- Legal Situation
- Clinical Applications
- Scientists Call for Research on Ukrain
- Obstructive Tactics
- Obstruction of Approval
- Obstruction in the Granting an Import Licence
- Prohibition of Selling Ukrain in Pharmacies
- Obstruction of Production
- Obstruction of Clinical Studies
- The Higher Administrative Court's Verdict of Unlawfulness as a Result of a Breach of Procedural Regulations
- Disregard of Positive Reports
- Unlawful Edicts
- Obstruction of the Use of Ukrain
- Consequences of the Obstruction of the Use of Ukrain
- Breach of Article 7 of the Austrian Constitution
- Misinformation on the Part of the Authorities
- Obstruction of the Announcement of Clinical Results
- Obstruction of Ampouling
Thiotepa and greater celandine alkaloids are in the pharmacopoeias (XXII, XXIII) and have been clinically used for a long time. I developed a new preparation for cancer therapy from these starting substances.
The Medical University of Vienna, Cancer Research Institute at Borschkegasse 8 established in animal tests that this new substance is effective against cancer and at the same time more than 300 times less toxic than its starting substances.
Experiments carried out at the Federal Institute for Experimental Pharmacological and Balneological Examinations (Bundesstaatliche Anstalt für experimentell-pharmakologische und balneologische Untersuchungen) showed that the new complex, which in the meantime had been named Ukrain, exerts a different influence on the oxygen consumption of normal and malignant cells. Oxygen consumption is initially increased in both healthy and tumour cells. After short time oxygen consumption in healthy cells returns to normal, in malignant cells it falls to zero: "No toxic symptoms were to be found after administration of Ukrain directly on the normal cells at a dose approximately one thousand fold greater than a conventionally administered dose. Further tests will be required to ascertain the effectiveness of Ukrain against malignant cells without damage to normal cells." (38)
This gave me grounds to make an application to the responsible office (on 28 June 1976) for registration of this new complex for the treatment of cancer patients who had exhausted all other modes of therapy in accordance with §8 lines 2 and 3 of the Medical Specialities Order (Spezialitätenordnung). (XI) This paragraph states (LXVI): "The following preparations are particularly unsuitable for registration: ... 2. [those] which are obvious imitations or replications of specialities registered in Austria insofar as an improvement has not been demonstrated in a technical or therapeutic direction..." This means that "replications" which would be suitable for registration according to the Medical Specialities Order are those that do represent an improvement in comparison to already registered specialities. A clear therapeutic improvement has been proved for Ukrain because it is effective against cancer and more than 300 times less toxic than its starting substances. The law further states in §8 line 3: "...[specialities] whose production specification is contained in the latest or an earlier edition of the Pharmacopoea Austriaca VIII or the Deutsche Arzneibuch, 6th edition." This clearly applies to Ukrain – both Thiotepa and greater celandine alkaloids had already been in the Pharmacopoea Austriaca and the Deutsche Arzneibuch long before application was made for registration.
On the basis of these facts the preparation should have been very quickly approved for patients who had exhausted all other forms of therapy in order still to be of help in their hopeless condition.
Unfortunately, so far registration has still not been granted in Austria due to illegality as a result of a breach of procedural regulations, as established by the Higher Administrative Court (Verwaltungsgerichtshof) with its finding Zl. 95/10/0124 from 26 February 1996 (XXXIII). Ultimately, as long ago as 24 February 2005, the European Court of Human Rights adjudged the Republic of Austria to have contravened administration regulations in the case of Ukrain. (XXXII)
The studies of oxygen consumption gave the first indication of the selective effect of Ukrain against cancer cells. In the following years other scientists at several universities and research institutes confirmed this new and unique property for cancer therapy, including such renowned research institutes as the National Cancer Institute (Bethesda, Maryland, USA, XXV), Rochester University (USA, 147), the Universities of Tübingen (184), Ulm (182) and Münster (243; Germany), the Universities of Milan (245) and Pisa (LXXI, Italy), the University of Pretoria (139; South Africa), Instituto Nacional de Cancerologia, Mexico City (255; Mexico) and others.
The greatest wish of all cancer researchers was to develop a medicament that killed only cancer cells and for a long time this problem was considered insoluble. But with the development of Ukrain it became clear that a solution is possible after all. Ukrain turned the old dream into palpable reality and levelled the way for other new preparations. For this invention Dr. Nowicky was nominated for the Nobel Prize in 2005 (LXXIV) and the Alternative Nobel Prize in 2007 (LXI).
Applications made, with the same documentation presented to the federal ministry, for the approval of Ukrain in other countries were granted there (LXXV) despite the fact that Austria is the country of origin of Ukrain, where until today it has still not been approved. If registration had been granted in Austria in accordance with the valid legislation at the time, as the country of origin the preparation could have been registered far more easily in other countries. Great damage has been caused by the rejection of approval in Austria as the country of origin because as a consequence preclinical and clinical trials had to be repeated locally to provide proof of the efficacy and harmlessness of Ukrain in each country. If approval of the preparation had not been illegitimately refused (XXXIII), all this could have been avoided and cancer patients in other countries could have been given access to the drug more quickly.
Because Ukrain is registered in many countries and has been presented at many renowned international congresses, as well as being described in the specialist literature, doctors may request Ukrain for patients in accordance with §8 of Austrian Medicines Law which states: "A medical speciality does not require registration if 1. it is to be used to carry out non-clinical or clinical studies or clinical tests, or 2. a doctor, dentist or veterinarian who is licensed to practice independently in Austria attests that the medical speciality is urgently needed to prevent a threat to life or serious damage to health and that this success cannot be anticipated with an approved and available medical speciality according to the state-of-the-art." (LXXVI)
The preparation was registered in Ukraine in 1998 and on account of its therapeutic successes registration has already been extended twice for a further five years, most recently on 12 November 2008 (№ UA/9110/01/01, LXXV).
The well-known Parisian physician Dr. Musianowycz heard about Ukrain and informed himself about the preclinical data. The plant was familiar to him because he had written a work about greater celandine as a student.
He was the first to use this preparation clinically with 17 patients who had exhausted all other modes of therapy. On 11 April 1979 he described a case of a seriously ill breast cancer patient who had completely exhausted other forms of treatment: "The case of this patient shocked those around her, initially also the doctor in attendance and the nurses who were taking care of her. After two injections the blisters diminished and dried out. After ten days the blisters were already scarred over. At the same time it could be seen that the craters on the breasts healed and the eschar on the whole thorax scarred over, both on the back and in the region of the breasts." (XLI p. 3)
Doctors established that Ukrain relieved pain in many cases of patients who had exhausted other forms of therapy, whereupon they no longer had to take pain-killers and their quality of life improved. The report of the Ludwig Boltzmann Institute for Clinical Oncology at Lainz Hospital, Vienna from 30 June 1980 states: "During this therapy an increasing improvement of the general condition was observed, a local temperature increase in both tumours... and a reduction of pain... The patient felt better, also mentally." (XLIV)
In 1983, on the basis of his experience with Ukrain in the treatment of patients with metastasising melanomas, the renowned Austrian dermatologist and melanoma specialist Prof. Dr. Peter Wodniansky remarked that this medicament can save patients' lives. It was therefore no wonder that he felt obliged to inform the Ministry of Science and Research, which he did on 12 June 1984. He reported his good result and requested that the potential of Ukrain should be investigated in a clinical study. "This completely exceptional result impressed me so much – with a melanoma patient who is already excreting melanin in the urine one can hardly expect months – that I requested Prof. Dr. Klaus Wolf, head of the I University Skin Clinic to test Dipl. Ing. Nowicky's preparation clinically. Professor Wolf agreed to this test without further ado – so that I would now like to join in with the request for further support." (VIII) Unfortunately this has not happened until now even though on 23 June 1993 the Ministry of Health's Pharmaceutical Advisory Board (Arzneimittelbeirat) approved a clinical study with melanoma patients. (IX)
Enough evidence has been provided for the efficacy of Ukrain against melanomas. At the National Cancer Institute (Bethesda, Maryland, USA) of all the tested cell lines the sensitivity of melanoma cells to Ukrain was highest – in this test all the melanoma cells died. (XXV)
Another group of scientists investigated the effects of Ukrain on melanomas in vivo on animals and established that the preparation inhibits the growth of the main tumour as well as metastases in mice (107).
With regard to the successfully treated case of melanoma by Prof. Wodniansky, not one other similar case of a full remission with melanin in the urine has been described in the specialist literature. Preclinical studies as well as clinical experiences of other doctors confirm that it was no coincidence. Other doctors have also reported similar successes, such as Dr. Nowicki: "A 66 year-old female patient with a malignant melanoma on the lower leg with massive lymphedema on the bone and multiple metastases in the cerebrum and spinal canal was discharged from hospital as incurable. After the third course of Ukrain therapy the massive primary tumour and the lymphedema regressed, the primary tumour could be excised and the metastases in the central nervous system became smaller. After the 7th course of Ukrain therapy no further metastases were demonstrable. The patient has been free of recidivism for three years, feels healthy, is free of symptoms but is still under Ukrain medication. (complete long-term remission)..." (IV page 27)
At all international congresses it is confirmed that metastasising melanoma is still an incurable disease. It is therefore incomprehensible why approval has still not been granted for Ukrain in the face of all these positive proofs and indications so as to provide help for desperate patients who have exhausted all other modes of therapy.
Although even the recognised melanoma specialist Prof. Wodniansky wrote about an unexpected therapeutic success, such cases are denied by Austrian professors. Instead of examining this case precisely and initiating clinical studies, the successes were dismissed as "spontaneous remissions" (self-healing).
As a skin cancer specialist Prof. Dr. Pehamberger, the chairman of the Austrian Society of Dermatology, should have borne in mind that patients throughout the world with metastasising melanoma could expect no help. On account of the unique cure in the case described by Prof. Wodniansky which was presented to Prof. Pehamberger (XXVII), it would not only have been appropriate to initiate a study but also, for reasons of science and humanity, to advocate the approval of Ukrain so that it would be widely used. However, this was not the case.
The case described by Prof. Wodniansky also clearly shows the clinical efficacy of Ukrain against melanoma. Both the efficacy (XIV) as well as the safety (XXX) of Ukrain have been sufficiently demonstrated, whereby the most important toxicological tests were carried out by the Austrian Research Centre Seibersdorf in accordance with GLP (Good Laboratory Practice). These studies confirmed without a doubt that Ukrain is not damaging to health. (XXXI) What evidence is still needed when the disease is still incurable? What evidence is still needed simply to start a clinical study?
Why has there been no reaction from doctors, Austrian scientists and the Ministry of Health to such remarkable successes? During this period around 7,000 people have died of malignant melanoma in Austria, around 1 million throughout the world. (Source www.dep-iarc.fr)
The well-known Vienna physician Dr. Thomas Kroiss wrote about his experience with Ukrain: "I have been using the medicament Ukrain in the treatment of cancer patients for 16 years. In my experience it enables malignant tumours of small dimensions to be treated in such a way that they do not return. I have also seen that in 99% of cases no side-effects appeared with Ukrain therapy (assuming the correct dosage)." (IV p. 5)
Ukrain also brought about inhibition of tumour growth, thereby prolonging life and improving the quality of life. With its malignotoxic properties, which have been demonstrated in vitro by the National Cancer Institute (Bethesda, Maryland, USA), Ukrain destroyed all tested cancer cells but no healthy cells. (XXV) The therapeutic index (the ratio between the toxic and therapeutic dose of a medicament) of Ukrain is 1250, which speaks for great safety. For this reason there are no known cases of an overdose of Ukrain. The therapeutic index for conventional cytostatica is in the range of 1.4 to 1.8.
The efficacy of Ukrain has also been confirmed by many doctors in clinical application in the treatment of various types of cancer. On 29 April 2004 Dr. Manfreda from the Allgemeine öffentliche Krankenhaus des Landes Kärnten (Carinthia General Hospital) in Klagenfurt reported on a breast cancer patient: "Diagnostic findings at the beginning of therapy: 5x5 cm sized exulcerated supraclavicular metastases. Subjective feeling of pressure in the region of the eyes and feeling of tension L. supraclavicular... Already after 6 injections no further exulceration was visible L. supraclavicular, however the tumour size itself was unchanged. Subjectively the feeling of tension had disappeared as well as the feeling of pressure in the region of the eyes which had existed for two years. At the last examination on 8.4.1980 the patient was free of subjective complaints." (XLV)
Dr. Hiltraut Fussenegger stated: "Overall Ukrain appears to me to be successful against pain. Patients' mental state also improves. The administration of pain-killers can also be reduced." (IV p. 18)
Dr. Thomas Matschurat describes: "A 44 year-old patient with a colon carcinoid local recurrence. Radiochemotherapy, OP April 1995, LAR, colostomy. Summary evaluation and post-operative staging: pT4, pN0, cMX, stage II, G2-3, R2, lowly differentiated, neuroendocrine carcinoma, tumour infiltration as far as the pelvic wall, tumour-free regional lymph nodes.
Therapy: Ukrain and adjuvants for around one year. At the end of February 1996 a small residual tumour was observed radiologically. At the latest examination no residual tumour was found. The patient is in complete remission and continues to take Ukrain prophylactically...
47 year-old patient. August 1993 diagnosis of a mamma carcinoma L. (T2,NX,MX). Histology: invasive, ductal mamma carcinoma left, ER + 6 fmol/mg PR X3 mol/mg.
8/93 Tumour node extirpation mamma L.
Since the beginning of 1995 increasing swelling and hardening of the left breast.
6/95 Ukrain therapy with adjuvant vitamin/mineral therapy. This led to a rapid improvement in the general condition and of the acute local situation, as well as the encapsulation of the tumour recurrence from healthy tissue.
17.07.95 Ablatio L., axilla revision, implantation of a NaCl prosthesis.
Histology on 18.07.95: 8 cm, lowly differentiated, invasive, ductal carcinoma of the left breast PT4, G3
After the OP treatment was continued with Ukrain, mistletoe lectins, a tumour vaccine and vitamins and traces elements.
The patient has been free of recurrences until now, end of August 96..." (IV pp. 29-30)
Dr. Adolf Langer, Vienna: "I would be pleased to present my numerous – medically proven – cases where the patients owe their survival to the effect of Ukrain.
It seems to be that Ukrain can develop still more variegated modes of action in terms of an improvement in the whole organism and I am also able to demonstrate this scientifically with hard medical data." (IV p. 31)
After the presentation at the 13th Congress for Chemotherapy in Vienna in August-September 1983 (XI) of the first therapeutic successes with Ukrain in the treatment of more than 100 patients who had exhausted all forms of therapy, many doctors became interested in the preparation and took it into their therapy schemes on the basis of § 12 of the Austrian Medicines Act (Arzneimittelgesetz) (LXIII) (corresponds to the current § 8) (IV) which is also shown by congress presentations (LXXVIII) and the specialist literature. (LXXIX)
At this conference it was announced that Ukrain had brought about complete tumour regression in a proportion of patients, as reported by Prof. Wodniansky and other doctors. Dr. A. Langer wrote: "I treated a very similar case with Ukrain, a 30 year-old patient with colonic cancer and lymph node metastases, who had had a hemicolectomy exactly like Ms. Jakob and in addition also extended bone and particularly liver metastases. After 3 months Ukrain therapy the liver metastases had disappeared. This was demonstrated by several CTs, MRIs and ultrasound." (IV p.30).
Complete remissions after Ukrain therapy can be illustrated by three examples. The tumour of a 9 year-old girl was treated with chemo- and cobalt therapy. However, after the tumour no longer responded to the treatment and continued to grow, Ukrain therapy was started. After six series of therapy a complete remission with bone regeneration was achieved, as documented by X-rays at St. Anna Children's Hospital, Vienna. (XLIII)
The second case is a 10 year-old girl with Ewing's sarcoma. Disease progression after chemotherapy and radiotherapy was shown at an MRI examination. She was treated with Ukrain combined with local hyperthermia. After one therapy cycle the MRI examination showed no further tumour progression. The following cycles of therapy brought about complete regression of the tumour. (XLIII)
Ukrain has also been successfully used in the treatment of rare diseases, as shown by a case of xeroderma pigmentosum. Xeroderma was diagnosed in the young S.S. at the age of 10 months. The first case of skin cancer was found at the age of 6 years-old. Chemotherapy was unsuccessful, the tumours grew and at 8 years-old a malignant melanoma was diagnosed in the nasal region. Without surgical intervention a full remission was achieved with complete tumour regression, as can be seen from the photograph. (LXXX)
In another group tumour growth was halted without noteworthy side-effects. Dr. Kadan, Dr. Schmid and Dr. Dekan describe two patients with small-cell bronchial carcinomas. With one patient: "The very poor general condition improved spontaneously so that the next three months the previously moribund patient who had been tied to the bed could lead an almost normal life."
With the second patient: "At the end of treatment practically all subjective complaints disappeared and after a long time the patient is leading a pain-free life and can work again." (XLVI)
No effect was seen in a third group of patients, but also no deterioration of the general condition as is observed with chemotherapy. Dr. Matschurat reported: "Over the past 2 years I have treated various patients with different kinds of tumours in various stages of disease with Ukrain as adjuvant therapy. Tolerability of the preparation was good in all cases and it was not a further health burden for the patients treated. It was successful in all cases in that it regularly improved the patients' general condition in comparison to the period before therapy." (IV p. 31)
Prof. Hitzenberger and Univ.-Doz. Liebeswar could not hide their astonishment in their concluding report from 3 November 1992 and asked themselves why Ukrain had not yet been approved. We quote from this report: "The question arises as to why an application was made to the Pharmaceutical Advisory Board at all, because this substance has always been repeatedly tested in Austria, and that since the summer of 1983." (X p. 9)
The astonishment of the two scientists becomes more comprehensible when the fact is considered that by 1986 more than 450 case reports of patients treated with Ukrain had already been submitted to the Ministry of Health. By 1992 Ukrain was the subject of 38 scientific publications (LXXIX) and had already been presented 52 times at international specialist congresses. (LXXVIII) A special edition of the specialist journal Drugs under Experimental and Clinical Research, Supplement to Vol. XVIII, 1992, Bioscience Ediprint Inc., Geneva, Switzerland was dedicated to Ukrain. (XXVIII)
The clinical application of Ukrain proved that this preparation can relieve pain and improve the quality of life for many patients who have exhausted other forms of therapy, that it prolongs life and in some cases has also saved lives (some patients in a hopeless condition who used Ukrain as monotherapy are still alive today more than 25 years later).
Doctors consider the registration of Ukrain to be extremely desirable and highly recommend it
A series of practising Austrian doctors and scientists who were impressed by the results of treatment have requested the ministry to approve Ukrain in an accelerated registration process.
Dr. Siegfried Wagner: "As a continuation of my successful treatment with Ukrain I regard the approval of the drug Ukrain in Austria as extremely desirable." (IV page 5)
Prim. Dr. Hans-Jörg Klein: "I would find the approval of the drug Ukrain by the Federal Ministry extremely desirable." (IV page 7)
Dr. Peter Kadan: "Personally I would very much welcome approval of the drug Ukrain as well as the widespread routine application of Ukrain for tumour diseases, because in my view – after many years of experience with Ukrain – a considerable improvement of the general prognosis ... is to be anticipated." (IV page 9)
Dr. Uta Konstantopoulos confirmed: "A patient with inoperable bile duct cancer + liver metastases was discharged without further therapy after a small surgical intervention (gall bladder drainage) in Feb. 96. Since March 96 we have been injecting Ukrain. The patient is in an excellent general condition and has in the meantime been on a one-week hiking holiday and made two long-distance journeys... In summary I would like to state that Ukrain is excellently tolerated and I have seen a clear positive influence on the course of advanced disease in several patients. Therefore I very much hope that Ukrain will be approved and registered as a medicament as soon as possible." (IV page 19)
Dr. Omar Abu-Dayeh: "During my observations I established that the preparation Ukrain is a real help and a positive supplement to other treatments. Besides the remissions achieved it should be noted that patients feel well during and after treatment and their lives become more worth living. I thereby regard the official registration and approval of Ukrain in Austria as desirable and I endorse it most warmly." (IV page 26)
Dr. Grazyna Nowicki (no relation): "I have been prescribing Ukrain for around 7 years. Most of the approximately 15 patients I have treated with it had exhausted all other forms of therapy and, given up by conventional medicine, were desperately looking for a last possibility of treatment. It should firstly be stated that an unexpected subjective and objective improvement both in their physical as well their mental states occurred with all of these patients after the first Ukrain injections – which I can in no way define as a placebo effect. The patients improved their eating and sleeping habits, and reported relief of pain, which in many cases made the administration of strong analgesics superfluous... I am including a couple of case reports of the most remarkable therapy successes with Ukrain:...
A 67 year-old patient with metastasising breast cancer (bone and lung metastases, malignant pleural effusion and ascites) was discharged from hospital and sent home as incurable. Her general condition was deplorable. After the 3rd series of Ukrain therapy the disappearance of all tumours, metastases, the pleural effusion and ascites was observed at the hospital. The patient stopped Ukrain therapy after the 7th cycle of treatment. Seven months later she had a recurrence (short-term remission)...
In summary, also in view of my many years of experience at an ENT clinic abroad, I state most clearly that Ukrain should be made widely available as a possibility for treatment of oncological diseases in accordance with the medical ethos and conscience and its registration ... should be authorised.
Rapid registration and thereby the simultaneous wide and fast availability of this highly effective cancer therapeutic agent for those who need it should be most urgently recommended." (IV pages 27-28)
In his Pharmacological-Toxicological Expert Report on Ukrain Dr. Walter Knapp makes the following conclusion: “Summarising the results of pre-clinical investigations, Ukrain can be certified as possessing an interesting spectrum of activity, which could be usefully applied to the successful treatment of malignant diseases. The acute and chronic toxicity of Ukrain is low… The results of pre-clinical investigations document that the preparation is well tolerated and offers a high level of therapeutic safety. An advantageous ratio of activity to side effects can be expected. To date, clinical experience of the use of Ukrain in patients confirms the product to be harmless.” (LIV, page 19)
The clinical report by Dr. Duma from 1996 states: "The results of experimental and clinical studies show the special efficacy of Ukrain therapy with adenocarcinomas. Histological and histochemical examinations of surgical specimens after therapeutic amputation of the breast with patients pre-treated with Ukrain show tumour regression caused by Ukrain through numerous focal necroses in the specimens after 20 days of Ukrain therapy... In summary it can be stated that Ukrain is effective in the treatment of malignant tumours through its selective maligno-toxic properties. Its few side-effects and immunostimulating effect could make a significant contribution to the efficacy of tumour therapy and improve patients' quality of life. (XII, pages 50-51)
In his "Commentary on the Expert Report" in 1998 Harald von Eick recommended "the registration of Ukrain even if also under certain conditions": "Nevertheless I take the view that the data situation is sufficient to grant registration..." (XIII, page 14)
In his clinical expert's report on 16 June 1998 DDr. G. Nahler stated: "…Results of those few controlled trials with Ukrain were consistently better than in control groups. Furthermore, some of the case reports describe treatment effects in patients resistant to any other therapy… Ukrain seems to be better tolerated than other tumor therapies.“ (XIV page 23)
Many professors have called for wide-ranging research on Ukrain.
As long ago as 1979 Dr. Musianowycz from Paris remarked on Ukrain: "The product deserves scientific examination and experimentation." (XLI page 1)
Many doctors and scientists have felt it necessary to inform both the health and science ministries about good therapeutic successes with patients with various tumours who had exhausted all other forms of treatment (VIII) and asked for the interesting results of Ukrain therapy to be investigated.
In 1996 Dr. Alois Denk wrote: "It would be medically desirable to continue research the efficacy of Ukrain and with appropriate results it should be allowed to benefit the general public." (IV page 17)
In 1996 Dr. Hubert Denz reported: "In a case of pancreatic cancer we found a temporary regression of the tumour demonstrated by computer tomography... There were only very slight side-effects in the form of a slight feeling of warmth, in general the treatment was excellently tolerated... Well planned clinical studies should be called for which provide a standardised dosage, form of application, duration of therapy and documentation of the results. A Phase II study should be carried out first to evaluate the optimum form of therapy. Application with pancreatic cancer seems to make most sense because the results of chemotherapy are so far very modest and go hand in hand with considerable side-effects for patients who are mostly in any case weakened. In addition there are several positive reports about therapy with Ukrain for this tumour." (IV pages 15-16)
The following examples of obstructive tactics against Ukrain will be described below:
- Obstruction of Approval
- Obstruction in the Granting an Import Licence
- Prohibition of Selling Ukrain in Pharmacies
- Obstruction of Production
- Obstruction of Clinical Studies
- The Higher Administrative Court's Verdict of Unlawfulness as a Result of a Breach of Procedural Regulations
- Disregard of Positive Reports
- Unlawful Edicts
- Obstruction of the Use of Ukrain
- Consequences of the Obstruction of the Use of Ukrain
- Breach of Article 7 of the Austrian Constitution
- Misinformation on the Part of the Authorities
- Obstruction of the Announcement of Clinical Results
- Obstruction of Ampouling
News of the successes of Ukrain spread among doctors and patients and helped the medicament to be widely used. Mag. Kowarik heard about Ukrain and declared himself willing to sell it at his pharmacy "Zum goldenen Reichsapfel", Singerstr. 15, 1010 Vienna. We informed Mag. Kowarik that the application for the treatment of patients who had exhausted all other modes of therapy had been made to the Ministry of Health on 28 June 1976 (XI) and approval was expected soon.
Because a large number of patients purchased Ukrain at his pharmacy and Mag. Kowarik was informed by doctors about the surprisingly good results of treatment with Ukrain for patients who had exhausted all other modes of therapy, he informed the ministry at the time and asked for approval to be granted as quickly as possible. He contacted Dr. Jentzsch, the civil servant responsible for the registration of drugs at the Ministry of Health. However, he said that he would retire before Ukrain was granted approval. (I)
From this moment on, the difficulties began. Instead of these results being supported and new hope and help given to cancer patients, we found ourselves confronted with various obstacles. This forced us to devote valuable time not to research but to the struggle with chicanery.
After Ukrain was registered in other countries, the dispensing chemist Mag. Kowarik applied to the Ministry of Health for an import licence for a patient who had exhausted all other forms of therapy, for which Ukrain had been prescribed in accordance with §12 AMG (Austrian Drugs Act). The ministry refused to grant a licence. (LXXXI, LXXXII)
The dispensing of Ukrain in pharmacies was officially prohibited. (II)
Following the request of the Ministry of Health we informed them of the name of the company producing Ukrain. The company was then forced to refrain from doing business with us. (III) I thus had to look for other producers and no longer inform the ministry who these were.
450 case reports were presented to the ministry which adequately confirmed the reproducible efficacy and safety of the drug as well as the positive benefit-risk ratio.
Then the ministry already demanded randomised clinical studies.
Interest in Ukrain grew continuously from all sides. In 1995 the Austrian Ministry of Science commissioned Dr. Reinthaller to carry out a clinical study with Ukrain. Dr. Reinthaller drew up an appropriate study protocol. However, the Ethical Commission insisted on the imperative inclusion of a placebo group, which Dr. Reinthaller regarded as unethical and saw himself forced to pull out of the study under those conditions. (IL)
Generally the ministry stated that a placebo-controlled study was one of the most important conditions for the approval of Ukrain. (L) The ethical intolerability of this demand is even shown by a quote from the book "Richtlinien für klinische Studien" ("Guidelines for Clinical Studies"): "no sensible person would have the idea of comparing cytostatica to a placebo." (LIII)
No doctor was prepared to carry out such a study in Austria and so we were forced to conduct these studies abroad.
In fact the first randomised studies with Ukrain were undertaken in Ukraine. (67, 112, 185) In these studies Ukrain was not compared with a placebo but with standard treatment at the time. The first study included patients with colonic cancer and was carried out in accordance with a previously compiled protocol which had been approved by the Austrian authorities. The publication devoted to the study (67) directly pointed out that "the study protocol was approved by the Pharmaceutical Advisory Board (Arzneimittelbeirat) at the Federal Ministry of Health, Sport and Consumer Protection." (67 p. 3) The results were presented to the ministry. Nevertheless, the study was devalued by the civil servants at the Ministry of Health because it was carried out in an Eastern Bloc country.
Reports of successful treatment with Ukrain accumulated and by 1999 there were already 139 specialist publications about the preparation. (LXXIX)
Through participation at international congresses and reports in the specialist literature doctors from various countries informed themselves about Ukrain and also used it.
At the time Polish doctors reported on treatment with Ukrain: "The treatment was generally well tolerated. After one course of Ukrain administration a significant increase in the proportion of total T-cells and T-helper cells was observed. The normalisation of the helper/suppressor cells ratio and activation of NK-cells was also found. Restoration of cellular immunity was accompanied by improvement of the clinical state of patients... Objective tumour regression ... was seen in 50% of patients and during 18 months of observation no progress of the malignant process was noted. Better tolerance and effect of radio- and chemotherapy was also shown." (LIX)
Then the attention of the world-famous surgeon and pancreas expert Prof. H.G. Beger from the University of Ulm was drawn to the preparation. The author of 21 books and more than 600 scientific publications was dissatisfied with the results of treatment of pancreatic cancer – a very aggressive form of cancer – and was looking for new possibilities to help patients.
He heard about Ukrain from publications in the specialist literature and contributions at congresses and became interested in the preparation.
Prof. Beger started in vitro tests with Ukrain. In the experiments on pancreatic cancer cell lines the scientists in his group established that Ukrain causes a stop in the cell cycle of malignant cells in the G2/M phase through tubulin inhibition, which they reported at the 117th Congress of the Deutsche Gesellschaft für Chirurgie (German Society of Surgery) in May 2000 (Berlin, 2-6 May 2000, 143) and at Gastrointestinal Surgery Today – The Ulm Surgical School in September 2001 (Ulm, 8 September 2001, 181).
This was a very important study for the decoding of the precise mechanism of action of the preparation Ukrain.
After the Ulm scientists had demonstrated the in vitro efficacy of Ukrain against pancreatic cancer cells they checked the toxological studies and assured themselves that the preparation was not a danger to health. Soon afterwards Prof. Beger initiated a randomised clinical study in Germany with the approval of the Ethics Commission: "The Phase II study was financed with research funds from the University of Ulm. The study medication was partly made available by the producer. There was neutral external study monitoring and the statistical evaluation was carried out by the Biometry Department of the University of Ulm." (186)
In this prospective, controlled, monocentric study 90 patients with inoperable pancreatic cancer (predominantly stages T4a and 4b) were randomised into three treatment arms of 30 patients each: Arm A received chemotherapy with Gemcitabin which was regarded as standard, Arm B received Ukrain as monotherapy and Arm C a combination of Gemcitabin and Ukrain. Survival rates after 12 months were 13% in Arm A, 29% in Arm B and 32% in Arm C. The patients in this study were further observed with the result that the longest survival time in the Gemcitabin arm was 19 months, 26 months in the combination arm and in the Ukrain monotherapy arm three patients lived longer than 28 months and were still alive at the time of the publication. (52)
All of this did not particularly impress the civil servants at the Ministry of Health. Because the efficacy of Ukrain had been soundly demonstrated they had to accept the efficacy of the drug. However, because they did not know to what this effect is to be attributed they rejected the application for approval of Ukrain for patients who had exhausted all other forms of therapy: "In Part III it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA." (XXXIV)
Later this verdict of rejection was also confirmed by the Higher Administrative Court (Verwaltungsgerichtshof) on almost the same grounds: "In Part III it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA." (LVIII) Patients who had exhausted all other forms of treatment were thus not given the opportunity to improve or perhaps even save their lives.
Instead of checking these interesting results as suggested by Dr. Musianowycz (XLI p. 1), Prof. Wodniansky (VIII), Doz. Denz (IV pp. 15-16), Dr. Denk (IV p. 17) and many other doctors and scientists, the attempt was repeatedly made to explain these therapeutic successes with Ukrain as self-healing – so-called spontaneous remissions.
However, the high rate of success makes this supposition appear as completely groundless. In addition, therapeutic successes occurred where no spontaneous remissions at all have been observed, such as for example with children's osteosarcomas. (XLIII)
The tumour remissions should clearly be seen as the result of the Ukrain treatment used and not as self-healing. Furthermore, these effects have also been established by in vitro and in vivo studies, where there could be no self-healing.
If these reports of the efficacy of Ukrain appeared insufficient to the civil servants, in view of the sad situation with cancer treatment they should have nevertheless seen them as strong evidence and taken them as a reason for planning a clinical study.
If Ukrain had only brought about a halt to tumour growth in patients who had exhausted all other modes of therapy, that alone should have been enough to approve registration of the preparation for the treatment of these patients. However, Ukrain caused tumour regression in many of these patients, as can be seen from case reports of doctors who used Ukrain in their practices in the treatment of patients who had exhausted all other forms of therapy. (IV)
The Pharmaceutical Advisory Board (Arzneimittelbeirat) also approved a clinical study outside of hospitals according to § 42 of Austrian Medicines Law (AMG) in their letter of 23 June 1993. (IX)
The ministry refused the application for approval in 1995 despite all this proof of efficacy and safety. (LXXXIII)
In 1996 the Higher Administrative Court (Verwaltungsgerichtshof) overruled this verdict "on grounds of unlawfulness as a result of a breach of procedural regulations." (XXXIII)
The ministry was aware that it is the task of the applicant to commission appropriate experts with drawing up expert reports. In accordance with this the necessary reports were commissioned from sworn experts.
However, the federal ministry appointed Prof. Eichler as an unofficial expert. Prof. Eichler demanded from the applicant that all documentation should "be in accordance with today's state-of-the-art" but disregarded the fact that he drew up his report in 1997 but the application dated back to 1976.
On 15 January 2001 the authorities appointed Prof. Winkler as an unofficial expert.
On 6 February 2001 Prof. Winkler presented his report in which he claims: "In Part III it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA... Neither the documentation for Part III nor for Part IV would justify the approval of this substance." (XXXIV)
On 25 April 2001 the applicant rejected Prof. Winkler as an expert witness because he is not an expert in the field of oncology and is extremely closely connected to the ministry. (LXXXIV)
The application for rejection of the appraiser was not granted.
With all his reports Prof. Winkler showed not only that he does not have the necessary knowledge in the field of oncology but also that he is far removed from the necessary objectivity in that he only emphasised weaknesses in the dossier and disregarded all positive studies.
In all his reports he almost rhetorically repeats the claim which is absolutely unimportant for patients who have exhausted all other forms of therapy: "In Part III it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA." (XXXIV) This is sufficient reason for him to refuse approval for the preparation Ukrain for which both the efficacy and safety (the positive benefit-risk ratio) have been adequately demonstrated and make it inaccessible for patients who have exhausted all other modes of treatment. For these patients it means taking away the last possibility to improve their quality of life, prolong their lives or even to save them, as described in the above-mentioned case reports.
In his second report on 2 April 2001 Prof. Winkler claims on page 4 "that Ukrain has no specific effect on tumour cells." (LXXXV)
He proves his bias with this claim because he referred to one single study from the University of Pretoria, South Africa and paid no attention to other publications on the subject.
He was thereby in breach of his most important obligation – an expert witness must always be objective, committed to the truth and impartial. As far back as 1992 scientists from the Universität für Bodenkultur (University of Natural Resources and Applied Life Sciences), Vienna showed that Ukrain has a different effect on the oxygen consumption of malignant and normal cells. (38) A ten times higher concentration of Ukrain had to be used for normal endothelial cells than for human osteosarcoma cells in order to achieve a 50% inhibition of growth. Scanning laser microscopy showed a high accumulation of Ukrain in cancer cells, whereby its concentration in normal cells was considerably lower under the same experimental conditions. (36)
In 2000, in a study of A431 and ME180 epidermal cancer cells and LNCaP prostate cancer cell lines, scientists from Rochester University, USA demonstrated that Ukrain causes the accumulation of cancer cells, but not of normal cells, in the G2M phase. There was also an increase of the CDK inhibitor p27 in these cancer cells. (147).
The results of the South African group which were so highly praised by Prof. Winkler have until now not been confirmed by any other independent group. On the contrary, all subsequent studies on this subject have demonstrated the selective effect of Ukrain on cancer cells.
Scientists from the University of Tübingen, Germany observed the different effects of the preparation on malignant and healthy cells in a study of the effects of Ukrain on the cell cycle and apoptosis induction with and without radiation. The combined application of Ukrain and radiation led to higher toxicity against the colonic cancer cell line CCL-221 and the glioblastoma cell line U-138MG. Ukrain exerted a radio-protective effect on the normal cell lines. (184).
In an interesting study at the Instituto Nacional de Cancerologia, Mexico City, Mexico researchers found that "Ukrain induces apoptosis (programmed cell death) in a series of cancer cell lines by activating the so-called internal cell death pathway. Interestingly the non-transformed (benign) fibroblasts remained insensitive to the preparation." (255)
None of the chemistry and pharmaceutical experts who previously wrote about the preparation Ukrain made any kind of recommendation with regard to its approval – which is also not their duty. Both Mag. Vymazal (LXXXVII) as well as Dr. Tittel (LXXXVIII) only presented the preparation in their reports and described relevant chemical and pharmaceutical methods with which the quality and reproducibility of the preparation can be determined. The fact that Dr. Robert dared to give a negative recommendation without having read the documentation leads to the suspicion that he wanted to fulfil the instruction of the ministry to corroborate the decision to reject registration at all costs.
Since 1993, after a clinical study was approved in accordance with § 42 (IX), hundreds of doctors have begun to use Ukrain in the treatment of patients who have exhausted all other forms of therapy. They have also reported on their successes.
However, instead of approval being granted for registration, Austrian doctors have been put under pressure with different methods to force them to refrain from using Ukrain, such as the unlawful edict of 25 February 1994 about the prohibition of the use of Ukrain: "The use of Ukrain outside a clinical study still remains prohibited." (XVIII)
This assertion is unlawful because it contradicts § 12 of the Austrian Medicines Act (Arzneimittelgesetz) which states: "Medical specialities are not required to be registered if 1) they are for use in non-clinical or clinical studies, 2) a doctor, dentist or veterinarian who is licensed to practice independently in Austria attests that the medical speciality is urgently needed to prevent a threat to life or serious damage to health and that this success cannot be anticipated with an approved and available medical speciality according to the state-of-the-art..." (LXIII)
In addition this edict contradicts the approval of the Pharmaceutical Advisory Board from 23 June 1993 for a clinical study in accordance with § 42. In this kind of clinical study various oncological diseases which occur in the normal practice of doctors in urban and rural areas were intended to be treated with Ukrain. The design of this study is adapted to the normal possibilities of general practitioners and certain limitations such as exist in more rural areas. Many of these cases are patients who have already been pre-treated and where the disease is progressing. (IX) The edict was thus in obvious contradiction of the previous decision of the Ministry of Health.
Since 1979 many doctors and scientists have advocated that the efficacy of Ukrain should be investigated in a clinical study. However no such study has been organised on the part of the ministry. On the contrary, with the Ministry of Health's demand for a placebo-controlled, double blind study (L) conditions were created which all doctors found unethical and therefore could not fulfil: "I regard the lack of a placebo group as the most serious absence in the suggested study." The existence of a placebo group in the study would mean that half of the patients – in this case with recurring abdominal cancer – would be intended to receive no real treatment but would only be given water. It is natural that no doctor would accept these conditions.
The suspicion arises that all steps have been taken by the ministry to prevent the clinical application of Ukrain and thus obstruct the gathering of evidence for its efficacy.
It is not surprising that the Higher Administrative Court (Verwaltungsgerichtshof) annulled this edict as unlawful. (XXXIII)
Despite all obstacles more and more doctors began to use Ukrain in accordance with § 12 of the Medicines Act (AMG) in the treatment of patients who have exhausted all other forms of therapy.
As a result evidence continually increased for the efficacy and safety of Ukrain. To prevent this increase, as previously mentioned, two edicts were issued by the Ministry of Health, one on 25 July 1986 (XVII) and another on 25 February. 1994 (XVIII). It can easily be shown how the first decree was not only unlawful but also not objective. The edict declared: "According to our knowledge not one single proof of the adequate efficacy of Ukrain has been published in the specialist literature." However, at that time Ukrain had already been presented 17 times at international conferences and two publications had been dedicated to the preparation. By 1994 it was already 76 congress presentations (LXXVIII) and 48 publications in the specialist literature. (LXXIX)
It is noteworthy that the two unlawful edicts were signed by civil servants who were soon about to retire.
Because these edicts could not prevent many doctors using Ukrain for patients who had exhausted other forms of therapy, in 1996 doctors were harassed with disciplinary proceedings (XV) and charges. (XVI) Many doctors also distanced themselves from Ukrain and let patients down from fear of having difficulties with the ministry.
The serious consequences that this brought with it are shown by the case of young Stefan Dan. He was discharged from hospital as completely incurable and his parents were told that their son would neither be able to walk nor speak.
When the parents came to us with him all there was to see of him was tumour, bones and praying eyes.
At the time we did not see the slightest chance to save the child but did not want to take away his parents' last hope. (LI) In accordance with § 12 (LXIII) the doctor in attendance had prescribed Ukrain, which had brought about a clear improvement. During this two-year therapy the child began to speak, to walk and even ride a bicycle." At a check-up in hospital the parents were forced to stop therapy with Ukrain under the threat of charges based on unlawful edicts from the Ministry of Health from 1986 and 1994 although they could be offered no other possibility for treatment." (XC)
Despite the legal effect of § 12 and despite the fact that the use of Ukrain had been approved by the Pharmaceutical Advisory Board (Arzneimittelbeirat) they were forced to stop treatment. This had disastrous consequences for the child. The tumour grew again, surgical intervention could not stop the further progress of the tumour and Stefan will be paralysed for life. (XXXIX)
Not one single similar case is described in the literature. This case alone should be enough for approval to be granted.
However, some courageous doctors did not allow themselves to be intimidated and drew up the case reports quoted above. (IV).
Veterinarians who had achieved successes thanks to treatment with Ukrain were also incomprehensibly forced to stop this promising therapy. (XXI).
On the basis of the facts outlined here Ukrain should have automatically been granted approval because the application for the treatment of patients who had exhausted all other forms of therapy was made on 28 June 1976. (XI)
Austrian Constitution, Article 7: "(1) All federal citizens are equal before the law. Prerogatives based upon birth, gender, status, class and creed are excluded." (XCI)
In rejecting approval for Ukrain the main point of criticism mentioned was that the structural proof, i.e. the structural formula, for the active pharmaceutical ingredient of Ukrain was allegedly missing. However, according to the Austrian Medicines Act it is not even necessary to submit the formula. The expert witness and the authorities were demanding something that the law does not require. The successful approval of the medicine Iscador during the same time period should be mentioned in comparison to the approval procedure for Ukrain. Iscador is also of plant origin and submission of the structural formula was not demanded. It is also not necessary to fulfil the conditions of the Medicines Act.
Because the legislative body is obliged to link the same legal consequences to the same matters of fact the equality clause was breached. However, at the same time Dr. Nowicky's right to fair process was also infringed by the unlawfully commissioned, biased expert witness. This all the more as Dr. Nowicky pointed out this circumstance in his submissions and attempted to have another expert witness engaged. The authorities ignored this.
The demand for a placebo comparison is especially remarkable along with the simultaneous requirement that "current standard therapy may not be withheld from any woman." This is a contradiction in itself because a placebo comparison could only be made if a comparison group of patients in not given treatment, meaning that treatment would only be simulated. Apart from the fact that no doctor could be expected to act in this way with such a serious disease as cancer because he would be exposed to criminal proceedings, it is also unethical to the highest degree to make such a request to patients.
It follows from the above that this clinical trial was prevented de facto with, contradictory demands that could not be fulfilled, thereby infringing the equality clause and the right to fair process.
Therefore the following grounds for complaint result from the above-stated facts:
- The constitutionally guaranteed principle of equality was infringed because the same legal consequences were not linked to the same matters of fact.
- The right to fair process safeguarded under the constitution and the European Convention on Human Rights was infringed because the ministry did not perform its tasks in guiding procedures, unlawfully commissioned expert witnesses who were not suitable for this specialist field and furthermore did not replace an obviously biased witness despite the evidence and wish of the applicant.
- The unlawfulness of the exercise of direct administrative authority and coercive power was seen with the edict Zl. II/520.382/1-9b/86 of 25 July 1986 and the circular Zl. 21.405/1117-II/A/8/93 of 25 February 1994, based on the edict of 25 July 1986.
If the Ministry of Health is now of the opinion that it cannot be legally accused of not consulting other experts apart from its official expert – who was furthermore unlawfully commissioned and incompetent in the subject – but that it was the responsibility of the complainant himself to entrust experts with the refutation of the official report, the following must be stated: if the ministry takes this view it would have been obliged to inform the complainant of this before proceedings were concluded so that he could have commissioned such an expert. He would certainly also have done so, especially because the authorities now maintain they would also have examined such an expert report. At the latest at the time when the complainant asked the authorities for a new expert, they should have instructed him that they were not willing to appoint such an expert but that the complainant was free to commission his own expert and the authorities would have to examine his report. However, the authorities did not do so, which represents a great fault in the proceedings to the detriment of the complainant.
In 1993, 17 years after the application for Ukrain, the American company Bristol-Myers Squibb was granted approval for the highly toxic product Taxol very quickly after application after submitting only 17 case reports. Austria was the first country in the world in which Taxol was approved although Austria is not even its country of origin. At the time of approval there were no comparative studies of Taxol with other cytostatica. "There are no studies of the possible carcinogenic effect of Taxol. In vitro and in vivo studies on mammal cell systems proved Taxol to be mutagenic... The distribution, metabolism and excretion of paclitaxel are not fully clarified in humans... The effect of a kidney or liver insufficiency on the excretions of paclitaxel has not been examined... Administration should be strictly intravenous because local tissue irritation and vascular wall damage can occur with paravenous and intraarterial administration..." (Prescribing information TAXOL® Concentrate for Solution for Infusion, 1993, VII)
It can be seen from the prescribing information for Taxol that a whole series of studies were not carried out although this information was compiled in 1993. However, the application for Ukrain was made in 1976 (XI) and these studies were carried out with Ukrain. Despite support for approval from 9 doctors (IV) and 4 experts (XII, XIII, XIV, LIV), my application was rejected on the basis of reports by two non-official experts and Prof. Winkler was not sure "whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA," (XXXIV), and Prof. Eichler described the therapeutic successes with Ukrain as "self-healing." (LXIV)
Granting approval for Taxol and the rejection of approval for Ukrain is a gross infringement of the constitution which guarantees equal rights to all citizens in Austria.
One single such therapeutic success as described by Prof. Wodniansky (VIII) would have been more than enough to grant approval for Ukrain immediately as well as the fact that the preparation is produced from two already approved starting substances and because of the law at the time of application (28 June 1976) for patients who had exhausted all other modes of therapy (XXXII) as in the case of melanoma, it should also have been granted immediate approval based on the Medical Specialities Order (Spezialitätenordnung) of 1947. Nevertheless the application for approval was rejected with the notification of 25 April 2002 (XXXIV) although at this time randomised studies with colorectal and pancreatic cancer patients had already been submitted. (67, 112, 182, 185, 247).
For diseases which are incurable and for which a new remedy promises help – in this case Ukrain – it should automatically be granted approval according to an unwritten law. Ultimately at least the possibility exists to help patients suffering from melanomas, pancreatic cancer and colonic cancer with a medicament that has been proved to have no side-effects and does not reduce the quality of life.
Ukrain was refused approval because the authorities were not sure "whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA." (XXXIV) This claim requires no commentary. How many other medicaments exist with modes of action that are not completely explained and how many are also used in practice and bring help to patients?
The Ministry of Health refused the approval of Ukrain with the notification GZ 2.921.726/7-II/C/16b/95 on 2 June 1995. (LXXXIII) This decision was nullified on grounds of "illegality as a result of a breach of procedural regulations" by the Higher Administrative Court (Verwaltungsgerichtshof) on 26 February 1996 with its finding Zl. 95/10/0124. (XXXIII) It could have been expected that approval would then have been granted immediately. However, the civil servants continued their obstructive tactics and again refused approval thus depriving patients of an effective mode of therapy.
It should be asked how many cancer patients could have been saved with this treatment.
Civil servants from the ministry also attempted to convince Prof. Beger, a surgeon and world-famous expert in the field of pancreatic cancer, not to report on his successes with Ukrain therapy at a congress in 2007. (XCIII)
One result of these continual obstructions was also the fact that the official purchasing of the raw materials for Ukrain production was refused. (XXXVII). We were thus forced to buy them via third parties and pay cash without invoices. Obviously these expenses could not be declared on tax returns.
These perfidious obstruction tactics know no limits. We were unofficially informed that the Austrian authorities, with the help of foreign colleagues, had forced the ampouling companies to distance themselves from Ukrain production.
More than 200 scientists from 22 countries and 60 universities and research institutes have worked with Ukrain and published their studies. More than 250 research papers on Ukrain have been presented at renowned international specialist congresses. 14 doctors have reported their successes with Ukrain to the Ministry of Health and 9 of them advocated the rapid approval of the preparation. Four experts have also called for Ukrain to be approved quickly. But nevertheless the ministry has refused approval on the basis of only two reports. These reports were drawn up by two appraisers who disregarded all the positive results with Ukrain and breached their obligation with their lack of objectivity and called their impartiality into question. The appraisers commissioned by the ministry never saw anything positive in all the documentation on Ukrain and only looked for weak points. We attempted to reject one appraiser because he is not an expert in the field of oncology. This rejection was not accepted by the ministry and with his report he confirmed our fears. He wrote, "In Part III it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA." (XXXIV) However, every oncologist knows that neither Thio-TEPA nor greater celandine alkaloids alone are effective against colorectal tumours. In contrast, Ukrain is effective both in vitro and in clinical administration, which has been confirmed on the one hand by tests at the National Cancer Institute (Bethesda, Maryland, USA; V, VI) and on the other by case reports and randomised clinical studies with colorectal tumours. (67, 112)
Another expert, Dr. Jean-Louis Robert from Luxembourg (chairman of the European Quality Working Party) wrote in his report: "Since the deficiencies with regard to quality are of a fundamental nature, this report dispenses with going into detail on further individual points..." Does this mean that he drew up his report without having read the documentation?
On 28 June 1976 the application was made for the approval of Ukrain for the treatment of cancer patients who had exhausted all other modes of therapy. (XXXII). The efficacy and safety of Ukrain have been demonstrated in numerous studies. More than 200 scientists from 22 countries and 60 universities and research institutes have carried out research on Ukrain and published their results in the specialist literature. (LXXIX) More than 250 research papers on Ukrain have been presented at renowned international specialist congresses. (LXXVIII) At the time 14 doctors reported their successes with Ukrain to the Ministry of Health and 9 of them advocated the rapid approval of the preparation. (IV) Four experts have also called for Ukrain to be approved quickly. (LIV, XII pp. 50-51, XIII p. 14, XIV). These research works were continually submitted to the ministry.
Nevertheless the ministry asked the applicant to rework the documentation and draw up reports. The resulting private reports were sent to the ministry on 16 May 1997 with an accompanying letter from the Graff lawyers' office. (XCIV) Dr. Knapp stated in his report: "In summary, on the basis of preclinical test results Ukrain can be attested to have an interesting spectrum of action which makes its use in the treatment of malignant diseases appear successful. Ukrain has low acute and chronic toxicity... The results of preclinical studies substantiate good tolerability of the preparation and therefore lead to the expectation of high therapeutic safety with a favourable efficacy/side-effect ratio.
The safety of Ukrain has also been confirmed by so far available experience with clinical administration to patients." (LIV)
The Pharmaceutical Advisory Board (Arzneimittelbeirat) approved the use of Ukrain both in clinical studies and other use in accordance with §42. (IX) Despite this the ministry has always attempted to prevent the clinical use of Ukrain. Not one single step has been taken to investigate Ukrain, not to speak of supporting it, but everything has been done to prevent Ukrain being used. All indications of the efficacy of Ukrain have been ignored, even when these have been provided by Austrian scientists and doctors. (VIII, IV p. 17). Foreign scientists have also been called upon to stop their research on Ukrain and not publish their results, as was the case with Prof. Beger. (XCIII)
The European Court of Human Rights in Strasbourg also ruled that the period of time that the application for approval was left unprocessed by the Austrian authorities was too long. (XXXII) Nevertheless the verdict from France brought about no change because ultimately the rejection was based on the law in force now and not on the regulations valid at the time of application (these changed in the meantime).
The Higher Administrative Court (Verwaltungsgerichtshof) clearly established the unlawfulness of the decision of the Ministry of Health. (XXXIII) It could have been expected that this decision would bring with it automatic approval of Ukrain. Our astonishment can be imagined when the rejection from the ministry was confirmed and then reinforced by the Higher Administrative Court without a single positive report on Ukrain being mentioned. But what changed in this time? Not the unlawfulness of the decision in any case. The matter should be treated in accordance with legislation in force at the time of the application. What caused the European Court of Human Rights to judge the matter differently at a later date? What third party?
Have the responsible authorities considered how much suffering could have been prevented with the help of Ukrain therapy and how many people's lives could possibly have been saved?
The question arises as to who has been behind these obstructive tactics for so many years. In over 30 years many civil servants have changed or left their posts and new civil servants have arrived in their place. Much has changed – but not these stubborn obstructive tactics. It could almost be supposed that an extremely powerful force is behind all this for which there are also other priorities than helping suffering people.