Correspondence with Dr. Hauer

Dr. Christian Hauer
Schönherr Rechtsanwälte GmbH
Tuchlauben 17
A-1010 Vienna

02.09.2010

Dear Dr. Hauer,

In my letter of 26 August I asked you ten questions. Unfortunately these questions have so far remained unanswered. In addition, I wish to remark on the following.
In your reply of 26 August on page 1 paragraph 2 is stated, “In this regard I must first state that your application of 27.07.1981 was in fact dealt with and concluded with a decision by the responsible ministry (now the Federal Ministry of Health).” I do not know with what decision and when my application was dealt with. Please send me this notification of the decision.
You go on to write: “The expert witnesses called upon by the ministry essentially found fault with the following (whereby I am consciously repeating some of the reasons for their objections or mentioning them several times): the exact composition of Ukrain is not clear and the quality of the ingredients is not sufficiently clarified.”
In fact the ministry additionally appointed only one chemical-pharmaceutical expert witness, namely Dr. Jean-Louis Robert from Luxembourg (a qualified chemist, Chairman of the European Quality Work Group), who made a negative recommendation without studying the documentation.
“Furthermore, the pharmaceutical documentation is incomplete and incomprehensible.”
The pharmaceutical documentation on the preparation Ukrain was drawn up by the well-known Viennese expert Mag. Kurt Vymazal and later adapted in accordance with Good Laboratory Practice and continually updated by LAT Dr. Tittel GmbH (Germany). This documentation is thereby in accordance with the latest state of scientific knowledge and cannot be “incomplete and incomprehensible”. If you are of a different opinion please put this in concrete terms.
In your letter you often repeat that the documentation on Ukrain is not in accordance with the latest scientific knowledge without giving any concrete details. This documentation was drawn up by well-known Austrian and international experts. The real problem lies in the fact that the studies of these experts are accepted at EU level without any problems when they work for other companies but are completely rejected when they write about Ukrain. The Austrian Ministry of Health appointed other expert witnesses such as Dr. Robert, who immediately recommended rejection without having read the documentation on Ukrain. As a chemical-pharmaceutical expert witness he should state precisely which methods would, in his opinion, be most suitable for the characterisation of the Ukrain complex and what is missing in the documentation. However, he did not waste a single word on this and simply recommended that Ukrain should not be approved, which is not part of his task at all.
The second expert witness, Prof. Winkler, whom I rejected for a good reason, confirmed with his report that he is no expert in the field of oncology and was also prejudiced through his lack of objectivity.
You mention doctors’ first-hand reports but forget the recommendations of well-known experts.
It can be pointed out that in 1996 Dr. Walter Knapp comes 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 activity, which could be usefully applied to the successful treatment of malignant diseases. The acute and chronic toxicity of Ukrain is low… The results of pre-clinical investigations document that the preparation is well tolerated and offers a high level of therapeutic safety. An advantageous ratio of activity to side effects can be expected. To date, clinical experience of the use of Ukrain in patients confirms the product to be safe.” (LIV, page 19)
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. (XII, pages 50-51)
In his "Commentary on the Expert Report" in 1998 Harald von Eick recommended "the registration of Ukrain even if also under certain conditions": "Nevertheless I take the view that the data situation is sufficient to grant registration..." (XIII, page 14)
In his clinical expert's report on 16 June 1998 DDr. G. Nahler stated: "…Results of those few controlled trials with Ukrain were consistently better than in control groups. Furthermore, some of the case reports describe treatment effects in patients resistant to any other therapy… Ukrain seems to be better tolerated than other tumour therapies.“ (XIV page 23)
Due to good successes in the treatment of patients with various tumours who had exhausted all other forms of therapy many doctors and scientists found it necessary to inform both the ministries of health and science (VIII) and asked for the interesting results of treatment with Ukrain to be reviewed.
In 1996 Dr. Alois Denk wrote: "It would be medically desirable to continue research the efficacy of Ukrain and with appropriate results it should be allowed to benefit the general public." (IV page 17)
In 1996 Dr. Hubert Denz reported: "In a case of pancreatic cancer we found a temporary regression of the tumour demonstrated by computer tomography... There were only very slight side-effects in the form of a slight feeling of warmth, in general the treatment was excellently tolerated... Well planned clinical studies should be called for which provide a standardised dosage, form of application, duration of therapy and documentation of the results. A Phase II study should be carried out first to evaluate the optimum form of therapy. Application with pancreatic cancer seems to make most sense because the results of chemotherapy are so far very modest and go hand in hand with considerable side-effects for patients who are mostly in any case weakened. In addition there are several positive reports about therapy with Ukrain for this tumour." (IV pages 15-16)
A series of practising Austrian doctors and scientists, who were impressed by the results of treatment with Ukrain, requested the ministry for an accelerated procedure in the approval of Ukrain.
Dr. Siegfried Wagner: "As a continuation of my successful treatment with Ukrain I regard the approval of the drug Ukrain in Austria as extremely desirable." (IV page 5)
Prim. Dr. Hans-Jörg Klein: "I would find the approval of the drug Ukrain by the Federal Ministry extremely desirable." (IV page 7)
Dr. Peter Kadan: "Personally I would very much welcome approval of the drug Ukrain as well as the widespread routine application of Ukrain for tumour diseases, because in my view – after many years of experience with Ukrain – a considerable improvement of the general prognosis ... is to be anticipated." (IV page 9)
Dr. Uta Konstantopoulos confirmed: "A patient with inoperable bile duct cancer + liver metastases was discharged without further therapy after a small surgical intervention (gall bladder drainage) in Feb. 96. Since March 96 we have been injecting Ukrain. The patient is in an excellent general condition and has in the meantime been on a one-week hiking holiday and made two long-distance journeys... In summary I would like to state that Ukrain is excellently tolerated and I have seen a clear positive influence on the course of advanced disease in several patients. Therefore I very much hope that Ukrain will be approved and registered as a medicament as soon as possible." (IV page 19)
Dr. Omar Abu-Dayeh: "During my observations I established that the preparation Ukrain is a real help and a positive supplement to other treatments. Besides the remissions achieved it should be noted that patients feel well during and after treatment and their lives become more worth living. I thereby regard the official registration and approval of Ukrain in Austria as desirable and I endorse it most warmly." (IV page 26)
Dr. Grazyna Nowicki (no relative): "I have been using 'Ukrain' for about 7 years now at my medical practice. The large majority of about 15 patients whom I personally treated were patients for whom all therapy options had failed. They had been given up by conventional medicine and were desperately looking for a last therapy option. It should be mentioned that all of these patients experienced subjective as well as objective improvement of their physical and psychological condition after the first few injections of Ukrain - a fact which I most definitely cannot define as a placebo effect. The patients improved their eating and sleeping habits, reported immense relief from pain - such that the use of strong analgesics was rendered unnecessary in many cases … I enclose 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 the 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 do most urgently recommend early marketing authorisation as well as wide and rapid availability of this highly effective cancer therapy to those who need it." (IV Pages 27-28)
The following questions are raised:
1. Why have you left out these clearly positive recommendations by experts?
2. Why was the Federal Ministry of Health not satisfied with these 6 reports? Mag. Vymazal and LAT Dr. Tittel GmbH demonstrated with their state-of-the-art experimental methods that the exact composition of Ukrain is clearly described and the quality of the ingredients is sufficiently clarified. The methods of proof worked out by LAT Dr. Tittel GmbH guarantee full production quality. Dr. Knapp demonstrated the safety of the preparation through the analysis of the toxicological data and Dr. Duma, Mag. von Eick and Dr. Nahler proved its efficacy with their analyses of the published studies and research results, which you can also see from the enclosed publication “NSC 631570 (Ukrain): Efficacy, Safety and Quality “ (www.ukrin.com/docs/Efficacy2.pdf).
3. The ministry would have had to grant approval on the basis of these 6 reports. The suspicion arises that the ministry intentionally disregarded these reports and brought in the new expert witnesses Dr. Robert and Prof. Winkler in order to have a reason to refuse approval.
Since this is a matter of public interest I shall take the liberty of publishing this letter and your much-appreciated reply on the internet.
Best regards, 

Dr. Wassil Nowicky

Enclosure: NSC 631570 (Ukrain): Efficacy, Safety and Quality

Dr. Christian Hauer
Schönherr Rechtsanwälte GmbH
(Schönherr Attorneys Pvt. Ltd.)
Tuchlauben 17
A-1010 Vienna

Vienna, 18th February 2010

Dear Dr. Hauer,

As Ukrain has been approved in many countries, has received the status of an orphan drug in the USA and Australia, was first presented at the 13th International Congress of Chemotherapy in Vienna (http://www.ukrin.com/docs/13.congress.pdf) and at several renowned international specialists' conventions (http://www.ukrin.com/docs/congresses.pdf), and has also been described in the published medical literature (http://www.ukrin.com/docs/Bibliography_5.doc), it may be prescribed by doctors for their patients, pursuant to §8 (previously §12) AMG (Medicinal Products Law). According to §8 AMG: "Medicinal products require no marketing authorisation if: 1) these (products) are intended to be used for conducting non-clinical or clinical trials or clinical tests, or 2) a doctor, dentist or veterinarian authorised to practice his profession in his country independently certifies that the medicinal product is urgently required to prevent a life-threatening condition or grave health damage and, according to the current level of science, such an outcome cannot be anticipated by the use of an approved and available medicinal product." (http://www.ukrin.com/docs/amg-1994-12.pdf). The law is superior to an official notification. Austria is a constitutional state and a law cannot be negated by an official functionary. Besides, Ukrain is approved in Austria for clinical trials (http://www.ukrin.com/docs/Arrouas_1993.pdf) and, according to §42 AMG, any doctor may use this preparation in his medical practice, even outside of hospitals.
Regarding this type of clinical testing, various oncological diseases encountered in routine practice by urban and rural doctors have been treated with Ukrain. The analytical methods were adjusted to the scope of options available at the office of a general practician and certain limitations of rural areas, especially because many of the patients had undergone previous treatment and a large percentage of them suffered from progressive disease.

About 250 Austrian doctors were involved in these studies.

The results of these studies were continuously presented to the ministry. In their reports the doctors recommended early marketing authorisation for Ukrain (http://www.ukrin.com/de/tatsachen#klinischeanwendungen, http://www.ukrin.com/docs/Gansauge_2002.pdf, http://www.ukrin.com/docs/Gansauge_2007.pdf, http://www.ukrin.com/docs/Susak_1996.pdf, http://www.ukrin.com/docs/Bondar_1998.pdf, http://www.ukrin.com/docs/uglanica_1998.pdf, http://www.ukrin.com/docs/Uglyanica_1996.pdf).

For instance, Dr. Adolf Langer in Vienna said: "I will be glad to present my numerous medically provable cases in which patients owe their survival solely to the effect of UKRAIN. It would appear that UKRAIN is capable of developing several other modes of action by way of improving the entire organism and I am also in a position to prove this scientifically by presenting solid medical data." (IV Page 31)

Dr. Grazyna Nowicki (no relative): "I have been using 'Ukrain' for about 7 years now at my medical practice. The large majority of about 15 patients whom I personally treated were patients in whom all therapy options had failed. They had been given up by conventional medicine and were desperately looking for a last therapy option. It should be mentioned that all of these patients experienced subjective as well as objective improvement of their physical and psychological condition after the first few injections of Ukrain - a fact which I most definitely cannot define as a placebo effect. The patients improved their eating and sleeping habits, reported immense relief from pain - such that the use of strong analgesics was rendered unnecessary in many cases … I enclose 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 the 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 do most urgently recommend early marketing authorisation as well as wide and rapid availability of this highly effective cancer therapy to those who need it." (IV Pages 27-28)

The well known Viennese doctor Dr. Thomas Kroiss wrote the following about his experience with Ukrain: "During my treatment of cancer patients for more than 16 years now, I have been working with the medication Ukrain. In my experience, with Ukrain one is able to treat malignant tumours of small dimensions in a way that they do not recur. I have also experienced that, when treating patients with Ukrain (provided one uses the right dose), no side effects occurred in 99% of cases." (IV Page 5)

The widespread use of Ukrain has led to an increasing number of cures (http://www.ukrin.com/docs/congresses.pdf, http://www.ukrin.com/docs/Bibliography_5.doc, http://www.ukrin.com/docs/Aschoff_2000.pdf, http://www.ukrin.com/docs/Aschhoff_2003_xp.pdf, http://www.ukrin.com/docs/Nowicki_2003.pdf).

We suspect that the officials issued their orders of 25th July 1986 (XVII), later on 25th February 1994 (XVIII), and finally their negative order of 6th August 2009, in order to suppress this evidence.
Instead of granting marketing authorisation as requested by doctors, Austrian doctors have been pressurised by various means with a the intention to compelling them not to use Ukrain.

Some of them, such as Stefan Dan's treating physician, were harassed with criminal charges (XVI), and others with disciplinary proceedings (XV). Many doctors have also distanced themselves from Ukrain and have abandoned patients in whom all treatment options had failed in order to avoid getting into difficulties with official authorities.

The disastrous consequences of these actions for patients are demonstrated in the following case.

As mentioned in the book "Krebsmittel Ukrain, Kriminalgeschichte einer Verhinderung" (The anti-cancer drug Ukrain, a criminal history of prevention) written by Dr. Eleonore Thun-Hohenstein, Molden Publishers http://www.ukrin.com/de/buch, Stefan Dan will remain paralysed for the rest of his life because of illegal actions taken by Austrian health authorities (see Page 7 and ff as well as Page 185 and ff). At a control investigation in the hospital, Stefan Dan's parents were coerced with threat of penalties, with reference to illegal orders of the Health Ministry from 1986 and 1994, to discontinue the treatment prescribed for him by his doctor according to § 12 AMG, although no other therapy option could be offered to him. This is even more incomprehensible in view of the fact that the treatment with Ukrain achieved such a visibly successful effect in a case of a disease that is incurable until the present day (generalised lymphangiomatosis) so that Stefan was even able to ride a bike (http://www.ukrin.com/de/verhinderungstaktik-folgen). If the therapy had been continued Stefan would have fully recovered his health, as in the case of a child with Ewing's sarcoma (http://www.ukrin.com/docs/fallberichte.pdf). Thanks to treatment with Ukrain, this girl is now completely healthy and alive until the present day. Both cases are known to the public through the television.
I do not understand what priorities were involved in this matter.

An application for marketing authorisation for Ukrain was submitted to the Federal Ministry of Health and Environmental Protection on 27th July 1981 (http://cmiskp.echr.coe.int/tkp197/view.asp?item=1&portal=hbkm&action=html&highlight=Nowicky&sessionid=40878743&skin=hudoc-en).

In his letter dated 14th August 1981 the Federal Minister informed me that, in order to obtain marketing authorisation, I need a license to manufacture drugs. I immediately applied for such a license at the office of the official authorities in charge. After seven years, in May 1988, I was granted a license decree (http://www.ukrin.com/docs/Konzession.pdf) which I immediately presented to the Federal Ministry. Thus, all conditions for marketing authorisation according to §8 Line 2 and 3 of the (Medicinal) Speciality Law of 1947 were fulfilled. Yet, even today, nearly 30 years after submission of the application, Ukrain has not received marketing authorisation on illegal grounds, because of supposed violations of procedural law (http://www.ukrin.com/docs/im_namen_der_republik-1996.pdf).

As my lawyer, kindly instruct me as to how I can avail myself of my rights in the constitutional state of Austria. What legal steps should I take in order to achieve marketing authorisation in accordance with the legal situation at the time of submission of the application? This would eliminate the possibility of insurance companies refusing to reimburse the cost of treatment for Ukrain (http://www.ukrin.com/fall-hedwig-jakob). At the same time, it would enable cancer patients to select their treatment on their own (http://www.ukrin.com/de/node/129).

As it is a matter of public interest, I will publish this letter as well as your valuable legal instructions in the Internet.

With best wishes,
Dr. W. Nowicky