Eleonore Thun-Hohenstein WHO’S AFRAID OF A CURE FOR CANCER? The struggle for an alternative cancer drug Translated from the German by Steve Gander Millions of people all over the world die of cancer each year. According to statistics from the International Agency for Research on Cancer (IARC) Globocan, the figure was 5,182,632 in 1998. Of these, 921,194 died of lung cancer, three times as many men as women; 627,850 died of stomach cancer, 426,934 of cancer of the liver, also three times as many men as women. In Austria a total of 18,955 died of cancer in 1998, 3,123 of lung cancer. Here too, men account for three times more deaths than women. Breast cancer killed 1,677 women. Incidence of lung, breast and stomach cancer is increasing worldwide. Oesophageal cancer is on the increase. After the age of 55 the number of deaths from cancer rises dramatically. 1 Introduction Who in the world is afraid of Ukrain? – And who must be protected from it at all costs? These are the main questions to be investigated in this book. It is also the story of the way in which the emergence of a promising anti-cancer drug has been obstructed – perhaps for reasons which are not always so mysterious. It is also the first and only drug which destroys cancer cells while leaving healthy cells undamaged, as proven by, among others, the US National Cancer Institute (NCI), an internationally recognised research institute. The mechanism of action of the drug was deciphered at St. John’s University, Newfoundland in Canada. At international cancer congresses, doctors and researchers from all over the world have reported their successes in using Ukrain. There is certainly no shortage of success stories. Hundreds of case histories prove that Ukrain has been effective, even in apparently hopeless cases where conventional medicine had failed. However, Ukrain is no wonder drug. There are also cases in which it has failed, especially when the disease is too far advanced; although even then, in not just a small number of cases, significant prolongation of life can be expected and particularly a decisive improvement in the general condition. All patients so far have agreed on this: the quality of life during and after treatment increased in a way they had not known previously - in contrast to conventional chemotherapy which also destroys healthy cells and weakens the immune system. Cancer patients and their relatives know the suffering of undergoing ‘chemo’ and how many additional drugs must be taken to reduce that suffering as much as possible – i.e. make it to some extent tolerable. The anti-cancer drug Ukrain is interesting because it is completely non-toxic, as proven decades ago at the Pharmacological Institute of the University of Vienna and later confirmed by numerous researchers and doctors worldwide. Furthermore, it has no damaging side effects such as hair loss or extreme nausea and therefore needs no extra drugs to combat the side effects. Ukrain appears to be especially effective where conventional medicine has unfortunately so often failed, such as with lung cancer with metastases, colon cancer, melanomas or types of cancer which form metastases in the liver and intestines. Many cases will be described in more detail in this report. The layman may ask why, if Ukrain is so promising, is it not long-established in general cancer therapy? That is the question. Its inventor, Wassil Jaroslaw Nowicky, an Austrian citizen originally from Ukraine, has been struggling to obtain official approval for more than twenty years – approval which the Austrian Ministry of Health has stubbornly refused. Tirelessly Nowicky has repeatedly submitted documentation which the authorities have demanded, only to then be told that they are still not satisfactory. Like Don Quixote he has struggled against a bureaucracy which, as we shall see, does not want to register his drug. But Nowicky has not given up. He has a deep streak of stubbornness. He is likeable and ready to help others but when it is a question of his invention he is imperturbable, hard- headed and liable to flare up. He will not let it out of his own hands. He has devoted his entire life to his research and he is utterly convinced of its value – and events have proven him right. 2 His misfortune is that he can only be granted registration of a medicine in the country of which he is a citizen.1 His even greater misfortune is that the authorities responsible refuse to grant it. Without registration a drug may only be dispensed at a chemist in exceptional circumstances, which are precisely defined under medical law. It is of no importance whether it is effective or whether it cures patients or not. The law particularly demands that a drug, when properly used, has no damaging effects beyond those that can be justified according to current medical knowledge. This means that when a drug is registered, damaging effects (risk) must be accepted when the sum of desired effects (benefit) is greater. In general, when dealing with cancer drugs, this relationship between risk and benefit is very generously defined by the registration authorities. Since 1980 several highly toxic substances with a relatively low response rate and low efficacy have been registered in Austria. Despite the fact that these substances not only constitute great potential danger for cancer patients, but also for medical personnel. (More about these drugs later.) In addition, with many cytostatica a relatively low margin of dose error can prove fatal. Therefore a cancer drug which was completely harmless and without side effects would be of enormous importance. It would also have a very favourable effect on the costs of cancer treatment. (The National Cancer Institute estimated the costs for 1990 at 104 billion dollars.) In view of these facts, any country and its ministers, authorities, health insurance institutions and doctors ought to be grateful if a drug is developed in their country which fights cancer without damaging health in any way. For this reason there is an accelerated procedure for these cases in many EU states and in the USA to make such a drug available to patients as quickly as possible. The dilemma of conventional cancer treatment with chemotherapy is that these drugs principally consist of cell toxins which kill or inhibit the growth of all fast growing cell systems, both healthy and malignant alike. It is therefore totally incomprehensible that over a period of twenty years an inventor has not been able to register an anti-cancer drug which on top of all other factors was also developed with considerable support from the Austrian Ministry of Science. In this case there can be no doubt about a positive risk-benefit ratio. At therapeutic doses Ukrain is non-toxic (it can even be drunk if it is not possible to inject it); it has no damaging side effects and its therapeutic efficacy is greater than conventional cytostatica. This has been confirmed in over one hundred scientific studies, clinical studies abroad and in numerous case reports. The inventor of this substance has been honoured worldwide (with the exception of Austria) with a total of 45 international and national awards. Papers on his drug have been presented at international cancer congresses. At the International Congress on Chemotherapy in July 1997 in Sydney, Australia a complete conference sequence was dedicated to Ukrain. ‘It is certainly no quack remedy,’ was even confirmed years ago by one of the civil servants responsible for registration. However, there can be no question of it being registered. The same ministry and the same civil servants who certified a positive risk-benefit ratio for such highly toxic substances as Taxol and Cisplatin for cancer treatment have fought against Ukrain with almost religious zeal. Whereby the facts of the case for registration are extremely simple: the preparation is not toxic and therefore not dangerous. The Ministry of Health has had the relevant proof for a long time. The therapeutic efficacy has been clearly demonstrated in studies on cell cultures (in vitro), in animal experiments (in vivo) and in clinical studies. In addition, the economic importance of such a preparation should also be considered. It would be an excellent product for export with an enormous world market and, as an intelligent product is apparently what the Austrian government so much wants to support. Since the raw 1 The only exceptions are Ukraine and Belarus, which suffering from the effects of Chernobyl successfully tested Nowicky’s cancer drug and granted him registration. 3 materials for Ukrain come from plants there would also be benefits to agriculture. There are reasons why its inventor has been offered millions by powerful international concerns for his worldwide patent and the relevant know-how. So why has this drug been persecuted by the registration authorities as though it were an enemy? This persecution culminated in the statement by one of the top civil servants at the registration authorities to interested parties from other countries who were interested in licencing agreements: ‘Ukrain will never be registered in Austria.’ The fact that such a standpoint of one of the civil servants can amount to an almost insuperable hurdle lies in the nature of Austrian medical law. This uses expressions such as current scientific knowledge, practical experience, state-of-the-art and others. However, it does not define what state-of-the-art actually is. It is therefore subject to the discretion of the civil servants interpreting the law, who can therefore subvert its intention, namely to protect patients. In this way the registration procedure can be drawn out to eternity by continually demanding new proofs, even when they are not required. This prolongs the procedure and uses up the time in which the patent is in force. At the same time the gathering of experience of the use of the preparation has been purposely obstructed by the ministry by putting pressure on doctors who successfully use the drug and not repealing edicts which are in contravention of the law or have misleading contents even when their incorrectness has been acknowledged by the ministry in writing and recognised by the highest court in the land. As a result, the health insurance institutions do not compensate patients for treatment costs even when treatment was obviously successful. The question arises as to who finally benefits from the ministry’s attitude. The patients need not be protected because the drug is not dangerous. The Austrian economy can only be damaged: delaying registration shortens the time for which the patent is effective and therefore also reduces economic profits and tax revenues. The solution to the puzzle is perhaps closer if the question is turned around: who is damaged by the registration of a drug? The question is aimed directly at the financial interests of international pharmaceutical companies. Perhaps here is the solution to the puzzle and the story of this incomprehensible delaying action suddenly turns out to be less mysterious. After all, an American doctor had expressed the opinion that this new drug could replace most current chemotherapeutics. During the course of my research this report has turned more into a crime story. Acts such as theft, telephone tapping and even direct threats cannot be attributed to coincidence for long. The obstruction, for which civil servants at the Ministry of Health and Consumer Protection (in the text below named Ministry of Health) are shamefully to a great extent responsible, has taken on ever more brutal forms over the course of the years so that once even the secret service became involved. I have spoken with those who are for and against, with doctors and with scientists and collected the evidence which is now part of this crime story. The two special issues of the medical journal ‘Drugs Under Experimental and Clinical Research’ from 1992 and 1996 and the ‘Documentation of Research Work on Ukrain’ under project director Dr. Peter Locatin, all sponsored by the Austrian Ministry of Science have been particularly helpful in covering the scientific aspects. I would also like to express my thanks to Dr. Heinz Talirz for his valuable thoughts on the practice of drug registration. In order to make the book more easily readable for laymen, I have kept specialist terms to a minimum. 4 Our First Meeting Our first meeting was brief and disappointing. I was sitting in my office with my desk overflowing with paper. It was just before six o’ clock. I had urgent work on hand and another appointment in the evening. There was a knock at the door and a shy, almost frightened-looking man came in. He introduced himself as Jaroslaw Nowicky. In excruciatingly bad, grammatically almost unintelligible German, he tried to explain to me what he wanted. He was working on the development of a substance that could revolutionize the treatment of cancer. Since I was the newspaper’s science correspondent, I should be interested. Another fantasist, I thought, used to the most incredible ‘scientists’ turning up at my office. On top of that, I was becoming increasingly irritated by his adventurous German. It came at me like machine gun fire, made no useful sense and, in view of being pressed for time, induced in me a paralyzing mixture of desperation and impatience. To get a moment’s air, I asked my uninvited guest to leave me the most important papers from his full-to-bursting briefcase. I would look at them in peace and then call him. After giving me his address and telephone number, he said goodbye. Later he told me of his bitter disappointment. He had been advised to come to me because I was the only one who would listen to him and write the article he so hoped for. He had already made unsuccessful approaches to other newspapers and now he expected that I too would somehow file his documents and forget about them. I almost did. But a few weeks later I had finished what I had to do earlier than expected and began a sporadic inspection of the mountains of paper on my desk – which mostly meant throwing away out of date news reports, invitations, notes, magazines and so on. I eventually worked my way down to a ‘potentially usable’ pile in which Nowicky’s documents awaited their exhumation. Out of fairness to him, I was just going to look through them quickly and let him know. I did not really expect to find anything newsworthy. However, I knew from experience that from time to time you strike lucky. And I did here. The papers were clear and comprehensible and, as far as I was able to judge on a quick first reading, did in fact contain sensational material in the field of cancer research – if it would all stand up to thorough investigation. Many people are interested in reading news about medicine – especially articles about cancer – so a journalist can count on receiving special attention. Maybe I had a scoop. I called the number Nowicky had left me and arranged a meeting. He came. Once again loaded with piles of paper. I had armed myself with patience – a scarce commodity in my case – and with the necessary stern expression, requested him simply to answer my questions at first without expanding on them too much since an information overflow would only lead to confusion. Of course, I had to interrupt him repeatedly because I was having a problem understanding his grammar. He submitted himself to my questioning with great patience. After almost two hours, I had discovered the essentials. And that was sensational enough. Jaroslaw Wassil Nowicky had developed a substance from the plant greater celandine which, when intravenously injected, accumulated in tumours. Due to its auto-fluorescence, it could make tumours visible under ultraviolet light. The same phenomenon could be observed with metastases. This demarcation of the tumour would be a great help to surgeons who must cut deep into healthy tissue. Furthermore, veterinary surgeons had reported that tumours were easy to remove when animals had been injected with this preparation. 5 The fact that oxygen consumption in cancer cells is increased for fifteen minutes and then leads to the death of the cells while the oxygen consumption of healthy cells is increased for five minutes and then returns to normal was a most remarkable discovery. If this phenomenon had been given attention in 1980 and this process observed under the microscope, we would have discovered what, seventeen years later, under the name ‘angiogenesis’, was to bring new findings about cancer to international cancer research. And it could have been realised at that time how Nowicky’s substance Ukrain can prevent the formation of metastases. In view of the fact that cancer is still the number two cause of death worldwide, one might have thought that medical science would have at least taken an intensive interest in the phenomenon of the increased oxygen consumption and subsequent death of tumour cells. In addition, there were indications that in some cases even tumour regression had been observed. In any case, Nowicky’s substance was the first and only one which attacked cancer cells without destroying healthy cells. However, there can be no talk of any interest from the authorities responsible. On the contrary. In the course of subsequent years, I was witness to not only indirect but sometimes criminal persecution of this outsider who had had the audacity to discover something that others, with enormous funds at their disposal, had been searching for in vain. He would now be punished by having his research findings consistently ignored. He was chased out of one university laboratory only to suffer the same fate at the next, as though he should be made a living example of the proverbial fate of inventors. After I had observed these perfidies for a few years, though I must admit that initially I even secretly believed that Nowicky was paranoid, I decided to document this persecution until I had concrete evidence. In the meantime, eighteen years have passed since my first article appeared in the now defunct Austrian news magazine ‘Wochenpresse’. Since then, medical reports of cures brought about by Ukrain have been piling up but there is still no end to the suppression of this invention. No clinical study has been carried out in Austria, foreign studies are not recognized and conspiratorial vested interests, both inside and outside the Ministry of Health, are still directed against the registration of this drug which has been tested worldwide and presented at well over two hundred international congresses by researchers from all over the world. Wherever possible, obstacles have been put in the inventor’s way and the authorities have even used illegal means to threaten his livelihood. As persistently as this persecution has been continued, the inventor has steadfastly continued his work. Until recently, I thought that my articles and all the others in various newspapers had achieved absolutely nothing. However, now I know that these publications were the impetus for the fact that since 1984, whenever the need was the greatest, crucial assistance was at hand – certainly not from the Ministry of Health, which was responsible - but from the Ministry of Science. What follows, is a documentation of this assistance and the methods used by the opponents of Nowicky’s drug, Ukrain. 6 Nowicky Leaves the Country of His Birth When I first met Jaroslaw Nowicky, he had already been in Vienna for nine years. He not only had a turbulent past behind him but also his first experiences of the life of an outsider scientist. He was born on 15 October 1937 in a small village in Galicia. It was not the best time to grow up. He was just seven as he and his parents were deported west to a concentration camp. He spent most time behind barbed wire at the Neumarkt camp near Nuremberg. His father had hidden a Jewish friend, a capital crime under Nazi rule, which had extended over Poland and Ukraine since the beginning of the war. At the end of the war, they returned to their ‘liberated’ home country but Stalinist Russia was also not the safest of places. At first, Nowicky’s family lived apart to avoid deportation to Siberia. Whoever had spent too long in the West, even as a prisoner, had to be ideologically ‘cleansed’ and polished up in accordance with communism. The gulags were full of such people. Thanks to the family’s separation, young Jaroslaw was able to graduate from high school in Broschniv-Osada and subsequently studied at the radio technology faculty of the Technical Academy in Lvov. Because he was the only one who was not a member of the Comsomol - also highly suspicious in the period following Stalinism – he was sent to work in a factory in Petropavlovsk in Kazakhstan. Since under dictatorships it is often the case that one office does not know what the other is doing, the grotesque situation arose in which Nowicky was sent to a top-secret military factory where he was refused permission to pass even the first perimeter fence. The politically suspect were not allowed even to set foot inside a restricted area. Because nobody knew what to do with him, he was just sent away. No other camp, no forced labor, simply free - but thousands of miles away from Lvov. He had to find work somewhere in order to survive. This intermezzo lasted four months until he arrived back at his starting point of Lvov. In 1961, as a qualified engineer, he began work in a television factory, which he left just one year later as chief engineer. He then taught in Lvov at a technical high school where he lectured both in Russian and Ukrainian – which promptly led to his suspension. Illegally – for although Russian was the language used in all schools throughout the Soviet Union, it was not expressly forbidden to speak Ukrainian. Nowicky often used Ukrainian so that students from less educated backgrounds, who knew little Russian, could follow his lessons. But now politics gave him a four-year break. Not for the first time, Nowicky proved his incredible endurance. Once he got his teeth into something, he never let go. As he was turned down for every other teaching job on the grounds that he was no longer to be trusted to speak in front of young people he quoted the law which said that the Ukrainian language was indeed allowed in the Soviet Union and that he therefore had the right to teach in that language. Ukrainians were secretly longing to become independent and, despite all obstacles, would not give up their language. Nowicky began to be a thorn in the side of the authorities. And this time, also the KGB. At first his efforts were in vain. However, because he did not give up, the KGB began to harass his father. For Nowicky this was too much. He traveled to Moscow to inform the head of the KGB, Yuri Andropov, of these injustices personally. After checking in to a small hotel in the capital, he went to the headquarters of the KGB close to the notorious Lubyanka. He told the guards that he had to speak to Andropov personally. ‘On what business?’ ‘I will tell Andropov myself,’ said Nowicky. ‘If we don’t know what it’s about, you can’t make an appointment with him.’ 7 ‘When a Soviet citizen has something very important to say to the head of the KGB he ought to be allowed to say it,’ answered Nowicky. He was accompanied to the door. He left his name and the address of the hotel. Next day he appeared again. The boss was not there. Nowicky would wait. ‘What’s it about?’ ‘I will tell him personally.’ Next day he was there again. The boss is away on business. Nowicky would wait. This scene was repeated for twenty-seven days. On the twenty-eighth day a letter was waiting for him at his hotel. He should make himself ready to be picked up at ten o'clock. On the dot of ten a big black KGB car arrived in front of the door and took him to the Lubyanka. And then he was standing in front of Andropov to say something ‘very important’ to him - that his subordinates were not obeying the law, that they had suspended Nowicky without good reason. His father had even been threatened, without any justification, by Andropov's own people. Suddenly Andropov stood up, his face red, and banged on the table with his fist. Nowicky was also overcome with anger and banged on the table. He protested against being punished without reason. ‘I'm a human being, just like you are!’ The head of the KGB calmed down. Glancing at his watch, Nowicky got up to go. ‘Stay here,’ Andropov barked at him. ‘I asked you for three minutes and the three minutes are up. I had to wait twenty-eight days for these three minutes.’ Nowicky turned to the door and went out. Andropov called him back but he continued on his way. In the outer office Andropov's staff were talking excitedly but Nowicky remained unflustered and left the building in which he had stood up to the most powerful man in the Soviet Union. Back in Lvov, he was told that after four years he had been rehabilitated and even that some people who had reported him, including fellow teachers, had been punished. However, what sounds like a success story, nevertheless cost several years and very much in energy and effort. Even today, when Nowicky talks about these times, there are almost tears in his eyes, so strong are the memories. The minor government officials in Lvov had not reckoned with his tenacity. They were later also to discover that they should not underestimate his perseverance. Nowicky did of course use these apparently lost years for other purposes. With a group of scientists from the medical faculty in Lvov, he began working on the development of a treatment for cancer. This was triggered by his brother being diagnosed with testicular cancer. Nowicky recalled that in his country, herb women had always used greater celandine against cancer and had reported cases in which skin cancer had been cured through the long and repeated application of the milk of Chelidonium majus L. (greater celandine), whose popular name in his language was ‘wart herb’. Nowicky discovered that a young assistant doctor in Ivano-Frankivsk (previously called Stanislav) was working with greater celandine and had achieved some interesting results with some patients and also with animals. The doctor, Anatoli Ivanovich Potopalsky was producing an injection solution from greater celandine and Thiotepa, which he called ‘Amitosin’. At first, the doctor denied having such a drug but Nowicky was not willing to leave empty-handed. ‘I know that you have a drug. If you don't give it to me, I'll break into the institute,’ he threatened. ‘I only need the extract.’ 8 ‘Who will inject it?’ asked the doctor. ‘I will,’ said Nowicky emphatically. ‘Can you do it?’ ‘I'll learn.’ He then learnt how to give injections by practicing on apples. However, it was not so easy to give his brother intramuscular injections. He was in a hospital ward surrounded by other patients. With the help of a friend who stood guard, Nowicky gave his brother injections in the toilet. The patient went into a high fever, up to forty degrees. However, his condition improved. Nowicky took his brother home and continued the series of injections for two months. When it then appeared that the tumour had disappeared, he took his brother to Lvov and from then on dedicated himself to the yellow milk of Chelidonium majus L., greater celandine, an ordinary plant with yellow flowers which grows on walls and wherever it is not weeded out. Nowicky was by no means the first person to investigate the milk of this plant. It had been known for a long time that it was made up mainly of alkaloids, basic nitrogen compounds from which 32 different alkaloids have so far been isolated. Some have been found to be cytotoxic, which means that they damage cells. Cancer researchers were very interested in these, and with good reason, but of course without coming up with any special results. Other alkaloids in the plant were ignored. Nowicky studied case reports from natural medicine. He noticed that whenever cures were reported it was always when the milk of greater celandine was used from plants which had been picked in winter. The proportions of the individual alkaloids, their quantity and quality, depends on the seasons. In winter the plant contains some alkaloids which almost disappear in summer. Nowicky concentrated his research on a group of eight of these winter alkaloids. However, it would not be possible for him to carry out this research in Lvov and at this time he decided to emigrate to Vienna. As a Ulan, his father had fought in the army of the former Hapsburg monarchy and had told stories painting Austria and Vienna in glowing colours, so that without any idea about what really awaited him the son staked everything on being allowed to emigrate. In the former Soviet Union this was an almost hopeless cause. Nowicky's thick skin and tenacity were required once again. In 1956, Nowicky had worked as an interpreter for Polish at an international youth festival in Moscow. There he had met a woman from Vienna named Anna who worked at the Atlas publishing house. They had become friends and had later kept in touch. Nowicky suggested that they went on holiday together to the Black Sea resort of Soshi. There he asked her to help him emigrate. The only possible way to do this was by getting married. Anna agreed and it was then left to Nowicky to fight for permission to leave the country in order to get married. Not unexpectedly, this was at first refused. He wrote a total of 380 complaints to various authorities. Once again the KGB became interested and summoned him for questioning - even with his mother. The official wanted to force her to use her influence over her son. ‘Do you have children?’ she asked him. ‘Yes, three.’ ‘And do they do what you tell them to do?’ she asked. A shrug of the shoulders was the answer. Finally, the military became involved and Nowicky had to submit to questioning by a general. ‘Why can't you marry in Lvov?’ he asked. 9