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Criminal Story of a Prevention - Ukrainian Anti Cancer Institute

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had been confirmed a long time previously by the Pharmacological <strong>Institute</strong> <strong>of</strong> the University<br />

<strong>of</strong> Vienna.<br />

In 1998 Spängler said that he had prepared a report for the Ministry <strong>of</strong> Science just a<br />

few years previously. At that time there had been the first indication <strong>of</strong> the possibility <strong>of</strong><br />

continuous research into Ukrain. Had he been in favour <strong>of</strong> Ukrain? ‘Yes, <strong>of</strong> course!’<br />

In 1993, as the drugs commission finally gave approval for wide-ranging clinical<br />

studies, it became clear that these could not be carried out. The costs were set so high that<br />

Nowicky had no chance <strong>of</strong> meeting them.<br />

It was in exactly this year that the registration regulations were made more strict. As a<br />

result, the process had become so expensive that small companies no longer had a chance<br />

while large concerns were favoured. ‘Nowadays you have to reckon with 500 million dollars,<br />

all in all, up to registration,’ said the German biologist Harald von Eick, who worked for a<br />

pharmaceutical company for ten years and knows the business from the inside. Such high<br />

sums can only be raised by big companies. Interestingly, no protests were heard from this<br />

direction as costs for registration were increased. ‘The only voices raised in protest came from<br />

medium-sized and small pharmaceutical companies who now have no chance <strong>of</strong> bringing<br />

their drugs onto the market, no matter how good they are,’ said von Eick.<br />

The competition was eliminated.<br />

‘This process will intensify still more through the mergers <strong>of</strong> giant pharmaceutical<br />

companies,’ says von Eick. ‘Small and medium-sized competition has been swept out <strong>of</strong> the<br />

way. The question arises as to whether the pharmaceutical industry and the authorites, who<br />

have always had a very close relationship, had not also been working together in this case.<br />

Our cartel laws are obviously not good enough to prevent such mergers.’<br />

And coming back to the case <strong>of</strong> Nowicky, ‘Without a distribution organisation it will<br />

not work.’<br />

He said that worldwide, ‘The clinical picture does not look at all bad. But the<br />

authorities can always withold approval on formal grounds. There are already enough studies<br />

available which show that patients treated with Ukrain improved, whereas the condition <strong>of</strong> the<br />

control group was always worse.’<br />

Von Eick says that for this reason alone, ‘It is an ethical duty to approve this substance<br />

provisionally. If the studies currently in progress do not produce the expected results,<br />

approval could be revoked. Then Nowicky would have the chance to finance the approval<br />

procedure through the sale <strong>of</strong> Ukrain.’<br />

In the same year that the registration regulations were made drastically stricter and the<br />

Ministry <strong>of</strong> Health finally gave approval for clinical studies with Ukrain, there was yet<br />

another meeting at the ministry which was intended to make clear to Nowicky how pointless<br />

his efforts were. Present at this meeting in November 1993 were the registration civil servants<br />

Jentzsch and Michtner, their head <strong>of</strong> department Liebeswar and the petitioner without a<br />

chance, Nowicky. The subject was: clinical studies.<br />

He was told that it was impossible for an individual researcher. ‘Only a large company<br />

can have clinical studies carried out.’ Nowicky remembers that he was told, almost<br />

triumphantly, that the total costs would run to 100 million dollars. Therefore, without a<br />

company there was no chance.<br />

‘Which company?’ Nowicky asked.<br />

‘That doesn’t matter,’ was the answer.<br />

‘When is it paid?’ he asked.<br />

And again, ‘That doesn’t matter.’<br />

‘If it doesn’t matter to you then I’ll set up a company myself.’<br />

And Nowicky, who still did not think <strong>of</strong> giving up, founded Nowicky Pharma.<br />

Of course, subsequently it proved impossible to carry out clinical studies. Nowicky<br />

would have had to come up with at least € 70,000 per patient. And again when the Ministry <strong>of</strong><br />

29

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