Topic: Anti-doping case; September 16, 2004 – February 11, 2006
Homologous Blood Transfusion Test (HBTT): meant to detect transfusion of blood from another person

Performed at:

•	ATHENS: Athens Olympic Laboratory for the IOC, August 2004
•	LAD: Laboratoire Suisse d’Analyse du dopage for the UCI, September 2004

Key facts about Tyler Hamilton:

•	Tyler Hamilton has always known there was something wrong with the HBTT because he has always known he did not transfuse blood from another person into his body
•	He vowed to spend every last penny he had in pursuit of an explanation for the test results that form the basis of the case against him
•	He has been forced to go to extraordinary lengths to gain an understanding of the test and the results used against him
•	His sixteen-month quest revealed the information detailed below

Key facts about the HBTT:

•	The method used for this test is called Flow Cytometry
•	Flow cytometry, even when implemented correctly, cannot prove a homologous blood transfusion has taken place. This point was even acknowledged by USADA’s experts
•	Within the medical and scientific communities, flow cytometry is primarily used for white blood cell analysis, not red blood cell analysis
•	Reagents (antibodies that are mixed with red blood cells) used for the HBTT were not developed for use in flow cytometry, in fact, they are being used in an “off label” context, meaning the antibodies are being used for a different purpose and in a different way than intended and validated by the manufacturer
•	Flow cytometry can be a finicky test method, that produces varying results depending on the skill level of the technician and the quality of the materials used to conduct the test
•	The HBTT uses flow cytometry to analyze protein cells (antigens) on the surface of red blood cells. The scientific community (outside of anti doping) admits to knowing very little about antigens. Only recently (2005) was the condition of “antigen suppression” discovered by researchers in which antigens appear in blood, disappear and then reappear. Why this occurs, is unknown. (“Blood”, 2004)

Facts obtained from suppressed documents discovered December 2005:

•	The test validation was rushed and under-funded
•	Materials (Antibodies) needed to properly run the test were not available to the Athens or LAD labs in 2004
•	Less than one month before Tyler's Vuelta sample (taken September 11, 2004) was tested, one of the authors of the test method issued a strong warning to the International Olympic Committee that the LAD was producing “unreliable” results, and “the test used in Lausanne (at LAD) was not the same test used in Sydney and Athens.” (At the time this warning was issued, LAD and Athens were supposed to be collaborating on the test’s validation)
•	The issues raised about the LAD’s capability were never addressed in writing. In fact, they appear to have been ignored. No changes were implemented at the LAD from July 2004 through November 2004 per their own standard operating procedure (their own guideline for running the test)
•	The majority of the LAD’s preliminary validation work was conducted on a machine (flow Cytometer) that was later discovered to have technical problems. The LAD only conducted 3 proficiency tests on a new machine prior to conducting Tyler’s anti-doping test in September 2004
•	There is no evidence the LAD’s new machine was regulated with rigorous validation before the 3 proficiency tests were run (in late August 2004), which would be a common practice within the science community
•	A number of false positives were encountered by Athens and LAD during proficiency and validation testing (Including an additional 6-7 from Athletes during the Olympic Games) Despite public claims by authors of the test (from Australia) and prosecution witnesses to the contrary
•	Blood samples of other athletes (and cyclists) were used for validation and proficiency testing without the written consent of each athlete. (per testimony: Cyclist’s samples were provided by the UCI during the Spring, summer and fall of 2004). This violates privacy rights of the athletes
•	Technical problems could cause the appearance of mixed populations in single population blood: 1. Antibodies provided by some manufacturers 2. Inaccurate gating 3. Inappropriate concentration of antibody and 4. Inexperience of the technician
•	Controls (confirmation pre-tests) run in Athens and by the LAD proved that both labs were having significant problems with the test – however, both labs moved forward even though they knew the HBTT did not work completely or consistently
•	The LAD introduced the HBTT without independent authorization or oversight by the anti doping agencies. (LAD didn't receive ISO (International Standards Organization; who provide independent approvals per the WADA code) accreditation to run the HBTT until October 2005 – 13 months after Tyler was tested)
•	The UCI, never required or requested certification from the LAD concerning their capability to run the HBTT and later stated this is not their policy
•	Validation concerns raised by 1. The laboratory technicians 2. Outside experts and 3, By WADA, were never addressed or investigated because proper amounts of time, money and materials (antibodies) were not available to complete the appropriate work
•	A vague positivity criteria was adopted for the HBTT per the urging of USADA, with the goal of making HBTT test results nearly impossible to challenge if an athlete was charged. This criteria also rationalized away the need for the labs to do the extensive scientific validation that was truly necessary for analytic positivity criteria development

Facts from Mr. Hamilton’s Test data

•	In Athens, Tyler’s blood sample was mistyped. His test results from the Games are also biologically impossible. The only reasonable possible explanations are: technical error, critical/terminal illness or genetic anomaly
•	Examination of Athens HBTT data run on other athletes during the Games, revealed that a significant number of other tests showed the same kind of results
•	The Athens test data doesn't match the LAD data taken 3 weeks later. In addition, LAD proficiency test data from a 9/2/04 sample doesn't match anti doping test data taken on 9/11/04
•	USADA alleged Tyler transfused 1 unit of blood sometime around June 1, 2004 and no new transfusions took place after that. If this is the case, all the data (mixed populations) should match, regardless if it is from different labs
•	Alleged “supporting health test data” (pre-race measurements taken by the UCI of hematocrit, hemoglobin, & reticulocyte), taken from Tyler in the spring of 2004 was proven to be inaccurate when calibration data from the machines used to conduct those tests were analyzed. The hematocrit machine showed a high bias and the reticulocyte machine showed a low bias

Facts about Accreditation

•	The Athens lab director abandoned the “flexible accreditation” approved by WADA and the IOC which was intended to cover the HBTT during the Olympics. This action reduced the test’s status to a “pilot project”, meaning it was an “experimental procedure” during the Games
•	Article 4.2.2 of the WADA code states “the flexible accreditation process is the sole responsibility of the laboratory director, who doesn’t need to seek approval from WADA or other accreditation body for the method to be implemented in the laboratory.” The Athens Lab director did not take responsibility for the HBTT during the Games
•	USADA, the UCI and the LAD were asked in January 2005, September 2005 and again on January 12, 2006 to provide documentation regarding the status of the LAD’s accreditation to run the HBTT by September 11, 2004. No such documentation was ever produced

Facts about Chimerism & Vanishing Twin Phenomena:

•	Chimerism was identified by the authors of the test methodology as a potential cause for false positives
•	Because a false positive study was never conducted in support of the HBTT, it was argued that potential causes of mixed blood cells could not be ruled out
•	Tyler never stated he was chimeric or had a vanishing twin, which was misreported by the media. The authors of the original test method identified these phenomena in their own published papers as potential causes of mixed populations among other reasons - bone marrow transplant and serious illness. However these assumptions were never validated or examined by the authors of the test
•	USADA sent Tyler’s remaining blood samples from Athens and the Vuelta to a DNA expert to be tested for micro chimerism in August of 2005
•	Tyler sent his own fresh samples to an expert in Austria who developed a Chimerism test in June of 2005
•	All tests prove that Tyler is not a chimera, and did not have a vanishing twin
•	Additional flow cytometry testing conducted on Tyler’s blood at MIT in December of 2004 and January of 2005 (on a sample stored in September 2004) failed to provide an explanation for the Athens and LAD test results – as they could never be reproduced
•	Tyler exhausted every opportunity and resource available to him to try to determine the cause of these test results but was never able to draw a medical or scientific conclusion

Critical expertise was provided to Mr. Hamilton by:

**Dr. Carlo Brugnara, Harvard Medical School%% **Dr. David Housman, MIT%% **Rebecca Wallace, MIT%% **Dr. Michael Strong, Puget Sound Blood Center%% **Dr. Jim Stray-Gundersen, University of Utah%% **Dr. Gerald Sandler, Georgetown University%% **Dr. VK Gadi, Fred Hutchinsen Cancer Institute%% **Dr, David Nelson, University of Rhode Island%% **Dr. Wolfgang Mayr, University of Vienna%%

Conclusions drawn by Tyler Hamilton & his experts:

Tyler's test results are flawed and inaccurate

The HBTT was rushed into use before it was properly validated and before the required proper materials (antibodies) were available to conduct the test

The anti-doping system is lacking in critical areas: 1. Well-funded research and 2. Independent review of new test methods

Proper oversight of accreditation is needed. Labs should not be able to implement tests by their own choosing

USADA and the LAD and Athens laboratories all acknowledged issues with the test, the validation, and the capability of some of the materials (antibodies) used. Yet, they proceeded with charges against Tyler based on their belief that some parts of the test worked properly while simultaneously ignoring the components they knew did not work properly

No athlete should be tested or charged with a doping violation through the use of a test that is not properly validated and generates fluctuating or inaccurate results

Tyler Hamilton Case

Timeline

06/14/2004: Tyler meets with the UCI to discuss results of a blood test conducted (for research purposes) on a B sample of and April health test. He agrees to see an expert in Boston recommended by the UCI for further testing during the off season. He is cleared to continue racing

07/15/2004 Per the LAD, the UCI begins officially implementing the HBTT at the Tour de France. LAD tests 3 Samples, none of which are Tyler’s.

08/18/2004 Individual Time Trial, Athens Olympics

08/19/2004 Tyler provides blood sample in Athens

08/20/2004 Tyler’s sample is tested in Athens

08/22/2004 Sample declared, “negative suspicious”

09/11/2004 Tyler wins Vuelta, Individual Time Trial Blood sample is taken at 8PM

09/16/2004 Tyler is told he tested positive for HBTT

09/17/2004 Tyler learns of IOC positive by USA Cycling

09/18/2004 Tyler attends meeting with UCI and IOC

09/20/2004 Athens B sample arrives in Lausanne frozen Tyler’s test results leaked to media Tyler stores a blood sample in Spain for testing on a later date

09/21/2004 Day 1 of B testing Phonak press conference addresses leak

09/22/2004 Day 2 of B testing Vuelta B is called Positive Athens B is called Inconclusive

09/23/2004 Tyler recommends being suspended from Phonak until case is resolved

10/20/2004 V. Ekimov files with CAS over Athens gold

11/04/2004 UCI warns phonak may not be in pro tour

11/05/2004 WADA report issued stating: “Botched test”allowed Hamilton to keep Olympic Gold”

11/22/2004 Phonak and UCI meet over PT status

11/25/2004 Tyler accepts termination of his Phonak contract, to aid the team in regaining Pro Tour status

11/30/2004 UCI announces Phonak is out of Pro Tour

12/14/2004 MIT tests Tyler’s blood w/ flow cytometry, - Results are negative

01/18/2005 Tyler testifies before CAS for Phonak

01/20/2005 Tyler transports blood sample to MIT from stored in Spain since 9/20 for testing

01/31/2005 CAS upholds Phonak appeal, PT status is granted through 2006

02/28/2005 USADA hearing begins, Denver, CO

03/02/2005 USADA hearing concluded

04/18/2005 Tyler is found guilty, suspended 2 years

05/18/2005 Tyler files appeal with CAS

09/06/2005 CAS appeal begins, Denver, CO

09/08/2005 CAS appeal is adjourned. USADA, LAD, Athens and Sydney are provided 3 weeks to produce validation documents

09/29/2005 Only part of document request is provided. LAD and Athens inform Tyler he must come to the labs if he wants to see the data because it was too much work for them to produce the documents on their own

10/00/2005 LAD receives ISO accreditation to run the HBTT 13 months after declaring Tyler positive

10/20/2005 CAS upholds lab offer to Tyler – he is told he must go to the labs if he wants the validation documentation

11/28/2005 Tyler attends Lausanne lab for documents

11/29/2005 Tyler attends Lausanne lab for documents

12/01/2005 Tyler attends Athens lab for documents. Tyler is provided suppressed emails detailing issues with the test

12/02/2005 Tyler attends Athens lab for documents

01/10/2006 CAS appeal continues, Denver, CO

01/12/2006 CAS Panel requests USADA, WADA, LAD and UCI provide documentation of the LAD’s accreditation status in Sept 2004

01/13/2006 No certification is provided that LAD was accredited to run the HBTT in September 2004.

02/10/2006 CAS dismisses Tyler Hamilton’s appeal upholding his suspension through September 22, 2006

Download Tyler Hamilton's Case