Expert Critical of Lagat EPO Test

Cleared Miler's Case Suggests Testing Is Flawed

(The following is a release from James Templeton, agent to miler Bernard Lagat, who was recently cleared of EPO doping charges by the IAAF. Included are summary comments by Dr. Hans Heid of the German Cancer Research Institute in Heidelberg, Germany, on Lagat's test. Heid is a scientist engaged by Lagat and his lawyers for his defense.

Although Lagat was exonerated by a negative B-sample test, he has called for a halt in EPO testing until a more fair and reliable test can be developed. Heid's report is critical of several aspects of the current EPO testing protocol as followed in Lagat's case and posits a theory as to why the A-sample results appeared to be at odds with those from the B-sample. Comments by Templeton and Lagat precede Heid's summary below.

A previous version of the summary which appeared earlier in this space was only a working document. This is the official version.)

HIGHLIGHTS OF THE REPORT:-

1) REPORT FULLY EXONERATES BERNARD LAGAT - the summary notes that the urine of Mr. Bernard Lagat did not contain any recombinant erythropoietin (rhEpo) and therefore he had not committed Epo-doping;

2) REPORT STATES THAT THE COMPLEXITY OF THE TEST, COMBINED WITH TRANSPORTATION AND HANDLING SHORTFALLS, COULD HAVE LED TO THE INITIAL ERRONEOUS ANALYSIS THAT BERNARD'S A-SAMPLE WAS POSITIVE;

3) REPORT NOTES THE EPO TEST IS TOO LENGTHY, HAS PROBLEMS AND SHOULD BE SIMPLIFIED AND IMPROVED MARKEDLY -- The summary notes these various issues and problems, suggests ways to improve the test. It refers to and agrees with internal WADA documents which themselves encourage development of new EPO tests.

REACTION TO THE REPORT: BERNARD LAGAT CALLS AGAIN FOR CURRENT EPO TEST TO BE HALTED UNTIL REVISIONS AND IMPROVEMENTS ARE MADE.

"The report confirms and reinforces what I have always maintained, I have never taken any illegal nor legal performance-enhancing drug," commented Bernard Lagat on Monday.

"But it goes much further and shows that the present testing for EPO is fundamentally flawed. I repeat my call for the IAAF and WADA to suspend all EPO testing right now, until revisions are made and a credible test can be developed. WADA or other anti-doping agencies should certify a reliable test which does not risk the future of an innocent athlete.

"I have always been in favour of eliminating drug taking from athletics and strongly endorse drug testing but it must be fair and reliable, and seen to be fair and reliable. I don't believe that is the case with testing for EPO at the moment," added Bernard.

To recap briefly, Bernard has been the second-ranked 1,500 metres runner in the world since 2001 but on August 22, the eve of the 2003 World Championships, he was informed that he had provided a positive test for the banned substance EPO.

Bernard was immediately suspended from competition by the IAAF but on October 1 was cleared of having taken EPO or any other illegal drugs, following further testing of the urine sample he had provided in an out-of-competition test on August 8.

"I wouldn't want any fellow athlete to suffer the way I did during those five weeks. The experience was the reverse of natural justice. I appeared to be guilty until I was proven innocent," said Bernard.

Dr Heid's summary report states quite clearly that there are serious procedural issues, with many potential pitfalls in the way the testing for EPO is presently conducted.

The report is also critical of the scientific basis upon which the test has been constructed, with particular note to the lack of consideration given to the possible influences of different nutritional, ethnic or physiological backgrounds.

Dr Heid's report was completed in October but its distribution was delayed until now while we absorbed its implications.

We are currently in discussions with the IAAF about the issue of financial compensation, which I hope can be mutually resolved, as Bernard lost the opportunity to pursue his profession at a crucial moment in his career.

Both Bernard and I are also concerned about details of the IAAF announcement on October 1, which confirmed that Bernard was free to compete again.

We believe that this announcement was neither fully accurate, nor did it state clearly that Bernard had been exonerated, and are looking to the IAAF to make an unequivocal declaration that there were no traces of performance-enhancing drugs found in either of Bernard's samples.

James Templeton
November 26, 2003

(Summary report follows. The full report is available upon request)

Dr. Hans Heid

Deutsches Krebsforschungszentrum
Heidelberg
Abteilung Zellbiologie / A010
Leiter: Prof. Dr. rer. nat. Werner W. FrankeGerman

Cancer Research Center
Heidelberg, Cell Biology / A010
Head: Prof. Dr. rer. nat. Werner W. Franke

Im Neuenheimer Feld 280
D-69120 Heidelberg
E-Mail: h.heid@dkfz.de
Telefax: 06221 42-3404
Telefon: 06221 42-3475

Heidelberg, October 8, 2003

Summary

of the report¹ of the testing of the B-sample of Bernard Lagat in the laboratory of Prof. W. Schänzer, Institute of Biochemistry, Germany, Sport University, Cologne from Monday, September 29, 2003 until Wednesday, October 1, 2003:

A) All experts² present agreed that the urine of Mr. Bernard Lagat did not contain any recombinant erythropoietin (rhEpo) and he therefore had not committed Epo-doping.

B) While the test of Mr. Lagat´s B-sample did not reveal any reactive components in positions taken as indication of a positive test, the original A-sample showed bands in this region which, however, were not fully identical with those of the reference recombinant Epo and might well be due to glycoprotein modifications.
C) The test used involves many steps with many pitfalls. Only very experienced and critical “bench biochemists”, as those working in the Cologne lab, can responsibly handle the complicated and error-prone procedure. There are several problems with background staining, reproducibility, technical artifacts, losses of proteins during the enrichment steps and losses and changes as result of glycoprotein modifications etc.

D) The test takes too long and is not suitable for mass screening. It should be simplified and improved markedly, e.g. by using ready-made gels, avoiding the double blotting procedure, minimizing glycoprotein modifications etc.

E) Most importantly, the antibody used does not provide an unequivocal identification of rhEpo and specifically does not discriminate between natural and recombinant erythropoietin! A specific monoclonal antibody exclusively reacting with the recombinant glycoproteins is desirable and should be generated.

F) IEF as the only criterion is not sufficient to allow a clear decision, certainly not without a specific antibody. Two-dimensional gel electrophoresis, combined with specific mass spectrometric detection, should also be examined as a “second weapon”, notably in cases of “confirmation tests”.

G) There is currently no published epidemiological study available that deals with the various possible influences resulting in modifications of the Epo-molecule(s) (nutritional, ethnical, physiological, altitude etc.).

H) The recently introduced activity tests for enzymatic activities in certain urine samples places utmost importance to the need of a unified, carefully controlled handling and storing of the samples.

I) In the same line, the internal report for WADA also asks for necessary improvements and changes of the test. On page 15 of this report it is therefore stated: “The development of totally new urinary EPO tests should be encouraged and funded.”

Note: Evaluation report of Epo test for WADA can be read or downloaded under http://www.wada-ama.org/en/t3.asp?p=37147.

Dr. Hans Heid

1. Full report is available.
2. Present at the testing were the following:

Mr. Heid from the German Cancer Research Center in Heidelberg, Germany as Mr. Lagat’s expert;
Mr. Saugy the IAAF representative and the head of the Anti-Doping-Lab in Lausanne, Switzerland;
Mr. Schänzer as the head of the Anti-Doping-Lab in Cologne, Germany.