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Anti-Cancer Preparation Ukrain How registration has been prevented

Anti-Cancer Preparation Ukrain

How registration has been prevented

 

Until 1984 the Medical Specialities Order (Arzneispezialitätenordung) of 1947 was in force in Austria (http://www.ukrin.com/docs/1947-spezialitaetenordnung.pdf). According to this order it was only necessary to demonstrate the therapeutic benefit of a new preparation if it was produced from components that were already registered. Before 1984 comprehensive preclinical and clinical studies were not required.

In 1976 is was established that Ukrain has a selective effect. This means that it is only toxic for cancer cells but not for healthy cells (http://ukrain.ua/statti/038.HTM). It was also demonstrated that the preparation rapidly accumulates in cancer tissue, which can easily be seen through the autofluorescence of the substance in UV light (http://www.ukrin.com/docs/Hohenwarter_1992.pdf, http://www.ukrain.ua/present/ukrain.html). At the same time Ukrain is 300 times less toxic than its starting substances (http://www.ukrain.ua/statti/043.htm) and the therapeutic benefit was thus clearly to be seen. On 25 January 1980 I was granted the patent “Procedure for the production of new salts from alkaloid derivatives of thiophosphoric acid” (Austrian patent No. 354644) by the Austrian Patent Office.

On 27 July 1981 I wrote a letter to the minister Dr. Kurt Steyrer asking for a prompt decision on registration for the sake of future cancer prevention (http://www.ukrin.com/docs/1981-07-27-brief-zulassung-1981.pdf). In the reply from Minister Dr. Kurt Steyrer on 14 August 1981 I was informed that I needed a licence in order for the preparation to be registered. I made the relevant application. In 1988 I received a licence for the production of alkaloid derivatives and submitted it to the Federal Ministry of Health, Sport and Consumer Protection (http://www.ukrin.com/docs/Konzessionsdekret.pdf). In 1993 I received notice that I had to provide clinical studies carried out in accordance with the study plan approved by the ministry (http://www.ukrin.com/docs/Arrouas_1993.pdf).

This contained a study plan for:

1. open controlled study of colorectal carcinoma

2. clinical study of malignant melanoma

3. clinical study outside of hospitals in accordance with §42 AMG (Medicines Act).

In this kind of clinical study it was intended that various oncological diseases, as occur in the normal practice of urban and rural doctors, should be treated with Ukrain.

In 1996 such comparative studies with metastasising colorectal cancer were submitted to the ministry (http://www.ukrin.com/docs/Susak_1996.pdf). These studies showed that the survival rate (21 months) in the group treated with Ukrain was 78.6%; in the comparison group, treated with chemotherapy, the figure was only 33.3%.

Another study of colorectal cancer showed a fatal outcome in 25% of cases after 14 months of chemotherapy and X-ray radiation compared to only 8.3% in the group treated with Ukrain as monotherapy (http://www.ukrin.com/docs/Bondar_1998.pdf). With regard to the patients in this study, after 12 years 75% of the Ukrain group are alive compared to 45.8% in the group which received chemotherapy (http://ukrin.com/en/node/294, 2nd International Conference on Drug Discovery & Therapy February 1-4 2010 Dubai U.A.E.).

“Case Reports from Doctors, Scientists and Patients about Ukrain” was also submitted to the Federal Ministry of Health, Sport and Consumer Protection in 1996 (http://www.ukrin.com/docs/erfahrungsberichte.pdf). The doctors called for rapid registration.

In 1995 a report on the “Chemical, Pharmaceutical and Biological Documentation” was demanded. Mag. Kurt Vymazal drew this up and I then submitted it on 14 May 1995. In the chemical-pharmaceutical documentation Mag. Vymazal stated that the production of Ukrain was safe and the method of analysis sufficiently elaborated to confirm the quality of the preparation.

On 2 June 1995 my applications of 1976 and 1981 were rejected (Zl: 2.921.726/7-II/C/16b/95).

On 26 February 1996 the notification of rejection (Zl: 2.921.726/7-II/C/16b/95) was declared unlawful and annulled by the Higher Administrative Court due to infringement of procedural regulations (http://www.ukrin.com/docs/im_namen_der_republik-1996.pdf).

On 8 May 1995 the Ministry of Health demanded a placebo-controlled double-blind study (http://ukrin.com/de/node/293). These conditions are unacceptable for cancer patients on moral grounds and the Universitätsklinik für Frauenheilkunde in Vienna refused to carry out such a study.

After the results of the toxological study carried out abroad raised doubts on the part of the Ministry of Health, it was demanded that the preparation be examined in Austria at Forschungszentrum Seibersdorf. This demand was also met.

On 10 October 1996 Dr. Walter Knapp submitted his “Summary evaluation of the non-clinical data for the application for registration of the injection solution Ukrain, effective substance: Chelidonium Majus L. alkaloid thiophosphoric acid derivatives”, where he comes to the following conclusion: “In summary, the preclinical test results confirm that Ukrain has an interesting range of effects which make its use in the treatment of malignant diseases appear effective… The safety of Ukrain has also been confirmed by previous experience of clinical use with patients.” (http://ukrin.com/de/node/295, http://www.ukrin.com/de/tatsachen#klinischeanwendungen,

http://www.ukrin.com/wirksamkeit7#_Toc289932269).

An expert assessor was then demanded for the clinical studies. Dr. Stefan Duma drew up a report which I submitted on 24 February 1997. Among other things Dr. Duma stated in his report: “The results of experimental and clinical studies show special efficacy of Ukrain therapy with adenocarcinomas.” (www.ukrin.com/docs/Duma_1997.pdf)

Subsequently a new demand was made that a report on the clinical data should be drawn up especially by DDr. Nahler. In his report he recommended the use of Ukrain stating, “The results of these few controlled clinical studies with Ukrain were always better than the control group… Ukrain appears to be better tolerated than other cancer therapies.” (http://www.ukrin.com/docs/ClinExpRep_2002.pdf)

The authorities then demanded an expert report on the chemical data, which was drawn up by Dr. Gerolf Tittel and submitted by me on 11 April 2000 (http://www.ukrin.com/docs/Tittel_2000.pdf).

All the authorities’ demands were thus met.

Thereupon the Ministry of Health advised me to submit a supplementary application for patients who had exhausted all other forms of therapy. This application was supposed to receive rapid registration because the health insurance companies would then pay for the cost of treatment with Ukrain. This was why, on 05.032001, I made an application (GZ:921.726/13-VI/16/02) for the registration of Ukrain for patients who had exhausted all other forms of therapy.

Instead of granting this application, in an unusual step two further assessors were commissioned, possibly in order to find new reasons to reject the application. Despite the fact that I rejected one of the assessors as being biased, both assessors were accepted by the Ministry of Health. On the basis of their recommendation the application for registration as a medical speciality for patients who had exhausted all other forms of therapy under the proviso “after standard therapy has failed” was rejected in the shortest time with the notification of 25 April 2002 (GZ: 921.726/13-VI/16/02).

Prof. DDr. Winkler, assessor for non-clinical and clinical data, came to the conclusion, quoted from the notification GZ:921.726/13-VI/16/02: “Acute tolerance of the substance appears good” and then “In Part III it is not ascertained whether the observed effects can be attributed to the complex or to free alkaloids and/or free Thiotepa,” and therefore finally “Registration of Ukrain cannot be recommended.”

As chemical-pharmaceutical expert, Dr. Jean Robert came to the conclusion, quoted from the notification: “Because the quality deficiencies are of a fundamental nature, this report declines to address individual points in detail.” The supposed quality deficiencies remained undefined in his report.

Alongside this, the authorities tried to persuade me to withdraw my application from 1976 (http://ukrin.com/docs/1998-0108%20Bundesanstalt%20f.%20chemische%20und%2...

ntersuchungen.pdf) and then to make a new application. However, there was no way I could follow this demand – I have still not withdrawn my applications of 1976 and 1981.

Since the authorities stopped dealing with my applications I saw myself forced to submit a complaint to the European Court of Human Rights, which I did on 28 March 2002.

On 24 February 2005 the European Court of Human Rights found that Austria had breached administrative regulations in the case of the registration of Ukrain

(http://www.ukrin.com/docs/case_nowicky_austria.pdf).

Despite the proven efficacy, safety and quality of Ukrain (http://www.ukrin.com/docs/Wirksamkeit2.pdf,

http://www.ukrin.com/de/wirksamkeit8,

http://www.ukrin.com/docs/Knapp_1996.pdf) and the judgements of the Austrian Higher Administrative Court and the European Court of Human Rights, my applications of 1976 and 1981 have unlawfully still not been dealt with and procedural regulations have been breached.

Because this medicament with negligible side-effects has not been registered, cancer patients have been denied the chance of improving their quality of life or at least easing their suffering, prolonging their lives and in many cases even saving their lives without the usual almost inhuman side-effects of chemotherapy.

(http://www.economist.com/node/18743951/print,

http://ukrin.com/de/node/296)