Bastianelli claims she never knowingly ingested a banned substance. She admitted to her obsession with weight control stating “I wanted to lose weight, like any girl.” She consulted with her doctor to find weight loss products that were not on the WADA banned substance list. Her doctor prescribed the drug Benfluorex. Benfluorex is an anti-diabetic drug that improves insulin sensitivity and glycemic control; as such it is often prescribed for weight loss. Benfluorex is not on the WADA banned substance list but it is structurally similar to Fenfluramine (which is listed) (“Bastianelli tests positive for diet product,” July 28).

“I’m disgusted with my trusted chemist for preparing a mix of herbs for me aimed at weight loss.

“Like always I wanted to read the list of products used and amongst them was benfluorex, which doesn’t figure among the list of banned substances.

“However, laboratory analysis demonstrated that this product contains the ingredient responsible for my positive test.

“But how could I know that?”

Today, she provided a sample of the Benfluorex product to prosecutors for analysis to support her contention that she unknowingly consumed a banned substance.

On Tuesday she said she had given the product to the prosecutor so that it could be analyzed. She expressed regret at not being able to take part in the Olympics and said she hoped to take part in the next world championships to defend her title.

Italian officials are unsympathetic. She will no longer represent Italy in the Beijing Olympics.

Italian Cycling Federation President Renato Di Rocco spoke critically of Bastianelli’s positve fenfluramine test stating that she ”committed an incredible act of naivity.”

“She was positive for flenfluramine, that is in dieting products. She’s obsessed about her weight. She only eats salad.”

Italian Olympic Committe (CONI) president Gianni Petrucci was even more “unyielding.”

“Marta Bastianelli has betrayed Coni, the (Italian Cycling) federation and the world of cycling.”

It is truly unfortunate that the complexities of WADA/IOC testing result in such mistakes by athletes.

Bastianelli and/or her physician would have to be very familiar with the pharmacology of Benfluorex and Fenfluramine to appreciate the structural similarities and the risk for an adverse analytical finding. This just emphasizes the requirement that athletes must perform thorough research into any substances that they utilize.

Benfluorex (RN: 23602-78-0)

• 2-((alpha-Methyl-m-(trifluoromethyl)phenethyl)amino)ethanol benzoate (ester)
• Ethanol, 2-(alpha-methyl-m-trifluoromethylphenethylamino)-,benzoate
• N-(2-Benzoyloxyethyl)norfenfluramine

Fenfluramine (RN: 458-24-2)

• Benzeneethanamine, N-ethyl-alpha-methyl-3-(trifluoromethyl)-(9CI)
• Phenethylamine, N-ethyl-alpha-methyl-m-(trifluoromethyl)-

Athletes are using various “biosimilar” EPO agents for which WADA has not yet developed a detection method. WADA’s ballyhooed test for the previously undetectable Mircera (pegylated EPO) was an admission that the already flawed existing EPO test was unable to detect variants of EPO; the announcement of the new CERA (Mircera) test at the 2008 Tour de France was considered a major victory.

There are also dozens of “copycat” or “biosimilar” versions of EPO. These are variants of EPO that are produced by different methods or exist as slightly different biological forms of EPO e.g. darbepoetin alfa, epoetin alfa, epoetin beta, epoetin gamma, epoetin delta, epoetin epsilon, epoetin zeta, epoetin theta, epoetin kappa, epoetin omega. The existence of biosimilar versions of EPO is a major problem for drug testers (“Concerns over Olympic drug test,” July 21).

Because the medicine has been so successful financially, companies in India, China and Cuba have developed drugs that do a similar job in the body, but have a slightly different molecular fingerprint. These cheap versions of EPO, often called biosimilars, can be easily bought over the internet.

[...]

“There are now a number of compounds that bind to the EPO receptor, and there is no single test for them, you can order it here over the internet and it will be delivered to you here in the UK or in Germany; Chinese-made doping substances” [according to Professor Werner Franke].

Some scientists who track and monitor the development of copycat EPO drugs say there could be up to 80 different versions now being manufactured in different parts of the world.

A few biosimilar versions are available in the EU and Eastern Europe; however, a plethora of doping options are commercially available with biosimilar EPO pharmaceuticals produced around the world, particularly in Southeast Asia, several of which could be purchased inexpensively over the internet.

Abseamed (Medice Arzneimittel Pütter)
Aranesp (Amgen)
Binocrit (Sandoz)
Bioetin (Nanogenpharma) [Vietnam]
Ceriton (Rambaxy) [India]
Dynepo (Shire)
Epocim (CIMEQ) [Cuba]
Epoetin Alfa Hexal (Hexal Biotech Forschungs)
Epofer (Emcure) [India]
Epofit (INTAS Pharmaceuticals) [India]
Epogin (Chugai Pharmaceutical Company) [Japan]
Epokine (Macropharma Corporation) [Philippines]�
Eporon (Century Pharmaceuticals) [India]
Eporon (Dong-A Pharmaceutical Company) [Korea]
Eposino (Shandong Kexing) [China]
Eposino (Hindustan Bio Sciences) [India]
Epotin (Claris Lifesciences) [India]
Epotrex-NP (Novell Pharmaceutical) [Indonesia],
Epoyet (Bio Sudis) [Argentina],
Eritina (Chalver Laboratories) [Columbia]
Eritrogen (Bioprofarma) [Argentina]
Eritromax (Blausiegel ) [Brazil],
Erykine (INTAS Pharmaceuticals) [India]
Erypo (Janssen-Cilag)
Espo (Kirin Brewery Company, Pharmaceutical Division) [Japan]
Espogen (Hoffman Health) [Pakistan]
Gerepo (North China Pharmaceutical Group Corporation) [Malaysia]
Hemapo (Innogene Kalbiotech) [Singapore]
Hemax (Seignior Pharma) [Pakistan]
Hypercrit (Biogalenic) [Venezuela]
Mircera (Roche)
NeoRecormon (Roche)
PDpoetin (Pooyesh Darou Pharmaceuticals) [Iran]
Renoge (Biomedis) [Philippines]
Retacrit (Hospira/STADA) [Germany]
Shanpoietin (Shanta Biotechnics) [India]
Silapo (Bioceuticals Arzneimittel AG)
Vintor (Emcure) [India]
Wepox (Wockhardt) [India]
Zyrop (Zydus Biogenyc) [India]

I think the science director of WADA could be considered delusional in his claim that WADA is catching all users of recombinant EPO.

Dr Olivier Rabin is WADA’s science director. Is he happy that the test is catching all the drug cheats?

“I am reasonably confident, yes,” he told the BBC. “Now, it would be very presumptuous on my part to say that we are absolutely 100% sure we are going to get everyone. But I can assure you that if you were to take recombinant EPO and that would be in your urine – then, yes, we would detect it.“

Maybe the public will buy it, but the athletes already know better.

Hat tip to Trust But Verify.

According to the German television station ARD, Spanish doctor Marcos Maynar offered these services as for internal testing allowing athletes to monitor their doping to ensure that their use of performance enhancing drugs would not be detected by doping controls at the 2008 Tour de France and other pro cycling events. Maynar responded to the allegations that he aided and abetted doping by suggesting that ARD had ulterior motives stemming from bitterness over disgraced cyclist Jan Ullrich (“Marcos Maynar niega que quiera favorecer el dopaje,” July 21).

“Since Jan Ullrich’s tested positive, the Germans have wanted to shit on the Spaniards.”

Maynar admits to sending out the email but only to help pro tour teams with their own internal controls; he denies that his services would allow athletes to escape the detection of performance enhancing drugs. Marcos Maynar and his brother Juan Ignacio Maynar are both experts in anabolic steroids and work at the university laboratory. They claim their blood and urine testing services and legally recognized analysis for biological passports were developed to generate a badly need source of revenue for the University. He strongly denies that he supports doping in cycling (“Spanish lab allegations and confessions in Tour doping,” July 20).

But Marcos Maynar Marino from the university, who sent the email, insisted in a statement that the offer was made to assist the teams to find dopers, not to support substance abuse.

‘We are not supporting doping but try to prevent team-members from doing something which could destroy the team,’ Maynar said.

Maynar’s credibility with regard to doping has been hurt by his alleged involvement in other doping scandals.

In June 2004, Maynar was implicated in a nationwide steroid bust called Operación Gamma II that shutdown a network of steroid distributors providing anabolic steroids to bodybuilders and athletes at gyms in various cities in Spain.

In May 2006, Maynar was found to share clients with Eufemiano Fuentes, the mastermind behind the Operación Puerto doping scandal.

In May 2008, Maynar was the team doctor for the Portueguese LA MSS team who authorities found guilty of systematic doping.

Maynar said he was surprised by the raid, insisting that the team always “presented normal levels.”

“My relationship with the team is merely as a collaborator. I only go to races to control the hematocrit levels of the cyclists and look after the nutritional part of the athletes,” Maynar was quoted as saying.

Hat tip to Cycling Fans Anonymous.

WADA gave notice to cyclists competing at the 2008 Tour de France that they were now able to detect the performance enhancing drug Mircera (methoxy polyethylene glycol-epoetin beta), a third generation version of erythropoietin (EPO) belonging to the category of drugs known as Continuous Erythropoeitin Receptor Activators (CERA).

Doping experts concerned with the fairness of the doping protocols administered by WADA-accredited labs were quick to raise questions about the new CERA doping detection methods (“Larry: New CERA test, looking at Hamilton’s HBT,” July 20).

The TdF news concerning the detection of CERA has raised a lot of questions, including legal questions. How is it that AFLD can use a “secret” test, one that is not referenced in any of the WADA rules? How can we know that the lab’s test is valid? If there are no WADA rules for the test, how can the lab determine that the results of the test are sufficient to prove an AAF?

The folks at Trust But Verify (TBV) offer an excellent primer on unaccredited WADA anti-doping methods used to detect adverse analytical findings (AAFs). TBV, citing precedent from the Tyler Hamilton case, explains why it is legal for WADA-accredited labs to use “secret” and “unaccredited” testing methods in some cases.

[I]t is not necessary for WADA to approve a lab method before the method can be used to prove an AAF.

The panel also ruled that a WADA lab CAN use an unaccredited test method to prove an AAF, so long as the lab can prove two things. First, the lab must prove that the unaccredited test method was conducted “in accordance with the scientific community’s practices and procedures.” Second, the lab must prove that it “satisfied itself as to the validity of the [unaccredited] method before using it.” If the lab can satisfy this two-pronged burden of proof, then (according to the Hamilton decision) the lab gets the benefit of the presumption under WADA Code 3.2.1. If the lab cannot satisfy this burden, then the lab method in question cannot be used, and the AAF against the athlete must be dismissed.

The reasoning in the Hamilton case was based on the panel’s assumption that sometimes WADA labs must use unaccredited test methods. New forms of doping arise all the time, but the formal lab accreditation process is relatively slow (the method at issue in the Hamilton case was not formally validated until more than a year after the lab’s finding of the Hamilton AAF). If labs are going to detect new performance-enhancing drugs (PEDs), they may have to do so with new (and thus unaccredited) test methods. But since accreditation is an important step in making sure that test methods are “fit for purpose”, the panel reasoned that the validity of unaccredited test methods must be defended by the lab and ultimately ruled upon by the arbitration panel.

This means that AFLD may still be required to scientifically validate the new CERA test in the cases of Miguel Beltran, Moises Duenas Nevado, Riccardo Ricco and any other cyclists who accused of allegedly using Mirecera during the 2008 Tour de France.

Steroid and doping expert Dr. John Hoberman of the University of Texas wrote an article about the Festina scandal at the 1998 Tour de France for me almost ten years ago. Hoberman thought that the public had finally accepted that the Tour de France during a “definitive outing of the Tour as a virtual pharmacy on wheels.”

The Tour debacle has finally made it acceptable to say in public and without provocation what many have known for a long time, namely, that long-distance cycling has been the most consistently drug-soaked sport of the twentieth century. 

Unfortunately, we still have not come to terms with an acknowledgement of the scope of doping in cycling. We continue to entertain incredulous stories that doping in the sport is limited to certain generations of riders or specific geographical areas. We still believe in fairy tales that tell us a dope-free Tour de France is possible. It is not. So what should be done about doping in cycling?

We could continue to put our faith in anti-doping efforts. But the history of drug testing in competitive sports over the past 30 years or so has taught us that doping technology is always far ahead of doping detection. We can ignore history and pretend that things will be different this year or next year – or the year after that.

Hoberman puts forward an argument articulated by Hans Halter in the German newspaper Der Spiegel. The admittedly unpopular argument is to accept doping in such extreme sports such as cycling or, more accurately, to “quitely ignore” the pervasive and universal doping in the Tour de France (“A Pharmacy on Wheels – The Tour De France Doping Scandal,” November 15, 1998).

As one unblinkered observer put it at the height of the furor: “For as long as the Tour has existed, since 1903, its participants have been doping themselves. No dope, no hope. The Tour, in fact, is only possible because — not despite the fact — there is doping. For 60 years this was allowed. For the past 30 years it has been officially prohibited. Yet the fact remains: great cyclists have been doping themselves, then as now.”

[...]

There is, in fact, a case to be made for quietly ignoring the virtually universal doping that goes on in this “extreme sport,” an argument that accepts and even embraces the medically extreme and potentially fatal character of the ordeal itself. It is an argument that is (from its own perspective) properly contemptuous of medical humanitarianism and fastidious concerns about sportsmanship in the traditional (and here outmoded) sense of the term. This argument was boldly launched into the midst of the Tour madness by the German journalist, physician, and cycling fan Hans Halter, who presented it with the precisely correct doses of principled defiance and ironic pathos that this philosophy of “sport” requires. “No one can seriously expect,” Halter wrote, “that these extreme athletes, tortured by tropical heat and freezing cold, by rain and storm, should renounce all of the palliatives that are available to them.” Indeed, no one can, for those who accept the ordeal must concede to the martyrs at least a measure of relief. What the Tour scandal tells us is that modern society does not even know how to begin to draw the line.

Hoberman’s essay is still one of the most insightful articles into the doping culture in professional cycling that I have read. It hits uncomfortably close to the truth about the nature of “extreme sports.”

Faith in the new generation of cycling was shattered when Riccardo Ricco tested positive for EPO and the new CERA drug Mircera.  How could the story of “new cycling” explain why the 24-year old leader of the best young rider competition was doping just the same as the old generation of cycling? The old generation could no longer be blamed for the scourge of doping in cycling. Cycling needed a new story!

The Scotsman was happy to provide a new story to preserve the integrity of the Tour: Blame the country of Spain for doping problems in cycling! If Spain were eliminated from world maps, the Tour de France would apparently be a very clean sport. How did the Scotsman arrive at this conclusion? (“Tour’s three doping cases to date are all linked to a country where old cultures endure,” July 18)

• Two of the four riders failing drug test and/or implicated in doping scandal during the 2008 Tour de France are, in fact, Spaniards (Miguel Beltran and Moises Duenas).
• The other two riders, while NOT from Spain, rode for a Spanish team! (Leonardo Piepoli and Riccardo Ricco ride the Spanish road racing team Saunier Duval-Scott.)
• Spain has evil dope doctors that work with professional cyclists. (Dr. Eufemiano Fuentes was the Spanish mastermind behind Operation Puerto in 2006. Plus, Dr. Jesus Losa of Spain appears to have helped Moises Duenas dope.)
• Cyclist David Millar asserts that performance enhancing drugs and doping thrive in the “wild west” of Spain. Millar makes an incendiary attack on the Spanish culture as unworthy of competing in the Tour de France (no voluntary Millar-torium here). 

“They have this culture embedded in them and they honestly believe it is not possible to do these things without (doping]. It’s sad. You see that Christian (Vande Velde, Millar’s Garmin team-mate] is third overall, and he is doing it without any injections, without anything. If you can’t do it like that then you are not good enough – it’s as simple as that.”

• International Cycling Union (UCI) president Pat McQuaid has identified clandestine “cocoons” in Spain where doping is easily rationalized; professional cyclists “live in their own little world, surrounded by a small number of people belonging to the old guard; and they can be very influenced by those within that cocoon.” Notice how McQuaid masterfully interjects the “generational” story as a subplot in the “blame Spain” story.

Of course, a person would have to be incredibly naive to believe that doping in cycling is restricted to the geographical boundaries of a single country or to particular a generation.

Cycling is synonymous with doping. No fanciful stories or fairy tales will explain away doping in the Tour de France.

Mircera is a third generation version of erythropoietin manufactured by pharmaceutical giant Hoffman-LaRoche that has been called “Super EPO.” The big news at the Tour is not that another cyclist was caught doping, it is that a cyclist was caught using a performance enhancing drug that was widely considered “undetectable.” The quick withdrawal of the entire Saunier Duval team from the Tour supports speculation that Mircera was the team’s secret weapon (“Riccardo Riccò tests positive; Saunier Duval team withdraws from Tour de France,” July 17).

Recent rumors in the sport had suggested that some riders were using an undetectable new oxygen-enhancing drug widely thought to be Roche’s Micera. The existence of a test for CERA was not announced, but Riccò’s positive for the substance suggests that it has not escaped the attention of anti-doping officials.

WADA spokesperson Frédéric Donzé took used the opportunity to congratulate WADA on a job well-done.

“WADA is very much aware of the development of new EPOs and biosimilar EPOs in an expanding market.”

“In the case of Mircera (CERA ) thanks to the cooperation of the manufacturer of this substance (Roche) and of WADA-accredited laboratories, WADA received the molecule well in advance and was able to develop ways to detect it,” he said. “This case shows the significant work that WADA conducts in anticipating doping trends, including by closely cooperating with pharmaceutical companies at very early stages of the development of molecules or substances for therapeutic purposes to develop detection methods for anti-doping purposes.”

Mircera is an artificial form of erythropoietin (EPO) stimulators similar to Amgen’s Epogen and Aranesp. But Mircera is thought to be superior to Epogen and Aranesp due to the use of pegylation technology that provides a sustained release of erythropoiesis stimulating proteins (ESPs). PEGylated erythropoietin (PEG-EPO) results when a molecule of polyethylene glycol is attached. 

Mircera (PEG-EPO) belongs to a category of drugs called Continuous Erythropoeitin Receptor Activators or CERA because it continuously interacts with the EPO receptor producing longer lasting effects. Only 1-2 monthly injections of Mircera have similar results to three times weekly injections of Epogen. Detailed instructions on using Mircera can be found on the Internet.

Trust But Verify wonders if Ricco actually tested positive for Mircera or was simply caught with the product in his possession (during a police search of his room). TBV points to comments made by blood doping expert Professor Michael Audren to CyclingNews.com.

It’s a delayed-action EPO, which has a different molecular mass from EPO. It’s only been commercially available since the start of the year. We can tell when someone’s used it but we can’t declare them positive. In that respect it’s like Dynepo, another EPO-like product. We know that Micera was being used on the Giro, so I’m not surprised that it’s also turned up at the Tour. But I would be very surprised if they AFLD had declared Riccò positive for Micera, for the reasons I’ve just mentioned. Maybe they searched Riccò’s room and found the product itself… (emphasis added by TBV)

It would not surprise us if TBV and Professor Audren are correct; WADA is well-known for overstating their ability to effectively and reliably detect various performance enhancing drugs.

I started thinking, if I was to come up with a baseball variant to try and take on MLB, what would it look like? Well, it would be baseball, but, I’d market it as a faster, more exciting version. I’d make the following rules changes to try and re-enforce the brand [...]

No steroid testing. Leave that for the cops. This is baseball – let’s the conversation revolve around the action on the field, not off of it.

In a previous post, Markson expands on his feelings about steroids in sports with some insightful comments on the issue. Sports has had to deal with advances in technology in every aspect of the game including performance enhancing drugs. More often than not, sports have embraced advances in technology and incorporated them into the game. Sports have recently had a conflicted position with regarding to technological advances in pharmacological ergogens. But it’s difficult to counteract technology (progress).

The thing about technology is that it always evolves at a rate much faster than efforts designed to stop it. Don’t believe me, ask the recording industry. In the case of performance enhancing drugs, the drugs will always outpace the tests designed to detect their presence/ use. To try to combat this, testing has to become more frequent, more intrusive. Like anything the more frequent and more intrusive you make it, the more likely their will be false results. Which means there need to be procedures around appealing tests, results, etc. All of a sudden, testing requires an infrastructure, and then you’re in trouble.

Does this sound familiar? It should. It’s basically how the Tour de France and track and field operate. Bet you have no clue who won last year’ tour de france, but know Floyd Landis cheated. Likewise, bet you have absolutely no clue who holds what records for any track and field events, but are very familiar with the Marion Jones scandal.

The problem with false positives is very disturbing. The problem is compounded by the flimsy standards of evidence required for guilt by anti-doping agencies. I can’t imagine the degree of uproar if our own imperfect criminal justice system in the United States abandoned “beyond a reasonable doubt” and “preponderance of the evidence” and adopted the “comfortable satisfaction” standard advocated by the United States Anti-Doping Agency (USADA).

Markson continues by discussing how the ultimate outcome is the destruction of the sport.

This is what happen when you try to use policing measures to keep up with technology. The drug tests, their results, the appeals, etc. actually become the only interesting/ memorable thing about the sport. The become the brand of the sport. And, since this isn’t nearly as fun/interesting as remember the actual games or plays themselves, the fans eventually abandon.

Baseball should stick to the business of balls, strikes, beer and caps and leave police work to the pros [...]

At the end of the day, juice or no juice, talent and skill are still the ultimate arbiter of performance.

Most elite athletes strive to be the best at their sport without qualification. And most fans want to see the best without qualification. After all, who really cares who is the best cyclist riding on a bike that costs no more than $200 or the best baseball player who doesn’t lift weights? Let’s see the best.

“I may get in trouble for talking about it but I want people to know I’m doing everything in my power to stay clean,” said Clay, who began having extra tests done before last month’s world indoor championships.

In spite of Clay’s concerns, it is unlikely that Clay or Felix will face any sanctions by USADA for revealing the existence of “Project Believe” prior to its official launch.

Trust But Verify believes the “Project Believe” trial is based of cycling’s bio-passport program. The expensive nature, the importance of establishing a physiological baseline, and the frequency of urine and blood tests over time seem to confirm the similarities with cycling’s longitudinal testing programs (“Anti-doping program takes root,” April 17).

The project, according to athletes and antidoping officials familiar with it, aims to compile a physiological baseline of each of the initial 12 volunteers. Subsequent tests would be compared to the baseline numbers to see whether there are any changes that could be attributed to doping…

In one three-week period, [Clay] he said he was subjected to six blood and urine tests, with five vials of blood taken for each of the blood tests. Some of the tests were pre-planned, but others were surprises, he said.

Don Catlin believes athletes who do not use banned substances will eagerly embrace this new anti-doping system.

Don Catlin, an anti-doping expert and one of the foremost authorities on longitudinal testing, said the theory behind the USADA project is solid, a “much more powerful technique than simply taking one slice in time.”

“It’s no surprise that good athletes, clean athletes, will jump up and down for this thing,” Catlin said. “That’s great. It’s about time they started doing something. So now, it’s ‘OK, it’s here, it’s now.’ And I’m sure there are going to be issues about how to get on the program.”

Details on the cost of such testing have not yet been revealed.

Disgraced former Tour de France winner Jan Ullrich is to pay out a million euro fine to end a fraud case which German prosecutors have been investigating, Focus news magazine reported on its Web site Saturday.

Prosecutors accused the 1997 Tour de France winner of taking performance-enhancing drugs, leading under German law to fraud charges against the 34-year-old on the basis he deceived the public, sponsors and his team.

The United States does not have laws that specifically criminalize doping in sports. However, the Anabolic Steroid Control Act of 1990, passed as a direct result of doping scandals in sports, criminalizes the non-medical uses of anabolic-androgenic steroids. One of the primary objectives for the act has been to combat “cheating” in sports although it has been largely ineffective for this purpose. Instead, the federal government has had some recent success using perjury laws to prosecute athletes who use steroids. Maybe sports fraud prosecutions will join perjury as an additional way of making examples out of “immoral” athletes.