Awkward questions are being asked about the shortcuts some European scientists and companies are taking in their quest for profitable new drugs.
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.
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.
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.
The vaccine, tested on more than 200 terminally ill patients at Göttingen University, was a fake – and many of the first batch of human guinea pigs are already dead.
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.
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.
Professor Ulrich Zimmermann of Würzburg 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.
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.
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.
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".Reuse content