This article was posted on Businessweek.com
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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