- Awkward questions are being asked about the shortcuts
some European scientists and companies are taking in their quest for
profitable
new drugs.
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- In the wake of a scandal involving the German
pharmaceuticals
giant Bayer and revelations of human experiments with a fraudulent
"cancer
vaccine", EU-wide rules aimed at protecting patients from untested
drugs have been exposed as a complete muddle. Earlier this month, Bayer
was forced to withdraw its anti-cholesterol drug Baycol, admitting it might
have killed 52 people already worldwide, with another 1,100 potentially
crippled.
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- Germany's health minister, Ulla Schmidt, yesterday
accused
Bayer of sitting on research documenting Baycol's lethal side- effects
for nearly two months before the government in Berlin was informed. Bayer,
hinting at a Europe-wide communications breakdown among national agencies,
counters that it did comply with EU rules when it reported Baycol's
problems
to the authorities in Britain, where the drug was originally registered.
"It is German law, and not EU law, which applies here," Ms
Schmidt
retorted.
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- Yet many fledgling companies in the US bring their new
products for testing in Germany, hoping to complete the rigorous and
expensive
obstacle course in shorter time. A vaccine against cancer is the Holy Grail
of the pharmaceutical industry. So when a scientist from a prestigious
university claimed to have discovered it, the authorities did not waste
any time granting permission to try it out.
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- The vaccine, tested on more than 200 terminally ill
patients
at Göttingen University, was a fake ñ
and many of the first batch of human guinea pigs are already dead.
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- German scientist Alexander Kugler published a paper two
years ago purporting to show that his "fused cells" had defeated
kidney cancer in the test tube. The crucial evidence of this breakthrough
came from a photograph illustrating the miracle of vanishing cancer cells.
There was no other proof. Nor had anyone else duplicated his finding, as
is standard practice. Yet Dr Kugler received the prestigious Ernst-Wiethoff
medical prize.
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- More importantly, his group signed a deal with German
company Fresenius for the manufacture and testing of the vaccine. Within
months of the unsubstantiated "discovery", human trials were
underway.
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- Professor Ulrich Zimmermann of W¸rzburg University,
a leading authority in this field, had grave doubts from the very
beginning.
He alerted colleagues at Göttingen of
"accumulated
experimental errors" and "alarming misinterpretations" in
the paper.
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- An investigation followed, which discovered that Dr
Kugler
had taken the "conclusive" photographic evidence from the website
of US company Molecular Probes. By the time the experiments were stopped
earlier this year, the "Göttingen brew"
had been given to hundreds of patients.
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- Fresenius admits that nowhere in the world would the
"Göttingen brew" be allowed to be used
in clinical trials. But there is a loophole for "compassionate
use".
"What was conducted at Göttingen was not
a clinical trial but a 'healing experiment'," says Oliver Heiek, a
Fresenius spokesman. Such "healing experiments" are approved
by local ethics committees, whereas authorisation of clinical trials is
tangled up in miles of regional, national and supra-national red
tape.
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- Dr Kugler has been stripped of the scientific doctorate
he was awarded and is said to have "disappeared". The tests are
suspended while the investigation proceeds,. But Fresenius wants to press
on, saying early results were "encouraging".
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