Letter to Vice-Chancellor and Federal Minister of Finance

Vice-Chancellor and Federal Minister of Finance
Dr. Pröll
Bundeskanzleramt
Hintere Zollamtstraße 2B
1010 Vienna

Vienna, 26.8.2009

Dear Vice-Chancellor and Federal Minister of Finance,

It is difficult for politicians to judge the value of a preparation for cancer patients which has a selective effect (please see Facts), but doctors and health authorities should be fully aware of this. It should certainly be clear to these people what the observations of the well-known melanoma specialist Prof. Dr. Wodnianski meant for Austria and for mankind – (please see Facts). So far no other medicament in the whole world has been able to save a patient suffering from melanoma with metastases who was already secreting melanin in the urine. It is a very dubious fact that the authorities ignored this. It should be clear to them as doctors what a unique result Prof. Wodnianski submitted to them.

Prof. Dr. Wodnianski himself was so surprised by the full remission that he approached the ministry to request that a clinical study be carried out. As I have heard unofficially, health ministry civil servants prevented this study.

In the past 25 years more than 7,000 people in Austria have died from melanoma (www.dep-iarc.fr). Only those patients who received treatment with Ukrain have lived for years without relapse.

In the case of the child, Stefan Dan, on the basis of unlawful edicts – please see Facts – his parents were forced to stop the life-saving Ukrain treatment which was having astounding success – please see book and the internet: www.ukrin.com/en/obstructive-tactics-consequences). Stefan is now 17 years-old but because of this edict he will remain paralysed for his whole life.

The fact that Ukrain has not been approved is very dubious. Over the course of the years I have had to deal with all possible chicanery and use all my strength to struggle against all the obstructions instead of dedicating myself to my scientific work. I would like to mention just one example of what false statements are made by the health authorities when asked about Ukrain by foreign doctors or patients – please see enclosure Dr. Nordfors.

Prof. Beger, a world-renowned surgeon and pancreas cancer specialist, was prompted not to talk about Ukrain therapy at a planned symposium on the basis of notification from Austrian health authority civil servants – please see Palliative Study, Adjuvant Study, publication by Dr. Gansauge, protocol, letter to a journalist.

All imaginable obstacles have been placed in my path – please see Facts – and the health authorities have always been behind them.
I made my application for the approval of Ukrain for patients who had exhausted all other forms of therapy on 28 June 1976 in accordance with § 8 Z.2  and 3 of the Spezialitätenordnung (Medical Specialities Order) – please see Facts. Because of the fact that Ukrain is produced with two starting substances which are already approved and that Ukrain has considerable advantages in comparison to the starting substances and that it is effective and more than 300 times less toxic than those substances (Facts), the preparation should be granted approval very quickly. Applications should always be processed by the authorities on the basis of the laws valid at the time of application.

I was misleadingly called upon to withdraw my application from 1976 and to submit a new application. These requests from the ministry were repeated but I never withdrew my application of 1976 and always submitted supplementary applications, such as on 30 August 1986. The regulations for new applications at this time were that a clinical study should be carried out as proof of efficacy and such a study should be approved by the Pharmaceutical Advisory Board (Arzneimittelbeirat). I received this permission from the ministry on 23.6.1993. Approval was given to carry out a clinical study for malignant melanoma, colonic cancer and for clinical examination outside of hospitals in accordance with § 42 AMG (Medicines Act). In its concluding report the Pharmaceuticals Advisory Board showed surprise that the well-tolerated and effective preparation Ukrain was not yet approved – please see Facts.

Incomprehensibly no clinic in Austria wanted to carry out such a study and so I initiated a colonic cancer study in Ukraine (enclosure: Bondar, Susak) and presented the results to the ministry as well as case reports from doctors who had used Ukrain in their practises in accordance with § 42 and who requested rapid approval on the basis of their results – please see Facts.

In the following years new guidelines were drawn up, according to which clinical studies had to be approved by the Ethics Commission. With the support of Dr. Rozsenich, head of department at the Ministry of Science, Univ.Doz. Dr. Reinthaller declared himself willing to carry out such a study. He drew up the protocol and submitted it to the Ethics Commission for approval. It is both grotesque and inhumane that the Ethics Commission as well as the ministry demanded a placebo comparison. Dr. Reinthaller therefore withdrew from his intention of carrying out the study – please see letter: Univ.Doz.Dr. Reinthaller.

The application for approval from 1976  was rejected on the basis of the decision GZ 2.921.726/7-II/C/16b/95 of 2 June 1995, supposedly because I could not submit a study with a placebo comparison. On 26.2.1996 this negative decision was annulled as unlawful by the Higher Administrative Court (Verwaltungsgerichtshof) due to a breach of procedural regulations.

New regulations were again then issued, according to which new documentation was demanded. I was informed by the authorities that it was my obligation to commission expert witnesses. I did this and Dr. Knapp provided evidence for pre-clinical efficacy and safety, Dr. Duma and Dr. van Eick drew up reports on clinical efficacy and all three recommended that the preparation be approved – please see Facts. Dr. Vymazal and Dr. Tittel submitted reports on quality (Facts). Astonishingly the  health authorities deemed the reports to be insufficient although the expert witnesses had otherwise always been accepted by the authorities when working on behalf of other companies. The ministry then recommended DrDr. Nahler as the best expert witness and I commissioned him to draw up a report. DrDr. Nahler also recommended approval (Facts). The ministry could not reject approval on the basis of the six above-mentioned reports and the recommendations of doctors who had prescribed Ukrain in accordance with § 42 (Facts, pages 8-9, Arrouas). The suspicion therefore arises that in order to have a reason for rejecting approval the ministry took the unusual step of commissioning two new expert witnesses to draw up reports. One was Dr. Robert from Luxembourg who was to draw up a report on quality and the other was Prof. Dr. Winkler who was to report on efficacy and safety.

I objected to Prof. Dr. Winkler as an expert witness because of his close relationship to the ministry and because he was not competent in the field of oncology (Enclosure: Rejection). However, my request was disregarded. His report confirmed my assumption that he was not a specialist because he based his recommendation that approval for Ukrain should be rejected on the fact that "it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA." (www.ukrin/doc/winkler_2002a.pdf) No oncologist would make such a statement.

As a chemist it was the task of Dr. Robert to ascertain if the proposed quality assessment was sufficient. Instead of this he demanded a structural formula for a complex product. This request is extremely strange because every chemist knows that no structural formula can be drawn up for a complex. In addition he took the liberty of recommending that Ukrain should not be approved, which was not at all his responsibility and ironically he admitted himself that he would not even have to read the documentation in order to reach a negative judgement on Ukrain.

On the basis of these two expert witnesses my supplementary application of 30 August 1986 was rejected with the official notice of 25 April 2002 because I had not submitted a double-blind study with cancer patients. This is unlawful because at the time of application in 1986 there was no legal demand for such a study. As mentioned above, in rejecting my application the six positive reports and the recommendations of doctors and approximately 200 scientists who had demonstrated the efficacy, safety and quality of the preparation were ignored. There is no decision on the original application of 28 June 1976.

In 2002 the Higher Administrative Court (Verwaltungsgerichtshof) based its rejection on the following reasons (Enclosure):

"A larger-scale double-blind study carried out by a recognised and verifiable institution should be requested."

"… that in view of the missing evidence of the structure of the above-mentioned medical speciality approval could also not be considered with the specified desired condition."

"... it is not ascertained whether the observed effects are to be attributed to the supposed complex or free alkaloids or also free Thio-TEPA."

Judges do not have the appropriate specialist knowledge and are therefore forced to rely upon the documentation presented to them. How relevant the above reasons are has been demonstrated in some detail above. With such unlawful and illogical reasons the supplementary application from 1986 for patients who had exhausted all other forms of therapy was rejected and they were left to their sad fate.

If Ukrain had been approved in 1976 in accordance with the laws valid at the time, Ukrain would have become Austria's best and finest export product. This rejection has caused great economic damage to Austria. I therefore ask you to instruct the Procurator General and the Public Prosecutor's Department to check the facts and take appropriate measures.

Because this is a matter of public interest I shall take the liberty of publishing this letter and your much-appreciated answer on the internet.

Best regards,
Dr. Wassil Nowicky

Enclosures:
Facts
Potential
Book 'Anticancer Pharmaceutical Ukrain'
Nordfors
Bondar study
Susak study
3 studies Gansauge, Beger
Beger protocol and letter to a journalist
Letter: Dr. Reinthaler
Arrouas
Official notification 2002