Why a clinical study is missing
Looking back to the positive results of his experiments on himself and others on MS diseased doctors, a small group of patients were tested over a period of 3 months as to the postulate effect of Lactulose.
Following this was the employment of a forerunner product of the AEN.
Additionally, through Kluge, a chronological parameter of 32 patients was drawn up to optimize the therapy.
With the results of this therapeutic work from Kluge and the sufficient confirmation of the working hypothesis the then informal working group applied to the Federal ministry for Research and Technology asking for the support of a project for a clinical study of MS. After a processing time of about three quarters of a year and continuous supplementary supportive literature the proposal for the project was turned down on reasons that those sorts of jobs should be realised by the industry in Germany. After this, for us very astonishing statement, in 1997, under cooperation with the Permselect ltd., two experiments were undertaken in regard of and inclusion of clinical experts to accomplish a controlled clinical study. The second test with the Maternus Clinic in Bad Oeynhausen / Germany began very successfully. With the written assessment of the clinic at the end of 1997 there were already, after a few weeks, over 80% of the patients where a distrinct improvement was ascertained. Despite this positive tendency the co-operation through the Maternus clinic on the 14.2.1998 was terminated.
This act of procedure was for Permselect Ltd., who was the contract partner of the Maternus clinic, of utmost seriousness. Patients, who had wanted, despite everything, to carry on with the therapy could only do this as out-patients. At the same time, through us, a working cooperation with the German MS Association was sought after.
The German MS Association (DMSG) developed, however, an ever increasing rejection of the Kluge therapy which was underlined especially through the publication of polemic articles in the association’s magazine “Aktiv”.
As well as a reduction of the quality of life through the upholding of certain rules, the Kluge therapy was also accused of a “lack of natural scientific foundation……” [1]
through the scientific committee of DMSG accusations arose and patients were warned of the Kluge therapy.
The DMSG itself demanded a clinical study with a comparative control group, but it was not prepared to support such study. Should this really be left to the GSGN, an honorary working committee consisting of 9 people? This was our interpretation of a reply from the chairman of the committee of DMSG to Mr. Dr. R. Kluge (1998). We abstained from polemics and think that the success of our therapy speaks for itself.
The political health concept of the Federal Government’s Minister of Health, Mrs. Fischer, in those days, placed great importance on lowering costs and increasing efficiency and underlined this view repeatedly in public. This was, at that time (2000) the one before last attempt of the GSGN to secure public funds for a clinical study. In a letter to the Federal Health Minister we informed her of the fundamental advantages of the Kluge therapy, its modest financial expenditure and its practical freedom from side effects as well as its deployment range. In a written reply from the ministry we were informed that they had no financial means for our demands of independent examinations through a neurological specialist clinic and that we should therefore apply to BMFB, because it was a case for pure research.
In order not to give preferential treatment to any political party direction, we wrote at the same time identical letters to the chairman of the Political Health Committee of the German Federal Government. They preferred not to reply.
To be fair the MSK, which is also a society for MS patients, has to be mentioned. This society is more open towards new therapies. They asked for an article for their club’s magazine, which we supplied[2].
M.S.K. e.V. Blickpunkt I/00, Seite 26-27