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The Dutch company VOS BV has been accused of criminal negligence by
Dutch authorities for its role in the glycerine scandal in which at
least sixty Haitian children died in 1995. Officials now charge that
the company knew it sold glycerine not suitable for use in medicine
but concealed the fact from the Haitian pharmaceutical company which
later processed the raw material into fever reducing paracetamol
syrup.
Until recently, the company Vos, denied that it had any knowledge of
the glycerine's impurity. They declared that it had not been tested.
However, a Dutch newspaper revealed this week that the company knew
the glycerine did not meet standards for pharmaceutical use when it
was sold for medical use. The paper found evidence that a sample of
the glycerine was sent to a Dutch laboratory before the raw material
was shipped to the recipient in Haiti. Although the test results
showed that the glycerine was not suitable for pharmaceutical use, the
raw material was still sold, via a German company, with a
pharmaceutical quality certificate. While there was adequate time to
alert the Haitian pharmaceutical company which ordered the material,
no warning was sent.
After the deaths of dozens of children, the Haitian government
requested help from the US Food and Drugs Administration to discover
the origin of the glycerine. FDA officials visited a number of
countries to trace the raw material's origins. It was later determined
that the glycerine had originated in China, though the FDA has not
been able to identify its producer. The FDA report found that the
glycerine had been mixed with antifreeze, diethylene glycol. In high
doses, this chemical is fatal to children.
When questioned by the Dutch Public Health Service and the US FDA
about the incident last year, the chemical company, Vos BV, denied
that the glycerine had been tested by a laboratory before shipment.
However, documents from the SGS Laboratory which has carried out
testing for Vos for years show that a sample of the glycerine was
tested in February 1995.
According to a copy of the test report obtained by the newspaper, the
glycerine only had a purity of 53.9%. For pharmaceutical use, it must
meet a standard of 95%. However, the company pasted labels on the
barrels of glycerine bearing the certificate "GLYCERINE 98 PCT USP".
The designation USP (United States Pharmacopia) is an internationally
recognised qualification for processing in the pharmaceutical
industry.
Dutch legal experts predict that some Vos employees may be facing
severe criminal sentences if found guilty. A number of attorneys
representing the families of children who were injured by the
glycerine have filed suit against Vos and its parent company, German
company Helm AG. At present, Vos continues to deny all allegations.
All information requests are sent through to its parent company, the
German company Helm.
According to newspaper reports, Helm's reputation is not spotless. A
few month ago, a group of former employees charged the company with
criminal practices. They claim that in 1994 a shipment of water
damaged pharmaceuticals that were returned to Helm were simply
repackaged and resent, among other charges.
The criminal investigation is expected to last a few weeks.
This case illustrates the lack of controls currently regulating the
trade in raw materials. At present, only the quality of
pharmaceuticals can be regulated. In response to this tragedy and
others like it that occurred in recent years, the WHO has called for
stricter controls in the global trade of raw materials.