Olympics Again Put Oft-Abused Amgen Drug Under Scrutiny

The start of the Summer Olympics in Australia has recast the spotlight on biotech giant Amgen Inc., the discoverer, producer and licenser of what has become one of the most abused sports-performance drugs in history: Epogen.

In the 11-year history of Epogen--the brand name for a drug that mimics the natural hormone known as erythropoietin (EPO)--Thousand Oaks-based Amgen has faced sporadic complaints over its refusal to make the drug traceable through drug testing.

Because Epogen is so similar to natural EPO, it has been an extremely effective drug, but also one that is difficult to identify, making it hugely popular among athletes.

“Drug use on the elite level is rampant,” said Charles Yesalis, a professor at Penn State University and an expert on the International Olympic Committee anti-doping efforts. “EPO can give a 5% to 15% enhancement. You can’t afford not to do this.”

Athletes have been suspected of illegally using EPO to enhance their performance in everything from the Tour de France to the Olympics.

Amgen developed the drug to treat chronic anemia in patients suffering from kidney disease.

Before Epogen, many kidney dialysis patients had to undergo repeated blood transfusions to increase their level of red blood cells, which transport oxygen throughout the body. Epogen became a wonder drug, allowing bedridden patients to lead normal lives and turning Amgen into a biotechnology giant.

Amgen has been confronted many times with the use of EPO as a black-market sports drug. But the company maintains that its priority is in producing an effective medical drug--one that has proven to be a breakthrough in the treatment of anemia. The drug is manufactured only by Amgen and its licensees.

Amgen spokesman David Kaye said the company has had sporadic contact with sports organizations in the past and is aware of the occasional calls for Amgen to add a chemical marker to Epogen so it can be easily identified.

But he said that idea has been rejected because it would be costly to develop, possibly requiring new government approval.

“It would essentially be a new drug,” Kaye said. “Changing the drug would change what is put into the human body . . . . We’re not in the drug-testing business. We develop human therapeutics for sick people.”

The Food and Drug Administration said any significant change to a drug typically requires proof that the product is still safe and effective. But the agency added that it had no way of determining at this point whether adding a marker would be a significant alteration.

Kaye said Amgen, the world’s biggest biotechnology company, has spent significant effort educating doctors and patients on the use of Epogen, but policing the abuse of EPO by athletes is beyond the company’s responsibilities. “Anybody can abuse any drug,” he said.

EPO accounted for $1.8 billion in Amgen’s sales last year--more than half of the company’s annual sales.

When Amgen was formed, its research team quickly took aim at erythropoietin. It had long been known that the hormone, which is naturally produced in the kidneys, stimulated the production of red blood cells by bone marrow.

Amgen researchers, using genetic engineering techniques, located the gene responsible for EPO production and then developed a method using hamster ovary cells to produce the hormone.

The drug won the approval of the FDA in 1989 and was soon discovered by athletes as a way to improve their performance.

The idea is that a higher concentration of red blood cells allows the blood to carry more oxygen and thus improve endurance.

Before EPO, athletes used to extract their own blood and freeze it so they could infuse themselves with extra blood just before a competition. This process of “blood doping” was banned by the Olympic Committee in the mid-1980s.

EPO provided an easy way around the ban, although it came with a risk.

High concentrations of red blood cells can cause the blood to thicken, leading to the possibility of heart attacks and strokes, particularly during hard exercise.

EPO use has been sporadically blamed for the deaths of some athletes, although there has been no conclusive proof.

The potential risks have not stopped athletes from using the drug. Its use has become widespread in some sports.

The most sordid example came in the 1998 Tour de France, the grueling three-week bicycle race that is considered the most trying endurance competition in the world.

That year, the top-rated Festina team from France was expelled from the race after French customs agents discovered hundreds of vials of EPO and other performance-boosting drugs in a team car. Seven out of the 20 teams entered in the Tour eventually dropped out of the race.

After a decade, the IOC has begun to crack down on EPO use, saying last month that it will test for the drug at the Summer Olympics using two recently developed methods.

The IOC is the first major sports enterprise to begin widespread EPO testing.

The committee said it will test at least 300--and perhaps as many as 700 athletes--during the Sydney Olympics for EPO.

But experts say the IOC’s testing will probably do little to blunt the use of EPO because it will reach less than 10% of the athletes involved in the Olympics.

In addition, the two-part test used by the IOC--one for blood and another for urine--almost guarantees that few athletes will be caught.

The committee is requiring positive results in both tests for an athlete to be banned.

The blood test can detect EPO weeks after the drug was used, but the urine test goes back only three days.

“Only the silliest of athletes are going to get caught,” professor Yesalis said. “Unless you are exceedingly careless or stupid, this won’t have a deterrent effect.”

Yesalis said he did not believe it was Amgen’s responsibility to police the use of EPO. His position was echoed by John Hoberman, a sport historian and doping expert who is a professor at the University of Texas in Austin.

“It’s the responsibility of the sports world to clean up its own mess,” Hoberman said.

But Hoberman said the sports organizations have so far shown little will to eradicate the problem.

“After 15 years of watching this, I don’t see a cast of sports bureaucrats with the effectiveness or ambition to take this on,” he said. “Those people are not up to the job.”

Hoberman said that EPO and other performance-enhancing drugs that have become widespread because of genetic engineering are only the beginning.

Breakthroughs in gene therapy may soon make it possible to alter the genetic makeup of athletes to enhance such abilities as reaction time, muscle bulk and strength.

“We have a choice now,” he said. “It’s a choice between sports for human athletes or creatures.”