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MARCH 20, 2006

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BY ARLENE WEINTRAUB (P. 64)

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COVER STORY

ENDLESS SUMMER Dr. Ron Rothenberg (left) is 60. His patient Howard Benedict is 61. Theyre thriving on vitamins, testosterone, and other hormones
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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.
BY ARLENE WEINTRAUB

s 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. Theyre all coming to hear the 60-year-old Rothenbergs 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 surng at Cabo San Lucas, Mexico. Rothenberg put Benedict on a $10,000-a-year regimen of 30 vitamins and supplements, plus testosterone
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COVER STORY
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 bodys organs from deteriorating and dying. In addition to hotly disputed biologic drugs such as human growth hormone (hgh), theres 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. Thats 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 AntiAging Medicine (a4m), which issues a certication to doctors who want to hang out a shingle in this eld. 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 nowand 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 Rothenbergs self-published book: Forever Ageless. According to a4m, 1,500 doctors have sought board certication in anti-aging medicine since 1996. Rothenberg, who has about 300 patients, was No. 10 on the list, and hes proud of his status as a pioneer. Were reversing the aging process and improving quality of life, he says. I see it every day. Rothenberg and other practitioners in the eld have precious little scientic data to back up their claims that the potions gel and injections of human growth hor- AN EMPOWERED WOMAN Dancer Suzi Tillman, 51, extend life. But they insist the regimens will guarantee what mone. Benedict says his arthritis pain has eased so much that he rides his bike and surfs takes 15 supplements a day, rubs estrogen cream Rothenberg calls rectangularizationyears of healthy for hours at a stretch, after sucking down living followed by a short, acute dea huge protein smoothie he learned to into her skin, and feels like her young self again cline, as opposed to a slower, trianmake from Rothenbergs in-house nutrigle-like descent toward the grave. As Rothenberg puts it: tionist. Those other guys my age, theyre only out there surfRather than spending a few years in a nursing home, why not ing for a half-hour, says Benedict, 61. As a sly smile creeps fall apart fast and die? across his face, he adds: I feel like Im 20 years old with my The anti-aging movement is barely one step ahead of the wife. Its just amazing. controversies it has spawned. Many of the dietary supplements For Rothenberg, this is a typical day at the California these physicians recommend are not regulated as medications Healthspan Institute in Encinitas, which caters to patients eaby the Food & Drug Administration. That means the products ger to slow down the inevitable march toward Metamucil dont go through the rigorous safety and efficacy testing that mornings and Viagra nights. As 77 million baby boomers apmost prescription drugs face. Furthermore, some hormone proach retirement, the relatively new eld of anti-aging is racproducts prescribed by anti-aging physicians are made by speing to keep up with them. Anti-aging medicine goes way becialized pharmacists who, detractors say, may not be adhering yond Botox, Retin-A face creams, and medical spas that offer to the same fda standards of consistency and purity as massplastic surgery and laser-based cosmetic procedures. In fact, market drug manufacturers. The anti-aging arsenal could swell only a small portion of what these new medicine men and
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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 rst 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 its 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

ROTHENBERGS TRADE-OFF: YOU GET MORE YEARS OF HEALTHAND THEN FALL APART FAST

court unsealed a whistleblower suit against a unit of Pzer Inc., 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. Rothenbergs complete health assessmenta two-day process that includes meetings with a nutritionist and an exercise physiologistcosts $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 rst 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

Anti-aging doctors often prescribe vast quantities of alternative treatments to halt the cruel march of time. Critics are concerned about many of the things these physicians promote, including:
TREATMENT ANTI-AGING DOCS SAY CRITICS SAY

OCEANS OFPOTIONS
HUMAN GROWTH HORMONE NATURAL ESTROGEN AND PROGESTERONE DHEA THYROID HORMONES TESTOSTERONE CHELATION THERAPY

This biotech drugmost often prescribed to help short kids growimproves memory, mood, body composition, cardiac function, and more in adults. These plant-derived hormones protect against heart disease, osteoporosis, and Alzheimers, and they relieve menopause symptoms without the risks associated with Premarin and other synthetic hormones. Its the super-hormone, improving libido, muscle mass, memory, mood, and immunity, while lessening the risk of diabetes, cancer, and hardening of the arteries. The body produces less of this hormone as we age. Fighting that decline works wonders on energy, stamina, libido, mental vigor, and mood. It counteracts male and female menopause, beneting heart health, bone mass, and memory, and it makes Viagra pass. This chemical treatment, given intravenously, clears the body of excess metals such as iron, lead, and aluminum, in the process slowing heart disease.

It can cause high blood pressure and odd structural abnormalities in the hands and feet. And it may cause previously undetected tumors to grow. Many of these hormones are made by pharmacies that are not monitored closely enough by the Food & Drug Administration, so the products are not proven to be either safe or effective. By the time DHEA pills are digested, very little of the hormone actually ends up in the bloodstream. Show us more data proving it works. Dont mess with the thyroid gland. Too much of this hormone can cause heart arrhythmias and bone loss. And some doctors tests are unreliable. Male menopause? No such thing. And too much can cause hair loss and mood problems in men, and male traits in women. Beware. This process has not been proved to benet heart health. And it hurts the pocketbook, costing as much as $2,400 for a three-month regimen.
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COVER STORY
O.K. to diagnose the disease on Rothenberg, who, with his rapidsymptoms alone, as long as re speech and easy laugh, bears physicians document the diagnomore than a passing resemsis as being adult growth horblance to the comic actor Gene mone deciency, rather than a Wilder. I was losing my memocondition hgh has not been apry. Libido-wise, it was take it or proved to treat, such as fatigue. leave it. Today, with a regimen In response to concerns that too that includes supplements and much hgh can cause cancer, testosterone, he has enough enRothenberg ashes a reference to ergy to run his practice, train a study carried out by endocriother anti-aging physicians, and nologist Dr. Mary Lee Vance and even work once a week as an others that he says shows theres emergency room doctor. no cancer risk. At 8:30 a.m. on a crisp FebruHearing about this scene, ary day, Rothenberg takes the Vance is incensed. She says the stage at a seaside Holiday Inn in patients in the cited studies were given San Diego, eager to share his MASSIVE ASSAULT Some anti-aging enthusiasts just enough growth hormone to replace knowledge with edgling antisevere deciencies. And while they didnt suffer aging physicians. Hes the mod- take as many as 30 vitamins and supplements increased rates of cancer, other reerator of a conference sponsearch has shown that hgh can sored by San Diegos University a day, a regimen that can cost $10,000 a year promote tumor growth. Whats Compounding Pharmacy (ucp), which enmore, the hormone can spark high blood pressure, blood clots, joys a booming business selling anti-aging treatments. Rothenand structural changes in the hands and feet, according to berg asks how many of the 166 people in the audience are atVance, professor of medicine for the University of Virginia tending their rst anti-aging seminar. Hands shoot up all over Health System. Theyre misquoting [scientic] literature up the room. His enthusiasm rises. Aging is a disease that can be the wazoo, she gripes, referring to the anti-aging proponents. prevented or reversed, he booms to the newbies. We are not Lately, the fda has started to take notice of improper marprisoners of our destiny. Later, he dashes across the conference keting of hgh. The fdas office of criminal investigations purroom, with the microphone in his hand, elding questions for sued 55 hgh cases last year, which is more than four times the presenter Dr. Pamela W. Smith, who has started up 27 antinumber it looked into in 2000. The fda believes that a physiaging clinics in cities such as Chicago, Detroit, and Houston. cian who prescribes, dispenses, and/or administers hgh for an Admiring Rothenbergs boundless energy, she quips: Thats unauthorized use violates federal law, says agency spokesthe growth hormone! woman 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 ve years in prison for each of four counts, and $1 million in nes. rothenberg himself treats growth hormone with gravitas. Rothenberg believes that responsible anti-aging physicians Thats because federal laws, inspired by sports-doping scandals are simply restoring hgh in patients to its appropriate, youthin the late 1980s, bar doctors from prescribing hgh for uses ful levels. And the fact that theres no exact science to diagnosnot approved by the fda. One disease in adults that does qualing adult growth hormone deciency leaves them a lot of leeify is adult growth hormone deciency, which Rothenberg beway. Package inserts for products such as Genotropin, Pzers lieves many of his patients, including Howard Benedict, have. version of hgh, lay out guidelines for detecting the disease, The disease carries symptoms such as depression and increased but, says Rothenberg, theres nothing in the law that says how body fat. Blood tests can conrm the deciency, but theyre not to prescribe this. Its a gray area. always reliable, Rothenberg says. Its not just hgh that worries critics. Anti-aging doctors also At the conference, Rothenberg explains to doctors that its

Cancer Risk?

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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 ght menopause symptoms in women. Anti-aging doctors run a battery of blood and saliva tests prior to prescribing testosterone, and say theyre simply replacing whats 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 Wyeths Prempro and Premarin, got a bad rap in 2002, when a giant study by the Womens 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.

WHATS MISSING IS SCIENTIFIC EVIDENCE THAT THESE REGIMENS ACTUALLY SLOW DOWN OR REVERSE AGING. THAT PROOF MAY NEVER COME
gredients. 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 ling a petition to the fda requesting that the agency regulate the compounding pharmacists with the same stringent standards it applies to pharmaceutical manufacturing companies. Were concerned about what we believe is illegal mass-marketing, says Ginger Constantine, vice-president for womens health and bone-repair research at Wyeth. Theyre saying their products are safer, but they havent tested that. Federal regulators say that theyre 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 fdas 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. Im in the best shape of my whole life, says Grasela, 57. Dr. Alvin Yee, a protg of Rothenbergs who recently opened an anti-aging practice in Costa Mesa, Calif., says he designed an anti-aging regimen for himself, even

Through the Cracks

more recent studies have downplayed the heart disease risk, but in the meantime, anti-aging doctors have stepped in to ll 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 socalled compounding pharmacists. Historically, they have been permitted by law to customize medications for individual patientsfor example, people who react adversely to certain in-

One Pill Makes You Younger...

Get the Story on the Cover Story: For a podcast interview with Science Editor Arlene Weintraub by Executive Editor John A. Byrne, go to www.businessweek.com/search/podcasting.htm. Q&A with a Longevity Guru: Dr. Ronald Klatz, who coined the term anti-aging, is now head of the American Academy of AntiAging Medicine, which has been under attack by academics and traditional physicians. Anti-Aging Underground: For more on this story, watch BusinessWeek Weekend. Check your local TV listings, or go to businessweekweekend.com to view this and other segments from our weekly TV program.

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COVER STORY
though hes only 36 years old. Ive 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. Whats missing amid all this excitement, though, is any rm scientic proof that these regimens actually slow down or reverse the aging process. That proof may never come. A truly scientic study would have to span several decades and include a control group thats 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. Wheres the big double-blind study, placebo-controlled? Its never going to happen, Rothenberg concedes. A handful of 10year studies of hormone replacement are starting now, Rothenberg says, but hes not willing to wait for the results. Lets 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
members of his marketing staff with instructions to follow up. Rost alleges that the memo and other internal documents that are part of his case prove the companies knowingly marketed HGH to anti-aging doctors. By law, drug companies are forbidden to market any drug for so-called off-label use. Additional restrictions on HGH make it particularly sensitive. This is an anti-aging doctor saying that hes going to put a lot of money behind promoting [Pharmacias] formula, says Rost. Hassan...should have known. Its very illegal. Hassan left Pharmacia right when Pzer acquired it in 2003. In response to a request for comment, Schering spokesman Stephen Galpin said: Fred Hassan is prevented from commenting on this or any other issue pertaining to the former Pharmacia under a condentiality agreement with Pzer. But other executives who were close to Hassan say he did nothing improper. Goran Ando, who was vice-president for research under Hassan at Pharmaciaand who was hand-copied on the Abelove memowarns against attaching too much signicance to Hassans instructions. He passed along virtually every memo, says Ando, now a board member of several companies in Britain. As for associating with anti-aging centers, Ando says, We tried to discourage it. Documents reviewed by BusinessWeek suggest that executives below Hassan pursued a relationship with Abelove, and were aware of the legal implications of doing so. In February, Abelove sent a letter, copied to eight Pharmacia executives, describing

LEGALTANGLE AT THE FOUNTAIN OF YOUTH

chart by alberto mena/bw

being pursued by the office of the U.S. he drug human growth hormone Attorney in Boston. A spokeswoman there (HGH), one of the most tightly declined to comment. regulated substances on the The legal tangles could have broad market, is proving to be a thorn in repercussions. The documents the side of Pzer Inc. BusinessWeek examined suggest that Fred BusinessWeek has reviewed internal Hassan, former chief executive officer of documents shedding new light on Pharmacia, may have been aware of efforts allegations that Pharmacia Corp., a in the company to encourage the improper company Pzer acquired in 2003, promotion of Genotropin. Hassan is improperly promoted its drug Genotropin to currently head of Schering-Plough Corp., doctors who intended to use it as an antiwhich is not part of the investigations. aging treatment. The Food & Drug Hassans troubles go back to January, Administration has approved Genotropin 2000, when government concerns about the and other synthetic versions of human abuse of HGH were on the rise. A growth hormone to treat certain diseases. memorandum landed on Hassans desk But it is illegal for manufacturers such as from Dr. William Abelove of the Renaissance Pzer to promote the hormone for antiaging use, which is not approved by the FDA. Longevity Center in Florida. The letter BusinessWeek was shown the documents opened by saying: The Renaissance Longevity Center is initiating the most by Dr. Peter Rost, a former Pharmacia executive, who led a civil whistleblower suit aggressive ethical campaign ever launched against Pharmacia and Pzer in U.S. district for the marketing of human growth hormone. It went on to suggest a court in Massachusetts in 2003. The suit strategic alliance with Pharmacia. was unsealed in November, 2005, after the Handwritten notes at the top of the memo U.S. Justice Dept. declined to intervene. But Rost is continuing to pursue the suit with the indicate that Hassan passed the letter on to help of private counsel. Pzer has led a motion to dismiss, arguing that both Pharmacia and Pzer had acknowledged that there were Illegal use of human growth hormone problems and had sought to address is looming larger on the FDAs radar them. Separately, Pzers most recent 60 NUMBER OF ONGOING 10K, led on Feb. 28, says there are INVESTIGATIONS EACH YEAR 50 continuing Justice Dept. investigations into the marketing of Genotropin. 40 It isnt clear whether these 30 investigations are related to the allegations in the whistleblower suit. But 20 Rost says that after he led the suit, he 10 was interviewed by the Justice Dept., the FBI, and the FDAs Enforcement Div. 0 '00 '01 '02 '03 '04 '05 He says he has testied twice as a grand Data: FDAs Office of Criminal Investigation jury witness in a criminal investigation

TRACKING THE ABUSE

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insurers, by and large, have no supervisory role here. Most antiaging 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 ling the claims. So theyre 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 safetyor at least their pocketbooks.

Some critics have taken it upon themselves to ll 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 Universitys Perls and S. Jay Olshansky, professor of epidemiology at the University of Illinois at Chicago. They say theyre stopping or reversing aging, but

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what would be on the agenda at a meeting. Among other topics, Abelove wanted to discuss the ability for the Abelove Longevity Centers to purchase growth hormone at quantity discounted prices. Soon afterward, Pharmacia received legal advice on this matter from the law rm Morgan, Lewis & Bockius. The rm sent a condential memo to Pharmacias corporate counsel outlining the regulatory and legal implications of possible arrangements with Renaissance Longevity

whether Abelove got a price break on Genotropin. Abelove, a practicing physician in Miami and Weston, Fla., with a strong interest in anti-aging treatments, declined to comment on the contract because of a condentiality agreement he has with Pharmacia. Pzer and Pharmacia addressed Rosts allegations in the motion to dismiss the whistleblower lawsuit. Pzer says Pharmacia took corrective actions in 2002, including terminating all discount contracts for Genotropin. The issues were corrected by Pharmacia and later by Pzer, and Pzer voluntarily disclosed them to the government as soon as it was possible to do so, says Paul Fitzhenry, a spokesman for Pzer. Abelove is not mentioned by name in Pzers court lings. Fitzhenry says, however, that the WHISTLEBLOWER Rost alleges that his former Abelove contract was terminated before employer Pharmacia improperly promoted Pzer acquired Pharmacia. Rost, admittedly, has an ax to Genotropin as an anti-aging treatment grind when it comes to both Pharmacia and Pzer. Pzer red him late to Pharmacia from Morgan, last year after the case was unsealed, Lewis & Bockius references the prompting him to counter with a lawsuit Genentech action in a section charging wrongful termination. Rost has a labeled FDA Enforcement history of battling the pharmaceutical Risks. It advises that industry. He once alleged tax violations on Pharmacia should reduce the the part of international staffers at his risk by ensuring that doctors former employer, Wyeth. And in 2004 he had not receive cash payments or a public war of words with Pzer over drug free goods as a result of reimportation. Rosts allegations about conducting any research Genotropin extend far beyond what studies. An assistant to Pharmacia might have been planning with Stephen Paul Mahinka, one of Abeloves Longevity Center. His the lawyers who wrote the whistleblower suit also alleges that memo, said in a voice mail that Pzers Pharmacia used a research program as a policies prevent outside counsel from vehicle to reward physicians for prescribing talking to reporters. Genotropin and that the company Documents show that in May, 2000, improperly paid for anti-aging doctors to Abelove signed a consulting contract with attend meetings held at chic resorts. Pharmacia to pursue a broad range of Pzer says that these and other activities related to HGH, including allegations were addressed in its motion to reviewing marketing strategies, attending dismiss. As the drug giant and its former meetings on growth hormone, and employee trade jabs, HGH used as an antieducating Pharmacia employees about aging treatment is certain to remain under growth hormone. The contract included a the microscope. promise of a $50,000 payment. Its unclear Centers. The six-page memo, examined by BusinessWeek, lays out various legal risks inherent in providing the drug at a discount to Abeloves practice. It may be viewed, the memo says, as an improper incentive that encourages physicians to overutilize the drug, which could be found to be a violation of the Medicare/Medicaid AntiKickback statute. The lawyers had every reason to be fastidious. In 1999, Genentech Inc. pleaded guilty to a federal criminal charge that it improperly promoted its growth hormone. It paid a $50 million ne. The February, 2000, memo

COVER STORY
what evidence do they have? says Olshansky. What evidence do they have that its safe? Our job is to protect the public. The anti-aging industry is ghting back. In 2004, a4m led 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 a4ms ability to do business. The suit blasts Olshansky, for example, for once granting a4m a silver eece awarda 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 specically on the suit, which is still pending. Of Olshansky and Perls, says

THE BIGGER THE ANTI-AGING MOVEMENT GETS, THE MORE OPEN IT BECOMES TO TRULY OUT-THERE EXPERIMENTS
Klatz: Theyre not scientists. Because of our success, theyre trying to make a name for themselves. Theyre on a selfappointed soapbox. As for Rothenberg, he doesnt 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. Antilose weight, process sugar more effectively, and raise their ratio of muscle to fat. Elixir cannot go to the FDA with an antiaging proposition any more than Sirtris can. So the companys more practical goal is to get its drugs approved to treat diabetes and obesity. Human trials could start within two years. We werent out to discover the fountain of youth, though lots of people would like us to do that, says Peter DiStefano, Elixirs chief scientic officer. Regardless of what diseases the FDA approves these drugs to treat, the links between the worlds of biotech and anti-aging medicine are likely to become more intimate. The biotech drug human growth hormone is already a favorite tool of anti-aging doctors. Of the new treatments, 90% will have applications to anti-aging medicine, predicts Dr. Ronald M. Klatz, president of the American Academy of Anti-Aging Medicine. Theyre not youth pills, but they offer ways of intervening in the specic mechanisms of aging. Venture capitalists are taking notice. Sirtris, founded in 2004, has raised $45 million in private funding so far. Six-year-old Elixir has picked up $56 million. Both rms say theyve detected some interest on the part of Big Pharma, although no deals have been signed yet. The pioneers of this new science hate to be painted as the Ponce de Lens of the drug industry. For one thing, the explorer never managed to nd his precious fountain. Perhaps he was a few hundred years ahead of his time.

BIOTECHS DIET IN A BOTTLE COULD EXTEND YOUR LIFE

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f you cut a mouses daily calorie intake by 30%, it will live at least 30% longer than its normal two-year life span. Some say this is because the body under stress produces protective substances. The trick works with worms and fruit ies, too, and would probably extend life in humans, scientists believe. But wed all have to learn how to eat just enough to stay alive. This isnt about forgoing Girl Scout Cookies or three-course meals: A true anti-aging diet could be pure torture. A handful of biotech companies are developing drugs that produce the effects of such caloric restriction in the body without depriving people of food. Anti-aging doctors would love to prescribe a medication that would extend their patients life spans to 125 yearsextrapolating from mice. But companies would have no avenue for seeking Food & Drug Administration approval for such a treatment. It would be undoable, says Stephen J. Hoffman, an investor in anti-aging biotech Sirtris Pharmaceuticals in Cambridge, Mass., who also sits on its board. Thats because it would take a halfcentury and countless billions of dollars to prove that the drugs extend life in healthy people, he says. Instead, Sirtris and other startups plan to test their products in diseases common in older people, such as diabetes and obesity, where its relatively easy to obtain data that the FDA can scrutinize. Sirtris is focusing on genes that make enzymes called sirtuins, hence the company name. Scientists have found that by making sirtuins more active, they can mimic the

effects of caloric restriction. The company hopes to start testing pills containing sirtuin-enhancing chemicals on patients with diabetes, Huntingtons disease, and other ailments as early as 2007. Elixir Pharmaceuticals, also in Cambridge, hopes to reap the benets of caloric restriction by turning off part of the fat-gathering mechanism. Specically, the biotech is attacking ghrelin, a protein released in the stomach that makes us feel the urge to eat. A drug that prevents the body from using ghrelin may help patients

COVER STORY
posted multiple articles and studies to deaging centers are popping up all over the country, bunk the treatment. There is neither some with franchise-like models. Since any evidence nor any logical reason to 2003, Patrick Savage and his believe it works, he says. identical twin, Dr. Paul Savage, While Rothenberg isnt sure chelation have opened seven branches of therapy is a good t for his practice, he their anti-aging center, called admits that hes watching it closely. Ive BodyLogicmd. read the data, he says. And if I had a It all started ve years ago, bad angiogram, Id explore chelation therwhen Paul decided to seek help apy for myself before investing in surgery. from an anti-aging doctor. He After a busy day meeting prospective wanted to slim down his 267patients, Rothenberg dines on sushi and repound frame and get tips for lowerects on the anti-aging revolution. He says ing his stress level. After six months hes open to changing how he practices this on growth hormone and dhea, he nascent discipline, based on any research had shed 87 pounds, gained muscle that sheds light on what works and what mass, and felt great. Then Paul, who doesnt. For example, he used to recommend lives in Chicago, went to visit Patrick in ginkgo biloba, an herb that is supposed to Boca Raton, Fla., for Christmas. The boost brain power, but he rarely does so any brothers hadnt seen each other in a number of more. The data hasnt supported it, he says. Ive got an years. Patrick opened the door and said: open mind. Meanwhile, he has brought other members of Wow, Paul recalls. His wife was like: Oh, his family into the act. His 84-year-old mother, who teaches wow. Oh, wow. Soon Patrick started on his foreign languages, is now a own anti-aging regimen, and the two patient. And his 16-year-old made a business of it. They hope to dou- YOUTH WILL BE SERVED Centers such as BodyLogicMD son has undergone hormone ble the number of Bodytesting, just to make sure the teens testosterone Logicmd practices this are popping up all over America. It currently has levels are normal. year and increase their paRothenberg has tweaked his own tient base by at least 300%. seven branches and aims to double that in a year anti-aging regimen over the years. He Some patients are aware that antihasnt taken growth hormone in a while, but he still injects aging is controversial, but they say they must answer to how himself with testosterone, as well as taking thyroid hormone they feel. Pauls patient Suzi Tillman rst went to see him afand an assortment of multivitamins. The surfboard perched ter a hysterectomy left her feeling that her entire body had on the wall over his desk, together with large framed photosimply shut down. I wasnt sleeping, I couldnt think graphs of himself hanging ten, stand as testaments to his own straight, I called my children the wrong names, says Tillman, search for eternal youth. He still surfs when he can, and often 51, a former professional ballroom dancer who now teaches escapes to his vacation home in Cabo, where he grows codance and works with senior citizens. I felt ugly. For an emconut trees for fun. But the place he really likes to be is in the powered woman, this is scary. Now she is taking 15 suppleoffice, tailoring treatments to keep his patients youthful and ments a day and rubbing a cream made of compounded eshappy. Im like the personal family doctor from the Norman trogen into her skin. She feels like her old self. Oh, the relief Rockwell era, he says. to have that cloud gone. By the end of the day, all of the visitors Rothenberg has met The bigger the anti-aging movement gets, the less caution it for the rst time have signed on to be his patients. 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. am speeding toward a birthday that Im needed assurance that Im really much A FIRST-PERSON Chelation involves innot looking forward to. A big onethe younger than my numerical age. ACCOUNT BY ARLENE fusing a patient with kind of birthday that gets lampooned in After the hourlong test, the computer WEINTRAUB chemicals that are beHallmark cards of the sort that will spat out what it thought was my real age: lieved to bind to metals soon start arriving from friends and 45. My heart sank. Im not 45. I cant and clear them out of family. So it was with great anticipation possibly look 45. I hadnt felt so depressed the body. The process that I sat down in front of a machine called about a test since I got a uke D on a high may reverse heart disthe H-Scan, which many anti-aging school geometry midterm. With renewed ease, proponents say. doctors say can determine a persons real sense of purpose, I waited for advice from But it can cost as much age (the age described by the tissues of Dr. Ron Rothenberg of the California as $2,400 and take up to your body, not your drivers license). Healthspan Institute. I was counting on three months. And its The H-Scan uses software and various him to reverse the ravages of time.... heart benets have nevgizmos to assess 12 biomarkers of aging, er been proven, critics including memory, eyesight, hearing, and For a full account of say. The Web site quacklung capacity. I felt sure I would ace the the reporters day at the anti-aging clinic, go to www.businessweek.com/extras. watch.org, run by Dr. test, and in the process garner much Stephen Barrett, has

HOW YOUNG ARE YOU? ASK THE H-SCAN

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(bottom) photograph by andrew popper