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BACKGROUND: Failed British medical test sparked safety concerns


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By Annamari Sipilä in London
     
     A medical experiment took a disastrous turn for six men last spring. The men tested a drug intended for the treatment leukaemia, rheumatoid arthritis, and multiple sclerosis, manufactured by the German company TeGenero.
     During the test, the men began to complain about severe pain and an exploding sensation in their heads. They lost consciousness immediately afterwards.
     According to the two other young men who had been given placebos, the others "fell like dominoes".
     The tested men were rushed to the hospital's emergency room. Their bodies swelled, and their fingers and feet turned black. According to the doctors, their bodies had sustained severe damage.
     
The men's treatment is still under way. The most severely injured man may face having his fingers and toes amputated.
     According to the lawyers hired by the men, their immune systems are in disarray, and they may also face the risk of cancer.
     
According to the pharmaceutical company and the testing company Parexel, the men's serious illness came as a complete surprise.
     The subjects had been paid about EUR 2,900 for taking part in the tests.
     TeGenero announced about a month ago that it must discontinue operations due to financial difficulties. The disastrous test has frightened off all investors.
     The test subjects and medical companies are locked in a dispute over compensation for damage.
     
Helsingin Sanomat / First published in print 7.8.2006

More on this subject:
 Volunteering to test experimental drugs
 New rules restrict medical testing in EU
 FACTFILE: About one in five medical tests involve treatment of cancer

ANNAMARI SIPILĂ„ / Helsingin Sanomat
annamari.sipila@hs.fi


  15.8.2006 - THIS WEEK

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