Letter to Dr. Hauer

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