Eleonore Thun-Hohenstein WHO’S AFRAID OF A CURE FOR CANCER?
The Law’s Delay
Before a medicine can be sold in chemists and paid for by Austrian state health insurance, it must be approved by the health authorities. There is a special department at the Ministry of Health which deals with the many regulations for this procedure, which can be quick, bureaucratic or obstructive.
In the case of Nowicky and Ukrain it would have been astonishing if obstacles had not piled up during the registration process. Nowicky was forced into the realisation that the authorities measured with two different yardsticks. Foreign drugs from large pharmaceutical concerns were afforded better treatment and quicker approval, even if they were not registered in their country of origin, than the invention of a local outsider.
In 1986 Nowicky tried his luck for the first time and applied to the registration authorities for the approval of a new pharmaceutical speciality for the treatment of cancer. After a long delay and much red tape, he was informed that his documentation was unsatisfactory and much more information was required. From this point on the same answer, ‘unsatisfactory’, rang like a chorus through all his attempts to bring about the registration of Ukrain through continuously extending the documentation.
For example, there is the regulation that in order to be registered the company must be named which will be responsible for the production of the drug and the filling of the ampoules. Nowicky informed the ministry of the two companies which had given their written consent, Topoplan and Gerot. Soon afterwards, both companies suddenly pulled out of the agreement. Behind closed doors Nowicky heard that ‘pressure had been put’ on both firms. Now he had to look for new companies but told the civil servants responsible that he would inform them of the names when the preparation was registered.
Even if it is not surprising that an outsider who has no experience of the registration procedure must expect the authorities to demand additional documentation, the extra information which was demanded went on and on. Not only Nowicky saw it this way. Department head Rozsenich from the research department of the Ministry of Science described the way in which Nowicky was treated by the health authorities as less than helpful. ‘What’s outrageous is, that they don’t advise him,’ he said during a conversation on this subject. Rozsenich had been following Nowicky’s research work since 1978 and had supported him again and again: for instance with the contract provided via Professor Kuffner for € 22,000 for further research into the alkaloids. And also later when the assessor appointed by the Ministry of Health, Dr. Heribert Pittner, in one of his stereotypically negative reports, pointed out a weak point in the analysis which could only be carried out with expensive equipment which the institute of the Technical University did not possess, Rozsenich gave his approval to Professor Gutmann’s institute to spend € 110,000 on this equipment which had been lacking at the institute for a long time.
Still not unwilling at the beginning, Nowicky, who had received his PhD in 1993 and could no longer be labeled a crazy fantasist, provided more and more documentation for the registration of Ukrain. However, again and again, the information proved unsatisfactory. There were also grotesque scenes which revealed how tricky the procedure was.
The department responsible for registration demanded experiments which Nowicky, to be completely sure, commissioned an assessor for chemistry and a toxicologist to carry out, and also paid them. Later, as assessors for the Ministry of Health, these two pulled apart their own reports, describing them as ‘unscientific’ and not up to the latest standards. They must have forgotten that is was their own (sloppy?) work.
It is no wonder that all the additional documentation demanded led to a certain amount of confusion in the file, since the original order was brought into considerable chaos due to the extra information.
Expert witness Pittner had already made negative or ‘supplementary’ reports in January 1989 and in May and June 1990. A certain irritation can be can be noted in his new, once again negative, statement in April 1991 when he wrote of, ‘careful specialist detailed work,’ and remarked, ‘just as with previous submissions, the files have once again been handed in to the authorities in complete disorder.’ (In the report the experimental method for tertiary and quartiary alkaloids from greater celandine was demanded which required the equipment approved by the Ministry of Science.) Nowicky also remembers that documents which he had handed in were rejected several times only to be demanded again later.
In
Pittner’s report from 1991 it is remarkable
that he makes express reference to the screening programme of the National
Cancer Institute (NCI) in the
Despite this, the expert witness once again rejected registration but nevertheless admits in his statement that the ‘in vitro studies of the anti-proliferation activity of Ukrain are so interesting that further development of the preparation is justified.’
Pittner also agreed with Nowicky that, ‘Currently used cytostatic therapy is very aggressive and drastically reduces patients’ quality of life.’ It is difficult to understand why the expert witness Pittner still adhered to his negative standpoint and spoke out against the registration of Ukrain. He referred to regulations which he had not been called upon to check, making it easy for the registration authority civil servants to reject the application. On 16 November 1992 he made a statement, ‘for the last time about the individual parts of the documentation and their inadequacies’. However, the fact is that from 1996 Pittner suddenly no longer appeared as an expert witness. It was even reported that he had been suspended.
Pittner’s negative reports of course fitted in with the plans of civil servants at the Ministry of Health who several times told business people who were interested in Ukrain that no registration of this cancer drug could be reckoned with. Very early on, a potential investor was advised to risk no capital on the product, ‘There’s no hope.’
In 1997 as an executive from a large Dutch company visited the ministry because they wanted to make an agency agreement for Ukrain to use it against osteoporosis, he was astonished to hear the decisive answer, ‘Ukrain will never be registered.’ It seemed as if the civil servants were the accomplices of that professor whose remarkable statement had been reported to Nowicky, ‘Even if 99% of stage IV patients are healed, I will never register Ukrain.’
In any case, the intention once hit upon for mysterious reasons by the civil servants responsible, never to register Ukrain, scared off potential investors and others interested in the drug. Statements made under oath are available from such interested parties so that these events cannot be pushed into the realm of fairy-tales.
The tactics of obstruction were also aided by a lot of red tape. For example, on 30 December 1993 Nowicky handed in a report of a comparative clinical study to the appropriate department of the ministry. It was only there so that it could be stamped and then passed on to the office next door to be forwarded to the expert witness. The document was then kept for four full weeks before being stamped. It remained in the office next door for another ten days before it finally arrived at the expert witness’s institute. This was still Pittner, whose negative report was already complete five days later.
‘The methodology is inadequate,’ he complained. There was also no study plan: ‘The objectives are not stated.’ It was not made clear in the study, ‘What Ukrain is: a cytostacicum or an immuno-stimulator. The study does not meet the criteria for clinical studies demanded in the West.’
The study had been carried out at the National Ukraine Medical University of Kiev. There was good reason for interest in a new cancer therapy there, as can be seen from some quotes from the report:
‘The urgency of the cancer problem following the effects of Chernobyl,’ was reason enough to carry out, ‘…a scientific clinical study of the application of Ukrain as therapy for colorectal cancer,’ according to the decision of the Ethics Committee of the Institute for General Surgery and the Institute for Oncology of the National Medical University of Kiev. Mention is made that Nowicky provided, ‘around 1,000 ampoules of Ukrain free of charge’.
‘The aim of this study,’ it goes on, ‘was to investigate the application of Ukrain as monotherapy in colorectal cancer with unfavourable anthropo-genetic factors.’
Expert witness Pittner also remained unmoved by the conclusion of the clinical report, which contained some very remarkable statements:
‘The investigations carried out confirm the results of the good tolerance and atoxicity of Ukrain. Analyses show that, in comparison to complex conventional therapy, Ukrain therapy causes a significant improvement in the general condition (improvement in the quality of life) of patients with advanced colorectal cancer. It enables patients to be brought from an inoperable to an operable condition and thereby to prolong their lives.’
‘An important property of Ukrain is its ability to correct the immune system, which is an especially topical point in oncological treatment …’
Improvement in the quality of life, correction of the immune system, bringing from an inoperable to an operable condition – all of this made no impression on the expert witness. To justify the renewed rejection, he complained that it was not clear from the study what immuno-stimulators had been administered to the control patients who received normal chemotherapy. There is also no mention of remissions.
The study was carried out with two groups of 15 patients who were past medical care, that is, those who could only expect death. Pittner must have read the study only very superficially because it expressly states that 72.4% of patients treated with Ukrain, apart from the improvement in their general condition, had an average survival time of one and a half years whereas only 43.4% of the control group lived this long and suffered a deterioration in their general condition.
Even if this study was not carried out according to ‘western criteria’, it should certainly have been paid more attention in view of the fact that statistics show that in Austria alone over 2,000 patients per year die from colorectal cancer. It is incomprehensible that not even one cancer institute was prepared to repeat the experiment.
However, whatever Nowicky tried, he could never do the right thing in the eyes of the registration authorities. Everywhere there were barriers, bans, obstacles. It was as if it had been decided from the beginning to give Ukrain no chance. In 1979-80 Professor Spengler had investigated the phenomenon of the accumulation of Ukrain around cancer cells and its fluorescence in the area of cancer. This was a sensational discovery whose importance for diagnosis could not be overlooked. A urine test was also discovered, which, after the administration of Ukrain, produces different results for cancer sufferers and healthy patients.
‘It was very promising,’ Spengler remembered in March 1998. ‘I advised him (Nowicky) to study more cases of the same kind of cancer.’ Such as a group of patients with lung cancer or intestinal cancer, not just individual cases. ‘My hospital is too small to do that.’ He never had enough cases of the same type of cancer over a short period.
At that time Spengler had the impression that Ukrain was indirectly effective via the immune system.
In spring 1985 Dr. Salzer from the University Gynaecological Clinic of Essen declared himself prepared to carry out a clinical study. This was immediately blocked by the Ministry of Health which claimed that the toxocological tests had not been performed in accordance with GLP (good laboratory practice). However, the toxocological harmlessness had been confirmed a long time previously by the Pharmacological Institute of the University of Vienna.
In 1998 Spängler said that he had prepared a report for the Ministry of Science just a few years previously. At that time there had been the first indication of the possibility of continuous research into Ukrain. Had he been in favour of Ukrain? ‘Yes, of course!’
In 1993, as the drugs commission finally gave approval for wide-ranging clinical studies, it became clear that these could not be carried out. The costs were set so high that Nowicky had no chance of meeting them.
It was in exactly this year that the registration regulations were made more strict. As a result, the process had become so expensive that small companies no longer had a chance while large concerns were favoured. ‘Nowadays you have to reckon with 500 million dollars, all in all, up to registration,’ said the German biologist Harald von Eick, who worked for a pharmaceutical company for ten years and knows the business from the inside. Such high sums can only be raised by big companies. Interestingly, no protests were heard from this direction as costs for registration were increased. ‘The only voices raised in protest came from medium-sized and small pharmaceutical companies who now have no chance of bringing their drugs onto the market, no matter how good they are,’ said von Eick.
The competition was eliminated.
‘This process will intensify still more through the mergers of giant pharmaceutical companies,’ says von Eick. ‘Small and medium-sized competition has been swept out of the way. The question arises as to whether the pharmaceutical industry and the authorites, who have always had a very close relationship, had not also been working together in this case. Our cartel laws are obviously not good enough to prevent such mergers.’
And coming back to the case of Nowicky, ‘Without a distribution organisation it will not work.’
He said that worldwide, ‘The clinical picture does not look at all bad. But the authorities can always withold approval on formal grounds. There are already enough studies available which show that patients treated with Ukrain improved, whereas the condition of the control group was always worse.’
Von Eick says that for this reason alone, ‘It is an ethical duty to approve this substance provisionally. If the studies currently in progress do not produce the expected results, approval could be revoked. Then Nowicky would have the chance to finance the approval procedure through the sale of Ukrain.’
In the same year that the registration regulations were made drastically stricter and the Ministry of Health finally gave approval for clinical studies with Ukrain, there was yet another meeting at the ministry which was intended to make clear to Nowicky how pointless his efforts were. Present at this meeting in November 1993 were the registration civil servants Jentzsch and Michtner, their head of department Liebeswar and the petitioner without a chance, Nowicky. The subject was: clinical studies.
He was told that it was impossible for an individual researcher. ‘Only a large company can have clinical studies carried out.’ Nowicky remembers that he was told, almost triumphantly, that the total costs would run to 100 million dollars. Therefore, without a company there was no chance.
‘Which company?’ Nowicky asked.
‘That doesn’t matter,’ was the answer.
‘When is it paid?’ he asked.
And again, ‘That doesn’t matter.’
‘If it doesn’t matter to you then I’ll set up a company myself.’
And Nowicky, who still did not think of giving up, founded Nowicky Pharma.
Of course, subsequently it proved impossible to carry out clinical studies. Nowicky would have had to come up with at least € 70,000 per patient. And again when the Ministry of Science wanted to lend a hand there were ‘no patients’ in the hospitals which came into consideration for the study. They had already been ‘reserved’ for other pharmaceutical companies whose products the registration authorities were less fussy about.
For
example, in the same year of 1993 the cancer drug Taxol
from the
Taxol, developed by the Caribbean branch of Bristol-Myers in Mayaguez, Puerto Rico and distributed by Bristol-Myers Squibb in Vienna, is a highly toxic cancer drug that was registered within five months in Austria as the first country in the world even though the clinical study had not been completed at that time, a randomised study was just being repeated and the drug had not been investigated for possible carcinogenic effects.
Bristol-Myers
is one of the biggest pharmaceutical companies in the
It is also expressly stated in the 1993/94 codex for dispensing chemists, ‘Since serious over-sensitivity reactions can appear, appropriate equipment must be available for emergencies.’ Medical personnel must also take precautionary measures to avoid contact with skin and mucous membrane.
Taxol is administered as an infusion which takes three hours and patients must be pre-treated with cortisone preparations. According to the codex Taxol is for the treatment of metastasing breast or ovarian cancer ‘after standard therapy has failed’. Investigation of possible interactions with other cytostatica was also not required for registration. Even the fact that in in vitro animal tests Taxol had proved to be mutagenic (leading to genetic changes) could not hinder its triumph.
The American journal ‘Science’ calculated that Taxol would be extremely expensive because at least three cycles of treatment were necessary just to find out whether the patient would react positively to the drug. Thereafter, the cost of a course of treatment of ten therapy cycles would cost € 22,000, plus hospitalisation and other ‘overheads’. How the patient would cope with the side-effects was not included in the calculation.
For another cancer drug, which has been registered since 1993 – Cisplatin, a heavy metal complex compound which according to the codex is ‘highly toxic’ and regarded as a ‘potential carcinogenic’ – the possible side-effects take up half a page of the codex. Cisplatin is used as palliative therapy, which means that it is a treatment which does not fight the cause of the disease. Because it attacks the kidneys and can cause irreversible damage to kidney function as well as (‘rarely’) heart rhythm which can go as far as the heart stopping, this drug can in no way be described as harmless. Nausea, vomiting, stomach pains, hearing disorders, loss of hearing and cramp attacks are other ‘frequent’ side-effects which turn treatment into torture for patients.
At
the time that Taxol was registered in suspiciously
rushed circumstances by the Ministry of Health, doing without evidence that
had been absolutely necessary for Ukrain, there had already been far more
than 100 case reports for Ukrain in 1983, 80% of them from
A
comparison with the effects of Ukrain, which is neither toxic nor mutagenic
and besides slight nausea causes no negative side effects, should have caused
Austrian oncologists to have opened their ears, if not the authorities.
In any case, there are far more than 100 publications on Ukrain from
Numerous scientists are now investigating Ukrain. Professor Liepins
demonstrated Ukrain induced growth inhibition of one hundred percent on
the same human tumour cell lines investigated at Bethesda
and reported his findings at the 17th International Chemotherapy
Congress in Berlin in
June 1991. This was confirmed by EORTC (European Organisation for Research
and Treatment of Cancer) in Holland.
The Mayo Clinic in the
It is all the more curious that the pharmacist, Reinhard Fischill from Vienna wrote a letter to the Austrian pharmacists’ journal (Österreichische Apotheker Zeitung, 20 May 1996) saying, ‘As a pharmacist it makes my hair stand on end,’ when he reads, ‘The alkaloid derivative from greater celandine attacks only tumour cells and leaves normal cells undamaged.’ In addition, he pokes fun at the experiments carried out by Dr. Thomas Tritton at the University of Vermont which had shown that Ukrain was also effective where Cisplatin had failed.
Understandably, Nowicky was puzzled about the source from which Fischill drew his knowledge. All the documentation handed to the authorities for the registration process was confidential (as Dr. Jentzsch expressly assured me). The fact that Fischill worked closely with the Ministry of Health as a member of the Austrian Pharmacists’ Association and particularly that he is connected to the company Novipharm, which produces the mistletoe preparation Isorel, are far from being reasons to bring him to registration documentation, even those of a competitor. Isorel is used as an alternative cancer treatment; one that was quickly registered.
In reaction to Fischill’s allegations in his letter, Jentzsch, who until now has blocked the registration of Ukrain, explained to me on 8 February 1994, ‘It is certainly no quack medicine. We are all interested, but if the requirements are not fulfilled, there will be no registration.’ Asked whether, in view of the studies available until then from all over the world, the researcher should not be given a grant for further research, Jentzsch replied, ‘The ministry (of health) has always demanded that with such important things there should be intensive…’ he interrupted and corrected himself, ‘intensive is maybe overstated… cooperation with the Ministry of Science.’
At the Ministry of Science, however, there is another viewpoint. From 1984
the Research Department had, as the only government office, greatly promoted
Nowicky’s work. In addition to the grants already
mentioned, in 1992 and 1996 two special editions of the journal Drugs Under
Research were sponsored in which the most important results of Austrian
and foreign researchers were collected. The first special edition of 109
pages was presented at a symposium organised by the Ministry of Science
under the then minister, Dr. Erhard Busek on
25 May 1993. Cancer
specialists and doctors were invited to hear talks delivered by scientists
from
Years later, in the Oncological Department of Vienna General Hospital, I found out what clinical circles thought about an initiative like this. After Dr. S. had said in a radio discussion on 7 February 1997 that Ukrain was carcinogenic, I visited him a few weeks later at the hospital because I wanted to know what experimental results had led him to this statement which appears nowhere else in any literature on Ukrain.
However, as soon as we began talking, he threatened me with legal action if I named him in any report of our conversation. This was already disappointing. There had been no experiments at all investigating ‘carcinogenic’. He had only been talking about alternative remedies in general, thereby including Ukrain too. Most of them are carcinogenic. The fact that he could have mentioned in the radio programme that many cancer drugs approved by traditional medicine such as Cisplatin are carcenogenic (as explicitly stated in the codex) went under in a flood of jargon which could only confuse a layman.
The fact remained that Dr. S. knew of no studies which had described Ukrain as carcinogenic, nor had he carried out any such studies himself.
When I referred to the second special edition Update on Ukrain, in which there are reports of not only case studies but summaries of results presented at numerous congresses, the cancer specialist replied that the special edition sponsored by the Ministry of Science was only worth as much as a paid advertisement. I wanted to know what he meant by that. ‘The contributions,’ he said, ‘are of low scientific value.’
‘There are gaps in the knowledge of some professors and lecturers at the medical faculty,’ railed Department Head Rozsenich from the Ministry of Science, under whose auspices the special edition appeared. ‘What I condemn is that there are only very few doctors who are interested in complimentary medicine and research into it. If they don’t know internationally renowned journals, there is no excuse for them. Then research comes off badly. What quality can the teaching of such people have?’
In just this special edition there was a detailed paper by Professor Liepins describing how Ukrain causes the death of those cells which, for as yet unknown reasons, are not subject to programmed cell death (apoptosis) and therefore produce proliferating cancer.
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