Eleonore Thun-Hohenstein WHO’S AFRAID OF A CURE FOR CANCER?

Obstruction Intensifies

Not only medical experts and the courts, but even the secret service became involved with Ukrain. Not however in order to obstruct it, but to deal with the extremely suspicious events taking place in connection with this anti-cancer drug.

One evening, a member of the secret service, Johann Wagner, turned up at Nowicky’s flat and told the baffled inventor that it had been reported that the secret service of a Mediterranean country had given the order to liquidate Nowicky. However, the hired assassins had confided in the Austrian authorities.

This occurrence, which took place in 1996, was again brought to mind in spring 1998 when a registered parcel arrived at Nowicky’s Ukrainian Anti-Cancer Institute in Margaretenstrasse in Vienna. On the parcel was written that the sender was the headquarters of the tax office for Vienna, Lower Austria and Burgenland in Vienna’s third district; although the parcel had been sent from a post office in the ninth district of the city.

At the time, Nowicky was at a medical congress in the USA, so the packet was opened by the vice-president of the institute, Tibor Nemeth, who happened to be present when it arrived. Inside a normal shoe box was the skeleton of a lobster. Nowicky associated this with mafia messages such as the horse’s severed head in ‘The Godfather’.

Nowicky would have let it rest at that and just filed it under ‘terror’ if his accountant, Peter Obermayer, had not urgently advised him to report it to the police. Nowicky went to the police with the evidence. The shoe box and its contents were photographed, but no other action was taken. Of course, the tax office had nothing to do with the case in its official capacity.

On the other hand, Nowicky was informed by his accountant not only that the tax office was about to check his books (which in the meantime was carried out and no irregularities found) but that the tax office had demanded two ampoules of his preparation Ukrain so that they themselves could determine the cost of production, which they suspected Nowicky had stated too high. On the basis of what research the civil servants came to the conclusion that it cost € 20 per ampoule will remain a secret of the tax office.

As if this harassment was still not enough, foreign customers who had been ordering Ukrain for a long time and paying via bank transfer to the Creditanstalt bank without any difficulty were now suddenly confronted with Austrian antics. For example, instead of a small amount such as $3000 being credited to Nowicky’s account, the money was returned to the sender without explanation. It is all too easy to understand why Nowicky then changed his bank.

At almost the same time very many cheap Ukrain preparations were brought onto the US market, and these also appeared within just one week in England, Canada and Australia. Professor Liepins, who had known Ukrain from the beginning, investigated these cheap products which proved themselves as totally ineffective. The contents of one ampoule also proved not to be sterile. Since then the Food and Drug Administration has warned on the internet that Ukrain is unsterile and even could contain the AIDS virus. 

A letter from Nowicky drawing attention to this mistake in which he even named the institute whose products in which the AIDS virus was found remained unanswered. The error on the internet has also not been corrected.

At the same time as all these unpleasant occurrences, tests on the efficacy of Ukrain were being carried out in Ukraine, the country most damaged by the Chernobyl disaster. It was there that the story of Ukrain began and it was there that on 15 October 1998 the registration of Ukrain was unanimously approved.

Austria would be left standing if a miracle did not happen.

For three decades Nowicky had made efforts and put up with all the harassment so that his invention could move onto the world market from Austria; ‘out of gratitude’ as he says because this country had given him a home. He also knew very well the financial benefits which the country could reap. Each year Austria spends € 100 million in the USA on chemotherapeutic drugs alone – minus ‘commission’, by which ‘donations’ are also to be understood. And although Ukrain is not yet registered € 1.3 million come back to Austria from the sale of Ukrain alone. ‘The commercial aspect does not interest us,’ said Dr. Johann Jentzsch, Ministerialrat and the Ministry of Health, in a talk with me on 8 February 1994. When I pointed out the danger that Nowicky could go abroad he was almost euphoric; ‘He should go to Germany!’ he said with joy.

 A study carried out in Germany in February 1998 by Harald von Eick, director of business development at an international services company in the field of clinical research (CRO), who specialises in the market sectors ‘strategic management for immunology and oncology’ shows that the economic aspects of Ukrain are in no way uninteresting for the country in which Ukrain is produced and from which it is distributed. In view of the fact that Ukrain is non-toxic in therapeutic doses and that quality of life is significantly improved – even in the final stages of disease when all else has failed – von Eick sees the market potential of Ukrain as extremely positive.

If one supposes that in the first year in which Ukrain becomes available it will predominantly be used on patients in the final stages of disease who conventional medicine can no longer help, von Eick forecasts that Ukrain could gain a 30 percent market share in Europe in the first three years - which means that 76,500 patients would benefit from it. This is an unusually successful perspective for a new drug in the oncological field, wrote von Eick. Nowicky himself is rather more reserved in such forecasts. ‘On the basis of studies carried out so far on efficacy and tolerance, a market share of five to ten percent is realistic for the treatment of solid tumours such as cancers of the breast, colon and rectum, lung, prostate, and bladder as well as melanomas,’ according to his application to the trade and industry research grant fund.

Among the forms of cancer listed it is noticeable that three are included against which drugs are to a large extent powerless. These are breast, colon and lung cancer with metastases, as stated in a radio discussion between Austrian cancer specialists on 7 February 1997.

Nowicky’s current turnover, as stated in his application to the trade and industry research fun is € 500,000 in Austria and just over that abroad. The total market volume in the framework of the project was calculated as € 100 million in Austria and € 20 billion abroad. In the first phase a production and research organisation creating 50 jobs would be set up and this would expand to 200 jobs in the final phase. The cultivation of greater celandine for the extraction of raw materials is estimated to create 500 to 1,000 jobs in agriculture. It is not difficult to imagine what that would mean for farmers who are having a hard time making a living. Finally, the revenue from taxes is a factor which cannot be overlooked.

All these advantages could benefit another country if a miracle does not happen – only because the authorities and various interest groups in Austria have been able to prevent the drug’s registration. It is hardly credible that one single civil servant, or more of them, could have set the wheels in motion for this obstruction. The question also arises what interest they could have in doing so. It is rather more probable that large pharmaceutical concerns which themselves have spent billions developing chemotherapeutic drugs would have a few million to spare to obstruct a new anti-cancer drug: N.B. if that drug achieved much better results with extremely negligible side effects. The fact that these concerns were disturbed by the regular reports on Ukrain at national and international congresses is confirmed by the tempting offers which once again arrived from an international concern for the Ukrain patent and the relevant expertise.

Wassil Nowicky is not the first person in this country who has stared failure in the face due to a lack of understanding and good will, if not worse. All because he had the audacity to want nothing other than to promote his invention himself – not least for the good of the patients – and thereby to allow the country to benefit which twenty five years ago gave him a home and enabled him to carry out research – even if with many obstacles.

If he had not been encouraged by many scientists abroad, it is possible that he would have given up long ago, despite his innate stubbornness. In 1998 such encouragement came from the president of the German Oncological Association, Professor Dr. J. Beuth from Cologne University. He had worked out a programme with which ‘all legal conditions for registration would be fulfilled, especially proof of efficacy in the EU,’ as he wrote to Nowicky in a personal letter. Nowicky wanted to raise the comparatively moderate costs of € 80,000 through sponsors. However, this project was also cancelled due to fruitless controversy and troublemaking.

In the meantime Nowicky’s opponents in Vienna had also not been idle. And so that he would not forget that his ‘friends’ at the Ministry of Health were still keeping a careful eye on him, they gave him a reminder at every opportunity – such as in September 1998.

Nowicky read in an Austrian medical journal that Professor Dr. Ernst Kubista from the Gynaecological Clinic of the Vienna General Hospital had developed a test to check the sensitivity of cancer tissue to various chemotherapy drugs. Sterile tumour tissue was removed during an operation and exposed to the various drugs. The medical journal quoted Kubista as saying that the test would show with ninety percent certainty which cancer drug would be effective and which would not.

Nowicky wrote to the professor suggesting that he should also test Ukrain and that he would supply sufficient quantities of the drug at no cost.

The busy professor did not deem the letter worthy of an answer.

However, around three weeks later Nowicky received a letter from the Ministry of Health signed by the civil servant Michtner. In this letter medical legislation was quoted, where according to paragraph 3 it is forbidden, ‘to distribute drugs if it appears uncertain that they have no harmful effect when used normally.’

The absurdity of the whole letter is shown up by the fact, undoubtedly known to the ministry, that the Kubista test was to be carried out on tissue cultures (in vitro) and not on patients. Were they afraid that Ukrain could have demonstrated its effects? – And if so, what would happen then? Or was it simply a question of doing everything possible not to have to reverse the decision that Ukrain ‘will never be registered’?

The refusal of the Ministry of Health to grant an official certificate was part of this ploy. Nowicky had asked for a ‘Certificate of a Pharmaceutical Product’, the only purpose of which was to confirm that a drug by the name of Ukrain actually existed. Since Ukrain had been approved for clinical tests, whereby its existence appeared to be officially recognised, the untiring supplicant Nowicky thought that nothing could stand in the way.

The application was made on 5 November 1998. The enclosed documentation from the company Solvay, including a certificate from the Dutch Ministry of Health confirming that the company produced the drug according to GMP (Good Manufacturing Practice), was returned on the grounds that it was unnecessary. Nowicky was informed that on the following Monday, 9 November, the certificate could be collected from the ministry.

On 9 November the application could at first not be found. Two civil servants, Fleischig and Pfaffinger searched in vain for the document. Fortunately, Nowicky’s courier had brought a copy of the application. On the same day, in response to a telephone inquiry from Herr Pfaffinger, it was explained that Nowicky was the producer of Ukrain and the company Solvay was contracted to fill the ampoules. Everything appeared to be in order and on 12 November a short telephone call from Herr Fleischig informed Nowicky that the document could be picked up that morning.

So once again Nowicky went to the ministry. What then happened is described by Nowicky, who was in the habit of recording his experiences in writing. ‘I was handed a document which I had to sign to confirm receipt. I assumed that I would then be given the whole document but I was mistaken. Without further ado it was taken from my hands and I was given only the appended letter – signed on behalf of the Federal Minister. The letter contained a rejection of Nowicky’s application on the grounds that the Ministry of Health, ‘neither knows whether the company Solvay Pharmaceuticals from The Netherlands has approval to produce cytostatica such as Ukrain, nor is there any proof that the production of the drug is carried out by this company’.

The certification from the Dutch Ministry of Health stating that Solvay was an approved producer of human medicines and that the company actually did this in accordance with GMP regulations had been handed back as unnecessary at the time of the application. – Along with the documentation covering the second point of the rejection.

There was stated: ‘The manufacture of Ukrain is said to be contracted out. It should be emphasised that the company Nowicky Pharma has neither a trade licence nor approval in accordance with paragraph 63 for the production of parenteral drugs and can therefore cannot appear as the contractor in relation to such drugs. The existing patents and trade licence cover only the manufacture of the effective substance.’

Apart from the fact that it was intended that Solvay fill the ampoules, Nowicky had a ‘concession decree’ from 1988 giving him permission for ‘the manufacture of substances and preparations for medicinal use.’

His company, Nowicky Pharma, is entered on the register of companies. The height of this absurdity is the fact that in 1994 Nowicky had already received such a ‘Certificate of a Pharmaceutical Product’ rubber-stamped by the Ministry of Health without any objection.

If so much is ‘unknown’ to the ministry, it could be due to the fact that so much of the documentation was repeatedly handed back at the time of the application since it was deemed unnecessary.

Nowicky once again experienced how unhelpful information from civil servants at the Ministry of Health was, when in a letter of 25 November 1998, addressed to the Minister of Health, Eleonore Hostasch, he asked for the information: ‘What formalities are necessary to set up my own production of Ukrain according to the regulations of Good Manufacturing Practice here in Vienna?’ Since his letter was still unanswered in the middle of January 1999, he wrote an urgent letter to the minister on 22 January in which he referred to what he had been told by one of her civil servants. This passage is certainly worth quoting:

‘In reply to a brief enquiry to one of your civil servants I received the answer that I should first have the facilities built and then it would be considered whether I would be granted approval for GMP production. Please understand that I cannot spend around € 500,000 if it is possible that I would not receive approval for production in accordance with the regulations.’

 After once again referring to the fact that that his anti-cancer drug Ukrain was registered in two countries (Ukraine and Belarus) and that its efficacy had been sufficiently proven, he summarised his frustration in one sentence with an exclamation mark. ‘I applied for registration in Austria in 1978 and I am still waiting today!’ He continued: ‘If the same delaying tactics are used in this matter, i.e. the GMP certification, as in my application for registration, for which I have been waiting for more than twenty years, I will finally be left with no option but to take the production and distribution of Ukrain abroad, where my efforts are supported. I would therefore URGENTLY ask you to give me a clear answer to my question as quickly as possible.’

The answer arrived before four weeks had gone by, dated 19 February 1999 and signed by the civil servant Michtner who was responsible for registration. In just two sentences he managed to avoid the clear answer Nowicky had asked for. ‘With reference to your letter of 22.1.1999 addressed to the Federal Minister, may we point out that on the basis of your first letter of 25.11.1998 regarding this matter, in personal discussions it was requested that the question of the production of the drug Ukrain in Austria should be discussed in connection with the decision on the registration of Ukrain which is soon to be taken.’

The second and concluding sentence: ‘We would once again like to ask for your understanding that isolated consideration of questions arising in relation to the possible production of Ukrain in Austria can lead to no conclusive judgement.’

‘The decision on the registration of Ukrain which is soon to be taken’ went as follows. On 16 April 1999 seven civil servants, three of whom were only present for a short time, gathered in a room on the second floor of the Ministry of Health. Dr. Heribert Pittner also re-emerged to join in. Nowicky and a representative from Dr. Graff’s lawyer firm kept records of the conversation.

Initial discussion was once again about the chemical composition, the various stages of production, in short about a ‘definition’ of the compound. Nowicky pointed out that the ministry had been in possession of descriptions for years and that all this was clearly defined in his patent.

They then turned to his urgent request with regard to the formalities of building his own laboratory in Austria and producing Ukrain there. Nowicky asked them to consider the fact that the production of Ukrain was intended for countries in which the drug was already registered. It was therefore not reasonable that this matter should be connected to registration in Austria. On the one hand he could not build facilities which would then be refused approval, and on the other hand it could mean considerable revenue for the minister of finance and jobs for the country. Logically, he would have to know the regulations before beginning construction.

If the answer had been deftly avoided in the letter from the ministry, this time he was not deemed worthy of any answer at all.

There followed a general discussion about registration, during which the expert Pittner suddenly stated that clinical studies need not necessarily be carried out in Austria but could also be carried out in east European countries. This was sensational in view of the fact that previously such studies had been rejected as irrelevant and not up to western standards, with the undertone ‘dubious’.

This was also the fate of a clinical study carried out at the University of Kiev which had been thrown out by Pittner in 1993. However, this time Pittner expressly referred to it, calling it ‘very good’. It only had ‘methodological inadequacies’. In answer to the hopeful question of how long it would take until registration with a new application, the answer was ‘at least eight years’. And as if this dampener was not discouragement enough, Pittner added that the regulations could have changed by the time the new documentation was submitted. Then the whole process would have to be repeated in order to be in line with the latest medical knowledge.

The inventor, who was still not finally discouraged, then raised the question of registration in relation to the significant improvement in the general condition and the quality of life which had been confirmed by every doctor in every study. Here too, there was no chance. There are no objective criteria to prove this.

Once again, nothing gained for the patients.

Finally, Nowicky attempted to bring in the improvement in the immune status, which brings about the improvement in general condition as a logical result.

The objection was raised that there was already a registered drug for correction of the immune system. This was Isorel. Nowicky then wanted to know how it was possible that this drug was registered so quickly and what proof of its efficacy was necessary. They were not authorised to answer these questions.

Still attempting to find a tolerable period of time for registration, Nowicky then asked Pittner how long a clinical study for the indication ‘increase in immune defence’ would take. Three years at least, he was told. But since a prolongation could not be ruled out, it could easily take three times three, i.e. nine years.

This would mean that Nowicky would have spent thirty years attempting to get his anti-cancer drug registered and that the result would still be uncertain.

This has been a never-ending story of obstruction. The question as to who benefits from this obstruction hangs in the air. Or vice versa: who is damaged by the use of an anti-cancer drug which does not do harm and can also help?

In 1998, 5.8 million people worldwide died of cancer, of these 18,955 in Austria.

Millions are affected by this insidious disease and it will kill many more in years to come.

Should not every avenue be explored?