Where Can I Find A Mandingo

response to the BfArM 1 March 2006

Federal Institute for Drugs and Medical Devices BfArM

Kurt Georg Kiesinger Allee 3
D - 53175 BONN

your letter dated 21 February 2006 - 11.1.02-3413-141425/05

oil-containing infusion solutions

Dear Dercks-Müller

I thank them for the detailed replies to my letter 28.10.2005. I'm assuming that you answer my letter to the Ministry of Social Affairs of 21 Hessich December 2005, with further remarks on the same subject also exists. Otherwise, I submit to you a copy of this document.

D

he studies my office on "oil-containing infusion solutions for intravenous nutrition patients" were conducted during a single observation of a patient's treatment in a psychiatric hospital in Muenster, because the roads. Even if it is in treating the patient on 21.2.2005 with Intralipid - whose death was found on 22.2.2005 - is a single observation, can be but because the facts do not exclude that similar practices of the treatment personnel were also practiced in other patients. Thus, a fundamental review of working with oil-containing infusion products would be necessary at least in the affected hospital.

own scientific research results that you mentioned sense to the metabolic metabolism and drug effects of fat emulsions for intravenous administration, I have received, since my status no human experiments permitted substances demonstrated that adverse health effects in the past and in the literature was published. is

From manufacturer's site of fat emulsions sometimes pointed out that the original health hazards of the substances was counteracted by the fact that:

• the mixing ratio between the oil component and the carrier by the addition of emulsifiers so influenced was that the blood came into the "oil drop" this could be greatly reduced in diameter and so absorbed by the human metabolism, and that

• originally used (harmful) substances by emulsifiers (egg lecithin, alpha-tocopherol) were replaced in the human body would occur naturally in human blood and also better tolerated.

contrast, however, gave in 1950 by LeVeen et. al. Studies carried out, that "all the investigated synthetic surface tension-reducing agents" simply because of their surface tension-reducing effect of a hemolytic effect of exercise on the blood, ie, both blood plasma and blood cells would impair their integrity (Blood clotting disorders). This would - as a physical or chemical principle - are in my opinion, mutatis mutandis, to the body's own surface tension-reducing substances. (See: Le Veen, H. Papp, G. Restuccia, M., Mulholland, J. (1950): Problems in the intravenous administration of synthetic and natural fats for nutritional purposes The American. Journal of Digestive Diseases, Vol 17, No.1, p. 20-24).

The underlying my argument based on facts from scientific publications for the years 1950-1962 Effect of the drugs and ABBOLIPID LIPOMUL. The information I relied on objections to an intravenous infusion of oily substances based on a plausibility check between the initial scientific findings on the effect of oil-containing infusion solutions in the human circulatory system (blood emboli, organ embolism), the single observation of an apparently not the application requirements of the producers of the product administration to 21.2. 2005, the manufacturer and an informal comparison with respect to anonymous hospital staff in routine clinical practice, conventional administration.

My alleged Objections to both as a risk analysis on "false" or "erroneous" product applications are evaluated, other than a scientific basis for the compilation of legal assessment of the deaths of the hospital patient who died on 22.2.2005.

U

aking into account the interventions in this context, the public prosecutor's investigation (81 UJS 41441/05 TE Limburg) I can here only about the relationships I know of medical information provided in connection with the treatment of patient present:

1. The 87-year-old woman was on 11/02/2005 due to "hand pain" referred by their doctor to observe the local psychiatric hospital. According to employees of the practice of family doctors was "a swollen hand is often a sign of notifying stroke.

2. After several days' stay on Normal Station 2 "was the patient on Monday, 02/14/2005 occurring because of a" coma "in the intensive care unit (stroke, acute ward / 3) of the Hospital laid.

3. During her treatment in the ICU of the hospital to feed the patient was on a feeding tube. Intravenously it was during this time the drug ZIENAM administered.

4. on 21.2.2005, ie after 7 - day stay in intensive care, the transfer of the patient was on ward 3 at approximately 17:00 pm.

5. At 18.30 on the drug board members observed the patient of a 250ml syringe filling administered by gavage for nutrient solutions. This contained a whitish creamy substance and was labeled by hand with "Intralipid". Unaware of the effect of this drug and the application of rules, the members present at a hospital staff does not oppose the administration of this substance.

6. the occasion, according to hospital staff about 7 hours later the patient reported deaths of more extensive investigations were initiated on the administered substance that led to the conclusion that even in the 50 years, numerous Deaths of hospital patients after intravenous administration of similar composition agents were detected. Causes of death were there mostly blood emboli, probably by the infusion solutions mixed in emulsifiers were produced.

7. Apart from the aspect of the cited in the literature, adverse health effects of elevated amounts of fat in the blood was in the present case by the siphoning of the manufacturer in sterile dropper bottles that came with Mengendosimetern original packaging of Intralipid into a 250 ml syringe fatal application error before.

8. First, by transferring the substance to be administered intravenously, the sterility of the same is no longer guaranteed.

9. Second, joined the administration of the fat solution by syringe almost necessarily a blood embolism, because the person administering may not be able to provide the necessary slow Eintropfgeschwindigkeit the solution into the bloodstream, since they do several hours sitting next to the patient and this should be administered according to slow the drug.

10. handetikettierten The appearance of an injection syringe on the drug board also suggests that it is practiced in the form of administration is not a single error but a frequently practiced procedure.

In my view, these facts are sufficient to inform you as a supervising authority over the apparent misuse of the drug Intralipid (Baxter), in particular because neither be excluded that it is the here presented treatment of the patient in February 2005 not a single mistake that not even acted as oil infusions other manufacturers are subject to just such misuse.

principle and independent of the above-described case of the patient's treatment, the organization I represent or my office line of argument can be about the fat emulsion applications defined as follows:

• The effect of fat emulsions on human blood at example was the product LIPOMUL in literature 1950-1962 thoroughly discussed and described.

• It is assumed that fat emulsions for intravenous administration (with can cause dose-and infusion rate dependent constraints) to blood or organ embolisms ().

• An application of these substances to induce death in patients in whom there is no hope of cure may be the subject of theoretical, medical-ethical discussions.

• Because of the fundamental nature of such discussions must be conducted openly and with clear designation of meaning, object and purpose of the use of "death inducing substances." A "Umdeklaration" appropriate funding as "nutrient solutions" is not acceptable because in clinical practice on the one hand, the "failure to designate" the question of "euthanasia" and the other, the false designation of the death inducing agent to a slow habituation process in "SHUT DOWN" leads to a routinemäßgen handling of the staff involved with have the use of killing agents to follow. This can lead to situations (see above) in which "euthanasia" practiced in patients whose health status is not assessed as hopelessly.

• further offer to the existence of hospital departments, that is not least for historical reasons grown reputation to lead patients from the life that is not medically trained vicinity of such stations the opportunity to push unpopular person there to make it as supplying a process-termination mechanism. For this purpose, I refer you in particular to the publication of Vanja, C., et. al (1997) 100 Jahre hospital Weilmünster, published by Landeswohlfahrtsverband Hessen / Kassel, and herein to the article by Sandner, P., passages of text on page 148 .

If I find in my literature searches further critical arguments on the subject, I'll let you know, of course.

Sincerely

Biol Peter Zanger
Research Director CID / CID-Verlag
Weilmünster, Wednesday, 1 March 2006