Cross-Contamination in Pharmacies Confirmed; CAS Ruling Demonstrates Needed Flexibility

Column by Steven V. Selthoffer, Senior European Columnist

COLOGNE, Germany, July 30. REGARDING the recent turmoil and emotions erupting over the positive tests of Cesar Cielo, BRA, Henrique Barbosa, Nicholas dos Santos and Vinicius Waked for furosemide, combined with the possibility of the substance coming from cross-contamination in a pharmacy, interviews were conducted early last week, 72 hours prior to the published CAS announcement, with five different pharmacists at three different pharmacies in Germany.

The following is not a formal investigation or a scientifically-controlled laboratory test, nor about providing a potential loop hole for athletes to cheat, but, an examination of the issues recently highlighted by anti-doping experts and the steps anti-doping authorities are taking to address the situation.

Germany has some of the highest pharmaceutical (medicine) manufacturing, pharmaceutical administration and distribution standards in the world. Its pharmacists are some of the best-trained, and highest-educated professionals in the E.U., submitting daily to rigorous, government imposed, standards of operation, cleanliness and substance processing, storage and distribution.

The interviews were conducted openly on the pharmacy premises, chosen randomly, properly identifying the media organization, and the issues at hand.

The pharmacists were professionals, doctors/PhDs., helpful and willing to talk. But, three pharmacists chose not to give their full names. All asked not to disclose the name of their pharmacies due to any possible media and legal considerations. The terms and grounds of the interviews were accepted.

The pharmacists stated they were well aware of the work of WADA and the NADOs (national anti-doping agencies) and supported their work. The following are their answers and analysis.

The results were surprising and unexpected.

Pharmacists Confirm Cross-Contamination Risks

Pharmacy One
In speaking with Pharmacist 1 named "Mark" and his senior female colleague, he confirmed: "The pharmacies are not 100 percent sterile. There are hundreds of types… thousands of types of substances and medicines that come through our store every year."

"They are in powder form, packets, capsules, liquids, crèmes, etc. We have one space for filling the orders (a room about 3.5m long on one counter).

SW: Are all the orders and substances done there in the lab preparation area/counter? (on the same counter, with the same instruments)?

Pharmacist 1: "Yes."

SW: Knowing that the anti-doping authorities can take blood and urine tests and read them, at so many parts per million, could there be some substances in your blood from cross-contamination working here?

Pharmacist 1: "Oh! SURE! (laughter, more laughter…)

Pharmacist 2: "Yes! Of course."

Then, as the conversation continued, they discussed that cross-contamination could occur in medicines for other customers and that cross-contamination could happen to staff members, but, in harmless amounts. They then explained how they had separate eating areas, and delivery areas, etc.

Pharmacy Two
In interviewing the pharmacist at a second pharmacy, "Christine P.," PTA certified, stated, "We can never be 100 percent sure that something (not visible to the human eye, unseen, in micro amounts) does not go into another medicine/order (as in micro amounts, cross-contamination). We make everything in one room (less than 4m square, with a door and window, counter with a direct washbasin, built into the counter). It is cleaned at the end of the day, and sometimes after each use, but, it is not sterile."

Asking about their workload, "there are about 20 different types of substances/medicines we make a day there… we do an identity test on them when they come into our pharmacy."

"We do the identity test in the same area for each one."

Pharmacy Three
In the third pharmacy, I spoke with two pharmacists, who were knowledgeable in their respective fields of study. They knew about the recent nutritional food supply chain issues in China, and the cycling athletes (and others) testing positive for clenbuterol. They also stated knowledge of inadvertent cross-contamination issues with pork, beef, fish, and with other drugs in Europe and Asia.

SW: If you had to submit to a doping test like the athletes are required to submit to, throughout the year, would you be 100 percent clean from cross-contamination?

Dennis Effertz: Laughing, "NO!"

Karina Kehl: Smiling, confirming her hypothetical positive test, "No way! No!"

Dennis Effertz: "We work with hundreds of chemicals and substances. We have a lab room downstairs. It has rules about who can go in and who cannot."

SW: "May I go down to see it?"

Dennis Effertz: "No. Sorry. We follow all the rules, but, it is not 100 percent sterile (according to anti-doping standards)."

"We use the same counter space, the same instruments called (in German, unintelligible), that are used for measuring the substances and working on the trays. We wash them with water. We also use a cleaning agent, but, to say everything is 100 percent sterile is impossible."

"We would not mix up an order, nor would there be enough cross-contamination ever to affect or harm a patient/customer. But, there are small (micro) amounts of substances, sure… that could be transmitted. Sure."

Risk Management
"It's about risk management for the athletes," stated Mr. Effertz. "No matter how high the standards of compliance with pharmacies, the risks are high," due to the high number of substances in a small work environment in the same small, work space with the same tools/appliances.

Cross-Contamination Confirmed
The possibility of cross-contamination was confirmed by all five pharmacists in five out of five interviews from three different, randomly chosen, pharmacies. They also pointed out that pharmacies and family medicine cabinets are probably two of the highest risk areas where cross-contamination issues may occur.

The point is this, there is little information being provided to the athletes on actual high risk areas, per country, per category, where cross-contamination could occur. Currently, with the FINA World Championships in Shanghai, organizers have had to deal with possible contamination with nutritional food supply chain issues with clenbuterol and other substances by the CDC in China and have taken positive steps to limit the exposure to athletes by establishing a food control center inside the organizing committee headquarters.

As one former anti-doping executive said, "the anti-doping authorities have known about these issues for a long time, but, have been hesitant to come forward." That is understandable. There are numerous and complex considerations to take into account.

This is not about athletes being irresponsible or about applying anti-doping rule violations arbitrarily- it is about human existence. Clean athletes should not be facing career-ending allegations or missing Olympic Games or World Championships for the risks they experience as human beings.

Other risks beside cross-contamination with pharmacies are public knowledge: clenbuterol in pork, nutritional food supply chain issues, Asian fish stocks, drinking water… the list goes on and on.

Don't Even Try It- Think Again
Are there things going on that we don't know about? Yes. But, athletes who cheat, should never deceive themselves by thinking they can take unfair advantage in sport with the knowledge of these issues. They should never deceive themselves into thinking they will get away with it.

They won't. They will eventually be exposed, caught and brought to justice.

Anti-doping and the war on doping and corruption in sports is evolving and growing stronger. Anti-doping authorities are winning more victories every month. However, clean athletes need to be informed honestly, comprehensively, on time, and protected from the emerging risks.

Flexibility Good for Sport
The flexibility demonstrated by the Brazilian sport authorities and recently upheld in the CAS ruling were the right ones and a step in the right direction. More cross-contamination issues are currently being addressed by the anti-doping authorities and should not be career-ending for clean athletes.

We all agree for the need for a strong, ever-vigilant anti-doping system and to compete by the same rules, but, not all pharmacies, products, countries and standards are the same in every country, placing many athletes at risk and disadvantaged in comparison to others. The anti-doping experts in their deliberations are bringing more areas of risk for athletes to light, and these need to be weighed properly and taken into consideration.

** Note- the names of certain pharmacists and pharmacies were withheld upon request.

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