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MARCH 20, 2006
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COVER STORY
Selling The Promise Of Youth
The anti-aging industry is offering a dizzying array of hormones
and supplements. Business is booming. But some remedies are risky,
and the benefits are unproven.
COVER STORY PODCAST
As Dr. Ron Rothenberg bursts through the door of his anti-aging
institute in Southern California, a cell phone pressed to his
ear, his nurse warns him of the busy day ahead. There will be
four-hour consultations with each of three prospective patients,
she says. They're all coming to hear the 60-year-old Rothenberg's
pitch about how his tailored regimens of diet, exercise, and hormones
will make them feel younger and live longer.
In between the meet-and-greets, Rothenberg catches
up with patient Dr. Howard Benedict, a retired dentist. The two
men met in 1999 and became friends while surfing at Cabo San Lucas,
Mexico. Rothenberg put Benedict on a $10,000-a-year regimen of
30 vitamins and supplements, plus testosterone gel and injections
of human growth hormone. Benedict says his arthritis pain has
eased so much that he rides his bike and surfs for hours at a
stretch, after sucking down a huge protein smoothie he learned
to make from Rothenberg's in-house nutritionist. "Those other
guys my age, they're only out there surfing for a half-hour,"
says Benedict, 61. As a sly smile creeps across his face, he adds:
"I feel like I'm 20 years old with my wife. It's just amazing."
For Rothenberg, this is a typical day at the California
Healthspan Institute in Encinitas, which caters to patients eager
to slow down the inevitable march toward Metamucil mornings and
Viagra nights. As 77 million baby boomers approach retirement,
the relatively new field of anti-aging is racing to keep up with
them. Anti-aging medicine goes way beyond Botox, Retin-A face
creams, and medical spas that offer plastic surgery and laser-based
cosmetic procedures. In fact, only a small portion of what these
new medicine men and women do is aimed at making patients look
younger. Instead, anti-aging doctors seek to turn back the internal
hands of time by prescribing megadoses of supplements that they
believe prevent the body's organs from deteriorating and dying.
In addition to hotly disputed biologic drugs such as human growth
hormone (HGH), there's an alphabet soup of supplements that includes
DHEA, antioxidant vitamins C and E, glucosamine, Omega-3, and
more. Women have been consumers of hormone replacement therapies
for decades. Now men are also being primed to view middle age
in terms of male menopause, sometimes called andropause. That's
one reason more patients than ever are starting to gobble up the
anti-aging promise.
Controversies
The movement even has its own professional group: the American
Academy of Anti-Aging Medicine (A4M), which issues a certification
to doctors who want to hang out a shingle in this field. A4M sponsors
conferences, sells books and DVDs about anti-aging, and serves
as a general clearinghouse of information for patients looking
for the nearest clinic. It also waves around research showing
that the industry pulls in $56 billion a year now -- and that
number could swell to $79 billion by 2009. The promise A4M and
its members dangle before patients is summed up perfectly in the
title of Rothenberg's self-published book: Forever Ageless. According
to A4M, 1,500 doctors have sought board certification in anti-aging
medicine since 1996. Rothenberg, who has about 300 patients, was
No. 10 on the list, and he's proud of his status as a pioneer.
"We're reversing the aging process and improving quality
of life," he says. "I see it every day."
Rothenberg and other practitioners in the field
have precious little scientific data to back up their claims that
the potions extend life. But they insist the regimens will guarantee
what Rothenberg calls "rectangularization" -- years
of healthy living followed by a short, acute decline, as opposed
to a slower, triangle-like descent toward the grave. As Rothenberg
puts it: "Rather than spending a few years in a nursing home,
why not fall apart fast and die?"
The anti-aging movement is barely one step ahead
of the controversies it has spawned. Many of the dietary supplements
these physicians recommend are not regulated as medications by
the Food & Drug Administration. That means the products don't
go through the rigorous safety and efficacy testing that most
prescription drugs face. Furthermore, some hormone products prescribed
by anti-aging physicians are made by specialized pharmacists who,
detractors say, may not be adhering to the same FDA standards
of consistency and purity as mass-market drug manufacturers. The
anti-aging arsenal could swell substantially in coming years as
a whole complement of experimental biotech drugs comes on stream
(page 72).
Many critics are crying for the FDA to crack down
on the anti-aging industry, especially on the renegades who illegally
hawk their wares all over the Net. The claims of the promoters
range "from the extreme fringe to the downright illegal,"
says Dr. Thomas Perls, associate professor of medicine and geriatrics
at Boston University, who has been such an outspoken opponent
of the anti-aging industry that A4M sued him and another professor
in 2004 for defamation.
HGH is by far the most controversial weapon in the
anti-aging arsenal. A substance produced in the body, it was synthesized
by several biotech companies in the early 1980s. The first products
were approved by the FDA in 1985 to help short children grow taller.
Lately the anti-aging industry has latched on to HGH as a tool
for boosting immunity, memory, heart function, muscle mass, and
more. (An upcoming book, Game of Shadows by Mark Fainaru-Wada
and Lance Williams, has created a stir by alleging that baseball
slugger Barry Bonds took HGH, among other performance enhancers.)
Rothenberg, who has taken growth hormone himself,
believes it could help people live to be 125. But it's illegal
for anyone to distribute HGH for anti-aging purposes, and critics
believe many players in the anti-aging industry who prescribe
it are violating laws and endangering patients in the process.
The drug industry formally opposes the efforts to link HGH with
anti-aging, but behind the scenes, companies may not have done
much to douse the enthusiasm: In December a federal court unsealed
a whistleblower suit against a unit of Pfizer Inc. (PFE ), accusing
the drug giant of promoting HGH for anti-aging use (page 70).
Then there are concerns that anti-aging promotions
may be more like scams. Because aging is not actually a disease,
very little of the expense is covered by insurance. That leaves
patients paying often substantial fees out of pocket. Rothenberg's
complete health assessment -- a two-day process that includes
meetings with a nutritionist and an exercise physiologist -- costs
$2,500 or more. The patient often walks away with a long shopping
list of diet supplements and natural hormones that can run $250
a month. And HGH can set patients back by as much as $2,000 a
month. "Buyer beware: These anti-aging clinics are marketing
themselves as one-stop shops for getting tuned up after 60,"
says Daniel Perry, president of the Alliance for Aging Research,
a skeptical Washington (D.C.) group that advocates for the study
of aging. "But people are spending a lot of money to get
treatments that may not be medically necessary."
Rothenberg points to himself as proof that anti-aging
medicine works. A former hippie, he earned an M.D. at Columbia
University. He practiced tropical emergency medicine in the Amazon,
then returned to the U.S. and taught seminars on the subject at
the University of California at San Diego, where he is still on
the faculty. (He was also the local rattlesnake expert.) He first
started injecting himself with HGH about a decade ago. Having
just passed his 50th birthday, he felt off his game -- tired,
disengaged with his patients at his San Diego practice, and less
lively on his surfboard. "I was losing my edge," says
Rothenberg, who, with his rapid-fire speech and easy laugh, bears
more than a passing resemblance to the comic actor Gene Wilder.
"I was losing my memory. Libido-wise, it was take it or leave
it." Today, with a regimen that includes supplements and
testosterone, he has enough energy to run his practice, train
other anti-aging physicians, and even work once a week as an emergency
room doctor.
At 8:30 a.m. on a crisp February day, Rothenberg
takes the stage at a seaside Holiday Inn in San Diego, eager to
share his knowledge with fledgling anti-aging physicians. He's
the moderator of a conference sponsored by San Diego's University
Compounding Pharmacy (UCP), which enjoys a booming business selling
anti-aging treatments. Rothenberg asks how many of the 166 people
in the audience are attending their first anti-aging seminar.
Hands shoot up all over the room. His enthusiasm rises. "Aging
is a disease that can be prevented or reversed," he booms
to the newbies. "We are not prisoners of our destiny."
Later, he dashes across the conference room, with the microphone
in his hand, fielding questions for presenter Dr. Pamela W. Smith,
who has started up 27 anti- aging clinics in cities such as Chicago,
Detroit, and Houston. Admiring Rothenberg's boundless energy,
she quips: "That's the growth hormone!"
Cancer Risk?
Rothenberg himself treats growth hormone with gravitas. That's
because federal laws, inspired by sports-doping scandals in the
late 1980s, bar doctors from prescribing HGH for uses not approved
by the FDA. One disease in adults that does qualify is adult growth
hormone deficiency, which Rothenberg believes many of his patients,
including Howard Benedict, have. The disease carries symptoms
such as depression and increased body fat. Blood tests can confirm
the deficiency, but they're not always reliable, Rothenberg says.
At the conference, Rothenberg explains to doctors
that it's O.K. to diagnose the disease on symptoms alone, as long
as physicians document the diagnosis as being adult growth hormone
deficiency, rather than a condition HGH has not been approved
to treat, such as fatigue. In response to concerns that too much
HGH can cause cancer, Rothenberg flashes a reference to a study
carried out by endocrinologist Dr. Mary Lee Vance and others that
he says shows there's no cancer risk.
Hearing about this scene, Vance is incensed. She
says the patients in the cited studies were given just enough
growth hormone to replace severe deficiencies. And while they
didn't suffer increased rates of cancer, other research has shown
that HGH can promote tumor growth. What's more, the hormone can
spark high blood pressure, blood clots, and structural changes
in the hands and feet, according to Vance, professor of medicine
for the University of Virginia Health System. "They're misquoting
[scientific] literature up the wazoo," she gripes, referring
to the anti-aging proponents.
Lately, the FDA has started to take notice of improper
marketing of HGH. The FDA's office of criminal investigations
pursued 55 HGH cases last year, which is more than four times
the number it looked into in 2000. "The FDA believes that
a physician who prescribes, dispenses, and/or administers HGH
for an unauthorized use violates federal law," says agency
spokeswoman Laura Alvey in an e-mail. She points out examples
such as the case of a Florida dentist who last year pleaded guilty
to federal charges of illegally selling HGH over the Internet.
He could face up to five years in prison for each of four counts,
and $1 million in fines.
Rothenberg believes that responsible anti-aging
physicians are simply restoring HGH in patients to its appropriate,
youthful levels. And the fact that there's no exact science to
diagnosing adult growth hormone deficiency leaves them a lot of
leeway. Package inserts for products such as Genotropin, Pfizer's
version of HGH, lay out guidelines for detecting the disease,
but, says Rothenberg, "there's nothing in the law that says
how to prescribe this. It's a gray area."
It's not just HGH that worries critics. Anti-aging
doctors also prescribe testosterone, often in skin gels, and they
recommend the hormone DHEA, which can convert to estrogen and
testosterone in the body. They say the treatments enhance heart
health, sexual performance, and memory in men, and fight menopause
symptoms in women. Anti-aging doctors run a battery of blood and
saliva tests prior to prescribing testosterone, and say they're
simply replacing what's missing. But slipups can be costly: Too
much testosterone can cause mood disorders and hair loss in men.
In women, it can bring on acne, deepening voices, and unwanted
hair growth.
The hormones estrogen and progesterone have also
given rise to controversy. FDA-sanctioned synthetic versions,
such as Wyeth's (WYE ) Prempro and Premarin, got a bad rap in
2002, when a giant study by the Women's Health Initiative (WHI)
suggested the hormones might increase the risk of breast cancer
and heart disease. At that point, many traditional gynecologists
shied away from prescribing hormones.
Through the Cracks
More recent studies have downplayed the heart disease risk, but
in the meantime, anti-aging doctors have stepped in to fill the
void, promoting natural, or "bio-identical," hormones
as safe alternatives. Critics take issue with these products for
several reasons. First, bio-identical hormones are made by so-called
compounding pharmacists. Historically, they have been permitted
by law to customize medications for individual patients -- for
example, people who react adversely to certain ingredients. But
under FDA rules, they should not be manufacturing or selling drugs
to a mass market. To get into that business, they would have to
submit to strict supervision of their facilities, the quality
of their products, the claims on their labels, and the like. Critics
blast the FDA for letting too much activity slip through the cracks.
The second big complaint involves the very term
"bio-identical." The hormones prescribed by anti-aging
doctors are generally derived from plants such as soybeans and
sweet potatoes, and combined into proprietary recipes, which may
never be tested in human trials. Anti-aging proponents say the
substances are natural, safe alternatives to FDA-approved hormones
such as Premarin and Prempro, which are derived from the urine
of pregnant horses. But many doctors are leery of the bio-identical
pitch. "Yams do not make hormones like humans do," says
Dr. Bruce Bouts, an internist in Findlay, Ohio. "Compounding
pharmacies are selling a bill of goods."
In October, 2005, Wyeth weighed in on the debate
by filing a petition to the FDA requesting that the agency regulate
the compounding pharmacists with the same stringent standards
it applies to pharmaceutical manufacturing companies. "We're
concerned about what we believe is illegal mass-marketing,"
says Ginger Constantine, vice-president for women's health and
bone-repair research at Wyeth. "They're saying their products
are safer, but they haven't tested that." Federal regulators
say that they're on the case. "The FDA is aware of the concerns
raised about compounded bio-identical hormone products, and the
agency is evaluating this issue," according to Steven Silverman
of the office of compliance at the FDA's Center for Drug Evaluation
& Research.
Many anti-aging advocates have an almost cult-like
faith in the movement. John Grasela, who runs UCP with his brother,
Joe, says he has been taking many of the supplements he sells
for the past 10 years. "I'm in the best shape of my whole
life," says Grasela, 57. Dr. Alvin Yee, a protégé
of Rothenberg's who recently opened an anti-aging practice in
Costa Mesa, Calif., says he designed an anti-aging regimen for
himself, even though he's only 36 years old. "I've gained
eight to nine pounds of muscle," he says during a break at
the UCP conference, where physicians were enthusiastically perusing
the selection of powders, protein bars, and syringes lined up
against a back wall. "My girlfriend noticed."
What's missing amid all this excitement, though,
is any firm scientific proof that these regimens actually slow
down or reverse the aging process. That proof may never come.
A truly scientific study would have to span several decades and
include a control group that's taking a placebo. Imagine how difficult
it would be to persuade patients to participate in such a trial,
knowing that they could end up taking a sugar pill for 50 years,
rather than the pill that might actually extend their lives. "Where's
the big double-blind study, placebo-controlled? It's never going
to happen," Rothenberg concedes. A handful of 10-year studies
of hormone replacement are starting now, Rothenberg says, but
he's not willing to wait for the results. "Let's take our
best shot now."
One of the most important watchdogs in the practice
of medicine is conspicuously absent in the anti-aging industry.
Health insurers, by and large, have no supervisory role here.
Most anti-aging clinics and compounding pharmacists require their
patients to pay cash. The patients may be reimbursed later for
some services, such as standard blood tests, but the doctors themselves
are rarely filing the claims. So they're off the radar of the
insurance companies, which have been trying of late to break physicians
of what they consider to be bad habits, such as writing unnecessary
prescriptions for costly and potentially harmful drugs. That means
patients have one less entity looking out for their safety --
or at least their pocketbooks.
Some critics have taken it upon themselves to fill
in as watchdogs. A paper published in the Oct. 26, 2005, issue
of The Journal of the American Medical Assn. describes the distribution
of human growth hormone for anti-aging as both rampant and illegal.
An estimated 30% of the growth hormone prescriptions
in the U.S. are written for non-FDA-approved uses, according to
the paper, co-written by Boston University's Perls and S. Jay
Olshansky, professor of epidemiology at the University of Illinois
at Chicago. "They say they're stopping or reversing aging,
but what evidence do they have?" says Olshansky. "What
evidence do they have that it's safe? Our job is to protect the
public."
The anti-aging industry is fighting back. In 2004,
A4M filed a lawsuit against Perls and Olshansky in an Illinois
circuit court. The suit alleges that for years, the two professors
have engaged in "defamatory conduct" and interfered
with A4M's ability to do business. The suit blasts Olshansky,
for example, for once granting A4M a "silver fleece"
award -- a designation meant to shame medical professionals who
claim they have invented ways to reverse aging. The suit also
alleges that at a 2004 A4M conference, Olshansky left a bottle
of vegetable oil labeled "snake oil" for Drs. Ronald
M. Goldman and Ronald M. Klatz, who head A4M.
The parties on both sides declined to comment specifically
on the suit, which is still pending. Of Olshansky and Perls, says
Klatz: "They're not scientists. Because of our success, they're
trying to make a name for themselves. They're on a self- appointed
soapbox." As for Rothenberg, he doesn't let himself get distracted
by the controversy. "Growth hormone is no worse than any
drug that can be prescribed off-label," he says.
The public has little inkling about the expert bickering.
Anti-aging centers are popping up all over the country, some with
franchise-like models. Since 2003, Patrick Savage and his identical
twin, Dr. Paul Savage, have opened seven branches of their anti-aging
center, called BodyLogicMD.
It all started five years ago, when Paul decided
to seek help from an anti-aging doctor. He wanted to slim down
his 267-pound frame and get tips for lowering his stress level.
After six months on growth hormone and DHEA, he had shed 87 pounds,
gained muscle mass, and felt great. Then Paul, who lives in Chicago,
went to visit Patrick in Boca Raton, Fla., for Christmas. The
brothers hadn't seen each other in a number of years. "Patrick
opened the door and said: 'Wow,"' Paul recalls. "His
wife was like: 'Oh, wow. Oh, wow."' Soon Patrick started
on his own anti-aging regimen, and the two made a business of
it. They hope to double the number of BodyLogicMD practices this
year and increase their patient base by at least 300%.
Some patients are aware that anti-aging is controversial,
but they say they must answer to how they feel. Paul's patient
Suzi Tillman first went to see him after a hysterectomy left her
feeling that her entire body had simply shut down. "I wasn't
sleeping, I couldn't think straight, I called my children the
wrong names," says Tillman, 51, a former professional ballroom
dancer who now teaches dance and works with senior citizens. "I
felt ugly. For an empowered woman, this is scary." Now she
is taking 15 supplements a day and rubbing a cream made of compounded
estrogen into her skin. She feels like her old self. "Oh,
the relief to have that cloud gone."
The bigger the anti-aging movement gets, the less
caution it may be applying to experiments that are truly out-there.
A handful of anti-aging doctors now offer a treatment called chelation
therapy, which was once commonly used to treat lead poisoning.
Chelation involves infusing a patient with chemicals that are
believed to bind to metals and clear them out of the body. The
process may reverse heart disease, proponents say. But it can
cost as much as $2,400 and take up to three months. And its heart
benefits have never been proven, critics say. The Web site quackwatch.org,
run by Dr. Stephen Barrett, has posted multiple articles and studies
to debunk the treatment. "There is neither any evidence nor
any logical reason to believe it works," he says.
While Rothenberg isn't sure chelation therapy is
a good fit for his practice, he admits that he's watching it closely.
"I've read the data," he says. "And if I had a
bad angiogram, I'd explore chelation therapy for myself before
investing in surgery."
After a busy day meeting prospective patients, Rothenberg
dines on sushi and reflects on the anti-aging revolution. He says
he's open to changing how he practices this nascent discipline,
based on any research that sheds light on what works and what
doesn't. For example, he used to recommend ginkgo biloba, an herb
that is supposed to boost brain power, but he rarely does so any
more. "The data hasn't supported it," he says. "I've
got an open mind." Meanwhile, he has brought other members
of his family into the act. His 84-year-old mother, who teaches
foreign languages, is now a patient. And his 16-year-old son has
undergone hormone testing, just to make sure the teen's testosterone
levels are normal.
Rothenberg has tweaked his own anti-aging regimen
over the years. He hasn't taken growth hormone in a while, but
he still injects himself with testosterone, as well as taking
thyroid hormone and an assortment of multivitamins. The surfboard
perched on the wall over his desk, together with large framed
photographs of himself hanging ten, stand as testaments to his
own search for eternal youth. He still surfs when he can, and
often escapes to his vacation home in Cabo, where he grows coconut
trees for fun. But the place he really likes to be is in the office,
tailoring treatments to keep his patients youthful and happy.
"I'm like the personal family doctor from the Norman Rockwell
era," he says.
By the end of the day, all of the visitors Rothenberg
has met for the first time have signed on to be his patients.
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