• understanding the currently available methods for identifying use of hGH and understanding the viability of urine testing for hGH in the future;
• building a consensus on the most effective methods of implementing widespread blood testing for abuse of hGH;
• identifying future strategies for hGH testing; and
• understanding the United States Laws regarding the regulation and distribution of hGH

The current state of HGH testing involves blood testing. Anti-doping expert Don Catlin supervised growth hormone testing at the 2008 Beijing Olympics which involved approximately 1,000 blood samples; no athlete tested positive for HGH. In fact, no athlete has ever tested positive for human growth hormone using this test which has led many experts to question the effectiveness of the test (“Officials Question a Blood Test That Is Never Positive,” November 10)

Three hours into a conference held Monday by Major League Baseball on human growth hormone, the real question of the day emerged when officials from the commissioner’s office and the players union wondered aloud about how effective the current blood test for human growth hormone was if no one had tested positive.

[...]

Osquel Barroso, the senior manager of science for the World Anti-Doping Agency, was one such expert invited to the conference. WADA, which oversees the testing of Olympic athletes, has tested 8,500 athletes for human growth hormone since 2000 and has never had a test come back positive.

The big news at the Growth Hormone Summit was the increasingly viable urine test for human growth hormone that utilizes nanotechnology to identify urinary HGH markers. Don Catlin, CEO of Anti-Doping Research and Professor Emeritus at the UCLA School of Medicine is collaborating with Lance Liotta, MD, PhD of George Mason University to validate the utility of this test for WADA (“Researchers say they’re getting closer to HGH test,” November 11)

Don Catlin, a Los Angeles-based worldwide doping expert who oversaw blood testing for HGH at the Beijing Olympics, and Dr. Lance Liotta, a former pathology lab chief at the National Cancer Institute’s Center for Cancer Research, have launched a study to build upon Liotta’s ability to identify isolated markers of HGH in urine.

[...]

“This is a groundbreaking step that’ll change the game a bit,” Catlin said Monday at a first-ever Growth Hormone Summit staged at the Beverly Hills Hotel.

Don Catlin is becoming increasingly confident that the new nanotechnology urine test for human growth hormone will offer the ideal solution for HGH testing in sports. Many athletes have objected to the invasive nature of blood testing for HGH which previously seemed to be the only anti-doping measure capable of detecting molecules of such small size. But the nanotechnology technique has apparently overcome that obstacle (“MLB takes part in HGH summit,” November 11)

“That is what is exciting about what Dr. Liotta is doing. He has a technique that we think will do that,” Catlin said. “It is really brilliant.”

Ceres Nanosciences has patented the nanotechnology method of collecting HGH in the urine for analysis by standard lab testing equipment (“Scientists say breakthrough urine test for HGH developed,” July 23)

Virginia-based Ceres Nanosciences, partnered with George Mason University in Fairfax, Va., and Italy’s Istituto Superiore di Sanità, could have the test on the market within six months, company CEO Thomas Dunlap says. Ceres’ intention was first reported by the Washington Business Journal.

Widespread adoption of the test probably would depend on lengthy scientific reviews by anti-doping authorities, leagues and players unions. World Anti-Doping Agency representatives had a conference call with Ceres officials last week, WADA spokesman Frederic Donze says.

In the meantime, should any athletes test positive for human growth hormone, famed doping defense attorney Howard Jacobs was in attendance at the Growth Hormone Summit learning about the weaknesses and challenges of HGH testing that could be useful should he represent a “HGH-positive client” (“Researchers say they’re getting closer to HGH test,” November 11)

Southland attorney Howard Jacobs, who defended cyclist Floyd Landis in his doping case after Landis was stripped of his 2006 Tour de France title, said the summit raised “a lot of questions” that he would likely explore if he ever represents an HGH-positive client. “They haven’t validated any positive athlete samples,” Jacobs said. “You have to wonder how many studies they’ve conducted, plus there’s collection and transport issues.”

The human growth hormone conference also featured the following anti-doping experts and scholars.

• Moutian Wu, laboratory director for the 2008 Beijing Olympics; National Anti-Doping Laboratory and the China Anti-Doping Agency
• Anthony W. Butch, director of the UCLA Olympic Analytical Laboratory
• Dr. Don H. Catlin, founder and director of Anti-Doping Research
• Alan Goldhammer, vice president for scientific and regulatory affairs for Pharmaceutical Research and Manufacturers of America
• Dr. Richard I.G. Holt, professor of diabetes and endocrinology at the University of Southampton School of Medicine (U.K.)
• Dr. Lance Liotta, co-director of the Center for Applied Proteomics and Molecular Medicine at George Mason University
• Robert D. Manfred Jr., executive vice president for labor relations and human resources for Major League Baseball
• Matthew J. Mitten, professor of law and director of the National Sports Law Institute at Marquette University Law School
• Thomas H. Murray, president and CEO of the Hastings Center
• Dr. Thomas T. Perls, director of the New England Centenarian Study
• Dr. Douglas E. Rollins, executive director of the Sports Medicine Research and Testing Laboratory
• Travis T. Tygart, CEO of the United States Anti-Doping Agency (USADA)
• Frank D. Uryasz, president of the National Center for Drug-Free Sport.

Senators Charles Schumer, D-N.Y., and Chuck Grassley, R-Iowa, have dropped language in the bill that would have put HGH on the same legal plane as anabolic steroids, a move that would have severely limited access to the synthetic hormone.

For example, under the bill’s original language, HGH would not have been widely available through the mail and would not have been available in longer than six-month supplies. Because doctors specializing in childhood growth disorders often are far from patients, such controls could have caused hardship for families with children using the drug.

The atmosphere of steroid hysteria resulted in overwhelming bipartisan support for the original HGH bill practically guaranteeing passage of the legislation. When it comes to steroids and performance enhancing drugs, it appears that emotional arguments generally trump intellectual arguments. But fortunately, and surprisingly, the Sen. Schumer and Sen. Grassley rationally examined the evidence of the adverse consequences, particularly for children, of making HGH a Scheduled-III controlled substance. 

“We’ve ran into some things that we didn’t anticipate. We were enlightened by the parents whose children legitimately need HGH,” Grassley told USA TODAY on Tuesday. “Making it (a more tightly controlled substance) would have created a lot of red tape for them.”

Sadly, Sen. Schumer and Sen. Grassley are not students of history when it comes to the Controlled Substances Act; otherwise, they would already known how political misuse of the Controlled Substances Act (especially involving doping in sports) can adversely affect availability of pharmaceuticals for patients who needs these therapies for health, wellness, and survival. The addition of anabolic steroids to the Controlled Substances List with the Anabolic Steroids Control Act of 1990 had adverse unintended consequences for untold numbers of patients who had legitimate medical indications requiring anabolic steroid treatment.

We can thank Sen. Mike Enzi (R-WY) and Sen. Richard Burr (R-NC), who were widely criticized for doing so at the time, for placing a temporary hold on the original HGH legislation thereby allowing reason to prevail over emotion in the Senate. But most credit should go to the MAGIC Foundation, a non-profit organization dedicated to “providing support services to the families of children afflicted with chronic and critical disorders, syndromes, and diseases that affect their growth,” for their activism in the matter.

WADA says the out of competition testing for HGH will begin within weeks The test will be used at the 2008 Beijing Olympics. Additionally, a WADA spokesperson says the the HGH screening kits will be used to analyze previously frozen blood samples from athletes.

The kits will allow doping authorities to analyze blood samples that have been frozen from earlier tests, Howman said.

Given WADA’s secrecy regarding the HGH screening kit, very little is known about the efficacy of the doping test. Daniel Rosen, author of Dope: A History of Performance Enhancement in Sports from the Nineteenth Century to Today, writes on his blog about the criteria for a truly effective human growth hormone test.

• Because most of us produce HGH naturally, the test must be able to effectively distinguish between natural and synthetic HGH. One possible way to do that would be through the use of carbon isotope ratio testing — although there is no guarantee that this technique would be used, or that it is the only method for making the distinction.

• The amount each individual produces is variable, so the criteria for a positive test must take that variability into account.

• Most people produce progressively less HGH as they age, so the amount that would be normally present in a 20-year-old will be different than for the same person at age 40, for example.

• The test should have been thoroughly vetted by peer review, and multiple studies with large enough test groups to draw statistically significant conclusions.

It remains to be seen how effective the HGH test will be. We will most likely learn after the first high profile case puts the new test in the spotlight.

Claims that growth hormone enhances physical performance are not supported by the scientific literature. Although the limited available evidence suggests that growth hormone increases lean body mass, it may not improve strength; in addition, it may worsen exercise capacity and increase adverse events. More research is needed to conclusively determine the effects of growth hormone on athletic performance.

This confirms what J.C. Bradbury, Ph.D. has been saying all along. Bradbury is the Associate Professor of Economics at Kennesaw State University and author of the Sabernomics blog where he has argued again and again that human growth hormone does not enhance athletic performance. According to Bradbury, there is no scientific evidence documenting the performance enhancing effects of growth hormone. He confidently dismisses any effect of HGH in MLB:

The impact of HGH on home runs in today’s game is zero. If a player is dumb enough to take this stuff, let him go right ahead.

Dr. Bradbury is correct at least when it comes to the lack of scientific evidence.

But he may still be wrong about growth hormone’s effects on sport performance.

Athletes knew anabolic steroids worked (anecdotal evidence) for DECADES before available scientific evidence supported this belief. There are several prominent bloggers who argue that, in spite of limited absence of scientific support, growth hormone does improve athletic performance.

Lou Schuler of Male Pattern Fitness points to the credible anecdotal evidence to support his views on growth hormone.

Athletes and their doctors believe the drugs work. I’ve been hearing this for years from the people I come across, who’re mostly trainers and strength coaches. I get a chance to chat with researchers or former pro athletes from time to time, and I hear the same thing. The only way you can convince yourself that human growth hormone doesn’t speed recovery and/or enhance performance is to ignore all the anecdotal evidence that comes from knowledgeable insiders who believe it does.

Lou addresses the shortcomings and limitations of the recent review in an article today (“Don’t Those Stupid Athletes Realize Their Drugs Don’t Work?,” March 18)

Once again, a study attempts to convince us of something that isn’t likely to be true…

To its credit, the story by the Associated Press calls bullshit on itself, citing the litany of limitations to this kind of reasoning that I’ve noted on MPF here and on my original blog here:

• Clinical studies aren’t conducted on elite athletes, and don’t measure “performance” in any way that would be meaningful to an athlete. For example, they don’t consider whether it would help them recover faster in between workouts, or have less downtime because of minor injuries.

• They don’t use the doses elite athletes use, and they can’t possibly take into account the combination of drugs an athlete might employ. Is growth hormone more effective when used simultaneously or in some sort of sequential pattern with anabolic steroids? You can’t test that in a lab.

• The studies can’t possibly track long-term use of HGH, so if there’s a chronic, cumulative effect that’s greater than the acute, short-term effect, you’d never know from the published research.

Gary Gaffney, M.D., University of Iowa School of Medicine, also addresses the review study. Gaffney believes growth hormone has beneficial effects on athletic performance; however, these effects may only be evident in its synergy with other performance-enhancing drugs (“Review from Stanford says HGH no benefit as PED,” March 17).

As we pointed out in the Huffington Post, HGH by itself may not be anabolic. There is evidence that the hormone is synergistic with anabolic steroids (or insulin or T4), which means that the effects of these hormones add to each other. Further, we don’t know the effects of the drugs on the most genetically gifted athletes – professionals.

However, a study is a study. HGH by itself in these doses used in young healthy men does not appear to be an impressive anabolic drug.

Given that athletes were decades ahead of the scientific community when it came to anabolic steroids, I tend to give credence to the anecdotal evidence. Also, based on growth hormone’s use in bodybuilding (whose participants are far ahead of athletes in other sports when it comes to pharmaceutical enhancement), there is a fair amount of support for the synergistic effects of growth hormone combined with anabolic steroids and other drugs.

Nelson Vergel, HIV activist and co-author of Built to Survive, published a letter on his blog that outlines how patients with legitimate medical needs for these pharmaceuticals suffer as a result of the steroid hysteria and legislation that limits the availability of anabolic steroids and human growth hormone (“Hearings on Steroids in Sports and the Impact on Treatments for HIV and other Medical Conditions,” March 12).

The difficulty now is that anabolic steroids are becoming much less available legally because of Federal pressure upon producers. The anabolic steroid most successfully used over the years to combat wasting has been nandrolone decanoate. Up until recently, this product was produced by Watson Pharmaceuticals. In 2007, however, Watson stopped producing nandrolone. Instead, it is promoting Oxandrine, an oral steroid that is less effective and has more adverse side effects, but is also proprietary and therefore commands a higher price. Since then, anyone who needs to use nandrolone must go to compounding pharmacies, which will then produce the medicine on a custom order. At this time, the only anabolic steroids that may be used legally in the United States are Oxandrine and nandrolone. So the choice is Watson’s expensive, less effective, propriety product or use of the compounding pharmacies.

This situation presents two major problems for patients who need anabolic therapies. The first is that a prescription filled by a compounding pharmacy is not covered by insurance or AIDS Drug Assistance Programs (ADAPs), so use of nandrolone is an out-of-pocket expense. Many patients suffering from HIV are in difficult economic circumstance. The added expense frequently puts the medicine out of reach.

The other problem is that compounding pharmacies are now under heavy scrutiny by the Drug Enforcement Agency to ensure that prescriptions are for legitimate medical needs. In theory, this would sound reasonable, but, in practice, the added delays, pressure and bureaucratic requirements have caused many compounding pharmacies to shy away from production of nandrolone. The most popular, Applied Pharmacy of Alabama, was providing the product reliably and at a reasonable price. However, the DEA insisted that the pharmacies verify the medical necessity of each prescription. That is not the role of a pharmacy. That is the role of the doctor writing the prescription. So the DEA regularly comes into the Applied Pharmaceuticals, gathers up all their records and keeps them for an unreasonable amount of time for review purposes. This amounts to blatant harassment solely to suppress production of a legitimate medication. For this reason, Applied Pharmacy has announced that it will no longer provide nandrolone or other hormone-based products. Other compounding pharmacies have similarly so halted production, and this has caused an increase in prices among the remaining producers and confusion among HIV prescribers who wrongly assume that nandrolone is no longer available in the U.S.

I have generously excerpted from this detailed letter written by Mark A. Meier, a constituent in Representative Nancy Pelosi’s district. I encourage readers to carefully read the entire letter at Nelson’s HIV blog to see see what is at stake.

Here’s the problem: The proposed legislation would re-classify HGH as a Schedule III drug, increasing penalties for its illegal use and limiting access in several ways. The penalties are fine, the parents agree. Limiting access for growth-challenged kids is the deal breaker.

The Champs, for example, would need to go to Mount Sinai Hospital in Manhattan once every month for a new prescription, which would last 30 days. Currently with each visit, they are able to obtain a three-month supply of HGH, with two refills. They only need to go once every nine months. Meanwhile, their insurance co-pays would triple for the extra doses.

Bondy blames the athletes for this problem. However, the immediate culprit is obviously Congress’ ill-informed attempts to eliminate steroids in sport by expanding the Controlled Substances Act to include non-addictive human growth hormone.

I do not understand why Congress thinks scheduling performance enhancing drugs is an effective tool for eliminating steroids in sports. I am not aware of many any professional athletes who have been prosecuted under the Anabolic Steroids Control Act. I can not name a single athlete who has failed a doping test in the United States and was criminally sanctioned as a result. History tells us that the Controlled Substances Act is ineffective at punishing professional athletes who use steroids. Including human growth hormone on the Controlled Substances list will only be another failure in more ways than one.

Now, perjury is another story. This seems to be a highly effective tool for punishing athletes who use steroids based on perjury investigations involving Barry Bonds, Marion Jones, Tammy Thomas, and Roger Clemens.

John Lombardo, has granted waivers to players who have failed drug tests but then explained their medical need for testosterone. NFL spokesman Greg Aiello won’t disclose names or reveal how many players have been allowed to pump synthetic hormones into their bodies except to say it’s “a very small number.”

This is the National League Football (NFL) version of the therapeutic use exemption that can be submitted after failing a drug test. An interesting article by Tom Farrey of ESPN the Magazine suggests this is a precedent opening the door to widespread use of hormones in sports like football.

It’s a little-used exemption to the league’s drug policy, but it’s a precedent-setting one: Any player who can show that replacing hormones is critical to his continued health should be allowed to take them.

The demonization of anabolic steroids and performance-enhancing drugs in sports fails when there is a legitimate medical need for treatment. No longer are anabolic steroids and growth hormone categorically bad or dangerous.

Tom Farrey cites recent studies showing that mild concussions can cause brain damage (pituitary dysfunction) resulting in growth hormone and/or testosterone deficiencies.

Players with testicular disease are not the only ones in need. At the base of the brain, encased in a small, bony shell, is a pea-size gland called the pituitary, which secretes hormones that help regulate everything from mood to energy level. For years, the gland had been overlooked in discussions of head trauma. But in the late 1990s, UCLA neurosurgeon Daniel Kelly noticed that many of his head-injury patients suffered from symptoms associated with pituitary failure: depression, fatigue, anxiety, poor concentration. His findings, which he published in 2000, have led to at least eight studies on three continents, which together involved more than 600 subjects. Each study confirmed the link between traumatic brain injury (TBI) and a loss of hormonal function. The most common deficiencies in men were those of growth hormone, which occurred in 15% to 20% of cases, and of testosterone, in 10% to 15%.

Most of the subjects in these studies had suffered a moderate or severe TBI with some bleeding in the head during a car accident, a fall or some other nonsports-related activity. But, Kelly says, “if you look at the literature, there’s a small but definite component of patients with milder head injuries who also lose hormonal function.” One study, in Italy, found pituitary dysfunction in as many as 37.5% of patients with mild TBI, the same level of injury NFL players typically incur when they get dinged.

Another interesting bit of information from this article includes information from World Anti-Doping Association (WADA) about the number of therapeutic use exemptions granted for testosterone and growth hormone.

International sports federations overseen by WADA have granted 15 therapeutic-use exemptions for HGH and 26 for testosterone.

As a society, we’ve already accepted brain damage as an acceptable consequence of playing certain sports. This likely risk in football from concussions doesn’t make the sport unacceptable. Yet, the dangers from anabolic steroids and growth hormone will likely continue to be unacceptable. At the very least, let’s hope that exemptions for the therapeutic use of steroids and other performance enhancing drugs is permitted in sports to preserve the health of affected athlete’s. (Therapeutic use by definition means the benefit outweighs the risk of harm.)

Thanks to Radley Balko for pointing us to this article. He also makes the following comment on the hypocritical concern given to the health of (football) athletes subjected to drug testing:

The league has banned HGH (on very little evidence), allegedly to protect its players from the harm it allegedly does to their health. But the game of football itself is causing debilitating, potentially life-threatening injuries to players, and we think little of it. These injuries are the entirely predictable result of the slobber-knocking hits that make the game so much fun to watch, both live, and from the six different angles in various highlight packages on SportsCenter.