Elite Health. (He declined to be interviewed.)
These promoters of HGH say there is a connection between the drop-off in growth hormone levels through adulthood and the physical decline that begins in late middle age. Replace the hormone, they say, and the aging process slows.
"It's an easy ruse. People equate hormones with youth," said Dr. Tom Perls, a leading industry critic who does aging research at Boston University. "It's a marketing dream come true."
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Associated Press Writer David B. Caruso reported from New York and AP National Writer Jeff Donn reported from Plymouth, Mass. AP Writer Troy Thibodeaux provided data analysis assistance from New Orleans.
For doctors of CFM, there is no scientific evidence of the benefits of treatment
According to the Council, the reduction in the production of some hormones cannot be considered cause of aging
On Monday, an opinion of the Federal Council of Medicine (CFM) condemned the Antiaging therapies. The treatments questioned are based on prescription hormones and other substances such as antioxidants and vitamins to slow or combat the aging of patients.
The opinion states that there is no scientific evidence to justify the practice, which may do harm to the health of those who receive treatment. The document serves to alert patients and doctors about the risks of treatment and opens space for punishments to health professionals who apply anti-aging therapies.
The authors of the evaluation stated that aging is a normal phase of the cycle of life, and should not be treated as disease. In this phase, it is common for the levels of some hormones fall, without which it may be considered cause of aging.
CFM alert that various bodies, both national and international, are positioned against the hormonal manipulation in healthy individuals. "Prescribe growth hormone to ' rejuvenate ' an adult who don't have disabilities of this hormone is to submit it to the risk of developing diabetes and even cancer," says Gerson Zafallon Martins, Coordinator of the Technical Chamber of Geriatrics of CFM.
According to the opinion, the anti-aging medical specialty is not recognized in the European Union and the United States. The CFM's Board confirmed that the document will serve as the basis for a resolution that will prohibit the use of hormones and anti-aging practices in Brazil.
Over the past four years, the entity stripped the professional record of five doctors who practiced the procedures without scientific proof. Ten other punishments have also been applied to other doctors.
Sociedade Brasileira de Endocrinologia e Metabologia
Regional São Paulo
Creation date 09.08.2012
[Translated from Portuguese, using Google Translator]
Firstly, it is important that there is nothing new in the use of hormones, so-called "bioidentical." Endocrinology already use for several decades, hormone replacement therapy for patients with a demonstrated deficiency of the same. These hormones (bioidentical) are used for hormone replacement in individuals with diseases that cause hormonal deficiency. Thus, thyroid hormones, growth, estradiol (female hormone), testosterone (male hormone) are all similar synthetic or highly similar or equal to those produced by the individual. Small changes made by the pharmaceutical industry in some molecules are designed to enable more prolonged effect and adequate dose. Therefore, these hormones are the same ones used by doctors to disclose such use the "bioidentical."
We need to reflect on three very different situations: • Hormone replacement in patients with diseases that cause a reduction in physiological production (in normal quantities) of hormones.
- In this situation, hypothyroidism, triggered by reduced function of the thyroid gland in this disease or after surgery, the picture is more common.
- There are other situations not as well known as the loss of pituitary function, when several hormones may be affected as the production of growth hormone deficiency, lack of stimulus to the gonads causing reduced testosterone production in men and estradiol in women, impaired production of cortisol (a natural steroid that all produce), lack of production of hormones that control body water, and reduced thyroid function as well, which also depends on the pituitary.
- Dysfunction of the ovaries before menopause occurs when the expected age or when the removal of the ovaries due to disease occurs in young women.
- Testicular dysfunction caused by infections, surgery, radiation therapy or chemotherapy with consequent reduction in testosterone production.
- Reduction in the production of cortisol by the adrenal adrenal, also rare.
In these situations, as well as diagnosis and treatment of disease that caused the loss of function of the gland, where there is no contraindication possible, endocrinologists prescribe drugs to replenish the amount of saline (closer to normal as possible) of hormones, or identical to natural where possible, or the effect similar as possible to the normal production expected gland patient. • reset occurs in situations where the expected loss function of the gland, with some damage to health, in that the replacement prove beneficial. This demonstration of benefits must be done within the research ethics with scientific evidence published in medical journals recognized in the academic environment.
. - In this situation, the typical example is hormone replacement therapy after menopause. The normal situation the loss of production of estrogen in women may have deleterious effects such as osteoporosis. The benefits of replacement are well demonstrated in this aspect. Even so, the replacement has risks that must always be assessed and counterbalanced with discussion of the benefits between the prescriber and patient, as not every woman will benefit from this replacement and the risk is not equal for all. In these cases, replacement can use synthetic hormone similar to estradiol normally produced by the ovary in a dose sufficient to benefits that are generally lower than those normally produced by the ovaries in young women.
- Another example could be the testosterone replacement in older men as it is demonstrated by the reduction in hormone levels of this hormone on testicular dysfunction, a kind of male menopause. In these cases, after hormone dosage to confirm the deficiency, replacement might be indicated after careful evaluation of the prostate and always weighing up the risks and benefits of this replacement.
- Age and aging also cause reduced production of growth hormone. The role of this physiological (normal) is still not well understood but it could be a way of protecting the body of the development and growth of tumor cells, for example. Therefore, caution is urged when prescribing growth hormone to elderly normal because, although some studies have shown benefit in the replacement of hormone associated with testosterone in elderly men, this assessment was made only in the short term and are not known the risks of Replacement for longer periods.
• The third and most critical situation is the replacement of hormones at doses above physiological (normal) in normal subjects and with adequate hormone levels normal or even unknown (for lack of proper evaluation) with the promise to slow aging improve sexual performance or physical.
- In this situation, are included some young people who want to increase muscle mass and believe in the promise of "hormone therapy".
- Athletes with the aim of overcoming limits.
- Men who want to improve sexual performance without a proper assessment of hormonal status.
- Women who want to increase muscle mass or reduce body fat percentage.
- Men and women behind the fountain of youth.
In these cases, if the dose used physiological (normal) of hormones, no difference occurs because there is a control mechanism that suppresses the normal production of the gland when the individual is using external hormone. For this reason the hormones prescribed in these situations, and is not indicated by the lack of evidence that benefits outweigh the risks, are being used in doses much higher than the physiological.
This, although initially it may cause positive results, which encourage the individual to maintain its use, usually has disastrous consequences. The use of hormones without indication may, depending on the dose and time, cause dysfunction in the gland that is usually responsible for its production. For example, normal men using testosterone may have infertility.
Furthermore, prescription doses above normal can lead to very serious consequences as "androgenization" in women using male hormones (increased hair, acne, hair loss), weight gain, or by use of anabolic steroids, diabetes, edema and joint pain by use of growth hormone, only to illustrate the risks of hormone use that "bioidentical."
Sources:
Dr. Nina Musolino - President of SBEM-SP
Dr. Evandro de Souza Portes - vice president of SBEM-SP
Baby boomers often look for miracle fixes that don't require lifestyle changes. SHUTTERSTOCK PHOTO
A doctor who has spent his career studying longevity wants people to know there's a difference between healthful aging and refusing to age at all.
Only the first option, he believes, is even remotely possible.
The anti-aging industry's promises of supplements or hormones that can arrest or delay the aging process are nothing but quackery, says Thomas Perls, a professor of geriatrics at Boston University who conducts the New England Centenarian Study.
"To me, it's like being able to build a rocket ship to get people to Pluto," he said last week during a webinar on brain health sponsored by the American Society on Aging.
Perls studies supercentenarians -- people age 110 or over -- to discover why they often manage to make it to the end of life with so few health problems. There is evidence, he said, that other people can achieve this same compression of disease and disability.
"Their example provides an enabling message about aging: The older you get, the healthier you've been," he said. "Most of that you have a role in determining, in terms of your health behaviors."
But too many Americans, Perls said, are looking instead for miracle cures that don't require lifestyle adjustments.
"Baby boomers believe they can get anything they want, and have a lot of money," he said. "They have seen their parents age and they succumb to anything they see on TV or the Web" that they hope can help them avoid the same fate.
Perls finds these consumers "gullible, and to a certain degree narcissistic." But he also blames a federal law, the Dietary Supplement Health and Education Act of 1994, for opening the floodgates to anti-aging quacks.
"It's really a ridiculous piece of legislation that allowed a multimillion-dollar industry to bloom," he said. "It takes away any safety mechanisms for the government to monitor what we see on our drug store shelves. They don't even have to report adverse reactions."
Unregulated anti-aging products and services range "from innocuous to very dangerous -- for example, growth hormone and testosterone," Perls said. "These are very dangerous and expensive, and certainly do nothing in terms of stopping or suspending aging. Please stay very, very far away from these clinics."
How can you tell if an anti-aging offer is too good to be true? Be skeptical when you see all positives and no downsides.
"One of the telltale signs of quackery," Perls said, "is when they show across-the-board improvements with no adverse reactions."
A WEBSITE THAT WALKS YOU THROUGH YOUR FOOT PROBLEMS
Back when I was waiting tables for a living in New Orleans, I had a boss who liked to say, "If your feet hurt, your mind hurts."
Now there's a website -- www.ipfh.org -- that could help ease your mind if you're having trouble figuring out a foot problem. Put together by a "non-profit" organization called the Institute for Preventive Foot Health, the site guides you through an interactive troubleshooting process, which you start by literally clicking on where it hurts. It's a handy way to get your mind around the idea of doing something about your feet, like maybe seeing a doctor. And the information is fairly clear and sound.
One thing you should keep in mind: the "institute" was founded by the maker of Thorlo socks, and you're going to see a lot of talk about how padded socks can make your feet more comfy.
Barbara Peters Smith is the health and aging reporter for the Herald-Tribune, and the editor of Health+Fitness. She can be reached at 361-4936 or by email at barbara.peters-smith@heraldtribune.com. Read more blogs at health.heraldtribune.com/pulse
Anti-aging isn't recognized by the American Board of Medical Specialties, meaning doctors can't officially be board-certified in it.
STORY HIGHLIGHTS
Thousands of physicians are catering to the baby boomers who are hoping to feel younger
Some unproven treatments for anti-aging are risky hormone therapies and fad diagnoses
Steven R. Goldstein, M.D., says two key nutrients for anti-aging are calcium and vitamin D
The anti-aging industry is expected to gross more than $291 billion worldwide by 2015
(Health.com) -- Hanneke Hops wasn't afraid of dying. What concerned her was growing old and not being able to run marathons, ride horses, or fly planes. So the 56-year-old Hayward, California, woman turned to Alan Mintz, M.D. -- a radiologist who founded the Cenegenics Medical Institute in Las Vegas, which specializes in "age management medicine."
She was prescribed recombinant human growth hormone (HGH), a synthetic version of a pituitary hormone hawked as a miraculous fountain of youth. Though the U.S. Food and Drug Administration (FDA) warns that taking HGH poses serious health risks, Hops -- unaware there was any harm -- began injecting it into her thigh six times a week.
She never did grow old. Six months later, in 2004, she was dead, her liver full of malignant tumors. While it is impossible to prove that HGH therapy contributed to Hops's death, the use of HGH has been linked to an increased risk of cancer. (Mintz said at the time of Hops's death that Hops would not have been treated if he knew she had cancer.)
Today, thousands of physicians are catering to the 78 million baby boomers who are hoping to feel younger, longer -- and willing to pay for the privilege. The anti-aging industry is expected to gross more than $291 billion worldwide by 2015.
The problem is, many of these so-called anti-aging doctors are making empty promises. "They're one step above snake oil salesmen," says Steven R. Goldstein, M.D., a professor of obstetrics and gynecology at New York University School of Medicine. They prey on women who have legitimate medical concerns such as poor sleep, flagging energy, and libido loss, he says, yet they often lack the training required to treat those problems.
Even worse, they peddle therapies -- most notably, the unapproved use of hormones like HGH and customized drug cocktails -- which are unproven and can even be deadly.
The rise of the anti-aging doc
Once, middle-aged women sought out a gynecologist for menopausal symptoms, or an internist for fatigue. Now a new brand of doctor is promising to treat the above, and deliver much more: better sex, a fitter body, dewier skin.
"They often try to convince people that aging is their fault: 'If you listen to us, we can fix the problem,' " says S. Jay Olshansky, Ph.D., a research associate at the Center on Aging at the University of Chicago.
Yet aging is a natural process, not a medical condition, and there isn't any therapy that can reverse it or slow it down, Olshansky says. Official medical associations from the Endocrine Society to the American Medical Association warn against using "anti-aging" interventions.
And while traditional doctors, such as endocrinologists (who specialize in hormones) and geriatricians (who focus on the elderly) are specifically trained to treat age-related conditions such as hormone imbalances, "not all anti-aging doctors have a degree or advanced expertise" in what they practice, Olshansky says.
In fact, anti-aging isn't a specialty that's recognized by the American Board of Medical Specialties, meaning doctors can't officially be board-certified in it. Yet it has its own professional society, the American Academy of Anti-Aging Medicine (A4M). Founded in 1992, A4M boasts some 24,000 members worldwide and offers a certificate in anti-aging medicine, available to any M.D.
Once a doctor sets up an anti-aging practice, she stands to make major profits. Many age-fighting treatments aren't covered by insurance, which means the M.D.s prescribing them are paid out-of-pocket, Olshansky says -- and that can add up to thousands per patient. At a time when physicians are getting lower and lower reimbursements under managed care, it's little wonder that doctors of all stripes, from emergency-room medicine to radiology, are flocking to this lucrative new specialty.
Unproven treatments
So how do you know if your doctor is making promises he can't keep? Here are the top dangers Health's investigation uncovered:
• Risky hormone therapies. The biggest weapon in the anti-aging doctor's arsenal is the willy-nilly prescribing of hormones. "The concept is that if you take a 60-year-old woman and duplicate the hormone environment from when she was 20, she'll feel like she's 20," says Nanette Santoro, M.D., director of the Division of Reproductive Endocrinology & Infertility at the Albert Einstein College of Medicine. "It is essentially the idea of drinking the blood of young children."
It's also hazardous, because most age-erasing doctors aren't trained in using these powerful substances. "In this entire field, I've only encountered one board-certified endocrinologist," says Thomas Perls, M.D., an associate professor of medicine and geriatrics at Boston University School of Medicine. "It's outrageous that people think they can prescribe these toxic hormone soups."
The main ingredient in that soup is HGH, which naturally declines in our bodies as we age. Anti-aging doctors claim that by boosting HGH levels with injections that can cost $12,000 or more per year, you can reduce body fat, build muscle, improve sexual function, and up your energy.
But "there is no scientific proof of this," Perls says. "And studies show that increasing HGH levels with drugs predisposes people to heart disease, diabetes, and cancer" -- suggesting that the hormone may have been a contributing factor in Hanneke Hops's death.
In fact, HGH is only FDA-approved for use in a handful of conditions in adults (including adult growth hormone deficiency, which is rare), and it is illegal to distribute a product containing HGH for anti-aging purposes.
Another hot hormone is bioidentical estrogen. For decades, women have relied on synthetic estrogen to relieve menopausal symptoms such as hot flashes and vaginal dryness. But when the Women's Health Initiative study on estrogen and progestin therapy was halted in 2002 -- due to a possible hormone-related increase in the risk of heart disease, stroke, blood clots, and breast cancer -- some doctors touted bioidentical versions, made from soy and yams, as safer (though there's no proof they're less likely to raise your disease risk).
Bioidentical creams and pills made by pharmaceutical companies are available via prescription and regulated by the FDA. Still, many anti-aging docs attempt to create their own bioidentical hormone cocktails tailored to their patients' special needs.
It's this customization that is most troubling to mainstream doctors. It involves taking a prescription to a compounding pharmacy, where pharmacists mix ingredients as outlined by your physician -- and the resulting concoctions are not approved by the FDA. "When the FDA looked at compounded medicines, 43 percent of them didn't have the things that they were supposed to," Goldstein says. That means the drug you're getting may not work -- or may have unpredictable side effects.
Whether there's even such a thing as an optimal hormone level is unclear, notes Cynthia Pearson, executive director of the National Women's Health Network, a nonprofit group that advocates for women's health issues: "Women can have very different symptoms at the same hormone levels."
• Fad diagnoses. One of the newer anti-aging buzz phrases is adrenal fatigue. The theory behind the syndrome is that chronic stress causes a decrease in the production of adrenal hormones, which can cause fatigue and sleep issues.
But while there is a legitimate condition called adrenal insufficiency, which is diagnosed by an endocrinologist using a battery of tests, "adrenal fatigue is a bogus diagnosis," Perls says. What's more, the standard treatment -- hydrocortisone -- can lead to osteoporosis, diabetes, and organ dysfunction, says Jeffrey I. Mechanick, M.D., clinical professor of medicine, endocrinology, diabetes, and bone disease at the Mount Sinai School of Medicine.
Heavy-metal toxicity is another trendy diagnosis. The concept: Removing the body's lifetime build-up of mercury, lead, and other metals can prevent or reverse age-related conditions such as heart disease. This is often attempted through chelation therapy, in which a synthesized amino acid called EDTA is run into patients' bloodstreams; the EDTA attaches to the metals, which are then flushed out of the body with urine. The process can take 20 to 40 two- to four-hour treatments, at a cost of at least $2,500.
But while chelation therapy may benefit those with heavy-metal poisoning (a rare problem), there's zero evidence it helps the rest of us. "It's quackery at its best," Perls says. "People have died from it." Case in point: In 2003, a 53-year-old Oregon woman died during her fourth round of chelation therapy. According to the medical examiner, the cause was a cardiac arrhythmia stemming from the EDTA infusion.
• Pill-a-palooza. Forget popping a simple multi-vitamin from the drugstore. "Many anti-aging doctors sell their own lines of nutraceuticals at very high prices," Perls says. "It's a profit margin that's better than what cocaine dealers get."
Don't waste your money, says Olshansky: "The vast majority of studies say anti-aging supplements don't work." Plus, they're not required to be FDA-approved before they're sold, so there's no guarantee that they're safe or effective. "We don't know if they could help, but they could be harmful," says Winifred K. Rossi, deputy director of the Division of Geriatrics and Gerontology at the National Institute on Aging.
The good news is, no one is saying that you have to just deal with hot flashes, weight gain, or any other midlife change. Fifty-plus women may not have the biology of twentysomethings, but they can still feel vibrant, healthy, and even sexy.
"Our best advice is not very different from what our mothers told us: Maintain a healthy weight, be active, eat nutritious food, and don't smoke," Rossi says. Two key nutrients also help: calcium (get 1,200 milligrams a day, preferably from food; 1 cup of yogurt has 415 milligrams) and vitamin D (aim for 2,000 IU daily in a supplement, since it's tough to get otherwise), Goldstein says.
Then, make sure you have the right medical team in place. Most women use their OB/GYNs as their go-to, but in your 40s, consider seeing a family-practice doctor or internist, too, says Pearson: "They're qualified to handle all the routine issues that come up as women hit middle age."
This back-to-basics approach may not sound as cutting-edge as special injections or souped-up supplements, but it's time-tested and a lot less costly -- for your wallet and your health. "Many of the benefits that are associated with HGH -- you can get those with exercise, for free," says Olshansky. "You don't have to spend $12,000."
By: AMY ROTHMAN SCHONFELD, Internal Medicine News Digital Network
06/06/11 FROM THE ANNUAL MEETING OF THE ENDOCRINE SOCIETY
Major Finding: During more than 2 decades of follow-up, 93 deaths were seen in 6,928 people who were treated as children with recombinant growth hormone for short stature, compared to an expected rate of 69.67. Increased mortality was seen particularly in those who received the highest dose. Mortality was associated with bone tumors, cerebrovascular disease, and cardiac disease.
Data Source: A population based cohort study of 6,928 short children who were followed for 116,403 person years.
Disclosures: Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.
BOSTON – After more than 2 decades of follow-up, mortality rates were significantly higher in patients who had been treated with recombinant growth hormone for short stature as children, especially those who received the highest doses.
Notable increases in mortality were observed related to bone tumors and diseases of the circulatory system such a subarachnoid or intracerebral hemorrhage, according to Dr. Jean-Claude Carel of the Hôpital Robert Debré and Université Denis Diderot in Paris, who presented the results at the annual meeting of the Endocrine Society.
According to Dr. Carel, although there has been a considerable amount of data linking recombinant growth hormone and health, few studies have provided long-term follow-up. The data released were French data from the SAGHE (Safety and Appropriateness of Growth Hormone Treatments in Europe) trial, a large study from eight European countries evaluating the health of individuals treated in childhood for idiopathic growth hormone deficiency (75% of the group), idiopathic short stature, and body length at birth that was short for gestational age. The study was initiated first in France (2 years before the rest of Europe), and thus the longest follow-up is available for this cohort.
The group consisted of 6,928 children who were treated during 1985-1996. Follow-up data on vital status were available in September 2009 for almost 95% of the patients, providing 116,403 person-years of observation. The mean age at the end of treatment was 15 years and the mean duration of treatment was almost 9 years. During the follow-up, 93 deaths were observed, compared with 69.6 expected deaths, yielding a higher standardized mortality ratio (SMR) of 1.33, which Dr. Carel said was significant but moderate.
Although the mean dose was 24.6 mcg/kg per day – lower than doses currently recommended today – there was a significant trend of increasing mortality and growth hormone dose (P = .04). In multivariate analysis adjusted for height at the start of treatment, mortality rates in the 285 who received high doses (greater than 50 mcg/kg per day) was almost three times that of the low-dose group (adjusted SMR, 2.94; 95% confidence interval, 1.22-7.07). No significant effects were seen for treatment duration or overall growth hormone exposure. Mortality was elevated in children with the shortest stature at treatment initiation (SMR, 1.57).
Further analysis about cause of death found that although overall cancer-related mortality was not higher than that of the general population, deaths resulting from bone tumors were five times higher than expected (SMR, 5.00; 95% CI, 1.01-14.63), and deaths resulting from diseases of the circulatory system were threefold higher (SMR, 3.07; 95% CI, 1.40-5.83). Particularly concerning were findings of more than a sixfold increase in deaths resulting from subarachnoid or intracerebral hemorrhage (SMR, 6.66; 95% CI, 1.79-17.05) and a sevenfold increase in other heart diseases (cardiomyopathy and cardiomegaly, SMR, 7.11; 95% CI, 0.80-25.67).
"These preliminary results should be taken with caution due to the low event rate, limited power, and potentially undetected confounders. Causality cannot be determined. Additional data are needed, including additional data from other European countries participating" in SAGHE, said Dr. Carel.
Dr. Carel reported ties to Lilly USA and Pfizer Global Research and Development.
December 23, 2010 — The US Food and Drug Administration (FDA) is looking into results from a French study that found that persons with idiopathic growth hormone deficiency and idiopathic or gestational short stature who were treated with long-term recombinant human growth hormone during childhood were at a small increased risk for death compared with individuals in the general French population.
The FDA made the announcement Thursday via its MedWatch Safety Information and Adverse Event Reporting Program. The agency did not define "small" or state anything more specific on the risks seen in the Santé Adulte GH Enfant (SAGhE) study.
"FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review," the posting states.
"At this time, FDA recommends that patients continue their recombinant human growth hormone treatment as prescribed by their healthcare provider."
Recombinant human growth hormone, also known as somatropin (rDNA origin) injection, is marketed under the following brand names in the United States: Genotropin (Pfizer), Humatrope (Lilly), Norditropin (Novo Nordisk), Nutropin and Nutropin AQ (Genentech), Omnitrope (Sandoz), Saizen (EMD Serono), and Tev-Tropin (Teva Pharmaceuticals).
Recombinant human growth hormone stimulates tissue growth, linear growth, and protein, carbohydrate, lipid, and mineral metabolism. It is approved for various indications in adults and children.
In the United States, recombinant human growth hormone is used in children to treat short stature resulting from growth hormone deficiency (including idiopathic growth hormone deficiency, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene deficiency, chronic renal insufficiency, idiopathic short stature, and children small for gestational age).
The French SAGhE Study
The French SAGhE study, part of the larger SAGhE Study in Europe, was started in 2007 in collaboration with Agence Française de Sécurité Sanitaire et des Produits de Santé, French Drug Agency, the Ministry of Health, and the National Cancer Institute of France. The aims of the study are to evaluate the long-term health of patients who have been treated with biosynthetic growth hormone in childhood, including long-term mortality and long-term cancer incidence. The SAGhE study in France has included 10,489 patients.
In SAGhE, there was a 30% increased risk for death with recombinant human growth hormone therapy compared with the general French population. There were 93 deaths in the treated group compared with 70 expected deaths.
The increase in mortality risk could be related to bone cancers and to cardiovascular diseases and cerebrovascular events — primarily subarachnoid and intracerebral hemorrhage.
The risk for death appeared to be dose-related and usually occurred in individuals given doses higher than typically prescribed for pediatric growth hormone deficiency.
The approved doses in the United States for pediatric growth hormone deficiency are less than 50 μg/kg/day, except during puberty, when a higher dose regimen is approved for a limited duration. The currently approved maximum dose for short stature indications other than growth hormone deficiency is 69 μg/kg/day, or 0.48 mg/kg/week.
The full FDA safety communication can be found on the FDA's Web site.
More information on the French SAGhE study and the SAGhE Study in Europe can be found on the study's Web site.
Adverse events related to recombinant human growth hormone products should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Patients given recombinant growth hormones could face a higher risk of death from bone tumors and brain hemorrhages, federal drug safety investigators are warning.
The FDA issued a drug safety communication on December 22, 2010, indicating that French researchers found patients given the hormones, designed to increase stature in people who suffer a hormone deficiency that has stunted their growth, were at a 30% increased risk of death over those not given the hormone treatments.
The risk of death was highest when the injections exceeded the amount of growth hormones normally prescribed to treat pediatric growth hormone deficiency, the FDA noted.
Recombinant human growth hormones (somatropin) are synthetic proteins designed to emulate naturally-occurring human growth hormones. They stimulate tissue growth, can increase height and boost the body’s metabolism when dealing with proteins, carbohydrates, lipids and minerals. It is approved for use in both adults and children and goes by a number of brand names in the U.S., including Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen and Tev-Tropin.
Researchers in France conducted a study known as the Santé Adulte GH Enfant (SAGhE) study, which looked at the long-term epidemiological effects of the hormone injections and the mortality of patients given the drug. There was a 30% increased risk of death when patients given somatropin therapy were compared to the rest of the population, particularly when doses exceeded typical pediatric use. The increased mortality appears to be caused by bone tumors and cardiovascular diseases, as well as cerebrovascular events.
In the United States, somatropin is usually given in doses below 50 mcg/kg/day, with the exception of patients in puberty, who can be given doses as high as 69 mcg/kg/day.
The FDA said it is continuing to review and analyze all of the data and will communicate its findings with the public. In the meantime, drug safety officials say that the actual risk increase is fairly small and the agency believes that the health benefits of the drugs continue to outweight the risks.
The FDA recommends that patients do not stop taking recombinant human growth hormones unless they have talked to a health care professional. The agency also asks both health care providers and patients to report any adverse events to the FDA MedWatch program at www.fda.gov/MedWatch/report.htm.
Mitsu Yasukawa/The Star-LedgerHenry Balzani, 63, in his anti-aging clinic in Clifton. Balzani, a gynecologist, became interested in anti-aging medicine several years ago. He contends his use of human growth hormone and testosterone, an anabolic steroid, have made him healthier, stronger and mentally sharper.
Henry Balzani, 63, boasts he can leg-press 720 pounds. He’s got the photo on his cell phone to prove it.
He says he has the energy and mental acuity of a man in his 20s. In just one year, he adds, he shed 30 pounds of fat and put on 10 pounds of muscle.
Balzani, a gynecologist, credits his physical turnaround to diet, exercise, vitamin supplementation and the restorative power of hormones.
He takes testosterone, human growth hormone and TA-65, an unregulated substance that fights the aging process at the chromosomal level, its manufacturers claim.
Impressed with the results and with his own research, Balzani and a partner last fall opened Total Life Rejuvenation, a Clifton anti-aging clinic that specializes in hormone replacement therapy, a treatment that boosts the body’s naturally declining hormones to youthful levels.
“There’s a big movement for this,” Balzani said, citing testosterone advertisements, celebrity endorsements and the fictional Samantha Jones, the libidinous huntress who plugs hormones in this year’s “Sex and the City 2.” “It’s becoming mainstream.”
By all accounts, the anti-aging business is booming, a trend fed by an eager public’s timeless thirst for elixirs and pills to flatten bellies, increase vigor and improve sexual potency.
And with every new patient and every new prescription, the medical establishment grows more alarmed.
Critics say anti-aging practitioners, operating in a gray area of both medicine and the law, too often cross the line by peddling powerful and potentially dangerous substances on the basis of medically faulty diagnoses.
“It’s a total ruse,” said Thomas Perls, an associate professor of medicine and geriatrics at Boston University Medical School and one of the anti-aging movement’s more outspoken foes.
“The population generally equates hormones with youth, and therefore for gullible or narcissistic individuals, it becomes an easy sell,” Perls said. “Any claims that this stuff works for anti-aging is absolute nonsense. It’s quackery.”
In recent years, prosecutors across the nation have charged dozens of doctors, pharmacists and clinic owners with illegally dispensing anabolic steroids and growth hormone to patients under the guise of anti-aging medicine.
Yet critics say most physicians who flout the law continue to get away with it, the result of lax state medical boards, weak federal oversight and the secrecy inherent in the doctor-patient relationship.
“Nobody’s watching,” said Alan D. Rogol, a University of Virginia professor and pediatric endocrinologist who has written extensively about the abuse of steroids and growth hormone. “Each patient sees his doctor, and his doctor has a doctor-patient relationship, and if he’s diagnosed as deficient — however that’s done — then a legitimate prescription is written.”
The U.S. Food and Drug Administration approves drugs for specific uses but doesn’t monitor physicians or the practice of medicine. That’s left to the states.
The agency that oversees doctors in New Jersey, the State Board of Medical Examiners, has taken disciplinary action against just three physicians for improperly prescribing steroids or growth hormone in the past five years, a spokesman said. In two of the cases, the physicians were first sanctioned by other states.
Moreover, New Jersey is one of just 16 states without a prescription drug monitoring program, which law enforcement officials call a cost-effective layer of protection against abuse and fraud. Under the programs, pharmacies are required to enter into a database information about every prescription they fill for controlled dangerous substances, a category that includes opiates like OxyContin and anabolic steroids like testosterone. Regulators would therefore have a snapshot of every doctor’s prescribing habits.
The federal government gave New Jersey a $350,000 grant six years ago to start a monitoring program. Nearly three years ago, Gov. Jon Corzine signed legislation that would put the money to work.
Today, the cash remains in a bank account, untouched.
“If 34 other states are doing this, why aren’t we?” asked former Assemblyman Fred Scalera (D-Essex), who held a hearing on the topic before the Assembly consumer affairs committee in September. Scalera, who gave up his seat for a private-sector job last month, said the grant expires in April, though the state could seek an extension.
“The purpose of the hearing was to put people on notice that this program needs to get done,” he said.
Thomas Calcagni, acting director of the state Division of Consumer Affairs, which oversees the Board of Medical Examiners, said state officials are committed to the monitoring program and are “moving with alacrity” to put it in place.
“Failure is not an option,” said Calcagni, a former federal prosecutor who took the consumer affairs post in May.
A request for proposals to find a software vendor for the database is now under review at the state Treasury Department, he said, and consumer affairs employees already have reached out to pharmacies to alert them to the new reporting requirements.
“Everyone’s in agreement that this can be a critical tool for us,” Calcagni said. “Right now we’re dependent on information coming to us somewhat sporadically, when there’s a complaint filed or an arrest made, so we’re more reactive. This will provide us with a steady stream of information we can monitor and take proactive steps when red flags are raised and troubling trends emerge.”
Calcagni added that the rise of anti-aging medicine, with its emphasis on tightly regulated hormones, also bears watching more closely.
“Somebody should step up here,” he said. “With this becoming an emerging area, it certainly merits the attention of the Board of Medical Examiners.”
At the federal level, the misuse of steroids and growth hormone falls under the purview of the U.S. Drug Enforcement Administration, but the agency has typically focused less on physicians and more on underground operations, including illegal steroid labs and criminal rings that sell or smuggle the substances.
“We’re not turning a blind eye to it, but we don’t tell doctors how to be doctors,” said Special Agent Doug Collier, a spokesman for the DEA’s Newark office. “It’s not our mission to stand guard at every doctor’s door to make sure they do their due diligence. That’s where the Hippocratic Oath comes in.”
Measuring Deficiency
For decades, women have taken hormones to ease the symptoms of menopause, though use of the drugs tailed off after a landmark study in 2002 found they increased the risk of heart attack, stroke and breast cancer.
More recently, anti-aging physicians have found a lucrative and rapidly expanding market in men. Thousands of websites, along with magazine and television ads, promote testosterone as the answer to sluggishness, irritability, weight gain, hair loss, depression and erectile dysfunction.
Andropause, otherwise known as male menopause, has become the movement’s hottest buzzword despite continuing debate among physicians about whether the condition really exists and, if it does, how prevalent it is.
A study published in the New England Journal of Medicine in June suggested just 2 percent of men between the ages of 40 and 80 show the constellation of symptoms consistent with andropause. To many doctors, the term is just another word for the body’s natural aging process.
Where anti-aging practitioners have gone astray, the critics say, is in stretching the definition of what it means to be hormone-deficient. A 40-year-old man might have normal levels of testosterone and growth hormone relative to other 40-year-old men, but the levels are likely to be well below those of a 20-year-old man.
To many anti-aging physicians, that’s a deficiency.
Rogol, the University of Virginia professor, has another name for it: bad medicine. “It’s a dangerous thing to put someone on testosterone unless you have a real diagnosis for a testosterone deficiency,” he said.
Testosterone, the primary male sex hormone, enhances strength, muscle mass and virility, but it has also been shown to cause heart problems, prostate enlargement, sleep apnea and an increase in red blood cells, which in turn raises the risk for stroke. In some cases, researchers say, testosterone and other steroids can also lead to recklessness, moments of confusion and increased aggression.
Growth hormone, too, has its benefits and dangers. Research shows it can boost muscle size, mainly through water retention, and burn body fat, but it also puts users at an increased risk of diabetes and can lead to joint pain and carpal tunnel syndrome.
In addition, longtime users are at risk of developing acromegaly, a potentially fatal condition that enlarges the internal organs and, in some cases, literally morphs a person’s facial features, creating a more prominent brow and jutting jawline.
Prescribed primarily for abnormally short children, growth hormone is regulated even more tightly than testosterone.
“There are seven or eight kiddie indications, three or four adult indications, and everything else is a felony,” said Rogol, who polices the use of HGH for the World Anti-Doping Agency, the group that monitors Olympic athletes for performance-enhancing drugs.
In adults, legitimate growth hormone deficiency affects just one in 100,000 people annually, according to the American Association of Clinical Endocrinologists. Yet anti-aging physicians use the diagnosis to justify prescribing HGH to patients across the country.
Rogol said he doubts many of those doctors and clinics could back up their HGH prescriptions with proper test results if pressed to do so.
“In a word, it’s bull,” he said.
Despite such criticism, sales of both growth hormone and testosterone continue to soar. Between 2005 and 2009, spending on various testosterone gels and liquids in the United States more than doubled, to just over $1 billion, according to IMS Health, a firm that provides market research to the pharmaceutical and health care industries. This year, doctors are projected to write more than 4 million prescriptions for the drug.
In the same time period, spending on growth hormone jumped 32.7 percent, to $1.3 billion, and the number of prescriptions climbed to 431,000, IMS Health found.
The explosive growth hasn’t been lost on doctors. Across America, chiropractors, orthopedists, pain-management physicians, internists, plastic surgeons and gynecologists like Balzani are reinventing themselves as anti-aging specialists who hawk hormones on their websites.
The movement has been helped along by an aggressive marketing campaign and by the likes of Suzanne Somers, the '70s sitcom coquette turned estrogen entrepreneur. Somers, 64, has pushed hormones on “The Oprah Winfrey Show,” among other television programs, and in several best-selling books.
In October, she suggested on the TV show “Access Hollywood” that hormone therapy might have prevented the aortic aneurysm that killed John Ritter, her “Three’s Company” co-star, and the Alzheimer’s disease that afflicted former President Ronald Reagan in his final years.
Perls calls Somers’ statements “absolutely irresponsible and harmful.” Rogol said the actress “doesn’t have a clue what she’s talking about.”
A less controversial argument on behalf of hormones comes from Rick Collins, a Long Island lawyer who has defended doctors and clinic owners charged with illegally dispensing the substances.
Collins, who has written extensively on steroid law and lectured at anti-aging conferences, questions why a mature man shouldn’t be legally permitted to choose hormone therapy if he’s weighed the benefits against the risks.
To make his point, he cites the theoretical case of an aging uncle who feels lousy but whose testosterone level is not clinically low. Testosterone therapy might make him feel better, but taking it could put him and his doctor at risk of prosecution, Collins said.
“Do we as a society want to prohibit that?” he asked. “It’s one thing for us to try to talk people out of decisions that involve risk, and it’s another to arrest them for it or to arrest the doctors who facilitate it. No one’s arresting the doctor who puts porn-star implants into a woman.
“We allow all sorts of choices to be made in this country based on the idea that personal autonomy over one’s body is of the highest value,” Collins said. “That’s what liberty is all about. That’s fundamentally American.”
Outspoken Advocate
In his Route 46 office in Clifton, Balzani has his own strong opinions about the law and the medical establishment, which he contends stifles innovation and favors treatment over prevention. “The law is usually behind, as is Western medicine,” he said.
Mitsu Yasukawa/The Star-LedgerHenry Balzani, 63, in his anti-aging clinic in Clifton. Balzani, a gynecologist, became interested in anti-aging medicine several years ago. He contends his use of human growth hormone and testosterone, an anabolic steroid, have made him healthier, stronger and mentally sharper.
By replacing hormones as they decline, Balzani said, people can stave off heart disease, high blood pressure, mental deterioration and the decrepitude of old age, living fuller, more productive lives.
The grandfather of five said he has no doubt about the effectiveness of the substances he prescribes. He said he’s benefitted from them himself.
By 2005, he said, he’d had three surgeries to deal with heart problems, and he’d ballooned to 260 pounds. Three years ago, at age 60, Balzani began a hormone regimen through Cenegenics, a Las Vegas company.
At the time, his testosterone level stood at 346, just above the normal range for a man between the ages of 50 and 60, he said. Now, Balzani said, his testosterone level is about 1,000, the very top of the range for a healthy man between 20 and 30.
“If I’m at a range that’s okay for a 60-year-old, how is that good for me?” he said. “That’s not good for me. I’m functioning less and less then. When I’m 90 years old, I want to be able to get up on my own without pushing on two handles.”
To the critics who dismiss his brand of medicine as quackery, Balzani counters that medical and scientific breakthroughs have often been met with skepticism or derision. That doesn’t make the critics right, he said.
“They said penicillin was quackery,” Balzani said. “They said the same thing about the airplane. What about a car? That was quackery.”
Were today’s society not so litigious, he added, doctors would be more willing to embrace new treatments, controversial or not.
“They are afraid, pure and simple,” he said. “To get physicians to think innovatively is very difficult because everyone is afraid of lawsuits.”
Certain of his convictions, Balzani said he has no such fear.
He opened Total Life Rejuvenation in November 2009 with Victor Biancamano, 36, the former office manager for a now-deceased Jersey City doctor, Joseph Colao.
Photos courtesy of Bayonne Medical Center/Leon ColaoJersey City physician Joseph Colao. The picture at left is from 1997. The photo at right was taken in 2005. A survivor of triple-bypass surgery, Colao underwent a transformation. His new body: tanned, toned and muscled. In 2007, Colao died of hardening of the arteries at age 45.
On Sunday, The Star-Ledger reported Colao often prescribed steroids and growth hormone when they weren’t medically necessary and that at least 248 New Jersey law enforcement officers and firefighters obtained steroids from him in just over a one-year period.
Biancamano, who left Colao’s practice shortly before the doctor’s death in August 2007, has since split with Balzani. Two months ago, Biancamano said, he began working with a group of anti-aging doctors he declined to name.
As the registered officer of Total Life Rejuvenation in the firm’s incorporation papers, Biancamano took the name with him. The website now lists locations across New Jersey, New York and Florida.
Balzani continues to practice anti-aging medicine under his own name in Clifton. In June, when The Star-Ledger interviewed both men in the Clifton office, Biancamano said he had no knowledge Colao was breaking the law and that he and Balzani fully comply with all regulations.
“My clinic is totally on the up and up,” Biancamano said at the time. “Do you think we would still be in business if we were doing something wrong?”
Both he and Balzani said they turn away bodybuilders, athletes and anyone under 35. In addition, they said, they take full medical histories from patients and run blood tests to determine if hormones are warranted.
“We don’t blindly prescribe anything,” Biancamano said. “We know every little thing about our patients.”
Balzani said he has a blunt discussion with each of those patients about the addictive nature of steroids and other hormones, along with their risks. Growth hormone, for instance, is not known to cause cancer on its own, but it’s believed to make existing cancers spread more quickly.
“You acknowledge that to people, get a family history,” Balzani said. “But people want to live their life healthier, and it’s their life to decide.”
Those who go through with the therapy pay out of their own pockets to avoid conflicts with insurance companies, he said. Human growth hormone, though cheaper than it was even a few years ago, still runs between $6,000 and $12,000 per year, and insurers increasingly flag its use for possible fraud.
At a time when many of his colleagues are winding down, Balzani sees his growing anti-aging practice as a refreshing new phase, one he expects will last many more years. And hormones, he contends, have helped him get there.
“People say, ‘You’re crazy. You should be retiring,’ ” Balzani said. “I’m starting a new life at 63. I believe in it.”
EU Regulators Question Safety of Growth Hormones
By John Gever, Senior Editor, MedPage Today Published: December 10, 2010
The European Medicines Agency (EMA) has announced a safety review of somatotropin products, in light of a new study suggesting a long-term increase in deaths.
"The review will look into all available data on somatropin to reassess the benefit-risk balance of these medicines," the agency said in a statement.
Somatotropin products are recombinant analogues of human growth hormone. The EMA review is focusing on those it has approved as well as others approved by individual European drug authorities.
In the U.S., brand names include Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, and Tev-Tropin.
The EMA said French drug regulators had received data from a long-term epidemiological study following patients who had received growth hormone treatments as children. Called SAGhE, the study has collected data on about 7,000 patients who started somatotropin therapy from 1985 to 1996.
"The study results suggest an increased risk of mortality with somatropin therapy compared to the general population. The risk appears to be particularly increased when high doses are used," above those recommended on the products' approved labels, the EMA indicated.
It did not specify the magnitude of the increased risk. The agency said more details would be presented next week at an advisory committee meeting.
Patients in the study had received the drugs for growth hormone deficiency or short stature of unknown cause.
"Based on this observational study alone, the risk cannot be associated with certainty to the growth hormone treatment. The results need to be confirmed and complemented with further analyses," according to the EMA statement.
FDA officials did not respond immediately to a request for comment.
Growth hormone drugs safety review
European Medicines Agency to check the safety of somatropin-containing medicines used to treat restricted growth
10th December 2010 - The European Medicines Agency is beginning a review of the safety of somatropin-containing medicines to make sure the benefits still outweigh the risks.
This follows long-term research in France which suggested an increased risk of death for patients treated during childhood with the drugs, but recommended further research to confirm the findings.
Somatropin is a human growth hormone, manufactured using DNA technology. It promotes growth during childhood and adolescence. It also affects the way the body handles proteins, fat and carbohydrates. It is used to treat a number of conditions associated with a lack of growth hormone and short stature. This includes children who fail to grow due to a lack of growth hormone, Turner syndrome or chronic renal insufficiency.
The French study looked at 7,000 patients treated during childhood for growth hormone deficiency or short stature without a known cause. The risk appeared to be particularly increased when higher than recommended doses were used.
There are three licensed somatropin medicines in the EU: NutropinAq, Omnitrope and Valtropin.
TESTOSTERONE LINKED TO INCREASED RISK FOR HEART ATTACK By Gene Emery
BOSTON | Wed Jun 30, 2010 6:23pm EDT
BOSTON (Reuters) - Testosterone treatments may build muscle mass in older men, but they may carry a risk of heart problems in people with poor mobility, U.S. researchers said on Wednesday.
The Massachusetts study, reported online by the New England Journal of Medicine, was halted after six months because the men using a hormone gel were developing so many heart, breathing and skin problems compared to patients applying a placebo gel to their shoulders or upper arms every day.
"I think the study raises important questions about the safety of giving testosterone to older individuals," Dr. Shalender Bhasin of the Boston University School of Medicine said in a telephone interview.
Levels of testosterone, the so-called male hormone, decline with age in men. Supplementing it in healthy men can build muscle mass and strength and lower the risk of disability.
The new test was the first to assess its effectiveness in men over 65 who already had mobility problems such as difficulty walking two blocks or climbing 10 stairs.
The 209 volunteers, with an average age of 74, also tended to suffer from obesity, diabetes, high blood pressure and high cholesterol at the start of the test. "One would expect that from a frail, older population," said Bhasin.
Recipients of the testosterone gel, sold under the brand name Testim by Auxilium Pharmaceuticals, became better at walking up stairs and performing chest- and leg-press exercises.
But by the time the study was terminated, 23 patients in the testosterone group and five in the placebo group had experienced a bad side effect such as fainting, chest pain or heart attack. One man in the testosterone group died of a suspected heart attack.
The numbers were too small to be statistically significant and the side effects encompassed a lot of different diagnoses, which may mean that chance played a role in the results.
Yet men receiving testosterone had more serious side effects and more side effects considered to be life-threatening, the researchers said, lasting for three months after the trial ended.
"The study was designed to study mobility limitation, a common syndrome with the elderly that predicts disability, poor quality of life and mortality," Auxilium said in a statement.
"We believe these men are not representative of the typical testosterone replacement therapy population."
Bhasin was surprised by the finding.
"Testosterone is not currently approved for older men with age-related decline or mobility problems," he said. However it is approved by the U.S. Food and Drug Administration for other patients.
Doctors thinking of prescribing testosterone for their older patients should realize that the treatment may pose a serious risk, Bhasin said. "There may be safety issues that they should weigh in their decision," he said.
Testosterone causes salt and water retention and that could have been a factor, the researchers said. The National Institute on Aging, which paid for the trial, also noted that the men in the study may have been getting exceptionally high doses of testosterone. Auxilium said they were getting double to triple the recommended dose.
[PERLS COMMENT: I am not at all surprised by this finding. From my review of medicial records seized from anti-aging clinics by government officials, among patients given hgh and testosterone, there were high rates of atrial fibrillation, extremely low HDLs (the good cholesterol), high LDL levels (bad cholesterol), high blood sugars and high blood pressure... mostly in what should have been healthy robust patients ages 20-50 years! And despite all these problems, the doctors kept prescribing the meds, sometimes adding others to try and combat the adverse effects. THe results are toxic hormone soups that maybe amke you feel good in the short term but can cause great harm in the long run]
[PERLS: OF COURSE I AM NOT SURPRISED AT ALL TO SEE THE ANTIAGING INDUSTRY ENTIRELY MISCONSTRUE AND BLOW OUT OF PROPORTION THE RECENT ANNALS OF INTERNAL MEDICINE ARTICLE THAT NOTED A TINY 4% IMPROVEMENT IN SPRINT SPEED ON A STATIONARY BICYCLE WITHOUT ANY IMPROVEMENT IN MUSCLE STRENGTH OR LEAN MUSCLE MASS. JUST AS WITH THE NEW ENGLAND JOURNAL OF MEDICINE ARTICLE STUDY OF 12 SUBJECTS THEY EXCLAIM THIS PROVES THAT HGH CAN STOP AND REVERSE AGING AND IS A CURE FOR ALL. NEVERMIND THE SIDE EFFECTS AND NEVERMIND A TOTAL DISREGARD FOR SOUND CLINICAL JUDGEMENT AND PROFESSIONAL AND ETHICAL CONDUCT.]
A Canadian doctor who’s treated U.S. pro athletes is facing charges that include the illegal distribution of human growth hormone. (Here’s the AP story and here’s the NYT’s more detailed take.) But does the stuff actually work?
As Slate wrote in 2007, a New England Journal of Medicine study published two decades ago found HGH had anti-aging effects on men over 60. That sparked the creation of an entire industry, notable for its testimonials by creepy-looking men who seem to have acquired 40-year-old bodies beneath their 65-year-old heads. (Some of those claims have sparked a warning appended to the NEJM study saying the research has “been cited in potentially misleading e-mail advertisements.”)
But there wasn’t much evidence to show that HGH did much to make athletes run faster, jump higher or hit more home runs, as the Health Blog reported in 2008. That is, until earlier this month, when researchers published the first evidence suggesting HGH has limited effects on athletic performance.
The randomized trial of more than 100 recreational athletes of both sexes was sponsored by the World Anti-Doping Agency (which bans the use of HGH in competitive athletes) and published in the Annals of Internal Medicine. It found that growth hormone improved sprinting ability by about 4% but not other measures of athletic performance the researchers tracked, such as endurance, strength or power. Men who also got testosterone injections saw an 8% boost in sprinting performance. Researchers said the study was too small to gauge the safety of HGH; side effects reported by study participants were minor and included swelling and joint pain.
It’s not clear whether the same results would translate to elite athletes, but the researchers told the AP that applying the improvement to a 10-second, 100-meter sprint would make the difference between winning and finishing last.
A prominent Milwaukee doctor who was involved in prescribing human growth hormone has been charged with tax violations, including not reporting nearly $500,000 in income over a three-year period.
Leon Cass Terry, the former chairman of the department of neurology at the Medical College of Wisconsin, has agreed to plead guilty, according to a plea agreement filed Tuesday in U.S. District Court in Milwaukee.
As part of the agreement, Terry, who lives in Whitefish Bay, has agreed to cooperate with federal officials in an investigation and grand jury case in another state, thought to be Connecticut.
The investigation is believed to involve the wrongful distribution of human growth hormone, a product that has been used by professional athletes, bodybuilders and others seeking its possible anti-aging properties.
The status of the case, which involves officials in Connecticut, was not known, although Terry is considered a witness, not a target, in that investigation, a source said.
Terry has been involved in prescribing human growth hormone with businesses in Florida and California dating back to the 1990s.
The charge against Terry says he worked as a consultant for Nexos Therapeuticals, which has an address in Miami. Terry's résumé indicates he was chief medical officer with the company from 2003 to 2007.
The plea agreement said he reviewed patient records and test results to see if they could get prescriptions for human growth hormone. In that job, he got 40% of the monthly profits from Nexos' hormone replacement business.
That income ranged from $4,000 to $8,000 a month.
Most of the work with patients was done over the phone and only occasionally in person.
A call to a number listed for the Miami business indicates it is no longer in service.
Terry could not be reached for comment.
His attorney, Nathan Fishbach, said he is cooperating with the government and will enter a guilty plea in a few weeks.
"He wants to move on with his life," Fishbach said.
Terry was a professor of neurology at the Medical College from 1989 to 2003. He was chairman of neurology from 1989 to 2000.
Terry was charged with reporting taxable income of $105,522 in 2005 and a total tax of $11,001 when the actual amounts were substantially more.
The plea agreement indicates that he understated his income by $497,211 for the years 2003, 2004 and 2005, resulting in an understatement of his tax by $170,576 for those years.
Nexos did not provide 1099 forms for those years, and Terry claims that he was told by the president of Nexos that the payments to him were not taxable, according to the plea agreement.
However, accountants who prepared tax returns for the company said the payments to Terry were classified as consulting services and were considered taxable.
Indeed, IRS investigators obtained records from Terry's purchase of a Porsche automobile in 2005 for $72,000. In documents for that purchase, he listed his income as $426,000, more than four times what he reported.
Terry faces up to three years in prison, although his sentence can be reduced if he provides substantial assistance to the government in its other investigation.
Staff writer Mark Mueller contributed to this report.
May 12, 2010, 5:52PM
A doctor with practices in New Jersey and New York was sentenced to five years’ probation today for his role in a ring that illegally supplied steroids and human growth hormone to cops, bodybuilders and hundreds of other patients.
Richard Lucente, 38, of Middletown in Monmouth County, agreed to give up his medical licenses in both states under a plea agreement reached with the Brooklyn District Attorney’s Office in March. He also was ordered to perform 200 hours of community service.
Lucente’s lawyer, John Meringolo, said his client had not practiced medicine in two months. Lucente had been affiliated with family practices in Middletown and Brooklyn.
Lucente spoke briefly during the hearing in Brooklyn Supreme Court, apologizing to his family and patients.
“I plan to spend the rest of my life and career trying to help people the best I can,” he said.
Initially charged in a 154-count indictment, Lucente had been accused of improperly prescribing anabolic steroids and growth hormone to nearly 300 people through his former practice in a Staten Island building dubbed the “Fountain of Youth.”
Among the charges was a count of reckless endangerment in connection with the treatment of patient Joseph Baglio, 40, a New York bodybuilder who was given steroids and growth hormone despite the fact he had received a heart transplant.
In March 2007, Baglio died of heart failure after undergoing gallbladder surgery. The New York State Board for Professional Medical Conduct later said the drugs likely weakened Baglio’s heart.
Lucente was more than two weeks into his trial when he pleaded guilty to a single count of conspiracy, admitting he received $27,000 in kickbacks from Brooklyn’s Lowen’s Pharmacy, which filled the prescriptions. Authorities have said New York City police officers received steroids and growth hormone through Lowen’s.
Lucente was first licensed to practice medicine in New Jersey in 2006. The state Board of Medical Examiners, which oversees doctors in New Jersey, has yet to revoke Lucente’s license but is aware of the case and will take action soon, spokesman Jeff Lamm said.
(William Perlman/The Star-Ledger) Attorney John Meringolo, left, with his client, Dr. Richard Lucente, a doctor who practiced in New York and New Jersey at Lucente's sentencing at Brooklyn Supreme Court. He received 5 years probation in a plea deal, after he admitted his role in a steroids- and human growth hormone drug ring.
Here is an example of physician who was prescribing growth hormone for unapproved uses and plead guilty to 333(e)(1) (the Federal law statute that prohibits distribution of growth hormone for purposes other than those approved by the Secretary of HHS, eg the FDA).
Along these lines, note that numerous states prohibit specifically prescribing. But even under 333(e)(1) if the physician’s prescription is unlawful (not one of the uses approved by the secretary of HHS) then it is not a lawful prescription and hence the physician is distributing. The other way to consider such prescribing is as “aiding and abetting” the distribution of hGH in violation of 21 USC 333(e)(1).
When it became obvious a few years ago that the record-smashing performance of Barry Bonds was the biggest lie contributing to what Pete Hamill recently called "the filthy deception of steroids," I composed a limerick that rhymed the "fountain of youth" he had searched for with a phrase that located where he had found it: "a very long way from the truth."
As a New York Met fan forlornly watching their 2010 baseball season begin with the all-stars Carlos Beltran and Jose Reyes still missing from their lineup, I have been thinking again about filthy deception in baseball. But not so much about steroids as about that other illicit supplement favored by athletes, human growth hormone, or HGH. Both Beltran and Reyes, like another accomplished sportsman named Tiger Woods, have been associated with the Canadian physician Anthony Galea, who is a known proponent of HGH and other suspect substances and treatments for athletes. Downhearted but curious, I've begun to make inquiries about this hormone that has lately been so much in the news. And one of the things I've found out is that its popularity boomed about 20 years ago when the belief began to spread that this was the one elixir in all the world that could reverse the inconvenient process of aging -- that humankind need look no further for the fountain of youth.
I wondered, since steroids and HGH are so often mentioned in the same sentences, what their similarities and differences are? I've learned that while steroids do indeed enormously enhance athletic performance, HGH does not have nearly the same effect.
Unlike steroids, HGH duplicates a hormone that exists naturally in the human metabolism. It is a synthetic form of growth hormone, a substance produced by the pituitary gland and that, according to my medical dictionary, "regulates somatic [bodily] and skeletal growth." It is, therefore, most active in childhood and adolescence, but it continues to sustain adult tissues and organs. Its production, however, slows down in middle age. So to the Ponce de Leons of the our generations, it has followed logically that replacing the growth hormone that older adults no longer produce would restore their declining physical virtues. The next step was to assume that even younger adults would be strengthened and otherwise athletically enhanced by supplements of HGH.
The start of this thought process may have been a 1990 University of Wisconsin study in which a group of 60-year-old men were injected with HGH for six months. The general results were denser bones, larger muscles and less fat. A report on the study in the New England Journal of Medicine concluded that these outcomes set the subjects' body-clocks back 10-to-20 years. The magical words had been spoken.
Whatever improvements were achieved, however, appear to have been cosmetic. Although HGH may cause muscles to grow, it does not strengthen them. This was the conclusion of a later study (2003) discussed in the same New England Journal. The article also pointed to a different study that showed that exercise was far more effective than HGH for strengthening the muscles of older people. Then a 2008 Stanford University study reported in the Annals of Internal Medicine found that in athletes, too, growth-hormone injections increased muscle bulk but not strength, and in fact might be a cause of muscle fatigue and joint-pain. The Mayo Clinic website seems to incorporate such studies where it states that "increase in muscle" caused by HGH "doesn't translate into increased strength."
This information, none of which is new, is a great surprise to me and seems to be under-reported. It suggests that many athletes are so determined to treat their bodies with substances or practices that promise them competitive advantage that they are easily duped by empty nostrums and medical charlatans who offer them not only useless hormone supplements but also such dubious techniques as "blood-spinning."
The connection between steroid-use and bodily harm has been well-observed. The performance-boost that many athletes have achieved with their help has been followed by various injuries and sometimes career-ending physical breakdowns. (Can anyone tell me where Carlos Delgado has gone since he almost single-handedly thrust the Mets into the 2008 National League East pennant race?) And now it appears that HGH can also cause harm without ever having offered the same benefit as steroids. The possible side-effects mentioned by the Mayo Clinic are not only joint and muscle pain but also swelling of the limbs, male breast-enlargement and possible contributions to diabetes and heart disease.
The reason that Delgado's teammate, Jose Reyes, was not in the Mets' opening-day lineup after missing most of last season with a damaged hamstring is that tests revealed he had an overactive thyroid, which required recuperative rest. Among the several possible causes of hyperthyroidism are a high consumption of seafood and increased human growth hormone. I don't know what sidelined this enormously talented shortstop, but I'm guessing it wasn't fish.
LOS ANGELES - A woman from Marina Del Rey, Calif., appeared in federal court here yesterday afternoon on a criminal complaint stemming from her alleged role in a scheme to sell Human Growth Hormone (HGH), counterfeit Botox, and "generic" Restylane over the Internet to spas across the country.
(Media-Newswire.com) - LOS ANGELES - A woman from Marina Del Rey, Calif., appeared in federal court here yesterday afternoon on a criminal complaint stemming from her alleged role in a scheme to sell Human Growth Hormone ( HGH ), counterfeit Botox, and "generic" Restylane over the Internet to spas across the country.
Rana J. Hunter, 60, was arrested Friday at her Marina Del Rey apartment by U.S. Immigration and Customs Enforcement ( ICE ) agents. According to the affidavit filed in the case, Hunter operated a business called Westgate Distributors which offered HGH, Botulinum toxin type A, marketed under the Allergan brand name Botox, and "generic" Restylane for sale over the Internet. Investigators determined some of Westgate's buyers were located as far away as Arkansas.
Hunter is charged in a criminal complaint with one count of illegally selling HGH. At yesterday's hearing, U.S. Magistrate Judge Fernando M. Olguin authorized her release on $65,000 bond pending trial. If convicted Hunter faces a maximum penalty of five years in prison and a $250,000 fine.
The investigation leading to Hunter's arrest began in March 2007 after ICE agents in Los Angeles received a lead from ICE's Cyber Crimes Center in Virginia. According to the case affidavit, during the ensuing probe, U.S. Customs and Border Protection ( CBP ) officers intercepted numerous packages containing vials of HGH and counterfeit Botox from China that were addressed to the Marina Del Rey mailbox listed on the Internet as Westgate's business address. The parcels were mislabeled variously as synthetic hair pieces, plastic molds and "sample iron oxide."
Within the last two months, an ICE undercover agent, posing as a supplier for clinics and spas, contacted the phone number listed for Westgate on the Internet. As described in the affidavit, the ICE undercover agent ultimately made two buys, including multiple vials of HGH and a substance purported to be Botox, along with syringes and needles. A subsequent laboratory analysis revealed the HGH was genuine, but the substance being sold as Botox contained no evidence of the Botulinum toxin.
"The illegal sale of health and pharmaceutical products over the Internet poses a serious risk to Americans who mistakenly assume these substances are safe," said Robert Schoch, special agent in charge of the ICE Office of Investigations in Los Angeles. "What's more, unscrupulous providers who buy these products and resell them are potentially putting their unwitting clients in harm's way."
"Our enforcement actions continue to pay off; we have an ongoing commitment that is focused towards intercepting commodities which may pose health and safety risks before they reach the consumer," said Kevin W. Weeks, director of the CBP Los Angeles Office of Field Operations.
ICE agents underscore the probe is ongoing. In addition to U.S. Customs and Border Protection, ICE received substantial assistance in the investigation from the U.S. Postal Inspections Service; the Food and Drug Administration - Office of Criminal Investigations; and the Social Security Administration - Office of Criminal Investigations.
The case is being prosecuted by the U.S. Attorney's Office for the Central District of California.
Hormone thought to slow aging associated with increased risk of cancer death
Chevy Chase, MD, March 3, 2010— According to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM), older men with high levels of the hormone IGF-I (insulin-like growth factor 1) are at increased risk of cancer death, independent of age, lifestyle and cancer history.
IGF-I is a protein hormone similar in structure to insulin and is regulated in the body by growth hormone (GH). Levels of GH and IGF-I decline progressively with age in both men and women and this drop is thought to be related to deteriorating health conditions found with advanced age. In an attempt to combat aging some people use GH as its actions elevate IGF-1.This study however showed that older men who had higher levels of IGF-I were more likely to die from a cancer-related cause in the following 18 years than men with lower levels.
"This is the first population-based study to show an association of higher IGF-I levels with increased risk of a cancer-related death in older men," said Gail Laughlin, PhD, of the University of California San Diego, and corresponding author of the study. "Although the design of this study does not explicitly show that the higher IGF-I levels caused the cancer death, it does encourage more study as well as a reexamination of the use of IGF-I enhancing therapies as an anti-aging strategy."
In this study researchers used data on 633 men aged 50 and older from the Rancho Bernardo Study, a population-based study of healthy aging. Study participants took part in a research clinic examination between the years of 1988 and 1991 where their blood was obtained and IGF-1 was measured. All participants had their vital status followed through July 2006. Researchers found that men in this study who had IGF-I levels above 100 ng/ml had almost twice the risk of cancer death in the following 18 years than men with lower levels.
"In this study, the increased risk of cancer death for older men with high levels of IGF-I was not explained by differences in age, body size, lifestyle or cancer history," said Jacqueline Major, PhD, lead author on the study, now at the National Cancer Institute. "If these results are confirmed in other populations, these findings suggest that serum IGF-I may have potential importance as a biomarker for prognostic testing."
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Other researchers working on the study include: the Principal Investigator and founder of the Rancho Bernardo Study, Elizabeth Barrett-Connor; and Donna Kritz-Silverstein and Deborah Wingard of the University of California, San Diego.
The article, "Insulin-like Growth Factor-I (IGF-I) and Cancer Mortality in Older Men," will appear in the March 2010 issue of JCEM.
Founded in 1916, The Endocrine Society is the world's oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit our site at www.endo-society.org.
A federal jury today convicted a Colorado Springs pharmacist on charges of illegally importing and distributing anabolic steroids and human growth hormones from China.
The jury convicted Thomas Bader, former owner of College Pharmacy, on 31 counts including two counts of conspiracy, following a four-week trial in U.S. District Court in Denver. The jurors, who started deliberating on Friday, acquitted Bader on one count of receiving smuggled goods.
The jury also found that $4.8 million in assets from the sale of the hormones plus property Bader owns in Colorado Springs should be forfeited to the federal government. Bader is scheduled to be sentenced on April 29.
During the trial, Assistant U.S. Attorney Jaime Pena argued that Bader and a sales representative were told that what they wanted to do was illegal and that they went ahead and did it anyway. Prosecutors claimed the steroids were distributed to body-builders who had no legitimate relationship to physicians.
Bader’s lawyer Charles Torres argued that Bader had successfully stood up for the rights of compound pharmacists in contesting regulations imposed by the U.S. Food and Drug Administration. Torres said prosecutors were trying to accomplish what the FDA failed to do in two civil lawsuits.
Torres said the verdict will be appealed.
“These are very complicated issues,” he said. “The law on this area is still up in the air.”
Thomas Bader, Colorado Springs pharmacist, made millions in illegal steriod distribution to docs and minors -- until a jury popped the bubble
Would you like those steroids shipped two-day or overnight?
Thomas Bader, a Colorado Springs pharmacist, was found guilty today of 31 counts related to importing and distributing anabolic steroids and Chinese human growth hormones. Twenty-three of those counts were for distributing the juice to minors.
Bader told physicians his illegal drugs were not subject to FDA approval due to lax restrictions on certain compounded drugs -- but the jury disagreed.
Now the steroid-slanger's $4.8 million bulk-up in assets is being seized by the federal government.
On top of supplying the 'roids to kids, Bader, who owned and operated College Pharmacy, managed to distribute the illegal, non-FDA approved Chinese drugs to physicians in Illinois, Florida, Georgia and Indiana between April 2004 and February 2007. The out-of-state physicians were under the impression the drugs were kosher, according to the indictment filed by the Denver U.S. Attorney's Office.
The company took care of business by shipping the drugs with Federal Express.
Bader, along with accomplice and College Pharmacy employee Kevin Henry, "intended to devise a scheme to defraud physicians to whom they marketed... and the patients of those physicians... by means of materially false and fraudulent pretenses and representations," according to the indictment.
The business, located at 3505 Austin Bluffs Parkway, is a compounding pharmacy -- a shop that combines FDA-approved medications for a new regiment specific to a patient. According to prescription drug watchdog group PharmWatch.org, "The College Pharmacy is one of several that supply nonstandard products to offbeat physicians who do chelation therapy, mesotherapy, and other dubious treatments."
The needle is twenty-one gauge, one and a half inches. A hog sticker. Forty of them arrived in a package from Greece. Ever received a package from overseas? You get that puff of air when you rip it open -- air that's traveled thousands of miles. Foreign, like stepping into a stranger's house. The syringe wrapper has instructions in Italian, French, Greek, and Arabic -- not a word of English. But it's a needle. Operation is self-explanatory. I had put them out on my desk a few days ago -- an unignorable fact. An invitation. A threat.
Buck up, laddie. Fortune favors the brave.
What's inside resembles oily piss: 1 cc of Equipoise, a veterinary drug injected into horses, and 2 cc's testosterone cypionate, ten times the testosterone an average man my size naturally produces in a week.
It was going into my ass; plenty of meat there. But the sciatic nerve radiates from my hip, and if I hot-shot the junk into a vein, I could go into cardiac collapse. I tucked a bag of frozen corn beneath my underwear to numb the injection site. The hash marks on the syringe were smudged away by my sweaty hands. That couldn't be a sign of quality medical equipment, could it?
What if I died in this shitty efficiency apartment in Iowa City? I pictured the landlord stumbling upon my body, rotten and bloated. The newspaper headline: "Dumbshit Canadian Found Dead with Needle in Ass."
The needle slid in so easily, I wasn't aware it'd broken the skin. I aspirated and injected into the deep tissue. When I pulled it out, a pressurized stream of blood spurted halfway across the room.
A while back I wrote a novel. A lot of first-time novelists don't stray far from home; their stories are drawn from their lives. Holds true for me: The main character is...well, me. That's not quite true. He's wealthier, pampered, more dismissive. But his deep-seated fears, his inborn weaknesses -- those we share intimately.
My character goes down dark roads. For the sake of the book, I thought I'd travel those roads with him.
He begins to work out obsessively. I began to work out obsessively.
He joins a boxing club. I joined a boxing club.
He takes steroids. I took steroids.
The thing is, I've never done drugs. I therefore lacked the ability to spot the dealer in a room. Such was my quandary when it came to steroids. Where to buy? Who to ask? I'd heard your local gym was a good place, but I didn't have the first clue how to go about that. So I typed "steroids" into Google, which promptly introduced me to an Internet scam. I purchased a bottle of what I thought was a steroid called Dianabol. But what I received was Dianobol, which, for all I know, were rat turds pressed into pill form. Effective as Flintstone chewables.
I'll not go into great detail about how I came to possess real steroids -- or "gear," as we 'roiders call them. The whole thing makes me look as stupid as I was. Suffice it to say the process involved an encrypted e-mail account, a money order wired to Tel Aviv, and weeks of apprehension -- Had I been ripped off? Would DEA agents break down my door? -- before the package arrived, pills and ampules and six vials wrapped in X-ray-proof paper.
Anabolic steroids hit U.S. gyms in the early 1960s, courtesy of John Ziegler, the Americans' team doctor at the 1954 World Weightlifting Championships in Austria. He watched in horror as his countrymen were decimated by Soviet he-men who, he later found out, received testosterone injections as part of their regimen. Ziegler teamed up with a pharmaceutical firm to create the synthetic testosterone Methandrostenolone, better known by its trade name, Dianabol.
The biological function of anabolic (tissue-building) steroids is to stimulate protein synthesis -- that is, heal muscles more quickly and effectively. New muscle is gained, in part, by tearing the tubelike fibers running the length of our muscles; protein molecules attach to the broken chains, creating new muscle. While on steroids, your muscle fibers become greedy, seeking out every stray protein molecule.
I had a misconception that being "on steroids" involved the ingestion or injection of a single substance, but that was quickly dispelled. Many steroids on their own are either singular of purpose or not terribly effective. This is where "stacking" comes in: You can put on mass (75 mg of testosterone), provide muscle hardness (50 mg of Winstrol), and keep water retention to a minimum (50 mg of Equipoise). This stack is injection-intensive: testosterone and Equipoise twice weekly, Winstrol daily. Eleven injections a week.
But that's only steroids. You need drugs to stave off the potential side effects: hair loss, gynecomastia (buildup of breast tissue due to increased estrogen, aka gyno, aka bitch tits), testicular atrophy, cranial and prostate swelling, erratic sex drive, liver impairment, hemorrhoids, impotence, cysts, acne, abscesses, renal failure. Hair loss, gyno, and testicular atrophy should be considered absolute rather than potential hazards: You simply cannot alter your body's chemical makeup so drastically without your body reacting. My own steroid cycle:
-- Dianabol (10 mg tabs, three per day for the first four weeks)
-- Testosterone cypionate (500 mg per week, ten weeks)
-- Equipoise (400 mg per week, ten weeks)
-- Nolvadex (antiestrogen drug; one to four pills daily depending on week)
-- Proviron (male-menopause drug; 25 mg daily)
-- HCG (human chorionic gonadotropin, derived from the urine of pregnant women; used during postcycle therapy to restore natural testosterone levels; 500 iu's twice weekly, administered with an insulin needle)
Some of this stuff showed up in the Mitchell report -- Lenny Dykstra allegedly bought Deca-Durabolin, testosterone, and Dianabol when he was with the Phillies, and Jose Guillen and infielder Matt Williams were both mentioned as testosterone-cypionate users. Doesn't look like it, but mine was a fairly mild cycle. Including diuretics and cutting and hardening agents, professional bodybuilders may have fifteen substances floating around in their systems at any given time. Like alcohol or drugs, a body's tolerance builds up. Top pros might inject up to 2,500 mg of testosterone weekly to produce the desired effect.
The first week of the cycle, my nipples start to itch. Onset of gynecomastia.
Dump enough testosterone into your body, your system counters by upping its estrogen output; this leads to a buildup of breast tissue. After long-term use it can get so bad, some men require surgical breast reductions. I woke up one morning and nearly had a heart attack at the sight of myself. My nipples were the size of sand dollars, stretched smooth as the skin of a balloon. My flesh looked as if it were swelling into small pouches, like the rubberized nipples on a baby bottle.
I appeared to have breasts. Pendulous, malformed...breasts. Or was I just chubby and still out of shape? I didn't know. Gave them a jiggle. Couldn't tell if it was fluid buildup or actual skin. Could you grow new flesh overnight? Maybe these had been there before, back when I wasn't studying every inch of my body. Either way, I didn't want tits -- that would go against the whole purpose of the exercise. I gobbled twice my daily allotment of antiestrogen meds and pulled a ribbed undershirt over my awful sweater puppies.
Double shots of Nolvadex would control the gyno. But by then my hair was falling out.
I went into this with my natural scalp of unruly, bushmanlike red hair. While I'd never been keen on its tendency to coil into ringlets, there had always been plenty of it. Then one morning I was showering, looking at my shampoo-foamed fingers, and spotted dozens of red strands. Soon they were everywhere: my pillow, between my teeth, falling onto the pages of books. I became hyperaware of the way wind felt through my hair: now much colder on the top of my scalp. Not a single follicle seemed moored to my skin.
Then one sleepless night (the steroids also triggered insomnia), my testicles shrunk.
Testicular atrophy is the most well-known side effect of steroid abuse. It's an inherent irony: Here you are trying to turn yourself into an überman while the most obvious manifestation of your manhood dwindles before your eyes. Female users suffer the opposite reaction: Their clitorises become so swelled that in extreme cases they resemble a tiny penis.
Basically, you inject so much testosterone that you rob your gonads of purpose; they enter dormancy for the duration of your cycle. And while I knew this would happen, the physical sensation was beyond horrible. This rude clenching inside my scrotum, a pair of tiny hands grasping the spermatic cords and tightening into fists. "No more testosterone!" my balls cried. "Closed for business!" I sat up in the dark, gasping, clutching them to make sure they were still there. Within days they had shrunk to half their normal size: sad, shriveled grapes.
Another sleepless night a week later, I swore I felt a ridge on my forehead.
Cranial swelling -- most often a Neanderthal-like ridge forming above the user's brow -- is commonly associated with HGH, or human growth hormone, originally made from the pituitary glands of fresh cadavers. But cranial swelling assumes many forms: In addition to "caveman brow," some users find semisolid lumps forming on their foreheads. Some grow to the size of hard-boiled eggs and require surgical removal.
The next morning, an inspection in the bathroom mirror: Was that a slight swelling across the top of my eyebrows? It seemed impossible -- this only happens in extreme cases. My own perceived bulge was not altogether solid, sort of mushy, but I had this terrifying sense my bone structure had somehow been altered.
This was the primary fear I ran up against: Were these changes happening? Would they subside once I quit 'roiding, or were they permanent? I could handle rampant hair loss, a caveman head, shrunken testicles, hell, even tits, so long as it was temporary. What if it wasn't?
My sixth injection goes badly.
I've been shooting my glutes, and while it's relatively painless, the skin has gone tight and I'm guessing the oil hasn't dissolved. I stick my thigh instead.
The needle goes in half an inch before hitting a major nerve. My leg bucks uncontrollably, knee nearly striking my forehead. Blood leaks from the puncture down my leg. I try my calf.
Sitting cross-legged, ankle propped on knee, I push the needle in. Goes in easy, but when I aspirate, the syringe fills with blood: hit a vein. Wipe the needle with rubbing alcohol, try another spot: blood again. Boot the excess onto a paper towel, plug a fresh needle onto the syringe, try again: blood. It's bubbling out of my thigh and the neat triangle of holes in my calf. What am I, all veins?
End up back at my glutes. After injecting, I regret it: A bubble of oil the size of a pearl onion now lies an inch under my skin. When I massage it, the bubble wobbles, all of one piece. It's still there come nighttime. I feel it pressed against my hipbone, solid as a ball bearing. Like the princess with a pea under her mattresses, I have a hard time sleeping.
To embark on a steroid cycle is to devote yourself to rituals. Wake up, eat, medicate, work out, eat, work out, eat, medicate, sleep. Repeat daily for sixteen weeks.
Eating becomes a ritual. To maximize muscle growth, you must take your weight and eat its equivalent in grams of protein per day. But I pushed my target further: 337.5 grams of daily protein.
Consider that a great source of natural protein -- a can of tuna -- contains thirteen grams. I'd have to eat more than twenty-five cans a day. The max I was ever able to ingest was twenty, forked straight from the can. It is sheer lunacy to eat twenty cans of tuna.
I managed to choke down six cans a day, supplemented with five to six protein shakes, and I still fell short of the target. I went through four 2.47-pound tubs of Muscle Milk a week, 158.08 pounds all told. I kept shoveling a limited spectrum of foodstuffs -- tuna, oatmeal, egg whites, boiled chicken -- into my mouth like a robot. Thankfully, Equipoise, developed to increase lean body weight in horses, gave my appetite a healthy boost.
Injections become a ritual. Run the vials under hot water to warm the oil. Draw 1 cc Equipoise, 1.5 cc's testosterone. Tap the syringe to release air bubbles, push the plunger until a bead forms at the pin tip. Swab the injection site and inject slooow, massaging to help it soak in. Wasn't much different from how any addict went about things. You reach a point where the careful steps and resultant anticipation becomes as heady as the rush itself. Sometimes I couldn't stop shaking as I prepared my needles.
The workout becomes a ritual. But I'd push myself past the limit. I'd lift until my arms hung like dead things. I took postworkout naps in the locker room, spread out on a bench, too exhausted to walk home. Once I caught the smell of ozone, saw these awful black lights, came to sprawled on the gym floor.
Week six my prostate swells up.
The prostate is an organ I associate with old men. Surgical-gloved fingers. Not in any way an organ I should be cognizant of. And yet I was, as this benign organ had swollen to the point that it felt like a fist-sized balloon pressed against my testicles. Another fairly common side effect for some professional bodybuilders is prostatitis, which can get to such an extent that they require catheterization. Imagine steroids as an A-bomb: If your testicles are ground zero, your prostate lies squarely in the fallout zone.
I was urinating fifteen times a day. A swollen prostate crimps the urethral tube, making it torture to piss. It also crowds the bladder, making it feel as if you always need to piss, even if there's nothing to pass. I'd stand over the toilet, coaxing, cajoling, only to produce a squirt. My urine took on the disturbingly rich hue of cask-aged brandy.
I heard "vigorous manual relief" helped ease prostate pain. But when I tried this, it felt as though the pipe connecting the sperm factory to its exit had been clothespinned -- not much came out, and the little that did looked embarrassed.
The key, I discovered, was continual application.
I became obsessed with manual relief. Three or four times a day I was manually relieving myself. With all that extra testosterone, it didn't take much to get the motor humming. I was relieving myself to photos of muscle-bound women gracing tubs of protein powder. I was relieving myself to Vanna White. I relieved myself to a perfumed insert ripped from a magazine. To a smell. Wake up, eat, jerk off, work out, eat, jerk off, eat, work out, eat, jerk off, eat, sleep.
The question you're asking by this point is, Why didn't he stop? Why, despite all the awful side effects, did he keep plugging needles into himself?
I'm sure my answer is no different from most users': the results.
Once we pass that period of massive physical change, puberty and growth spurts, we settle into a sense of our bodies. We understand its parameters and capabilities. And though it's disheartening to say, at thirty I was finding evidence of a body on its downslope. While I worked out plenty pre-steroids, I hadn't made a sizable gain in years. In gym parlance, I'd "plateaued."
Steroids shattered the inborn limitations of my body.
I first sensed their effects bench-pressing dumbbells. I usually max out at 170 pounds -- two 85-pound weights. But ten reps with the 85's felt like a warm-up. I was stunned. With trepidation -- I was now eyeing weights that if mishandled could break some ribs -- I picked up the 90-pounders. They went up easy; I gutted out ten reps. An out-of-body sensation: somebody else's arms pushing those weights, someone else's pectorals flexing.
I went up to 100-pounders -- benching roughly my own body weight. I'd been locked at 160 to 170 pounds for years, and in the course of a single workout, I'd shot up 30 pounds.
My workout weights skyrocketed. I was doing wide-grip chin-ups with a 35-pound plate strapped to my waist, shoulder-pressing 75-pound dumbbells, slapping 45-pound plates on the biceps bar, and bottoming out Nautilus machines. My body exploded -- 205 pounds to 235 in the space of a few weeks. In 'roider vernacular, I'd "swallowed the air hose."
I became a huffer, a grunter, a screamer. Anyone who frequents gyms knows those guys who make ungodly noises while hurling weight around. I'd always found their displays childish and tended to look away, as I would from a toddler having a tantrum in a supermarket. So imagine my surprise to find myself bellowing, shrieking, groaning. A silverback gorilla's mating ritual: I wanted everyone to know I was the biggest, toughest motherf**ker in the joint.
"Hoooo-aaahhh!"
"Eeeeeee-yahhh!"
"Wa-wa-wa-euuuugh-UH!"
Look at me! I'm a big, strong boy!
It was pathetic. I should have known better -- actually, I did know better, but I didn't let that stop me. Those "pumps" clouded all judgment. My glances at the gym mirrors were at first baffled, "Is that me?" double takes that mutated into looks of preening narcissism. I noticed how light played upon my chest and arms, the pockets of blue shadow filling my new contours.
All fake. Chemical sorcery. Freakish. I hadn't earned it. But it's like the woman with giant fake breasts: Everyone knows they're fake, but dammit if they don't still draw the looks.
That oil I shot into my hip hadn't dissolved. A deep, throbbing pain convinced me I'd developed an abscess. I had a pouch of weeks-old oil inside my hip, walled off by my immune system. If I was lucky, it was sterile. If not, it was infected, the surrounding tissue gone necrotic.
I decided to drain it by injecting an empty needle to draw out the stale oil. My hope was that it was still liquid; if it was congealed, gone to lard, I'd need medical attention.
The needle sunk into the pocket of infected tissue. The pain was expected and oddly bearable. Drawing back the plunger only earned me a few drops of clear broth. I disconnected the syringe and left the needle jutting out, applying pressure to the surrounding skin. Blackish fluid the consistency of crankcase oil dripped out. Disgusting and scary, but the pressure subsided. Once I'd squeezed it out, I filled another syringe with sterile water, attached it to the needle still stuck in my skin, injected it, unclipped the syringe, and squeezed the water out.
A decent job for an untrained meatball the likes of myself. Did the trick: A week later, I could comfortably sleep on my side again.
Week twelve I max out at 240 pounds. Packed on 35 pounds in less than three months.
My body had gone through an extreme thickening process. Pectoral muscles: solid slabs of meat hung off my clavicles. Latissimus dorsi muscles flared out from the midpoint of my back: the "cobra's hood." Triceps and biceps so swelled, my T-shirt sleeves bunched up at my shoulders, too narrow to fit over my arms.
Couldn't walk more than a few blocks before a fist-sized stone settled upon my lower back. There were areas I could not reach due to my new size; to scratch my back, I went to the kitchen for a fork.
One night I was watching a legal drama, one of those ripped-from-the-headlines shows. A morbidly obese man was suing a snack-cake company, which he held responsible for his obesity. The main ingredient in those snack cakes was high-fructose corn syrup, a compound that inhibits the hormone leptin, which signals to the brain that the stomach is full. Essentially, leptin tells us to stop eating. But if this signal is never received, a person will eat past the point of reason or safety.
Steroids are like high-fructose corn syrup: They fool a body into a sense that it is stronger and more resilient than it is. You accomplish feats that in your heart and mind you know are beyond you, but you feel so good, so damn strong, you convince yourself otherwise. After the weight-room euphoria wears off, you're forced to acknowledge the effects of self-delusion. My joints felt hyperextended: constantly popping and cracking, noises like lug nuts in a cement mixer. I felt calcified, hardened, and frighteningly old.
Within a month after my cycle ends, everything has changed.
The first thing I notice upon waking these days is that I feel...well, good. No sluggishness, only minor joint pain. Genuinely refreshed. Then, on my way to the bathroom one morning, I sense a new weight between my legs -- my testicles! Great to have you back, boyos!
The feeling of elation lasts ten paces: my bed to the bathroom mirror.
I'm staring at a human boneyard. Where are my pecs? I see two shriveled bags hanging off my chest. Arms -- dear Lord, my arms! Shapeless shoestrings dangling from a pair of rotten-apple shoulders. Stomach a deflated clown balloon. Legs belonging to a coma victim.
Step on the scale: 222 pounds. Thirteen pounds, most of it fluid, shed virtually overnight.
Now, only the most deluded of 222-pound men can stare into a mirror and see a zombified horror staring back. But I'd lost it. Most of what I'd gained: washed away. Popeye without his spinach. Weak and broken and utterly human. All the needles, the piss of pregnant women running through my veins, the fainting spells and sleepless nights, the muscle knots and bitch tits and shrunken gonads and the hair in my food and fears of abscesses and caveman brow -- every risk I'd taken, all that sweat and toil for f**k-all.
Things worsened at the gym. Chest day: dumbbell presses. I settled on the nineties; if I could lift them, it'd be a ten-pound increase over my precycle max.
I barely got them off my chest. I struggled through a single rep, arms quaking, and hit failure. The dumbbells crashed down as I rolled awkwardly off the bench. A total fraud. Everyone who'd been watching me heave massive weight about, bellowing like a steer in rut -- all these knowing eyes saw me as a charlatan.
I fell into a funk. Scoured my apartment: the tuna, the protein powder -- trash-canned all of it. Next order of business: large pizza, pepperoni and double cheese, wolfed down with gulps from a two-liter bottle of Pepsi. I yearned to get fat and disgusting. The rational part of my mind went, You did the research. You knew this would happen. But the other part -- the part most closely tied to my body, the part now used to the weight-room glances and the more defined, burlier cast of my shadow, the part that relished people ceding room on narrow sidewalks -- was not to be consoled.
I went to the doctor's office. I felt much better with the cycle over, but I still suffered aches and pains. The results:
A partially herniated disc. The result of either bad posture or an accumulation of pressure due to excess body weight. A chiropractic visit was scheduled.
An enlarged prostate. I was prescribed Avodart, which did wonders.
Fluid buildup on left knee -- again, the result of excess weight.
The doctor told me he'd get back to me with the results of my blood work.
I started out overweight at 205 pounds, ended up 208. My body now looked worse than before the steroids. Bloated somehow, like I'd died, my body abandoned in a gassy swamp. Small but prominent nipple-nubbins poked out when I wore anything tighter than a golf shirt.
Had it been worth it? The question presupposes my expectation to benefit from the experience. I embarked on the cycle to bring a sense of real-world truth to my novel. Feel what my character felt, experience that portion of his life to write with conviction about it.
I was somewhat ashamed. What had I done to myself? Jeopardized my chances at having a child? I worried about that more than anything else.
Had it been worth it? Somewhere along the line I'd been let off the hook. My grandfather, father, uncles, men of generations past -- they didn't get the free pass I did. Their lives were poverty, wars, factory floors, untilled fields. They endured. What have I ever had to endure? I felt unworthy of all I'd been so carelessly given. And loathed myself for taking it. Maybe this was a way to put myself back on the hook.
Self-destruction is an underappreciated art form.
I currently weigh 170 pounds. The blood tests showed my liver values were totally out of whack. As I had never been able to convince a woman that I was a viable prospect to make a baby with before using, I'll never know if an inability to conceive, should that end up being the case, is attributable to steroids or the innate decrepitude of my seed.
Did I take steroids to write a book, or did I write a book as an excuse to take steroids? Often all you want is to step off the path you've carved, the terrain having become too rocky -- or in my case, too smooth. And when my body began to fall apart, when the drugs began to destroy me, I persisted under the belief that all suffering on my part was long past due. I would endure. The eventual understanding that a certain nobility underlay my grandfather's suffering, whereas mine was not much more than a masochistic stubbornness -- I'd like to think that stopped me. And when I'd stare at myself naked and porcine in the bathroom mirror, like some escapee from the island of Dr. Moreau, I told myself that if nothing else, I'd suffered. Ashamed to admit I took pride in that, too.
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.
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?"
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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.”
