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Facts about the Austrian Authorities’ Accusations against Dr. Nowicky

 

Facts about the Austrian Authorities’ Accusations against Dr. Nowicky

“Give us a man and we will find a reason to destroy him.”

Felix Edmundovich Dzerzhinsky

 

This Russian official’s statement comes to mind when looking more closely at the practice of the Austrian authorities. What happened:

 

After an open letter of 30.08.12 from Dr. Nowicky to the Austrian Vice-Chancellor, Dr. Michael Spindelegger, which dealt with all the problems associated with the registration of Ukrain, Nowicky was arrested by about 60 Austrian police officers on 04.09.2012 four days later along with his family members and employees and was the subject of much “media attention”. All his business documents, cash assets and stored ampoules were confiscated. Not everything that disappeared was listed in the police search report…

 

Since the time of the application for the registration of Ukrain in 1976 more than 100,000 people in Austria have already died of colorectal cancer alone. It should be emphasised that this type of cancer is particularly dangerous and difficult to cure (the survival rate for patients treated with conventional therapy is approx. 40%). Studies with Ukrain have demonstrated astonishingly positive results in the treatment of colorectal cancer patients. If the authorities or assessors doubt the proven effect of Ukrain, should they not at least have the preparation tested by other doctors? Is the urgency of the subject and the risk to the lives of rectal cancer patients not great enough to follow up every glimmer of hope?

But what happened? Ministry of Health officials financed by taxpayers’ money have ignored and rejected all the very promising studies along with urgent recommendations and requests from 8 scientists to register Ukrain as quickly as possible and carry out further studies with the preparation. (www.ukrin.com/docs/erfahrungsberichte.pdf)

The confirmation of Ukrain’s good tolerability was also disregarded by the Pharmaceutical Advisory Board at the Federal Ministry of Health, Sport and Consumer Protection, which stated in its letter of 03.11.1992 (GZ 21.405/1011-II/A/8/92) that “the tolerability of the substance is very good.” (www.ukrin.com/docs/Arrouas_1993.pdf)

In contrast the Federal Ministry of Social Security and the Generations rejected “the application of 05.03.2001 for the registration of Ukrain as a medical speciality under the proviso “after standard therapy has failed” in accordance with § 22 Abs. 1 of the Austrian Medicines Act, BGBI.I  Nr. 33/2002 (AMG) with its notification of 25.04.2002 (GZ: 921.726/13-VI/16/02).

 

  • Who profits from the fact that cancer patients who have exhausted all other forms of therapy are denied a herbal treatment with no side-effects?
  • What caused state authorities in Austria and Germany to discriminate against and persecute scientists with worldwide reputations? Especially when they discover a means not only to improve the condition of cancer patients but demonstrably prolong their lives and in some cases even cure them completely? Dr. Nowicky is not the only cancer researcher who must struggle against the scandalous high-handedness of the authorities.
  • Who bears the responsibility for the probable, often avoidable, death of these patients?

 

The arrest of Dr. Nowicky in September and the subsequent justification for the operation speak for themselves. On account of the many enquiries about how the situation will develop, first the news from Dr. Nowicky that because of the confiscation by the authorities of all the ampoules and the threat / ban on the production of Ukrain to the production company in Germany there is currently no Ukrain available for further treatment. (www.ukrin.com/node/284)

 

Below are extracts from the charges of the Public Prosecutor’s Office followed by Dr. Nowicky’s comments:

 

ON THE DIRECTIVE FOR A HOUSE SEARCH AND CONFISCATION BY THE PUBLIC PROSECUTOR’S OFFICE FOR ECONOMIC CRIME AND CORRUPTION

 

1 St 24/12w Zu GZ 2 699606/1-II/BK/31o55, Vienna, 23 August 2012

 

Charge:

(Extract – notice the choice of words!)

...Wassyl Nowicky is under strong suspicion that, over a period still to be established up until now, he created for himself a continuous income through recurrent perpetration with the intention of illegally enriching himself through the behaviour of the deceived, with the claim made in different forms that the preparation developed by him “Ukrain” is a medicament:  

1.      against all forms of cancer,

2.      against radiation sickness,

3.      against AIDS,

4.      against many other diseases,

5.      is an empirically verified and highly effective medicament,

6.      offers a complete cure for every form of cancer,

7.      that is registered in several countries as a medical product for the treatment of cancer as a result of proper health authority registration proceedings,

8.      that thousands of people have already been completely cured of cancer as a result of its use.

Furthermore that::

9.      Wassyl Nowicky claimed to be a doctor

And that with these statements he:

10.  misled people into buying the preparation Ukrain at a price of up to EUR 77 per ampoule,

whereby:

11.  this act caused damages of probably EUR 50,000, but in any case over EUR 3,000.

 

In order to understand the background and connections between the following occurrences and argumentation, some explanation is required:

 

There was a staged demonstration against the medicament Ukrain in front of the Austrian embassy in Kiev on 14.102011 (it can be seen clearly in the video how a small group of participants are paid after the demonstration). A woman complained that her brother had died eight years previously in May 2003 because he had used Ukrain. The patient died on 6 May 2003 around five years after his lung operation.

 

On 07.12.2011 the woman filed a complaint (to the Austrian Public Prosecutor’s Office) against Dr. Nowicky claiming damages. Her accusation was: “We had to pay a high price for the wrong treatment and I therefore request that you institute criminal proceedings against W.M. Nowicky, to declare me the injured party and include unjust enrichment of EUR 12,500 (twelve thousand five hundred) and EUR 100,000 (one hundred thousand) immaterial damages.” (It should be noted that this claim was filed 8 years after her brother’s death.)

On 10.06.1998 the operation was carried out – ureteronephrectomy right. Her brother’s diagnosis: KIDNEY TUMOUR RIGHT. T3 N2M2. METASTASES IN THE RIGHT LUNG. Operation carried out on 10.06.1998 – ureteronephrectomy right.  The average survival time for this diagnosis is only months.

 

It should also be remarked that the Public Prosecutor’s Office did not refer her to civil law but, on 21.06.2012, sent the case to the Economic Crime and Corruption Prosecutor’s Office.

The first house search and confiscation of more than 5,600 ampoules of UKRAIN on 11.11.2011 was based on the following accusation:

From the notification of 11.11.2011 (GZ 670.015-17-11-INS): “According to information obtained by the Federal Office the medical speciality Ukrain, which is registered in neither Austria nor the EU, recently had approval withdrawn in Ukraine.” This claim made by officials is untrue because on 11.11.2011 approval was valid in Ukraine.

On 14.11.2011 registration in Ukraine was suspended (but has still not been withdrawn until now). Nevertheless the “non-registration” was already cited on 11.11.2011 as justification for the unlawful confiscation of the ampoules. Here it would appear that the officials must have had clairvoyant powers. This does not fit the facts because registration was first suspended three days later

Registration has still not been terminated until now. This is a legal difference.

After the unlawful official action of suspending the registration of UKRAIN in Ukraine, the Ukrainian minister of health was dismissed by the Ukrainian president!

 

Harassment continues

On 15.03.2012 the police began telephone surveillance, presumably to find reasons for the confiscation of the ampoules on 11.11.2011, at least retrospectively.

On 21.03.2012 I filed a public liability claim on account of the financial damages caused by the confiscation of more than 5,600 ampoules.

30.08.2012– Open letter from Dr. Nowicky to the minister (www.ukrin.com/node/284).

04.09.2012– House search and arrest on the basis of the order of 23.08.2012 GZ 2 699606/1-II/BK/31o55. Dr. Nowicky only received the arrest warrant on 09.11.2012 while imprisoned on remand – after nine weeks in custody!

The Public Prosecutor’s Office against Corruption ordered “the confiscation of the following in particular: business documentation, customer files, records of studies carried out, courses of treatment, diagnostic findings and other documentation relating to the preparation Ukrain and its production and sale.” The confiscation of the medicine Ukrain was not ordered. However, when the officers stormed my house they first asked to be shown where I stored the Ukrain ampoules because they were also ordered to confiscate them. I see this confiscation of ampoules as just as illegal as that of 11.11.2011.

 

Details of the accusations of the Public Prosecutor’s Office

 

The Austrian Public Prosecutor’s Office is accusing Dr. Nowicky, among other things, that he had a medicament produced and distributed that is not registered in Europe. It alleges that he illegally supplies UKRAIN as a medicament.

 

Statement of Dr. Nowicky about this accusation

 

In 1976 it was found that the anti-cancer medicament Ukrain accumulates rapidly in cancerous tissue and destroys cancer cells without damaging healthy cells. An application for the registration of the anti-cancer drug Ukrain was subsequently made to the Austrian Federal Ministry of Health. According to the law in force at the time, which remained valid until 1984, all conditions had been met for registration to be granted. The preparation Ukrain is produced from two registered starting substances and has a therapeutic advantage over both the basic substances. Ukrain is more than 300 times less toxic than its starting substances. According to the law at the time governing registration criteria neither clinical nor preclinical studies nor the submission of further documentation was necessary. This evident illegality was confirmed by the verdict of the Higher Administrative Court (VwGH) of 15. April 1996, Zl. 95/10/0124. Nevertheless, Ukrain has still not been registered.

 

Relevant legislation:

Medical Specialities Order (Spezialitätenordnung) BGBl. Nr. 99/1947

(www.ukrin.com/docs/1947 spezialitaetenordnung.pdf)

 

According to § 91 Abs. 1 of the Austrian Medicine’s Act:

“Applications for the registration of a medical speciality in accordance with the provisions of the Medical Specialities Order which were made before this law came into force but had not been decided upon at the time of the law becoming valid, are to be treated as applications within the meaning of § 13.”

Much documentation which must now be submitted under § 9a AMG was not required at that time. It was not then necessary to submit either clinical or non-clinical data. This means that the law that formed the basis for the decision on applications for registration made before 01.04.1984 stipulated considerably fewer requirements.

http://www.ris.bka.gv.at/GeltendeFassung/Bundesnormen/10010441/AMG%2c%20Fassung%20vom%2010.11.2012.pdf

 

1980 First patent granted for the Ukrain production process.

 

According to § 22 Patent Law:

(1)…Patent holders are authorised to exclude others from manufacturing the subject matter of the invention industrially, bringing it into circulation, putting it up for sale of using it or importing or owning it for the above-mentioned purposes.

 (2) When a patent is granted for a process the effect also extends to products directly derived from this process.

http://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10002181

 

C H R O N O L O G Y of efforts for registration

 

1976 Application for registration

The application for the registration of the preparation Ukrain as a medicine was made to the responsible authority in 1976 under the Medical Specialities Order (Spezialitätenordnung) BGBl. No. 99/1947.

The application has not been dealt with so far.

 

1981 Urgent letter to the Minister of Health

(www.ukrin.com/docs/1981-07-27-brief-zulassung.1981.pdf)

The ministry had still not granted registration. In reply to my urgent letter of 27.07.1981 I received a letter from the Federal Minister of Health, Dr. Kurt Steyrer, on 14.08.1981. I was specifically informed that only a production licence was necessary in order to be granted registration.

The application for the licence was submitted a few days later.

I only received the licence (Reg. Zl 4989/k/6/7, from MA der Stadt Wien 6/7 Bez.) in 1988 (7 years later) and submitted it to the ministry immediately. (www.ukrin.com/docs/Konzessionsdekret.pdf)

 

All legal requirements had thereby been fulfilled. However, instead of promptly granting registration, new and obviously unlawful demands were made by the ministry. At the same time the authorities tried to persuade me to withdraw my application of 1976. However, I could in no way agree with this demand. I have not withdrawn the application until now, as proven by a letter from 1998.

 

In 1992 I was informed that I should make an application to the Pharmaceutical Advisory Board (Arzneimittelbeirat) to receive permission to test the substance Ukrain in a phase III study. On 03.11.1992 this application was approved with a letter of 03.11.1992 from the Pharmaceutical Advisory Board of the Federal Ministry of Health GZ 21.405/1011 — II/A/8/92 with the following summary.

 

“In considering all the statements made it can be said that clinical studies in Austria can be further approved under certain circumstances because the substance is obviously very well tolerated. The precondition would be a study plan that complies with modern standards. This study plan would have to be submitted to the Medicines Committee before beginning studies in Austria.”

 

On 23.06.1993 the Federal Ministry for Health, Sport and Consumer Protection informed me with the notice GZ. 21.405/530-II/A/8/93:

“The Medicines Committee office would like to inform you that with regard to the study plans submitted for Ukrain, report No. 558, there are now no objections from a formal point of view.” (www.ukrin.com/docs/Arrouas_1993.pdf)

 

The following studies were approved:

 

1.      Open, controlled study of colonic cancer;

2.      Clinical study of malignant melanoma;

3.      Clinical study outside hospitals in accordance with paragraph 42 AMG.

 

On point 1: although approximately 5,000 people are diagnosed with colonic cancer in Austria and around 3,000 die of it each year, no clinic in Austria has so far been prepared to carry out such a study.

 

The studies were therefore carried out abroad in accordance with the approval of the protocol of 23.06.1993 and the results were submitted to the Ministry of Health in 1996 and published in the article “Ukrain Therapy for Colorectal Cancer”. The 21 months survival rate after treatment in the Ukrain monotherapy group was 78.6% and in the chemo- and radiation therapy group 33.3%.” (www.ukrin.com/docs/Susak 1996.pdf)

 

On point 2: clinical study of malignant melanoma. This study was only carried out as a historical comparison because all previous controlled studies of malignant melanoma had only shown a success rate of 10-20%. However, it is known that this disease can react sensitively to immunomodulating agents. Several doctors have treated malignant melanoma very successfully with Ukrain resulting in long lasting remissions. Prof. Dr. P. Wodnianski wrote to the Ministry of Science and Research on 12.06.1984 stating: “This most unusual result – with a patient who is already secreting melanine in the urine, one hardly expects a few months! – impressed me so much … that I too join in this request for further support.” In nine months the patient “gave the impression of being healthy or even cured.” (www.ukrin.com/docs/wodniansky.pdf)

An in vitro study at the National Cancer Institute, Bethesda, Maryland, USA demonstrated the very high sensibility to Ukrain of all malignant melanoma cell lines tested. (www.ukrin.com/docs/untersuchungen-invitro.pdf)

 

In Austria approximately 200 people per year die of malignant melanoma. No hospital has so far been prepared to carry out an approved clinical study. (www.ukrin.com/docs/nci-1.pdf, www.ukrin.com/docs/wodniansky.pdf, www.ukrin.com/docs/stabuc 1996.pdf, www.ukrin.com/docs/hamler 1996 1.pdf, www.ukrin.com/docs/Danilos 1992.pdf, www.ukrin.com/docs/zemskov 1996 2.pdf)

 

On point 3: for this type of clinical study  in accordance with §42 AMG various oncological diseases were to be treated with Ukrain as occur in the normal practice of town and country doctors. Many of these cases were of patients who had previously been treated and whose diseases were in progression. […] It can be considered certain that as a result of experience and studies so far, a significant improvement in the quality of life through Ukrain can be achieved as a minimum, even at advanced stages.

This study was carried out in Austria and the case reports about Ukrain from doctors, scientists and patients were submitted to the Ministry of Health in 1996. (www.ukrin.com/docs/erfahrungsberichte.pdf)

 

Here are some excerpts from these reports:

In 1996 Dr. Alois Denk wrote, “From a medical point of view it would be desirable to continue investigating the efficacy of Ukrain and, with the appropriate result, make it generally available.”

Also in 1996 Univ. Doz. 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 minor 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."

Dr. Siegfried Wagner: “As a continuation of my successful treatment with Ukrain I consider the approval of the drug Ukrain in Austria as extremely desirable.”

Prim. Dr. Hans-Jörg Klein: “For this reason I would find the approval of the drug Ukrain by the Federal Ministry extremely desirable." 

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 opinion – after many years of personal experience – a considerable improvement in the general prognosis … is to be expected.”

Dr. Uta Konstantopoulosconfirmed: "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.”

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."

Dr. Grazyna Nowicki(no relation): “I have been using Ukrain in my medical practice for around 7 years. Most of the approximately 15 patients who I have personally treated were cases of having exhausted all other forms of therapy and who, given up by traditional medicine, were desperately looking for a final opportunity of treatment. To begin with it should be mentioned that with all of these patients an unexpected subjective and objective improvement occurred 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 the easing of pain so that in many cases the administration of strong pain killers became superfluous… I am including a few case reports of the most remarkable successes achieved with Ukrain…

A 67-year-old woman with metastatic breast cancer (bone and lung metastases, malignant pleural effusion and ascites) who had been discharged from hospital as an incurable case. Her general condition was pitiable. After the third therapy series with Ukrain, the doctors in the hospital established that all tumours, metastases and the pleural effusion and ascites had disappeared. The patient stopped treatment with Ukrain after the 7th series and experienced a recurrence (short-term remission) 7 months later…

It may be summarised that, also in consideration of my several years of experience at an ENT clinic abroad, I clearly observe the following: Ukrain is a therapy option for oncological diseases and should be made widely accessible if one is to maintain one's medical ethics and satisfy one's conscience. Marketing authorisation for Ukrain … should be issued …

I most urgently recommend that Ukrain be quickly approved to make this highly-effective cancer therapy widely and rapidly available to those who need it.”

The authorities’ reaction

With its notification of 02.06.1995 (Zl: 2.921.726/7-II/C/16b/95) with regard to the registration of a medical speciality the Federal Ministry of Health and Consumer Protection rejected my application from 1976 on the grounds that the submitted documentation would never have been enough to prove the quality, efficacy and safety of Ukrain with the required safeguards. (www.ukrin.com/de/wirksamkeit)

 

This notification was annulled by the verdict of the Higher Administrative Court on 26.02.1996 (Zl. 95/10/0124; DNr 1302/0830HP) on account of unlawfulness as a result of a breach of administrative regulations.

 

The unlawfulness lay in the fact that in dealing with an application for registration from 1976 the Medical Specialities Order valid at the time stated that no clinical or preclinical studies were necessary because Ukrain is produced from two starting substances (Thiotepa and greater celandine alkaloids) which are already approved and has the following therapeutic advantages:

-  The preparation is more than 300 times less toxic than its starting substances,

-  Ukrain has a selective effect and is only toxic against cancer cells but not against healthy cells, whereas Thiotepa alone is toxic both for cancer cells and healthy cells, (www.ukrin.com/docs/selektivewirkung.pdf)

-  Ukrain accumulates in cancer tissue very rapidly after administration but alkaloids do not have this property. (www.ukrain.ua/present/ukrain.html)

 

Instead of granting approval the Ministry of Health demanded chemical-pharmaceutical, pharmacological and clinical reports.

 

In their chemical-pharmaceutical documentation both Mag. Kurt Vymazal as well as Dr. Gerolf Tittel showed that the production of Ukrain is ensured to be safe and the testing method sufficiently elaborated to confirm the quality of the preparation.

 

In 1996 Dr. Walter Knapp came to the following conclusion in his Pharmacological-Toxicological Expert Report on Ukrain: “Summarising the results of pre-clinical investigations, Ukrain can be certified as possessing an interesting spectrum of action, 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 show 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 safe.”(www.ukrin.com/docs/Knapp_1996.pdf)

The clinical report by Dr. Stefan 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.”

When I submitted these reports, the Ministry of Health demanded that the clinical report should be specially drawn up by Dr. Nahler.

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 cancer therapies.”

After these reports had also been submitted, the Ministry of Health advised me to make an application for the treatment of patients who had exhausted all other forms of therapy. This would be the way to be granted approval quickly and my preparation would become available to all cancer patients because the health insurance funds would take over the costs of treatment with Ukrain – all cancer patients would benefit from this. This was the reason that, on 05.03.2001 (GZ:921.726/13-VI/16/02), I submitted an application for the approval of Ukrain for patients who had exhausted all other forms of therapy.

 

Around 3,000 people per year die from colonic cancer in Austria alone. On the basis of the assurances from the ministry I had more than 300,000 ampoules of Ukrain produced in accordance with GMP guidelines for the treatment of these cancer patients.

My supplementary application of 05.03.2001 (GZ:921.726/13-VI/16/02) for the approval of Ukrain as a medical speciality under the proviso “after standard therapy has failed” was rejected by the Federal Ministry of Social Security and the Generations with its notification of 25.04.2002. This was a matter of patients who could no longer be treated; patients who were “sent home to die.” These patients were deprived of the possibility of saving their lives, improving their general condition or at least reducing their suffering without the inhuman side effects common with chemotherapy. And the authorities’ justification for this sounds like mockery in the ears of those affected: “In Part III it is not ascertained whether the observed effects are to be attributed to the supposed complex, to free alkaloids or to free Thiotepa.”

This justification comes from an expert witness I had objected to as being biased and the previous positive reports from the other four expert witnesses were disregarded. Nevertheless this justification from the biased assessor was the only decisive reason for rejecting the application.

At this point it should be emphasised that the commission had rated the preparation as being well tolerated and there were no objections to its use. The Ministry of Health thus had no doubt about the efficacy of Ukrain. But with the rejection of approval patients who had exhausted all other forms of therapy were denied a last chance of help. I repeat that this only happened because “it is not ascertained whether the observed effects are to be attributed to the supposed complex, to free alkaloids or to free Thiotepa.” Is this really a sensible reason for rejecting approval and taking away the last chance of therapy for patients who cannot otherwise be treated?

Because my application of 1976 had not been dealt with, I filed at suit at the European Court of Human Rights.

On 24.02.2005 the ECHR found against the Republic of Austria for failure to act with regard to my application of 1976 (Appl. no. 34983/02). (http://www.ukrain.ua/enclosures/menschenrecht.pdf) Unfortunately this verdict had no effect on the national authorities and my application from 1976 has still not been dealt with until now.

 

… So much for the accusation that UKRAIN is an unrecognised medicament in Europe which Dr. Nowicky “goes peddling”.

 

Comments on the individual accusations of the Public Prosecutor’s Office:

1.      On the accusation that Dr. Nowicky claims that Ukrain can help against all forms of cancer

Dr. Nowicky’s statement:The in vitro Ukrain-study at the National Cancer Institute (Bethesda, Maryland, USA) demonstrated the anti-tumour effect of UKR (NSC 631570) on the basis of the treatment of 60 different human cancer cell lines (solid tumours). .(www.ukrin.com/docs/untersuchungen-invitro.pdf)

The following cancer cell lines were examined in this study:

*    Malignant melanoma,

*    Colorectal cancer,

*    Ovarian cancer,

*    Lung cancer,

*    Kidney cancer,

*    Brain tumours.

 

The fact that Ukrain is effective against all forms of cancer has been proved by studies at the Institut de Cancérologie et d´Immunogénétique (France). These studies showed that Ukrain is effective against cancer cell lines and is at the same time less toxic than its starting substances.

These results have been confirmed by clinical application.

In his Clinical Report of 16 June 1998 Dr. 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 tumour therapies.”(Appendix 17)

The selective accumulation of Ukrain in cancer cells explains its favourable safety profile and its high therapeutic index of 1250. (The therapeutic index is the ratio between the toxic and therapeutic dose of a medicine.)

In contrast, chemotherapy has an inhibitive effect on cancer cell lines but simultaneously also inhibits healthy cells. This is why the use of chemotherapy causes its numerous, well-known side-effects such as hair loss, damage to the vascular wall, bone marrow depression, neutropenia, ventricular tachycardia, hypothonia etc.

Chemotherapy can only inhibit the growth of cancer cell lines but cannot kill them. This is why chemotherapy does not lead to a cure and can at best merely slow down the progress of disease.

This can be seen clearly from a comparative study of the National Cancer Institute (Bethesda, Maryland, USA) in which an in vitro comparison was made between the toxicity of Ukrain (NSC 631570) and 5-Fluorouracil (NSC 19893) against various cancer cell lines.www.ukrain.ua/present/ukrain.html. page 30)

 

The therapeutic index of conventional cytostatic drugs (chemotherapy) is in the range of 1.4 to 1.8, meaning that an overdose can have fatal consequences.

According to a current US study the treatment of cancer with chemotherapy can be counterproductive. The production of the dangerous protein WNT168, which helps cancer cells to survive, is possibly stimulated by chemotherapy in healthy cells.

Researchers at the Fred Hutchinson Cancer Research Center in Seattle made a “completely unexpected” discovery while looking into the question of why cancer cells outside the human body are much easier to kill than inside the body.

It is often observed among cancer patients that tumours can at first be contained but later continue with accelerated growth.

 

  1. On the accusation that Dr. Nowicky claims that UKRAIN protects against radiation sickness

Numerous in vivo studies have demonstrated the radio-protective effect of the preparation.

In the clinical application of Ukrain is has been observed that patients treated with the preparation tolerated radiotherapy better. The side-effects of this aggressive form of therapy are reduced to a minimum. This was the reason to investigate the radio-protective properties of Ukrain in tests in vitro and in vivo.

Tests were carried out on mice exposed to various doses of radiation and the Research Institute for Military Medicine (St. Petersburg, Russian Federation) in order to find out whether the radio-protective properties of Ukrain have their origin in the starting substances.

The experiments on mice demonstrated that Ukrain has a far greater radio-protective effect than its starting substances, which applies both to the survival rate of the animals and the protection coefficient. For example, at a radiation dose of 5.25 Gy the protection coefficient of Ukrain was 95.0 ± 4.6, and for the control group 50.8 ± 4.6. These observations indicate that the radio-protective effect of Ukrain is significantly different to that of its starting substances.[1]

Further tests have shown that NSC 631570 (Ukrain) modulates the cell components of the haematopoietic system in such a way that the overall resistance of the body to radiation increases. In tests on mice qualitative and quantitative changes were ascertained in the haematopoietic progenitor cells and in the myelokaryocytesand leucocytes in the blood of the irradiated animals after intraperitoneal application of NSC 631570 (Ukrain) (0.2 mg/kg). Animals in the control group were given a saline solution. The colony-forming units were counted in the spleen and the bone marrow as well as myelokaryotypes and leucocytes (lymphocytes and granulocytes). The results of this study showed that NSC 631570 (Ukrain) causes specific changes in the various populations of haematopoietic cells (stem cells, proliferating, maturing and competent cells). These alterations affect the size of the stem cell pool, the kinetics of stem cell proliferation, the direction of their differentiation pathways, the rate of circulation of stem cells and precursor cells, the efficiency of recolonisation of cell-depleted sites, and other parameters, which in turn modify standard responses of hemopoiesis and immunogenesis to irradiation so that the radioresistance of the whole organism increases.[2][3][4]

The radioprotective effect of NSC 631570 has been confirmed by infection models in mice where its effect was superior to that of the known radioprotector cysteamine.[5]

Compared to other agents, NSC 631570 exerted a strong radioprotective effect similar to that of lymphokinin. In this study, the effects of the preventive administration of cysteamine, naphthysin, Ukrain, lymphokinin, prodigiosan, and polyribonate on the 30-day survival of mice subject to doses of ionizing radiation were compared. Conventional radioprotectors were shown to prevent the death of experimental animals irradiated with doses ranging from LD50/30 to LD100/30 but were inefficient as a means of preventing mortality at doses with a medium lethal effect. In contrast, the bioregulators Ukrain and lymphokinin were more potent at doses ranging from LD50 to LD70/30 (1.5 times more potent than conventional radioprotectors). Polyribonate and prodigiosan were the least potent. The authors evaluated the radioprotective effect of Ukrain as ‘strong’ (Boyko V. N., Zholus R. B., Legeza V. I. A study of the influence of different types of radioprotectors on the survival of mice treated with ionising radiation over a wide dose range. Drugs Exptl. Clin. Res., XXIV (5/6), 1998, 343-347).

These radioprotective properties of NSC 631570 were confirmed in further studies in rats at the Institute of Applied Cell Culture (Munich, Germany). After peritoneal administration, Ukrain had no effect on the concentration of thyroid hormones in rat blood and increased the concentration of thyroid hormone receptors in the liver of intact rats during the first two months after administration. Ukrain normalised the level of nuclear thyroid hormone receptors influenced by short-term whole body gamma-irradiation of rats with 1 Gy, beginning from the first day after administration of the drug. Thus, authors concluded Ukrain can minimise the consequences of irradiation on the endocrine system of experimental animals (Luksa-Lichtenthaler G. L., Ladutko E. I., Nowicky J. W. Influence of Ukrain on the nuclear thyroid hormone receptors after short-term γ-irradiation. Drugs Exptl. Clin. Res., XXVI (5/6), 2000, 307-310).

Administered intraperitoneally, NSC 631570 exerted a protective effect on the hormonal system of irradiated female rats. Ukrain caused the normalisation of the intracellular glucocorticoid receptor system, affected by short-term whole-body gamma-irradiation of rats with 1 Gy beginning on the 10th day after administration of the drug. It was found that Ukrain minimised the consequences of irradiation in the endocrine system of the experimental animals(Luksa-Lichtenthaler G. L., Ladutko E. I., Nowicky J. W. Radiomodification effects of Ukrain, a cytostatic and immunomodulating drug, on intracellular glucocorticoid reception during short-term γ-irradiation. Drugs Exptl. Clin. Res., XXVI (5/6), 2000, 311-315).

The radio protective effect of NSC 631570 has also been studied and confirmed on in vitro models. Scientists from Eberhard-Karls-Universität (Tübingen, Germany) examined the effect of Ukrain alone or combined with radiation (1-10 Gy) on cell survival, modification of the cell cycle and the induction of apoptosis in the exponentially growing human tumour cell line MDA-MB-231 (breast cancer), PA-TU-8902 (pancreatic cancer), CCL-221 (colorectal cancer), U-138MG (glioblastoma) and in human skin fibroblasts HSF1, HSF2 and lung fibroblasts CCD32-LU. Without radiation Ukrain had a time and dose-dependent cytotoxic effect which was more pronounced in cancer cells than in normal cells. Combined with radiation Ukrain showed higher cytotoxicity towards the CCL -221 (colorectal cancer) and U-138MG (glioblastoma) cell lines but not towards the cell lines MDA-MB-231 (breast cancer) and PA-TU-8902 (pancreatic cancer). Most strikingly, a radioprotective effect was found in normal human skin and lung fibroblasts. Flow cytometry analyses supported differential and cell line-specific cytotoxicity of NSC 631570. CCL-221 and U-138MG cells accumulated in G2 after 24h treatment with NSC 631570, whereas no alterations were detected in the other tumour cells and normal fibroblasts tested. Differential effects of NSC 631570 in modulating radiation toxicity of human cancer cell lines and its protective effect in normal human fibroblasts suggest that this agent may be beneficial for clinical radiochemotherapy (Cordes N., Plasswilm L., Bamber M., Rodemann H. P. Ukrain®,  an alkaloid thiophosphoric acid derivate of Chelidonium majus L. protects human fibroblasts but not human tumor cells in vitro against ionizing radiation. Int. J. Radiat. Biol. 2002, vol. 78, No. 1, 17-27).

In their next study of the role of the proteins fibronectin and liminin in cell protection mechanisms against radiation scientists a the University of Tübingen already used Ukrain as a reference substance. (Cordes N., Blaese M. A., Plasswilm L., Rodemann H. P., Van Beuningen D. Fibronectin and laminin increase resistance to ionizing radiation and the cytotoxic drug Ukrain in human tumour and normal cells in vitro. Int. J. Radiat. Biol. 2003 Sep;79(9): 709-720).

NSC 631570 was effective in the treatment of recurring respiratory diseases in children from the Chernobyl region. A total of 38 children with recurring respiratory diseases from the area contaminated by radiation after the nuclear disaster were involved in the study. NSC 631570 was administered intravenously at a dose of 5 mg twice a week up to a total dose of 35 mg. The control group received radiotherapy. A clear anti-inflammatory effect was demonstrated in the Ukrain group in comparison to the control group – normalisation of the leukocytes and the blood sedimentation rate. The immunomodulating effects of NSC 631570 were expressed in the optimisation of specific humoral and cellular immunity: IgG concentration, phagocytic activity  of neutrophiles, the number of lymphocytes, T-lymphocytes and T-helper cells were increased as well as the helper-suppressor ratio. (Zahriychuk O. Ukrain, a thiophosphoric acid derivate of alkaloids of Chelidonium majus L., is effective in the treatment of recurrent bronchopulmonary pathology in children from areas contaminated after the Chernobyl accident. Int. J. Immunother. 2003, XIX (2-4): 47-53).

 

 

  1. On the accusation that Dr. Nowicky claims that UKRAIN is effective against AIDS

In my statement of 07.09.2012 while on remand I stated (and I quote), “that in the case of AIDS I have only claimed that there are indications of efficacy. I know of three cures of AIDS that I attribute to Ukrain.”

Marginal comment:

The increasing problem of AIDS has turned into a worldwide catastrophe because it is one of the most dangerous human diseases and is incurable with our existing medicine. At the moment there are only cautious indications that UKRAIN could possibly help against AIDS. Should these indication of cases of complete cure as a result of UKRAIN not be urgently checked and further clinical tests arranged and carried out? Is it ethically justifiable when possible help is not followed up? According to the constitution every state is primarily responsible for the protection of its citizens, especially in the field of medicine and health. Should this not apply to a legal, constitutional state with human rights such as Austria?  

Instead of that I have been accused of fraud without any scientifically proven reason that can be traced back to a fact after my application for the registration of Ukrain has not been dealt with over a period of 35 years. So far there are only indications that Ukrain can heal AIDS.

By delaying clinical and in vitro studies people are dying who would otherwise have had a chance of being cured. This applies both to AIDS as well as cancer patients.

 

 

  1. On the accusation that Dr. Nowicky claims that many other diseases can be cured by UKRAIN

 

·         Hepatitis  C

According to a study in St. Petersburg the virus could no longer be detected in 80% of the patients (s 84 FN 165).

A similar study was also carried out in Ukraine and confirmed the findings of the study in Russia. The results of the Ukrainian study were presented in January/February 2012 at the 23rd International Congress on Anti-Cancer Treatment in Paris.

  • Epilepsy

After treatment with Ukrain of three people suffering from epilepsy all three are now healthy and have a driving license, which is official evidence of their healthy condition.

  • Multiple sclerosis

Ukrain can help with multiple sclerosis. There is a patient who used Ukrain and is now “free from epileptic attacks” (witness statement of 05.09.2012, page 7).

 

  1. On the accusation that Ukrain is an empirically verified, highly-effective medicine

The fact that the preparation is empirically verified and highly effective has been confirmed by studies. I repeat that: the in vitro study of Ukrain at the National Cancer Institute (Bethesda, Maryland, USA) demonstrated the anti-tumour effect of Ukrain (NSC 631570) on the basis of the treatment of 60 different human cancer cell lines (solid tumours).

This study examined the following cancer cell lines:

§  Malignant melanoma

§  Colorectal cancer

§  Ovarian cancer

§  Lung cancer

§  Kidney cancer

§  Brain tumours.

 

These results have been confirmed in clinical application.

·         The efficacy of Ukrain with pancreatic cancer has been confirmed in numerous studies by Beger H. G., Gansauge F., Zemskov S., Aschhoff B., Susak Y.M. and Kroiss T.

·         Ukrain also has an immunomodulating effect, which has for example been confirmed by Professor Liepins A. in his study Activation of Spleen Cell Lytic Activity by the Alkaloid Thiophosphoric Acid Derivate: Ukrain.

·         The following study was presented at the 2nd International Conference on Drug Discovery and Therapy in February 2010 in Dubai (U.A.E.):Comparative Evaluation of the Complex Treatment of Rectal Cancer Patients (Chemotherapy and X-Ray Therapy, Ukrain Monotherapy” by Bondar G.V., Borota A.V., Yakovets Y.I., Zolotukhin S.E. Published in DRUGS EXPTL. CLIN RES XXIV (5/6) 221-226 (1998). In this study only 8.3% of patients treated with Ukrain showed new formation of metastases 14 months after treatment in contrast to 25% of patients treated with chemotherapy and radiotherapy, which means a three times better result for Ukrain.After 12 years 75% of the Ukrain group are alive and 45% of the chemotherapy and radiotherapy group. (www.ukrin.com/docs/dubai2010.pdf)

 

  1. On the accusation that Dr. Nowicky claims to offer a complete cure of all types of cancer with UKRAIN

 

As a matter of principle I do not claim that every cancer patient can be cured. Even if independent research institutes have shown that UKRAIN has a destructive effect on most cancer cell lines this does not mean that every cancer patient who has exhausted all other forms of therapy and been given up will be cured by UKRAIN. How it would be for patients who were treated with UKRAIN immediately after being diagnosed with cancer (before they have been perilously damaged by conventional chemo and radiotherapy) is difficult to estimate when the use of UKRAIN is confined to patients for whom conventional treatment has not been effective. So far experience has shown that after treatment with UKRAIN operations can often be carried out far more easily because in most cases the tumour becomes smaller and encapsulated – even in cases of patients who have exhausted all other therapies! Whether an operation is necessary or not can only be judged by the physician in attendance. However, there are enough documented cases and witness statements of cases where conventional therapy could not help and patients had been sent home to die and UKRAIN helped so much in the long-term that they are still alive today (16 to 34 years later). Why are these witnesses not questioned?

 

These case reports are not cases of self-healing but have been confirmed in further randomised clinical comparative studies:

As previously mentioned, the following study was presented at the 2nd International Conference on Drug Discovery and Therapyin February 2010 in Dubai (U.A.E.):Comparative Evaluation of the Complex Treatment of Rectal Cancer patients (Chemotherapy and X-Ray Therapy, Ukrain Monotherapy» by Bondar G.V., Borota A.V., Yakovets Y.I., Zolotukhin S.E. Published in DRUGS EXPTL. CLIN RES XXIV (5/6) 221-226 (1998).

In this study only 8.3% of patients treated with Ukrain showed new formation of metastases 14 months after treatment. The figure for patients treated with chemo and radiotherapy was 25%, meaning the result for Ukrain was three times better.

 

In addition, retrospective studies have also been carried out. Borota carried out a comparative study (PO-101): “Retrospective Analysis of Complex Treatment of Patients with Rectal Cancer”. Patients were divided into two groups, the first group was treated with Ukrain and the second in accordance with standard therapy. Both groups contained operable patients (stage 1). Treatment was carried out as follows: Group 1 Ukrain → Operation → Ukrain and Group 2 chemotherapy → radiotherapy → operation → chemotherapy → radiotherapy. The results show that 12 years after treatment with Ukrain 75% of patients survived in contrast to only 45% of survivors in the group treated with standard therapy.

The 75% survival rate 12 years after treatment with Ukrain is further concrete evidence of how helpful Ukrain is in the treatment of cancer.

The above-mentioned studies were carried out with operable patients and are documented in the specialist literature and available online at http://www.ncbi.nlm.nih.gov/pubmed?term=ukrain.

 

In view of the fact that in Austria approx. 5,000 people are diagnosed with colorectal cancer (cancer of the small intestine) per year and approx. 3,000 die of it, the health system is duty-bound to carry out the relevant studies if there is doubt about the efficacy of the anti-cancer preparation Ukrain. The preparation was developed in Austria and its selective effect was also demonstrated here for the first time. These findings about the selective effect of Ukrain have been confirmed by twelve international universities from different countries.

The failure to carry out these studies in knowledge of the above-mentioned findings from the studies carried out abroad could at least fall under the crime of failure to render assistance in an emergency – if not manslaughter or murder.

In view of such positive results why were the studies not completed in Austria?

Chelidonium majus L. can cure cancer, which is stated in the first printed book of medicinal herbs from 1536. The German name “wart herb” says something about its healing effect on tumours (warts are also tumours). The distinctive characteristic of Ukrain in contrast to its ingredients – alkaloids from greater celandine – is its ability to accumulate in cancer cells very quickly – without affecting healthy cells.

 

  1. On the accusation that Dr. Nowicky claims that UKRAIN is registered in several countries as a medical product for the treatment of cancer as a result of proper health authority registration proceedings

 

There have been proper registration proceedings and the resulting registration rights in the following countries, as evidenced by official notifications:

Registrations valid for 5 years:

Ukraine                                 from 1998, 2003, 2008

Georgia                                 from 1999, 2008

Tunisia                                   from 2010

UAE                                       from 2007

Mexico                                  from 2005

Aserbaijan                              from 2000

Tajikistan                               from 2000

Turkmenistan                        from 2000

Belarus                                  from 2005

Orphan Drug Status:

USA                                      since 2003

Australia                                since 2004

Currently registered:

Kosovo                                   from 17.05. 2012

 

What should be thought of a Public Prosecutor’s Office that questions such easily demonstrable facts or even denies them?

 

 

  1. On the accusation that Dr. Nowicky claims that thousands of people have been completely cured of cancer as a result of Ukrain

 

In my statement of 07.09.2012 while on remand I stated (and I quote): “I have never claimed that thousands of people have been cured of cancer, I can only have been speaking of it being used thousands of times.”

I also have no deliberate “intention to deceive” on the basis of information about the number of patients cured. This information can only be substantiated by clinical studies. These have not been carried out in Austria despite the approval of the federal ministry of 23.06.1993 GZ 21.405/530-II/A/8/93. On the basis of another clinical study carried out – Retrospective Analysis of Complex Treatment of Patients with Rectal Cancer – I can specify a 75% survival rate 12 years after the treatment of cancer patients with Ukrain. This fact is scientifically documented.

 

  1. On the accusation that Dr. Wassil NOWICKY claims that he is a doctor

I have never claimed to be a doctor. However, I have often, in accordance with the truth, used my academic title Dr. Tech. Chemie (PhD in chemistry). The statements of witnesses to the police have also confirmed this.

Some quotes from witnesses’ statements:

GZ 2699606/1-II/BK/31o55 30.11.2011 Stefan Hagenbüchl p.3 […] “he told me immediately that he wasn’t a doctor.”

GZ 2699606/1-II/BK/31o55 from 13.12.2011 Veronika Jagersberger […] “as far as I know my brother-in-law only received Ukrain treatment from his GP in the form of injections.”

GZ 2699606/1-II/BK/31o55 from 29.02.2012 Manuella Hellar p.2 […] “Dr. Blab told me that Nowicky wasn’t a doctor.”

These statements confirm that I never made any claims to be a doctor and there was neither the intention nor an attempt to deceive people.

 

  1. On the accusation that Dr. Nowicky illegally misled people into buying the preparation Ukrain at a price of up to EUR 77 per ampoule

In my statement of 05.09.2012 while in custody I said (and I quote):

-        I always refer patients to the doctor treating them.

-        Under §8 AMG (Medicines Law) I may only give Ukrain to patients with a prescription.

-        From the witness statement of 30 November 2011 by HAGENBÜCHL Stefan, born 13.2.1982: “I know exactly that Dr. NOWICKY was ‘most particular’ that he would not provide the medicament without a prescription…”

-        Yes, patients needed their medical records.

-        The doctors know (on the basis of studies I submitted) that 40 ampoules are necessary for treatment. However, at first I recommend patients to take only 10 ampoules.

 

  1. On the accusation that Dr. Nowicky caused damage

Since Ukrain has demonstrated its effect with the majority of patients without harming healthy cells in the process, there is no damage to health in the use of this medicament in contrast to chemotherapy etc.

The acquisition of Ukrain is a sales contract valid under the general rules of civil law and thereby gives rise to no financial damages.

I have never forced anybody to buy the preparation and in order not to mislead patients into spending their money for nothing I gave the first ampoule as a free sample. If Ukrain showed no effect I said that I could not help and recommended them to seek help elsewhere (see the witness statement of Dr. H. from 28.03.2012).

However, if the effect was felt after taking Ukrain – heat, warmth, tingling etc. – I recommended taking 10 ampoules initially in order not to put a financial burden on people After 10 ampoules it could be seen if the tumour was encapsulated and in that case it is usually recommended to reduce the tumour mass surgically. This increases the chance of eliminating remaining cancer cells with further treatment with UKRAIN.

 

 

FACTS OF THE CASE II

The Public Prosecutor’s Office accuses me of the following:

“On 21.03.2012 in Vienna, Wassyl Nowicky attempted with deliberate intention unjustly to enrich himself through the conduct of the deceived, the decision-makers at the Financial Procurator’s Office.”  

In claims to the Financial Procurator’s Office for compensation for public liability claims resulting from the confiscation of Ukrain ampoules by the Federal Office of Safety in Healthcare, he named as damages an ampoule price of EUR 145 (AS 127, 131 in ON 33/III), and thus attempted to induce the Republic of Austria into damages of over EUR 50,000 through misrepresentation of the facts.”

 

In summary it is the view of the Public Prosecutor’s Office that it is fraud to make a claim for public damages for a specific amount.

The 12th report of the Federal Criminal Office to the Public Prosecutor’s Office AZ: 1 St 24/12 w states:

“During the course of email surveillance invoices from Nowicky Pharma were found in which the price per ampoule was written as follows:

Contribution to costs/ampoule: 70 Euro

Actual value: 165 Euro”

The price of EUR 165 is lower than the price of other chemotherapies.

The costs that I invoice are made up of the following components:

-        48 years of research work

-        chemical components

-        herbal components

-        isolation of the effective substances from the plant

-        staff salaries

-        attending congresses and travelling

-        clinical and preclinical studies

-        operating costs etc.

 

As a businessman am I not free to set my own prices?

UKRAIN is a herbal preparation and it costs more to produce than chemical preparations such as cytostatica.

Another reason to set the price at EUR 145 in my public liability claim (apart with the right under patent law) is the fact that the confiscated ampoules have made further therapeutic successes impossible and thereby also part of my research and there will be no increase in the amount of evidence for the effect of Ukrain.

This circumstance was held against me in the accusation of fraud and was also the main reason for my arrest and a further basis for all measures on the part of the Public Prosecutor’s Office.

 

The Public Prosecutor’s Office listed “individual offences known so far” in the above-mentioned search warrant 1St/24/12w.

 

Point 1:

Anonymous complaint (AS 109ff in ON2/I) to the Federal Minister of Health

Dr. Nowicky’s comment on point 1:

I shall make no comment on individual attacks in the form of an anonymous complaint. It seems altogether dubious to cite an anonymous complaint as grounds for a house search and confiscation.

 

Point 2:

Complaint of Ms O.K. about her brother who died eight years ago.

Dr. Nowicky’s comment on point 2:

The patient S.I.H. had a carcinoma of the right kidney with three metastases in the right lung. The right kidney was surgically removed and after Ukrain treatment the metastases in the right lung were also removed. After using Ukrain he lived for five years, which in comparable cases is only achieved by 5% of patients.  

 

When renal cancer already forms metastases in distant organs (stage IV) only 5% of patients live longer than 5 years (http://www.internisten-im-netz.de/de_nierenkrebs-prognose-verlauf_1074.html). This means that the overwhelming proportion of patients (approx. 95%) with such a diagnosis have only months to live.

 

Point 3:

Telephone surveillance in which I describe a doctor as a criminal who despite the improvement in the patient B.B. during therapy with Ukrain insists on the surgical removal of the prostate.

Dr. Nowicky’s statement on point 3:

After taking Ukrain B.B.’s tumour decreased in size by three quarters. Instead of asking why the patient’s general condition had improved so drastically, the doctor recommended surgical intervention, which runs the risk of incontinence and impotence. After continuing to take Ukrain the patient was completely cured. He continues to enjoy quality of life as a person and a man.

 

Point 4:Dr. Nowicky is accused of making false statements about UKRAIN  to the chief editor of the “Barbara Karlich Show”, namely that Ukrain is registered in Austria, that he has authorisation to produce it and that there is no doubt in Austria about its efficacy and that he pressed him to make this known in the show.

Dr. Nowicky’s comment on point 4:

I told the chief editor of the Barbara Karlich Show, Thomas Hetzmannseder,  that the preparation Ukrain is approved in Austria for clinical studies:

1) an open, controlled clinical study of colonic cancer,

2) a clinical study of malignant melanoma and

3) a clinical study outside hospitals in accordance with §42 of the Medicines Law.

All the results of these studies were submitted to the Ministry of Health.

I also have a production license: MBA 6/7 – Gew 51228/1/88

270 specialist publications substantiate the efficacy of Ukrain and 176 of them can be found at www.pubmed.com.

 

Point 5: A patient questioned as a witness Ms. M.H. said in her witness statement that she saw one of my staff when she arrived. (She does not however mention that the staff member was still there when she wanted to buy Ukrain.)

Dr. Nowicky’s comment on point 5:

The witness M.H., who from a medical point of view was no longer treatable, turned to Dr. Blatt who prescribed Ukrain at her express wish in accordance with §8 AMG. She came to my office after 17.00 and wanted to buy only five ampoules. Because the staff member responsible for invoicing had already left and I was not in a position to write a bill, I told her that she would receive the bill next day when the staff member was in the office.

 

Point 6: Telephone surveillance: Dr. Nowicky is supposed to have given information to a woman named Olga, who he did not know, in relation to her son suffering from epilepsy.

Dr. Nowicky’s comment on point 6:

The complainant O.K. received no Ukrain from me.

However, to my knowledge there have so far been three epilepsy patients who have even been able to obtain a driving license after therapy with Ukrain. This is the medically confirmed cure necessary for such a claim.

 

Point 7: A witness statement by V.B. with information about counselling interviews between Dr. Nowicky, H. and visitors  about feelings of warmth and the urge to urinate.

Dr. Nowicky’s comment on point 7

The former staff member of Nowicky Pharma, Vienna, V.B. who was employed at the company from 1999 until 2011, was the only person who was questioned as a witness. All other staff members, even those who had only been employed for a short time (including the scientific consultant Dr. B.), were questioned as suspects. It is open to question what V.B. did to be made such an exception in the proceedings. 

 

I find outrageous the accusation that family members and staff employed at my pharmaceutical company are “members of a criminal organisation”. This label and allegation has damaged our reputation as a company in several respects.

 

I reserve the right to take legal action against the witness Vassyl Boychuk (born 22.02.1966) for his false statements, defamation and damage to my reputation. As evidence that he did indeed see cured patients I shall request a hearing and witness statements from Ms H. J., Mr S.D., Ms M.K. and Ms C.H. (Contrary to his statement Ms S.T. never refused chemotherapy. – Her doctor was treating her with chemotherapy and forbade her to be treated with UKRAIN. She died during this chemotherapy.) In the company the regulation applies that UKRAIN is only sold upon the submission of a doctor’s prescription defining them as a patient “who has exhausted all other forms of therapy” in accordance with §8 of the Austrian Medicines Act (AMG).

 

Point 8: A “crime story” about Ukrain told by Vassyl Boychuk (born 02.12.1972) in Kiev according to which falsified studies and documents, non-existent registrations and other crass untruths were the reason for registration being granted in Ukraine. Among other things he said that he heard about the nonexistent registration in Austria from the Ukrainian Ministry of Health.

Dr. Nowicky’s comment on point 8:

Vassyl Boychuk worked as a representative of my company in Kiev from 1999 and was dismissed by me in 2004 as a result of unlawful working practices. In this regard criminal proceedings are pending against him at the Kiev prosecutor’s office for fraud and theft.

A study that V.B. refers to had already been carried out and published in 1996.[6] In 1998 registration was granted in Ukraine under No. 3641. V. B. had only been employed at the company from 1999. How could he come to claim that the registration documentation was falsified?

 

The following witnesses are requested to prove that conduct was legal in relation to events at Hospital No. 10 in Kiev: J. S., O. P., Z., Y., K., Y. and K. To prove legality in relation to the study by Prof. Dr. Beger, I request him to be heard as a witness.

 

On the results of tests made by AGES Pharm. Med. for the Federal Office for Safety and Health Care. From the order for house search and confiscation 1 St 24/12w

Partial expert report from AGES PharmMed, AS 319ff in ON 2/1

 

In the directive 1St 24/12w (page 8f) (based on the above-mentioned report) it is alleged that:

  • the individual batches were not homogeneous,
  • the component alkaloid thiophosphoric acid derivate included on some labelling was not contained in the samples,
  • the composition of Ukrain corresponds to that of Choleodoron, which is used for liver and gall bladder diseases and not for cancer.

 

On the individual accusations:

I still do not know with what methods these tests were carried out, although I have asked to be informed of the methods.

On point 1: “The individual batches were not homogeneous.”

Ukrain is produced on the basis of greater celandine (Chelidonium majus L.) alkaloids. Because the alkaloid content in the plant can be different it is impossible to obtain the same sum of alkaloids. The German Pharmacopoeia (6th Edition) therefore recommends that the quality proof of the alkaloid content in greater celandine be calculated according to the proportion of chelidonin.

 

Point 2: “The component alkaloid thiophosphoric acid derivative included on some labelling was not contained in the samples.”

I produce Ukrain from trisphosphine sulfide / alkaloids with thiosphosphoric acid triaziridide (Thiotepa) and from the sum of alkaloids extracted from greater celandine The designation of thiophosphate acid derivatives on the packaging is therefore correct.

On point 2: The report claims that the composition of Ukrain corresponds to that of Choleodoron, which is used for liver and gall bladder diseases and not for cancer.

1.      It is alleged here that the composition of Choleodron and UKRAIN are the same. The composition of UKRAIN is clearly demonstrated under patent law. A first-class company was contracted to check the product. The obligation of proof therefore lies with the expert witnesses as to how they came to such a test result. UKRAIN has a different effect and is also composed differently to Choleodron. Such statements raise questions about the competence of the assessor.

2.      In contrast to UKRAIN, Choleodron cannot accumulate in cancer cells.

 

Concluding question: which of these accusations justifies imprisonment in custody for six weeks and the confiscation of commercial and private property?

 

P.S. More documentation, laws, decrees etc. related to Ukrain can be found on the following websites: www.ukrin.com and www.pubmed.com.

 




[1]    Boyko V. N., Zholus R. B., «A comparative evaluation of the influence of the complex drug Ukrain and its components on the effect of radiation.» Drugs Exptl. Clin. Res., XXIV (5/6), 1998, 331-333.

[2]    Boyko V. N., Voltchek I.V., Petrov A.S., Bubnov V.P., «Action of Ukrain, a cytostatic and Immunomodulating drug, on effects of irradiation»,  Drugs Exptl. Clin. Res., XXII (Suppl.), 1996, 95-100.

[3]    Boyko V. N., Belskiy S.N. «The influence of the novel drug Ukrain on hemo- and immunopoiesis at the time of its Maximum radioactive effect.» Drugs Exptl. Clin. Res., XXIV (5/6), 1998, 335-337.

[4]    Jagiello-Wojtowoczs E., Chodkowska A, Jablonski M, Olchowik G: Serum RANKL in rats treated with Ukrain and simultaneous exposition to ionizing radiation. J Ethnopharmocol, 2007

[5]    Boyko V. N., Levshina Ye. V «A study of the influence of a novel drug Ukrain on in vivo effects of low-dose ionizing radiation.» Drugs Exptl. Clin. Res., XXIV (5/6), 1998, 339-341.

[6]    «Comparison of chemotherapy and x-ray therapy with Ukrain monotherapy for colorectal cancer.» Publishedin DRUGS EXPTL.CLIN.RES XXII (3-4-5) 115-122

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