AP IMPACT: Big Pharma cashes in on HGH abuse

A federal crackdown on illicit foreign supplies of human growth hormone has failed to stop rampant misuse, and instead has driven record sales of the drug by some of the world's biggest pharmaceutical companies, an Associated Press investigation shows.

The crackdown, which began in 2006, reduced the illegal flow of unregulated supplies from China, India and Mexico.

But since then, Big Pharma has been satisfying the steady desires of U.S. users and abusers, including many who take the drug in the false hope of delaying the effects of aging.

From 2005 to 2011, inflation-adjusted sales of HGH were up 69 percent, according to an AP analysis of pharmaceutical company data collected by the research firm IMS Health. Sales of the average prescription drug rose just 12 percent in that same period.

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EDITOR'S NOTE — Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the second of a two-part series.

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Unlike other prescription drugs, HGH may be prescribed only for specific uses. U.S. sales are limited by law to treat a rare growth defect in children and a handful of uncommon conditions like short bowel syndrome or Prader-Willi syndrome, a congenital disease that causes reduced muscle tone and a lack of hormones in sex glands.

The AP analysis, supplemented by interviews with experts, shows too many sales and too many prescriptions for the number of people known to be suffering from those ailments. At least half of last year's sales likely went to patients not legally allowed to get the drug. And U.S. pharmacies processed nearly double the expected number of prescriptions.

Peddled as an elixir of life capable of turning middle-aged bodies into lean machines, HGH — a synthesized form of the growth hormone made naturally by the human pituitary gland — winds up in the eager hands of affluent, aging users who hope to slow or even reverse the aging process.

Experts say these folks don't need the drug, and may be harmed by it. The supposed fountain-of-youth medicine can cause enlargement of breast tissue, carpal tunnel syndrome and swelling of hands and feet. Ironically, it also can contribute to aging ailments like heart disease and Type 2 diabetes.

Others in the medical establishment also are taking a fat piece of the profits — doctors who fudge prescriptions, as well as pharmacists and distributors who are content to look the other way. HGH also is sold directly without prescriptions, as new-age snake oil, to patients at anti-aging clinics that operate more like automated drug mills.

Years of raids, sports scandals and media attention haven't stopped major drugmakers from selling a whopping $1.4 billion worth of HGH in the U.S. last year. That's more than industry-wide annual gross sales for penicillin or prescription allergy medicine. Anti-aging HGH regimens vary greatly, with a yearly cost typically ranging from $6,000 to $12,000 for three to six self-injections per week.

Across the U.S., the medication is often dispensed through prescriptions based on improper diagnoses, carefully crafted to exploit wiggle room in the law restricting use of HGH, the AP found.

HGH is often promoted on the Internet with the same kind of before-and-after photos found in miracle diet ads, along with wildly hyped claims of rapid muscle growth, loss of fat, greater vigor, and other exaggerated benefits to adults far beyond their physical prime. Sales also are driven by the personal endorsement of celebrities such as actress Suzanne Somers.

Pharmacies that once risked prosecution for using unauthorized, foreign HGH — improperly labeled as raw pharmaceutical ingredients and smuggled across the border — now simply dispense name brands, often for the same banned uses. And usually with impunity.

Eight companies have been granted permission to market HGH by the U.S. Food and Drug Administration, which reviews the benefits and risks of new drug products. By contrast, three companies are approved for the diabetes drug insulin.

The No. 1 maker, Roche subsidiary Genentech, had nearly $400 million in HGH sales in the U.S. last year, up an inflation-adjusted two-thirds from 2005. Pfizer and Eli Lilly were second and third with $300 million and $220 million in sales, respectively, according to IMS Health. Pfizer now gets more revenue from its HGH brand, Genotropin, than from Zoloft, its well-known depression medicine that lost patent protection.

On their face, the numbers make no sense to the recognized hormone doctors known as endocrinologists who provide legitimate HGH treatment to a small number of patients.

Endocrinologists estimate there are fewer than 45,000 U.S. patients who might legitimately take HGH. They would be expected to use roughly 180,000 prescriptions or refills each year, given that typical patients get three months' worth of HGH at a time, according to doctors and distributors.

Yet U.S. pharmacies last year supplied almost twice that much HGH — 340,000 orders — according to AP's analysis of IMS Health data.

While doctors say more than 90 percent of legitimate patients are children with stunted growth, 40 percent of 442 U.S. side-effect cases tied to HGH over the last year involved people age 18 or older, according to an AP analysis of FDA data. The average adult's age in those cases was 53, far beyond the prime age for sports. The oldest patients were in their 80s.

Some of these medical records even give explicit hints of use to combat aging, justifying treatment with reasons like fatigue, bone thinning and "off-label," which means treatment of an unapproved condition. In other cases, the drug was used "for an unknown indication," meaning that the reason for treatment wasn't clear.

Even Medicare, the government health program for older Americans, allowed 22,169 HGH prescriptions in 2010, a five-year increase of 78 percent, according to data released by the Centers for Medicare and Medicaid Services in response to an AP public records request. And nearly half the increase came in one year: 2007.

"There's no question: a lot gets out," said hormone specialist Dr. Mark Molitch of Northwestern University, who helped write medical standards meant to limit HGH treatment to legitimate patients.

And those figures don't include HGH sold directly by doctors without prescriptions at scores of anti-aging medical practices and clinics around the country. Those numbers could only be tallied by drug makers, who have declined to say how many patients they supply and for what conditions.

The AP approached every U.S.-authorized manufacturer to ask what efforts they make to market responsibly and prevent abuse. Only one HGH supplier, Novo Nordisk, agreed to an interview.

"We're doing our level best to make sure that the right patients are getting the right medicine at the right time," said company spokesman Ken Inchausti.

He said the company is aware of the abuse issue. He said if patients apply for assistance from the company's patient-support hub, prescriptions will be flagged for review if they are missing the most rigorous test or an endocrinologist's signature. He said the company won't sell HGH directly to doctors accused of bad practices and does not deal with anti-aging clinics.

Representatives of other FDA-approved HGH makers insist they do not encourage use by bodybuilders or athletes or wealthy baby boomers trying to recapture their youth. But some said they are largely powerless to control who uses their medications or why.

"Lilly cannot restrict the actions of distributors, pharmacies or doctors," Eli Lilly spokeswoman Kelley Murphy said in a written statement.

That argument doesn't fly for critics like Dr. Peter Rost, a retired Pfizer executive who filed a whistleblower lawsuit over the HGH marketing practices of Pharmacia, which later merged with Pfizer. He said drug companies are simply looking the other way and betting that their profits will eclipse the cost of any fines.

They view it as "good business," he said.

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PEDDLED ON INTERNET

Type "human growth hormone" into any Internet search engine, and it will spit back countless websites with overblown promises of smoother skin, better sex, weight loss and even renewed body organs.

Any doctor who actually prescribes the drug for those purposes is taking a legal risk.

FDA regulations ban the sale of HGH as an anti-aging drug. In fact, since 1990, prescribing it for things like weight loss and strength conditioning has been punishable by 5 to 10 years in prison.

Such marketing claims are routinely made at hormone clinics like Palm Beach Life Extension, whose owners are among 13 people now awaiting trial on federal charges in Florida in a steroids and HGH distribution case brought last year.

"Grow YOUNG with Us!" screamed a banner on the company's now-defunct website, which advertised that HGH can reduce body fat, improve vision, strengthen the immune system, aid kidney function, lower blood pressure and enhance memory and mood.

The clinic arranged to have its clients' prescriptions filled at Treasure Coast Pharmacy, in Jensen Beach, Fla.

In 2009, the FBI recorded a phone call between the pharmacy's owner, Peter Del Toro, and a doctor in Elkton, Md., who was cooperating with agents after being implicated in a related steroid-distribution case.

Their talk, documented in a court filing, illustrates how things often work in the networks of pharmacies and clinics that drive HGH sales.

Patients submitted a medical history form by mail and took a blood test. But in most instances, the indictment said, the evaluation was a sham: One doctor was charged with giving a clinic a pad of blank, signed prescriptions to save him the chore of signing off on each diagnosis. He got $50 for every drug order bearing his name, the indictment said.

Dr. Rodney Baltazar, the Maryland physician cooperating with the FBI, sometimes consulted briefly with patients via webcam. But he made it clear in the call that those evaluations were perfunctory at best.

Baltazar was a gynecologist, not an endocrinologist. He said he knew "a little bit" about HGH and testosterone, which are often prescribed in tandem, but he relied largely on clinic salespeople to set doses.

The pharmacist coached the doctor: Keep detailed medical charts documenting that patients are taking the drug for at least some kind of health problem, just in case the U.S. Drug Enforcement Administration ever came calling.

"Because somebody questions you, you want to be able to say, 'Here, look at his chart. You know, he's got fatigue. He's got, you know, a decreased sex drive. He's got increased body fat. He has some -- some slight depression, probably.' Whatever his signs and symptoms are."

None of these conditions is a legal reason to prescribe HGH. But the pharmacist said that most investigators will be satisfied and move on "because there's guys that are just selling stuff basically like a boiler room."

Del Toro was arrested along with 12 other people in September 2011 on charges that they distributed steroids and human growth hormone to people who had no legitimate medical need. He is awaiting trial. His lawyer declined to comment. Baltazar was sentenced to six months in prison for involvement in steroid distribution schemes.

At the height of the crackdown in 2007, the federal government went after Pfizer in a case involving anti-aging clinics. The company paid $34.7 million in fines to settle the case — 11 percent of the company's annual revenue from the drug.

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TROUBLED HISTORY

Blockbuster U.S. sales of HGH represent the latest frustration in 25 years of government efforts to control abuse of the growth drug made infamous by sports scandals.

First marketed in 1985 for children with stunted growth, HGH was soon misappropriated by adults intent on exploiting its modest muscle- and bone-building qualities. Congress limited HGH distribution to the handful of rare conditions in an extraordinary 1990 law, overriding the generally unrestricted right of doctors to prescribe medicines as they see fit.

Despite the law, illicit HGH spread around the sports world in the 1990s, making deep inroads into bodybuilding, college athletics, and professional leagues from baseball to cycling. The even larger banned market among older adults has flourished more recently.

For years, cheaper supplies from unauthorized foreign factories, particularly in China, fed the market via direct and Internet sales that sidestepped the medical establishment.

Though such shipments were banned under other law, the imports initially attracted little attention because they were usually labeled as raw pharmaceutical ingredients, which compounding pharmacies are allowed to bring into the country.

That flow began to be curtailed in 2006, when U.S. drug authorities stepped up efforts to block shipments at the border.

A handful of pharmacies across the country were hit with criminal charges over their handling of HGH. Federal prosecutors charged China's biggest HGH maker, GeneScience Pharmaceutical, with illegally distributing its Jintropin brand in the U.S. The company's CEO pleaded guilty in 2010.

With illicit supplies crimped, many pharmacies stopped selling unauthorized HGH. But tens of thousands of adult abusers began buying pricey U.S.-approved HGH that remained available in abundant supply, the AP found in its analysis of sales data.

Thus, pushed by a powerful demand, sales of U.S.-approved brands have swelled far beyond expected levels for a drug approved in just a handful of rare conditions.

Dr. Robert Marcus, a retired hormone specialist who left HGH manufacturer Eli Lilly and Co. in 2008, said that company was bent on stopping foreign counterfeits, not on cutting off abusers. "That's where their major level of frustration was — pharmaceutical fraud — rather than focusing on people who were using growth hormone illegitimately," he said.

Dr. Jim Meehan, of Tulsa, Okla., who has used HGH to treat aging problems and sports injuries, said the federal clampdown "never seemed to affect my patients and their ability to get Omnitrope, Tev-Tropin" and other government-approved brands.

The big drug companies have applauded the foreign crackdown and urged the government to do even more to combat sales of fake or fraudulently labeled HGH. In 2004, Bruce Kuhlik, speaking for the Pharmaceutical Research and Manufacturers of America, told a federal task force that unauthorized drug importation "is inherently unsafe" and industry representatives used Chinese HGH imports as their poster child.

In 2007, as the HGH embargo gained momentum, authorized makers picked up 41 percent more HGH orders, raising their annual total from 245,000 to 345,000, according to the analysis of the IMS Health data. Similarly, most of the drug's sales boom happened in the first two years of the crackdown, with 46 percent inflation-adjusted growth in yearly sales to $1.1 billion.

Steve Kleppe, of Scottsdale, Ariz., a restaurant entrepreneur who has taken HGH for almost 15 years to keep feeling young, said he noticed a price jump of about 25 percent after the block on imports. He now buys HGH directly from a doctor at an annual cost of about $8,000 for himself and the same amount for his wife.

Despite higher prices, the business has expanded in recent years largely on the strength of sales to healthy adults who can afford to indulge their hope of retaining youthful vigor.

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GROWING OLD

Many older patients go for HGH treatment to scores of anti-aging practices and clinics heavily concentrated in retirement states like Florida, Nevada, Arizona and California.

These sites are affiliated with hundreds of doctors who are rarely endocrinologists. Instead, many tout certification by the American Board of Anti-Aging and Regenerative Medicine, though the medical establishment does not recognize the group's bona fides.

The clinics offer personalized programs of "age management" to business executives, affluent retirees, and other patients of means, sometimes coupled with the amenities of a vacation resort.

The clinics insist there are few, if any, side effects from HGH. Mainstream medical authorities say otherwise.

A 2007 review of 31 medical studies showed swelling in half of HGH patients, with joint pain or diabetes in more than a fifth. A French study of about 7,000 people who took HGH as children found a 30 percent higher risk of death from causes like bone tumors and stroke, stirring a health advisory from U.S. authorities.

For proof that the drug works, marketers turn to images like the memorable one of pot-bellied septuagenarian Dr. Jeffry Life, supposedly transformed into a ripped hulk of himself by his own program available at the upscale Las Vegas-based Cenegenics Elite Health. (He declined to be interviewed.)

These promoters of HGH say there is a connection between the drop-off in growth hormone levels through adulthood and the physical decline that begins in late middle age. Replace the hormone, they say, and the aging process slows.

"It's an easy ruse. People equate hormones with youth," said Dr. Tom Perls, a leading industry critic who does aging research at Boston University. "It's a marketing dream come true."

Some scientific studies of HGH have found modest benefits: some muscle and bone building, as well as limited fat loss, but nothing like the claims of the anti-aging industry. And some of the value credited to HGH may instead come from testosterone, which is routinely provided with HGH by anti-aging doctors and sports suppliers.

Endocrinologists say it's natural for the body to produce less growth hormone as people age beyond their early 20s, because they aren't growing anymore. Only a tiny number of adults with extraordinarily low HGH levels — perhaps several thousand of them — are believed to suffer real deficiencies that can properly be treated with the hormone.

Still, anti-aging doctors routinely diagnose otherwise healthy middle-aged people with an HGH deficiency, simply because their levels are lower than in young adults. "Basically anyone going through midlife," can benefit from the drug, declared one prescriber, Dr. Howard Elkin, of Whittier, Calif., who has himself competed as a bodybuilder.

Dr. Kenneth Knott, of Marietta, Ga., said HGH helps his older patients feel "more vibrant" and look "more alive."

Like many anti-aging doctors, he diagnoses patients by testing for a blood component called insulin growth factor, which is indirectly tied to HGH. Endocrinologists use a more authoritative test that stimulates the pituitary gland to make HGH itself. Nearly all insurers insist on this stimulation testing, and that's why clinic patients almost always pay for HGH out of their own pockets.

Bob Vitols, a 50-year-old lab assistant at a veterinary medicine company in Lincoln, Neb., is a rare exception. His unusually generous health plan isn't allowed to challenge a doctor's prescription.

Four years ago, Vitols began feeling run down. So he Googled his symptoms on the Internet, decided he had a hormone deficiency, and sought out a clinic.

One doctor put him on testosterone replacement therapy. A second clinic added HGH after diagnosing him with osteopenia, a mild bone thinning common in aging adults. It is not, however, a condition that can properly be treated with HGH.

Despite the diagnosis, the treatments — which can cost $10,000 per year — have been covered by his health insurance, he said. He takes Genotropin, the HGH made by Pfizer. His prescriptions are filled via mail order by CVS Caremark Corp., one of the largest dispensers of prescription drugs in the U.S.

Vitols said the drug changed his life: his mood is better, and he isn't burning out every day at 2 p.m. "I feel like I could walk outside and just walk through a fence — and come out fine on the other side," he said.

His experiences with the drug haven't all been positive, though. Vitols said he initially developed elevated liver enzymes and went to a specialist, who told him to stop taking hormones immediately.

Instead, Vitols said, he adjusted his dosage, and the problem disappeared.

He also dumped the specialist:

"I could tell he was against hormones right at the start," Vitols said.

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Associated Press Writer David Caruso reported from New York and AP National Writer Jeff Donn reported from Plymouth, Mass. AP Writer Troy Thibodeaux provided data analysis assistance from New Orleans.

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AP's interactive on the HGH investigation: http://hosted.ap.org/interactives/2012/hgh

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The AP National Investigative Team can be reached at investigate(at)ap.org

EDITOR'S NOTE _ Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the second of a two-part series.

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AP IMPACT: Steroids loom in major-college football

WASHINGTON (AP) — With steroids easy to buy, testing weak and punishments inconsistent, college football players are packing on significant weight — 30 pounds or more in a single year, sometimes — without drawing much attention from their schools or the NCAA in a sport that earns tens of billions of dollars for teams.

Rules vary so widely that, on any given game day, a team with a strict no-steroid policy can face a team whose players have repeatedly tested positive.

An investigation by The Associated Press — based on dozens of interviews with players, testers, dealers and experts and an analysis of weight records for more than 61,000 players — revealed that while those running the multibillion-dollar sport believe the problem is under control, that is hardly the case.

The sport's near-zero rate of positive steroids tests isn't an accurate gauge among college athletes. Random tests provide weak deterrence and, by design, fail to catch every player using steroids. Colleges also are reluctant to spend money on expensive steroid testing when cheaper ones for drugs like marijuana allow them to say they're doing everything they can to keep drugs out of football.

"It's nothing like what's going on in reality," said Don Catlin, an anti-doping pioneer who spent years conducting the NCAA's laboratory tests at UCLA. He became so frustrated with the college system that it drove him in part to leave the testing industry to focus on anti-doping research.

Catlin said the collegiate system, in which players often are notified days before a test and many schools don't even test for steroids, is designed to not catch dopers. That artificially reduces the numbers of positive tests and keeps schools safe from embarrassing drug scandals.

While other major sports have been beset by revelations of steroid use, college football has operated with barely a whiff of scandal. Between 1996 and 2010 — the era of Barry Bonds, Mark McGwire, Marion Jones and Lance Armstrong — the failure rate for NCAA steroid tests fell even closer to zero from an already low rate of less than 1 percent.

The AP's investigation, drawing upon more than a decade of official rosters from all 120 Football Bowl Subdivision teams, found thousands of players quickly putting on significant weight, even more than their fellow players. The information compiled by the AP included players who appeared for multiple years on the same teams, making it the most comprehensive data available.

For decades, scientific studies have shown that anabolic steroid use leads to an increase in body weight. Weight gain alone doesn't prove steroid use, but very rapid weight gain is one factor that would be deemed suspicious, said Kathy Turpin, senior director of sport drug testing for the National Center for Drug Free Sport, which conducts tests for the NCAA and more than 300 schools.

Yet the NCAA has never studied weight gain or considered it in regard to its steroid testing policies, said Mary Wilfert, the NCAA's associate director of health and safety. She would not speculate on the cause of such rapid weight gain.

The NCAA attributes the decline in positive tests to its year-round drug testing program, combined with anti-drug education and testing conducted by schools.

"The effort has been increasing, and we believe it has driven down use," Wilfert said.

Big gains, data show

The AP's analysis found that, regardless of school, conference and won-loss record, many players gained weight at exceptional rates compared with their fellow athletes and while accounting for their heights. The documented weight gains could not be explained by the amount of money schools spent on weight rooms, trainers and other football expenses.

Adding more than 20 or 25 pounds of lean muscle in a year is nearly impossible through diet and exercise alone, said Dan Benardot, director of the Laboratory for Elite Athlete Performance at Georgia State University.

The AP's analysis corrected for the fact that players in different positions have different body types, so speedy wide receivers weren't compared to bulkier offensive tackles. It could not assess each player's physical makeup, such as how much weight gain was muscle versus fat, one indicator of steroid use. In the most extreme case in the AP analysis, the probability that a player put on so much weight compared with other players was so rare that the odds statistically were roughly the same as an NFL quarterback throwing 12 passing touchdowns or an NFL running back rushing for 600 yards in one game.

In nearly all the rarest cases of weight gain in the AP study, players were offensive or defensive linemen, hulking giants who tower above 6-foot-3 and weigh 300 pounds or more. Four of those players interviewed by the AP said that they never used steroids and gained weight through dramatic increases in eating, up to six meals a day. Two said they were aware of other players using steroids.

"I just ate. I ate 5-6 times a day," said Clint Oldenburg, who played for Colorado State starting in 2002 and for five years in the NFL. Oldenburg's weight increased over four years from 212 to 290, including a one-year gain of 53 pounds, which he attributed to diet and two hours of weight lifting daily. "It wasn't as difficult as you think. I just ate anything."

Oldenburg told the AP he was surprised at the scope of steroid use in college football, even in Colorado State's locker room. "College performance enhancers were more prevalent than I thought," he said. "There were a lot of guys even on my team that were using." He declined to identify any of them.

The AP found more than 4,700 players — or about 7 percent of all players — who gained more than 20 pounds overall in a single year. It was common for the athletes to gain 10, 15 and up to 20 pounds in their first year under a rigorous regimen of weightlifting and diet. Others gained 25, 35 and 40 pounds in a season. In roughly 100 cases, players packed on as much 80 pounds in a single year.

In at least 11 instances, players that AP identified as packing on significant weight in college went on to fail NFL drug tests. But pro football's confidentiality rules make it impossible to know for certain which drugs were used and how many others failed tests that never became public.

What is bubbling under the surface in college football, which helps elite athletes gain unusual amounts of weight? Without access to detailed information about each player's body composition, drug testing and workout regimen, which schools do not release, it's impossible to say with certainty what's behind the trend. But Catlin has little doubt: It is steroids.

"It's not brain surgery to figure out what's going on," he said. "To me, it's very clear."

Football's most infamous steroid user was Lyle Alzado, who became a star NFL defensive end in the 1970s and '80s before he admitted to juicing his entire career. He started in college, where the 190-pound freshman gained 40 pounds in one year. It was a 21 percent jump in body mass, a tremendous gain that far exceeded what researchers have seen in controlled, short-term studies of steroid use by athletes. Alzado died of brain cancer in 1992.

The AP found more than 130 big-time college football players who showed comparable one-year gains in the past decade. Students posted such extraordinary weight gains across the country, in every conference, in nearly every school. Many of them eclipsed Alzado and gained 25, 35, even 40 percent of their body mass.

Even though testers consider rapid weight gain suspicious, in practice it doesn't result in testing. Ben Lamaak, who arrived at Iowa State in 2006, said he weighed 225 pounds in high school and 262 pounds in the summer of his freshman year on the Cyclones football team. A year later, official rosters showed the former basketball player from Cedar Rapids weighed 306, a gain of 81 pounds since high school. He graduated as a 320-pound offensive lineman and said he did it all naturally.

"I was just a young kid at that time, and I was still growing into my body," he said. "It really wasn't that hard for me to gain the weight. I had fun doing it. I love to eat. It wasn't a problem."

In addition to random drug testing, Iowa State is one of many schools that have "reasonable suspicion" testing. That means players can be tested when their behavior or physical symptoms suggest drug use.

Despite gaining 81 pounds in a year, Lamaak said he was never singled out for testing.

The associate athletics director for athletic training at Iowa State, Mark Coberley, said coaches and trainers use body composition, strength data and other factors to spot suspected cheaters. Lamaak, he said, was not suspicious because he gained a lot of "non-lean" weight.

"There are a lot of things that go into trying to identify whether guys are using performance-enhancing drugs," Coberley said. "If anybody had the answer, they'd be spotting people that do it. We keep our radar up and watch for things that are suspicious and try to protect the kids from making stupid decisions."

There's no evidence that Lamaak's weight gain was anything but natural. Gaining fat is much easier than gaining muscle. But colleges don't routinely release information on how much of the weight their players gain is muscle, as opposed to fat. Without knowing more, said Benardot, the expert at Georgia State, it's impossible to say whether large athletes were putting on suspicious amounts of muscle or simply obese, which is defined as a body mass index greater than 30.

Looking solely at the most significant weight gainers also ignores players like Bryan Maneafaiga.

In the summer of 2004, Maneafaiga was an undersized 180-pound running back trying to make the University of Hawaii football team. Twice — once in pre-season and once in the fall — he failed school drug tests, showing up positive for marijuana use. What surprised him was that the same tests turned up negative for steroids.

He'd started injecting stanozolol, a steroid, in the summer to help bulk up to a roster weight of 200 pounds. Once on the team, where he saw only limited playing time, he'd occasionally inject the milky liquid into his buttocks the day before games.

"Food and good training will only get you so far," he told the AP recently.

Maneafaiga's coach, June Jones, meanwhile, said none of his players had tested positive for doping since he took over the team in 1999. He also said publicly that steroids had been eliminated in college football: "I would say 100 percent," he told The Honolulu Advertiser in 2006.

Jones said it was news to him that one of his players had used steroids. Jones, who now coaches at Southern Methodist University, said many of his former players put on bulk working hard in the weight room. For instance, adding 70 pounds over a three- to four-year period isn't unusual, he said.

Jones said a big jump in muscle year-over-year — say 40 pounds — would be a "red light that something is not right."

Jones, a former NFL head coach, said he is unaware of any steroid use at SMU and believes the NCAA is doing a good job testing players. "I just think because the way the NCAA regulates it now that it's very hard to get around those tests," he said.

The cost of testing

While the use of drugs in professional sports is a question of fairness, use among college athletes is also important as a public policy issue. That's because most top-tier football teams are from public schools that benefit from millions of dollars each year in taxpayer subsidies. Their athletes are essentially wards of the state. Coaches and trainers — the ones who tell players how to behave, how to exercise and what to eat — are government employees.

Then there are the health risks, which include heart and liver problems and cancer.

On paper, college football has a strong drug policy. The NCAA conducts random, unannounced drug testing and the penalties for failure are severe. Players lose an entire year of eligibility after a first positive test. A second offense means permanent ineligibility from sports.

In practice, though, the NCAA's roughly 11,000 annual tests amount to just a fraction of all athletes in Division I and II schools. Exactly how many tests are conducted each year on football players is unclear because the NCAA hasn't published its data for two years. And when it did, it periodically changed the formats, making it impossible to compare one year of football to the next.

Even when players are tested by the NCAA, people involved in the process say it's easy enough to anticipate the test and develop a doping routine that results in a clean test by the time it occurs. NCAA rules say players can be notified up to two days in advance of a test, which Catlin says is plenty of time to beat a test if players have designed the right doping regimen. By comparison, Olympic athletes are given no notice.

"Everybody knows when testing is coming. They all know. And they know how to beat the test," Catlin said, adding, "Only the really dumb ones are getting caught."

Players are far more likely to be tested for drugs by their schools than by the NCAA. But while many schools have policies that give them the right to test for steroids, they often opt not to. Schools are much more focused on street drugs like cocaine and marijuana. Depending on how many tests a school orders, each steroid test can cost $100 to $200, while a simple test for street drugs might cost as little as $25.

When schools call and ask about drug testing, the first question is usually, "How much will it cost," Turpin said.

Most schools that use Drug Free Sport do not test for anabolic steroids, Turpin said. Some are worried about the cost. Others don't think they have a problem. And others believe that since the NCAA tests for steroids their money is best spent testing for street drugs, she said.

Wilfert, the NCAA official, said the possibility of steroid testing is still a deterrent, even at schools where it isn't conducted.

"Even though perhaps those institutional programs are not including steroids in all their tests, they could, and they do from time to time," she said. "So, it is a kind of deterrence."

For Catlin, one of the most frustrating things about running the UCLA testing lab was getting urine samples from schools around the country and only being asked to test for cocaine, marijuana and the like.

"Schools are very good at saying, 'Man, we're really strong on drug testing,'" he said. "And that's all they really want to be able to say and to do and to promote."

That helps explain how two school drug tests could miss Maneafaiga's steroid use. It's also possible that the random test came at an ideal time in Maneafaiga's steroid cycle.

Enforcement varies

The top steroid investigator at the U.S. Drug Enforcement Administration, Joe Rannazzisi, said he doesn't understand why schools don't invest in the same kind of testing, with the same penalties, as the NFL. The NFL has a thorough testing program for most drugs, though the league has yet to resolve a long-simmering feud with its players union about how to test for human growth hormone.

"Is it expensive? Of course, but college football makes a lot of money," he said. "Invest in the integrity of your program."

For a school to test all 85 scholarship football players for steroids twice a season would cost up to $34,000, Catlin said, plus the cost of collecting and handling the urine samples. That's about 0.2 percent of the average big-time school football budget of about $14 million. Testing all athletes in all sports would make the school's costs higher.

When schools ask Drug Free Sport for advice on their drug policies, Turpin said she recommends an immediate suspension after the first positive drug test. Otherwise, she said, "student athletes will roll the dice."

But drug use is a bigger deal at some schools than others.

At Notre Dame and Alabama, the teams that will soon compete for the national championship, players don't automatically miss games for testing positive for steroids. At Alabama, coaches have wide discretion. Notre Dame's student-athlete handbook says a player who fails a test can return to the field once the steroids are out of his system.

"If you're a strength-and-conditioning coach, if you see your kids making gains that seem a little out of line, are you going to say, 'I'm going to investigate further? I want to catch someone?'" said Anthony Roberts, an author of a book on steroids who says he has helped college football players design steroid regimens to beat drug tests.

There are schools with tough policies. The University of North Carolina kicks players off the team after a single positive test for steroids. Auburn's student-athlete handbook calls for a half-season suspension for any athlete caught using performance-enhancing drugs.

Wilfert said it's not up to the NCAA to determine whether that's fair.

"Obviously if it was our testing program, we believe that everybody should be under the same protocol and the same sanction," she said.

Fans typically have no idea that such discrepancies exist and players are left to suspect who might be cheating.

"You see a lot of guys and you know they're possibly on something because they just don't gain weight but get stronger real fast," said Orrin Thompson, a former defensive lineman at Duke. "You know they could be doing something but you really don't know for sure."

Thompson gained 85 pounds between 2001 and 2004, according to Duke rosters and Thompson himself. He said he did not use steroids and was subjected to several tests while at Duke, a school where a single positive steroid test results in a yearlong suspension.

Meanwhile at UCLA, home of the laboratory that for years set the standard for cutting-edge steroid testing, athletes can fail three drug tests before being suspended. At Bowling Green, testing is voluntary.

At the University of Maryland, students must get counseling after testing positive, but school officials are prohibited from disciplining first-time steroid users. Athletic department spokesman Matt Taylor denied that was the case and sent the AP a copy of the policy. But the policy Taylor sent included this provision: "The athletic department/coaching staff may not discipline a student-athlete for a first drug offense."

By comparison, in Kentucky and Maryland, racehorses face tougher testing and sanctions than football players at Louisville or the University of Maryland.

"If you're trying to keep a level playing field, that seems nonsensical," said Rannazzisi at the DEA. He said he was surprised to learn that what gets a free pass at one school gets players immediately suspended at another. "What message does that send? It's OK to cheat once or twice?"

Only about half the student athletes in a 2009 NCAA survey said they believed school testing deterred drug use.

As an association of colleges and universities, the NCAA could not unilaterally force schools to institute uniform testing policies and sanctions, Wilfert said.

"We can't tell them what to do, but if went through a membership process where they determined that this is what should be done, then it could happen," she said.

'Everybody around me was doing it'

Steroids are a controlled substance under federal law, but players who use them need not worry too much about prosecution. The DEA focuses on criminal operations, not individual users. When players are caught with steroids, it's often as part of a traffic stop or a local police investigation.

Jared Foster, 24, a quarterback recruited to play at the University of Mississippi, was kicked off the team in 2008 after local authorities arrested him for giving a man nandrolone, an anabolic steroid, according to court documents. Foster pleaded guilty and served jail time.

He told the AP that he doped in high school to impress college recruiters. He said he put on enough lean muscle to go from 185 pounds to 210 in about two months.

"Everybody around me was doing it," he said.

Steroids are not hard to find. A simple Internet search turns up countless online sources for performance-enhancing drugs, mostly from overseas companies.

College athletes freely post messages on steroid websites, seeking advice to beat tests and design the right schedule of administering steroids.

And steroids are still a mainstay in private, local gyms. Before the DEA shut down Alabama-based Applied Pharmacy Services as a major nationwide steroid supplier, sales records obtained by the AP show steroid shipments to bodybuilders, trainers and gym owners around the country.

Because users are rarely prosecuted, the demand is left in place after the distributor is gone.

When Joshua Hodnik was making and wholesaling illegal steroids, he had found a good retail salesman in a college quarterback named Vinnie Miroth. Miroth was playing at Saginaw Valley State, a Division II school in central Michigan, and was buying enough steroids for 25 people each month, Hodnik said.

"That's why I hired him," Hodnik said. "He bought large amounts and knew how to move it."

Miroth, who pleaded no contest in 2007 and admitted selling steroids, helped authorities build their case against Hodnik, according to court records. Now playing football in France, Miroth declined repeated AP requests for an interview.

Hodnik was released from prison this year and says he is out of the steroid business for good. He said there's no doubt that steroid use is widespread in college football.

"These guys don't start using performance-enhancing drugs when they hit the professional level," the Oklahoma City man said. "Obviously it starts well before that. And you can go back to some of the professional players who tested positive and compare their numbers to college and there is virtually no change."

Maneafaiga, the former Hawaii running back, said his steroids came from Mexico. A friend in California, who was a coach at a junior college, sent them through the mail. But Maneafaiga believes the consequences were nagging injuries. He found religion, quit the drugs and became the team's chaplain.

"God gave you everything you need," he said. "It gets in your mind. It will make you grow unnaturally. Eventually, you'll break down. It happened to me every time."

At the DEA, Rannazzisi said he has met with and conducted training for investigators and top officials in every professional sport. He's talked to Major League Baseball about the patterns his agents are seeing. He's discussed warning signs with the NFL.

He said he's offered similar training to the NCAA but never heard back. Wilfert said the NCAA staff has discussed it and hasn't decided what to do.

"We have very little communication with the NCAA or individual schools," Rannazzisi said. "They've got my card. What they've done with it? I don't know."

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Associated Press writers Ryan Foley in Cedar Rapids, Iowa; David Brandt in Jackson, Miss.; David Skretta in Lawrence, Kan.; Don Thompson in Sacramento, Calif.;and Alexa Olesen in Shanghai, China; and researchers Susan James in New York and Monika Mathur in Washington contributed to this report.

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Contact the Washington investigative team at DCinvestigations (at) ap.org.

Whether for athletics or age, Americans from teenagers to baby boomers are trying to get an edge by illegally using anabolic steroids and human growth hormone, despite well-documented risks. This is the first of a two-part series.

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Jets bench Sanchez, will start McElroy vs Chargers

NEW YORK (AP) — Mark Sanchez is no longer the New York Jets' franchise quarterback.

He might not even be the backup.

Rex Ryan decided to bench Sanchez on Tuesday in favor of Greg McElroy after the fourth-year quarterback had another miserable performance in a 14-10 loss at Tennessee on Monday night that eliminated New York from playoff contention.

"I think it's best for our team, and for this game," Ryan said during a conference call.

So, it'll be McElroy under center for his first NFL start when the Jets (6-8) play the San Diego Chargers at home Sunday. Ryan hasn't decided whether Sanchez or Tim Tebow — listed as the No. 2 quarterback — will be the backup.

While Sanchez blew the second chance Ryan gave him a few weeks ago, Tebow was leapfrogged by a third-stringer, fueling speculation that the team has little confidence in him as a quarterback.

"I have to look at what I think is the best for the team and not necessarily the individual," Ryan said. "I'll say this about Tim and I've always said it: I know he wants to help this team be successful in the worst way and there's no doubt about that."

Sanchez threw four interceptions Monday night and wasn't able to handle a low snap with the game on the line, ending the Jets' hopes to get back into the postseason.

Things got worse after the game for Sanchez, who received a series of death threats from one disgruntled fan on Twitter. League spokesman Greg Aiello said the NFL's security staff was aware of the man's threats and was working with the Jets to assist on the matter. The team declined comment through a spokesman.

Ryan said after the loss that he wasn't ready to decide who would start against the Chargers, but told Sanchez he would be making a change at quarterback by going with either McElroy or Tebow.

"He respected my decision," Ryan said. "That's not easy, that's for sure."

After talking to his staff and members of the organization Tuesday, Ryan chose McElroy.

"This is my opinion, and I do believe that it's best for our team that Greg is our quarterback," Ryan insisted. "I'm the guy that's making this decision. Every decision I make is based on what I believe is the best decision for the team."

But Ryan was vague in his answers to why he selected McElroy above Tebow, choosing after being asked several times to not go into detail about what specifically factored into the decision.

"I can answer this question a million ways, frontward, backward, sideways, anything else," Ryan said. "It's my decision and I based it on a gut feeling or whatever."

McElroy, a seventh-round pick last year out of Alabama, helped lead the Jets to a 7-6 win over Arizona on Dec. 2 when Ryan pulled Sanchez from that game late in the third quarter. McElroy had modest numbers — 5 of 7 for 29 yards — but threw for the only touchdown of the game, and nearly led another scoring drive as the Jets ran out the clock.

Ryan decided to stick with Sanchez after that game, saying that the one-time face of the franchise gave the Jets their best chance at winning as they remained in the playoff hunt.

But Sanchez struggled in a 17-10 win over Jacksonville and again even more in the loss to Tennessee. McElroy, who gave the Jets a huge spark in his first NFL action, was inactive for both games. That hurt New York on Monday night when Ryan was unable to turn to McElroy since he was not in uniform for the game. Instead, Ryan went to Tebow for one series — which had been part of the game plan — but it was unproductive and Sanchez came back in for the next offensive possession.

Sanchez leads the league with 24 turnovers, including 17 interceptions, and has turned the ball over 50 times since the start of last season. His future with the team is uncertain because he signed a contract extension with New York in March that included $8.25 million in guaranteed money for next season.

Ryan would not commit to Sanchez beyond this season, and wouldn't discuss what the depth chart will look like.

"We have two games left and that's where my focus is going to be," he said. "What's past that will be determined later."

Sanchez was regularly booed during home games this season, falling out of favor with the fans who were excited when the Jets traded up to take him with the fifth overall pick in the 2009 draft.

"Has he had better days than (Monday night)? Absolutely," Ryan said.

There certainly were some good moments for the former Southern California star, particularly in helping lead New York to the AFC championship game in each of his first two seasons, but he failed to take the next step in his development.

While his frequent mistakes in reading defenses and miscalculating throws are a huge reason for his struggles, Sanchez also wasn't helped by a constantly changing cast around him. Several of the team's top offensive players — Thomas Jones, Leon Washington, Jerricho Cotchery, Brad Smith, LaDainian Tomlinson, Plaxico Burress, Alan Faneca and Damien Woody — have all been released, traded or allowed to become free agents since Sanchez's rookie season. He is also working with his second offensive coordinator in Tony Sparano after an up-and-down three seasons with Brian Schottenheimer.

Tebow, acquired from Denver in March, has had a minor role in the offense after being expected to play a major part. He is recovering from two broken ribs that sidelined him for three games, but returned Monday night and had little impact. It would seem unlikely that Tebow, who helped lead the Broncos to the playoffs last season, will be back next season.

When Tebow arrived in New York, he often said he was "excited to be a Jet," but there's little doubt that he no longer feels that way. He has done his best to hide his frustration throughout the season, especially when the wildcat-style offense was talked up by Ryan and Sparano as a highlight of the offense.

Tebow has instead just been a spare part on an offense that ranks 30th in the NFL. He is 6 of 8 passing for 39 yards, and has run 32 times for 102 yards — playing a more significant role as the personal punt protector on special teams.

"People can speculate anything they want," Ryan said. Obviously, as a football team, we're 6-8 and nobody's happy about that and ultimately, I'm the one accountable."

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