E-DRUG: Quality of Helm drugs

E-drug: Quality of Helm drugs
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It was discussed in e-drug a few month ago that there are doubts
about the quality of drugs supplied by the German company Helm.
Now there is new evidence that these doubts are justified and the
public prosecutor is investigating the case.

Helm, a questionable low price supplier of drugs

The company Helm is based in Hamburg, Germany and has more than
35 subsidiaries around the globe. Its total turnover has been 6
Billion DM in 1996 (approx. 3,5 Billion US$). Helm is mainly a
trader but also owns manufacturing plants like Rotexemedica
(Germany), a 30% share of Sinochem (China) and at least one unit
in India.

Some former employees of Helm have recently alarmed the press
about potentially health hazardous practices of the company and
presented many internal documents that proof widespread
manipulations. (Hamburger Rundschau 29 May and 5 June 1997)

Among those were:
Changing the origin of pharmaceutical substances: In 1995 at
least three batches of Trimethoprim BP93 from Korea and
Sulfamethoxazole BP88 from India the origin was neutralised i.e.
the batch numbers were cut out and replaced with new labels with
the origin China.

Bad quality: In 1994 two batches with damaged and wet packages
which were sent back to Helm ere simply repacked and sent off
again.

Extending shelf life: A batch of Sulfamethoxazole from India with
the label use before November 1996 were re-labeled with 10/98

Untidy practices: In some cases pharmaceutical substances like
rifampicine and Vitamin E were re-filled in new containers in the
outside without any safety precautions.

Manipulating labels to save duties: In a container with 248 drums
of pharmaceuticals all were labelled as paracetamol, although
only 42 really contained this substances and the rest consited of
13 other and more expensive substances. The Hamburger Rundschau
estimates that Helm saved about 180.000 US$ of export duties with
this single container.

Helm has established a pro-forma laboratory to fulfill certain
requirements but did not hire a pharmacist to run it.

Helm has also been involved by suppling diethyleneglycole instead
of glycerine to a Haitian company which resulted in the death of
88 Children in Haiti in spring 1996.

If you have additional evidence on spurious Helm drugs please
inform us. Please indicate if the information is confidental and
can only be used on this basis for the legal case.

Jorg Schaaber

BUKO Pharma-Kampagne,
August-Bebel-Str. 62,
D-33607 Bielefeld, Germany
Tel. +49-521-60550
Fax +49-521-63789
Email 100270.272@compuserve.com

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