Sorting out the hGH issue

Read the Novo Nordisk study findings

He is a quack. A kook. A huckster. The medical world looks at Ronald Klatz, the man who started the anti-aging medicine industry, and sees nothing more than a brilliant businessman who made hay off vulnerability and naïveté. They certainly don't see a doctor.

Such personal slights no longer bother Klatz. He just wants the establishment to listen. He has a lot to say about human growth hormone (hGH). He believes it's a drug that, if used properly, will change how we live – and could change professional sports for the better.

Take a sprained ankle. When a 16-year-old rolls his in a basketball game, he's back two days later. When a 40-year-old twists his during a pickup run, he takes two weeks to recover. The injury is the same. The difference, Klatz says, is in the pituitary glands' production of growth hormone: teenagers' pump with vigor, middle-aged men's drip meekly.

Unless, of course, they supplement them with synthetic hGH.

"There is this Puritan ethic in our country that anything in sports that isn't totally natural is bad," said Klatz, the author of "Grow Young with HGH." "I'm not saying it's right or wrong. I am for progress."

What Klatz considers progress Major League Baseball considers cheating, and hGH is now at the center of professional sports' great debate. Without a reliable test to detect the drug and with the IRS Criminal Investigation unit busting former Arizona relief pitcher Jason Grimsley in possession of $3,200 worth, hGH – illegal to use except in specific medical cases – remains among the most stigmatized drugs.

There is a growing group, however, touting injectible hGH for its therapeutic properties. According to an affidavit filed by IRS Special Agent Jeff Novitzky, "Grimsley added that he began using human growth hormone for its healing abilities," evidenced, perhaps, by his remarkably fast return from Tommy John surgery in 10 months. Former New York Yankees catcher Jim Leyritz told the New York Post he tried hGH to recover from shoulder surgery.

Countless others – some of whom Grimsley allegedly named – used hGH, too, which begs the question: What if Klatz is right? What if hGH does help athletes recover from injuries at a more rapid pace? Teams employ athletic trainers and doctors to bring back players as quickly as possible, and if research proved hGH safe and effective, there would seem a compelling case for using it regularly in rehabilitation instead of vilifying it.

Novo Nordisk, a Denmark-based healthcare company studying growth hormone therapy, could have that first slice of evidence. Over the last four years, a medical team studied the efficacy and safety of treating tibia fractures with somatropin (synthetic hGH) shots in Germany, Israel and South Africa. Their conclusion, as presented in March at the Orthopaedic Research Society annual meeting in Chicago:

"In closed (not breaking the skin) tibial fractures, hGH treatment accelerated healing significantly, which may be of benefit in people with closed fractures. No new hGH safety issues were identified."

Dr. Anders Dejgaard, the medical director at Novo Nordisk, said the research is close to publication in the New England Journal of Medicine. If so, the study could have an even greater effect than Dr. Daniel Rudman's seminal 1990 article in the New England Journal that spawned the hGH craze. Rudman's research showed the patients, men between 61 and 81 years old, experienced increased muscle mass, reduction of body fat and a slow-down of bone erosion while using hGH. Other studies since have concluded that hGH does little else and also causes swelling, joint pain and Carpal Tunnel syndrome.

"There could be a clinical trial that could be done on healing properties within a year or two, and that kind of clinical trial would be worth using," said Jay Olshansky, a professor of epidemiology at the University of Illinois-Chicago and co-author of an article in the Journal of the American Medical Association about illegal hGH distribution for anti-aging purposes. "Especially if you have a number of athletes who have used it and claimed a benefit. I'm all for proper evaluation and use of these substances as long as they've been properly evaluated. And there's potential there."

For this debate and the countless hours of good old-fashioned baseball discussion it will cause, Jason Grimsley, a 38-year-old relief pitcher on the downside of his career, is to blame.

Until Grimsley was pinched, hGH was the latest elephant ignored by MLB and the players' association. It always made the league's drug policy look a tad silly; while it made sense to ban a drug similar to anabolic steroids, why bother if there is no reliable test and samples are being destroyed?

All other matters hGH-related are serious and far-reaching, from scientific to criminal to monetary to moral. Why hGH matters goes further than sports.

Baseball, which seems to have plenty to lose in the hGH debate – trust, popularity and the veracity of already-questionable records – seems unbothered. The league still hasn't followed through with its proposed donation to help detect the drug via a urine test.

"It is important for you to understand that baseball has announced an intention to fund my proposal on growth hormone; however, they have not yet funded the grant," Don Catlin, the UCLA pharmacologist attempting to formulate a urine test for hGH, said via e-mail last week. "It is still in the discussion/negotiation stage."

Then again, Catlin and others admit, if and when MLB comes around with its funding, the likelihood it goes for naught is greater than not.

"Based on the views and technical knowledge of international experts working with WADA on research projects for hGH, urine testing for hGH does not currently appear very promising in comparison with detection of hGH in blood," said Olivier Rabin, the World Anti-Doping Association's director of science, by e-mail from Spain, where he's investigating a doping controversy. "Experts estimate that less than 1 (percent) of hGH can be detected in urine."

As such, law-enforcement officials will continue to focus on the suppliers. More than 30 percent of hGH prescriptions in the United States, Olshansky wrote, are for illegal reasons, including athletic-performance-enhancing and anti-aging.

Even though hGH is not classified as a controlled substance like anabolic steroids, it remains illegal to possess and use in all but three cases: short stature in children, wasting diseases such as AIDS and growth hormone deficiency in adults.

Still, hGH is big money. Most of the major pharmaceutical companies produce a version of somatropin, and Olshansky's article estimates worldwide sales of hGH between $1.5 and $2 billion per year. A Florida court ordered two businesses to pay $20 million in consumer redress after claiming an under-the-tongue spray would increase their levels of hGH. It was the largest judgment in the history of medical-fraud cases, according to the Federal Trade Commission, though a pittance of the companies' total sales: more than $70 million.

With hGH a given in everyday life, it was only a matter of time until it seeped into sports. Steroid testing in baseball made it an even more attractive drug, and its reputation as a healer only enhanced hGH's allure. Yet skeptics remain, from those who regard any type of performance-enhancing drug as cheating to medical professionals who won't change years of tuned practices based on anecdotal evidence.

"If something like this were magical or universal, you'd see it commonly in practice with the physicians," said one major-league athletic trainer. "I know I don't see or hear about it.

"Sounds like somebody's hypothesis of what could take place. Things are so new on that front that there haven't been studies or research. Bottom line: As athletic trainers, we're going to respond off of what the medical society deems appropriate."

The search for hGH started in a Berkeley, Calif., basement.

Choh Hao Li was a young Ph.D. graduate, and with anti-Asian sentiment raging in the 1930s, he took a job working in the University of California's Experimental Biology Laboratory. In the building's depths, Li was at the forefront of isolating hormones. He graduated to a bigger office and greater stature and, 32 years after he first tried, finally synthesized hGH from the pituitary glands of human cadavers.

In the liver, Li learned, hGH converts to insulin-like growth factor-1, another agent that promotes growth. (The synthesized version of IGF-1, Increlex, is thought to be another muscle-building drug used by athletes; it is not on baseball's list of banned substances.) Doctors used hGH synthesized from humans until it was linked to Creutzfeldt-Jakob disease, a fatal neurological disorder. The synthetic version of hGH was released in 1985, and it combined seamlessly with the growth hormone the body naturally produces.

Three years later, with steroids making headlines amid Ben Johnson's positive test at the Seoul Olympics, Congress' amended Food, Drug and Cosmetic Act – one introduced 50 years earlier, long before hGH was even synthesized – instilled harsher penalties for steroid and hGH distribution. The only uses for hGH, according to the U.S. Code, were "treatment of a disease" or a Secretary of Health and Human Services-sanctioned "other recognized medical condition."

Performance-enhancing drugs – more steroids than hGH – were suddenly the villain, and they had already begun creeping into baseball.

"In sports, everyone loves a good controversy," Klatz said. "Now people have a podium to stand on. It's like the issue of anabolic steroids. In the right hands, they're very healthy, very good things. In the wrong hands, you have a problem with abuse."

Before reading the Rudman study, Klatz had heard of hGH. After seeing the conclusion – "Diminished secretion of growth hormone is responsible in part for the decrease of lean body mass, the expansion of (fatty)-tissue mass, and the thinning of the skin that occur in old age" – he wanted to deliver the aging what he felt were their rightful doses of hGH, an expensive drug that could become more easily acquired with the recent FDA approval of Omnitrope, a generic version of somatropin.

Klatz, who has an M.D. from Central America Health Sciences University in Belize as well as a doctorate of osteopathy, founded the American Academy for Anti-Aging Medicine in August 1992 and incorporated in 1993. He encouraged the use of hGH even after a 1996 study at Veterans Affairs Medical Center in Milwaukee concluded the drug was more fake truth than Fountain of Youth.

That hasn't deterred hGH's popularity, nor law enforcement's zealous pursuit of it. From 1993 to 2002, the FDA's Office of Criminal Investigations averaged seven hGH cases per year. In 2003, it jumped to 17. The next year it was 32. And in 2005, the OCI sought 55 hGH-related cases.

At the same time, a section of the National Institute of Health's Web site that monitors ongoing and completed clinical trials lists more than 100 involving hGH.

What is a performance-enhancing drug?

Is it a substance that allows a player to perform at his peak level? In that case, Tylenol could be deemed a performance-enhancing drug to any player with a headache.

Is it a solution for a nagging problem? In that case, cortisone shots could be deemed performance-enhancing drugs for players with sore shoulders or knees.

"I don't think cortisone is actually used in that manner," the trainer said. "Cortisone is used as a treatment where, because of the ability to localize around an area where there's an injury, it's stable."

Fair point. The root of contention with testosterone boosters is that they give users distinct advantages over non-users. Yet biology does that, too. It is likely that Julio Franco, at 47 the oldest player in baseball, has among the lowest growth hormone levels. Is age a penalty, or should Franco be able to, much like a car low on oil, top off at a level healthy enough so there's no spillage?

"People are just behind the times," Klatz said. "This is the same reason the scientific establishment said Christopher Columbus was going to sail off the end of the world. I can't help it if certain people in my profession have a closed mind of reality.

"Hundreds of thousands of children and thousands of adults have used growth hormone. If this was really a dangerous drug, don't you think we'd have bodies lined up on the street? Don't you think we'd have the FDA up in arms? There's no evidence they can hang their hat on."

Counters Olshansky, who, along with co-author Thomas Perls, is being sued by the American Academy of Anti-Aging Medicine: "I don't think anyone can prove it wrong, but I don't think anyone can prove it right, and that's more important. Anyone can claim a benefit for anything. I could grind up glass into a powder and claim it has anti-aging properties and ask anyone to prove me wrong, and no one could do so. It's not the proof of negative; it's the proof of the positive."

Novo Nordisk's study could be the start. And likewise it could further complicate baseball's problems. What if the drug it's looking to snuff out now becomes a staple in doctors' offices across the country? Can baseball ever embrace something that spurred a loss of faith in the game?

Just like everything else that relates to performance-enhancing drugs, the questions will answer themselves. And separate the hucksters from the doctors, the truth from the lies and baseball from a sordid past or, perhaps, a time of great advance.