Selling The Promise Of Youth
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.
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!"
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.
By Arlene Weintraub