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WHO BENEFITS FROM THIS?

WHO BENEFITS FROM THIS?

 

NSC 631570 (Ukrain - www.ukrin.com , www.ukrin-drug.net, www.ukrain.ua) is a preparation with a selective effect: at therapeutic dose it leads to the death of cancer cells but not healthy cells (Appendix 1). The medicament was developed by an Austrian scientist of Ukrainian origin.

It is known that all cells have predominantly negative charges, but these have been proved to be more pronounced in cancer cells. This finding was the basis for the development of NSC 631570. It consists of greater celandine alkaloid derivatives that are positively ionised. As a result the substance accumulates very rapidly in tumour tissue, which can also be seen through the fluorescence of the tissue under UV light (Appendix 2).

Dr. Nowicky is the founder of a new mode of therapy called proton therapy and many scientists all over the world are devoting themselves to this promising approach. As a result Dr. Nowicky has been invited to many international specialist congresses as honorary speaker.

A fundamental property of the preparation is the stimulation of the angiogenesis factor which leads to encapsulation of tumour cells. It prevents further formation of metastases and makes it easier to remove tumours in surgery (Appendix 3-4, Appendix 2 pp. 4-10).

These properties have been confirmed in 188 publications from 60 independent research institutes and universities from 24 different countries (Appendix 5).

A total of over 300 publications have been dedicated to NSC 631570, and 180 of them are accessible to the public at http://www.ncbi.nlm.nih.gov/pubmed/?term=ukrain(PubMed).

After the discovery of its angiogenic properties and its selective effect which, at therapeutic dose, leads to the death of cancer cells but not healthy cells, on 28.06.1976 application was made for registration in Austria, its country of origin, in accordance with the Medical Specialities Order (Arzneispezialitätenordnung).

The preparation consists of starting substances that were already registered — greater celandine alkaloids and Thiotepa — and demonstrates a significant therapeutic advantage: NSC631570 is more than 300 times less toxic towards healthy cells along with its previously mentioned selective effect. These were reasons for registration to be granted under the law in force at the time.

During the course of the clinical use of NSC 631570 full or partial remissions have been documented along with improvements in the general condition. This fact alone should have led to the registration of the preparation but it should also be granted today in accordance with the law in force at the time because it was already “in the pipeline” (Appendix 6).

By 1992 evidence for the preparation’s efficacy, safety and quality (Appendix 7) as well as 400 case histories of patients who had exhausted all forms of conventional treatment had been submitted to the Austrian ministry. Doctors prescribed NSC 631570 to patients in accordance with §12 of the Medical Specialities Order BGBI Nr. 99/1947 and §8 Austrian Medicinal Products Act (AMG) in force at the time.

The ministry stated (GZ   21.405/1011-II/1/8/92, by the Medicines Advisory Board signed by  Prof. Dr.G.Hitzenberger and department head Dr.G.Liebeswar, (Appendix 8):

“In a Phase I test the producer J.W.N. born in 1937 experimented on himself. He had 2.5 — 50 mg applied i.m. and i. v. over a total period of 1 week to 3 years. The total quantity applied was 3,500 mg  and it was described as excellently tolerated.”

 

 

“In a Phase II study on patients with various oncological diseases just as few side-effects were observed.”

 “Clinical reports on patients report the following reactions:

1)    Standstill of tumour growth without further metastases

2) Partial remissions

3) Total remissions and

4) Total remissions that have already lasted for several years (up to 10 years).”

“Looking at all the findings it can be said that a clinical trial in Austria (…) can still be approved because the substance (Ukrain) is obviously well tolerated.”

The ministry’s proposal was taken up and the relevant trials carried out and the results presented to the ministry:

“The survival rate (up to 21 months) in the Ukrain-treated patients with non-metastatic colorectal cancer was 78.6% and 33.3% in a corresponding control group. Ukrain is a new effective drug in the therapy of colorectal cancer. It can be useful both for the therapy of metastatic colorectal cancer and for neoadjuvant therapy of non-metastatic colorectal cancer.” (Appendix 10)

Doctors who had used Ukrain in accordance with §42 AMG also asked for the preparation to be registered quickly (Appendix 9). Reports on their experiences also called for registration (Appendix 11). 

Many children who had been given up by conventional medicine as no longer able to be helped have also been successfully treated with Ukrain. They are still alive today, such as Stefan Dan (Appendix 28) and Daniel B. (Appendix 29). As can be seen from Daniel B.’s case history, he was diagnosed as a child with “Xeroderma pigmentosum”. By the time he was 16 he had undergone 56 operations. This is usually the maximum life expectancy for children with this type of disease. Daniel B., who began treatment with Ukrain at the age of 16, is now 32 years old, enjoys good health, works and drives a car.

In the case of Stefan Dan, who was diagnosed with generalised lymphangiomatosis, his parents were threatened with criminal proceedings if treatment with Ukrain was not stopped immediately. And all of this despite the fact that doctors were in any case forecasting an early death. This terrible story is told in the introduction to the book “Anticancer Pharmaceutical Ukrain - A Crime Story of Prevention” by Eleonore Thun-Hohenstein. As a result of stopping treatment with Ukrain there was renewed tumour growth in the back area and Stefan Dan had to undergo another operation. However, it did not stop the tumour growth, which is why his doctors, having no idea what else to do, recommended that he continue treatment with Ukrain after all. Stefan Dan is still alive today but suffered paralysis as a result of the operation. He could have been spared this if therapy with Ukrain had not been  stopped due to pressure from the authorities (Appendix 28).

Despite all of these circumstances NSC 631570 has still not been registered.

Paradoxically at around this time  Austria was the first country in the world to register a highly-toxic cancer preparation called “Taxol” (from Bristol-Myers) — and within only five months after application. It should be noted that a new drug’s country of origin, in this case the USA, should have been preferred for a first registration — and that it was registered on the basis of only 17 examples of its use (Appendix 12).

This appears to be a breach of §7 of the Austrian constitution which guarantees equal rights to all citizens.

On 28.03.2002 Dr. Nowicky filed a complaint to the European Court of Human Rights in Strasbourg for disregard of human rights.

On 24.02.2005 the court found that in the case of the registration of NSC 631570 the authorities had disregarded the rights of the applicant and ruled that the Austrian authorities should deal with the application for registration in accordance with the law. However, decision 34983/02 of the ECHR of 24.02.2005 was still not implemented by the Austrian authorities (Appendix 14).

On 11.11.2011 officials from AGES (Austrian Agency for Health and Food Safety) unlawfully confiscated 5,654 ampoules of NSC 631570 on the grounds that registration had been withdrawn in Ukraine (Appendix 15). This was not true, Ukrain never lost its registered status.

Thirteen days after the ampoules were confiscated a greater celandine preparation appeared in different Austrian clinics (Appendix 16 pp. 117-118) and medical insurance funds bore the costs for the product although there was no kind of accompanying  information. The effect was limited to an improved general condition but there were no remissions, as can be observed with Ukrain.

On 04.09.2012 the inventor of Ukrain was arrested and his company described as a criminal organisation of the basis of a claim by two leading AGES officials that the preparation had no effect. 268,000 ampoules were confiscated. The Public Prosecutor’s Office demanded reports to check these claims but no such report was ever submitted (Appendix 17,18,19).

Prof. Hans Beger and Doz. Dr. Med. Frank Gansauge, who had carried out and published studies on the treatment of pancreatic cancer with Ukrain (Appendix 20, 21), were working on another study with adjuvant patients suffering from pancreatic cancer. The results showed that 30% of patients lived for more than five years. Medical statistics show that only 2% of patients with this diagnosis live for two years. An extract from the interrogation record from Appendix 18 (p. 5-8).

Question: Could any change in patients’ clinical picture be registered during treatment with Ukrain?

Answer (Doz. Dr. Med. Frank Gansauge): In this regard I refer to my study.

 

Question: Were some patients completely cured?

Answer (Doz. Dr. Med. Frank Gansauge): No, not with the palliative patients. With the adjuvant patients there were around 30% who survived for five years.

 

Prof. Beger, the director of the study was paid € 780,000 not to publish these results. It has still not been clarified in whose interest this was done. A quote from the book by Dr. Eleonore Thun-Hohenstein “The Suppressed Cure for Cancer. The Fight against a Patent” (pp. 112-113):

“The background: Beger had finished a new study showing that 30% of pancreatic cancer patients lived for more than fives years after treatment with Ukrain, which is extraordinary with this malevolent form of cancer. Normally only a small percentage of patients with pancreatic cancer live for five years. From AGES point of view the publication of this study of course had to be prevented. On 16 September 2013 another text message was received: “Beger has pocketed a donation of € 780,000.”

 

On 07.08.2013 Dr. Nowicky was faced with another charge in relation  to the relabelling of NSC 631570. It is  well known that alkaloid salts are not subject to decay processes. This applies to NSC 631570 which consists of alkaloid salts. In court the question was asked as to why the ampoules had been relabelled. Dr. Nowicky stated that the relabelling had always been undertaken in accordance with the truth. During the course of this, three independent reports confirmed that no loss of quality could be found:

AGES report IAM (Results of test of Ukrain 13.12.2011);

Seibersdorf laboratory (Results of test of Ukrain. Seibersdorf Laboratories, 24.02.2015).

The expert witness commissioned by the court, Mag. Dr. Karl Dobianer, also came to the conclusion:

“In synopsis the results clearly show that the ampoules examined are not “out of date” or “worthless” (Appendix 23).

Relabelling is common practice in the pharmaceutical industry. One example is the concern Roche which relabelled the product Tamiflu four times. A quote from Roche spokesperson Nicolas Dunant: “It is normal that the shelf life of new medicines is checked and is extended if the results of analysis are positive” (Appendix 24).

There is basically no medicine that works identically with all patients. Despite being approved for clinical studies (Appendix 9) former patients who had exhausted all other forms of therapy were promised that Dr. Nowicky would repay their costs if they stated that no effect could be established. It should be mentioned that these patients were still alive thanks to treatment with Ukrain but among other things stated that their successful cures could only be attributed to various changes in nutrition.

As a result of these statements the court decided that Dr. Nowicky was obliged to repay the costs of treatment without questioning him on the subject. 

As previously mentioned, in the case of the greater celandine extract which was used in various Austrian clinics without information about the product or the producer all the costs were directly borne by the health insurance funds despite the fact that the product is more expensive than Ukrain and has never been officially approved for clinical studies (Appendix 16).

In the case of NSC 631750, for which there is documentary evidence of successful treatment, the health insurance funds always refused to bear the costs. One example is Mrs. Jakob, who had been given up by conventional medicine. Thanks to treatment with Ukrain she is now 94 years old. The health insurance funds refused to pay the costs despite the fact that no other form of therapy was possible or could be recommended (Appendix 25, 26 pp. 140-141).

Who benefits from this? Cancer patients? Certainly not. Austrian citizens? Certainly  not.

If the preparation had been granted registration in accordance with the law, Austria would not only have an excellent export product that would certainly be popular all over the world but the effect on the Austrian economy would be extremely positive as a result of tax revenues of over € 2.5 billion per year (Appendix 27).

The story of Dr. Nowicky and his product is an example of the Austrian way of doing things —  Semmelweis reflex (https://en.wikipedia.org/wiki/Semmelweis_reflex).

It is to be hoped that that this information also proves interesting for Austrian journalists. It would be surprising if they were to ignore these facts in view of the number of cancer patients, possibly even in their own families.

The registration of medical products should not be subjected to the will  of various individuals. If the legal stipulations are fulfilled, registration should be granted.

In the case of NSC 631570 all preconditions were fulfilled from the start but registration has nevertheless been unlawfully prevented until now with breaches of administrative procedures (Appendix 30).


 

 

1.  http://ukrin.com/docs/Brueller_1992.pdf

2.  http://ukrain.ua/present/ukrain.html

3.  http://ukrain.ua/statti/136.htm

4.  http://ukrain.ua/statti/141.htm

5.  http://ukrain.ua/mainnew.html#bibliography

6.  http://www.ukrin.com/docs/Brief_an_DrHauer.pdf

7.  http://www.ukrin.com/en/efficacy

8.  http://www.ukrin.com/docs/Zitate_Abschlussgutachten_1992.pdf

9.  http://www.ukrin.com/docs/Arrouas_1993.pdf

10.        http://www.ukrin.com/docs/Susak_1996.pdf

11.        http://www.ukrin.com/docs/erfahrungsberichte.pdf

12.        http://ukrin.com/en/node/387

13.       Eleonore Thun-Hohenstein: Anticancer Pharmaceutical Ukrain - A Crime Story of Prevention -https://www.amazon.com/Anticancer-Pharmaceutical-Ukrain-Eleonore-Thun-Hohenstein-ebook/dp/B007U9HKNO

14.       http://www.ukrin.com/docs/case_nowicky_austria.pdf

15.       http://ukrin.com/docs/2011-11-11-ages-niederschrift.pdf

16.       Monika Berthold, Elisabeth Buchner. Krebs besiegen ohne Nebenwirkungen: Die erstaunliche Erfolgsgeschichte von Ukrain - https://www.amazon.de/Krebs-besiegen-ohne-Nebenwirkungen-Erfolgsgeschichte/dp/3934246052

17.       http://www.ukrin.com/docs/Beschwerde-gegen-Anordnung.pdf

18.       http://ukrin.com/docs/Habicher_12_09_2014.pdf

19.       http://ukrin.com/docs/Unterkofler_12_09_2014.pdf

20.       Frank Gansauge, Marco Ramadani, Michael Schwarz, Hans G. Beger, Erkki Lotspeich, Bertram Poch. The Clinical Efficacy of Adjuvant Systemic Chemotherapy with Gemcitabine and NSC631570 in Advanced Pancreatic Cancer. Hepato-Gastroenterology 54 (2007), 917-920

21.       Frank Gansauge, Marco Ramadani, Jochen Pressmar, Susanne Gansauge, Bernd Muehling, Kerstin Stecker, Gregor Zahmerer, Gerd Leder, Hans G. Beger. NSC631570 (Ukrain) in the palliative treatment of pancreatic cancer. Results of a phase II trial. Langenbeck`s Arch Surg (2002) 386:570-574 DOI 10.1007/s00423-001-0267-5

22.       Zeugenvernehmung Dr. Med. Frank Gansauge, GZ: 2.699 606/I-II/BK31, Wien, am 19.10.2012

23.       http://www.ukrin.com/docs/Gutachten-Zusammenfassung.pdf

24.       http://ukrin.com/de/node/373

25.       http://www.ukrin.com/fall-hedwig-jakob

26.       Eleonore Thun-Hohenstein. The Suppressed Cure for Cancer. The Fight against a Patent -https://www.amazon.com/Suppressed-Cure-Cancer-Eleonore-Thun-Hohenstein-ebook/dp/B07123NDX6/ref=sr_1_1?s=digital-text&ie=UTF8&qid=1509109100&sr=1-1&keywords=Thun+Hohenstein+The+suppressed+Cure+for+Cancer

27.        http://www.ukrin.com/docs/AusWirkungenZulassung_0.pdf

28.        http://ukrin.com/de/node/385

29.        http://ukrin.com/en/node/386

30.        http://ukrin.com/de/node/388