Poisoned glycerine sold in Haiti
Some might well remember the glycerine-case in Haiti. This case hit the
press middle of 1996 quite extensively. Di-ethylene-glycol glycerine was
exported from China through Holland and Germany to Haiti, where it caused
death of at least 60 small children (the glycerine was used for
paracetamol-syrup). This e-mail message about the glycerine is to update
'e-druggers' interested in this topic and to inform others, because last
weeks again Dutch and German media paid a lot of attention to this case.
Recent media attention in the Netherlands and Germany
At February 9, 1997, the Dutch NRC Handelsblad opened the Saturday-newspaper
with 'Bedrijf betrokken bij giftig medicijn' [Company involved with poisoned
drug]. The headlines were followed by a whole-page article reconstructing
the trade with the di-ethylene-glycerine. The article was mainly based on a
recent FDA-report which proves that the Dutch chemical company Vos BV (a
daughter of Helm AG, Hamburg, Germany) was more involved than assumed
beforehand.
One and a half week later German television aired a 45 minutes documentary
called 'Todliche Medizin' [Deadly medicine]. This documentary on 'poisoned'
medicines started with the Haitian case, but also paid attention to a case
of Boehringer Mannheim in India, and in Germany itself (this time not
poisoned but counterfeited). At February 27 the German week-magazine Der
Stern published an article on counterfeited medicines. The
television-documentary-part on Haiti was shown on Dutch television one week
later and led to other articles in the press, and to questions in the Dutch
parliament.
Reconstruction
Hereunder the reconstruction of the trade with the two shipments (1 and 2)
of poisoned glycerine:
1. Production of glycerine(1 and 2) in China by a company called Anli
Chemical Industry, unknown location somewhere in China; sale to the company
Sinochem Beijing.
2. November 1994(1) and May 1995(2): Sale of the barrels of glycerine to Vos
BV in Alphen, the Netherlands, through Metall Chemie, Hamburg, Holland.
3. November 1994(1) and May 1995(2): Shipment of barrels from China to
Rotterdam harbour.
4. February 1995(1): sale of glycerine from Vos BV to CTC, Hamburg, Germany.
5. February 1995(1): sale of glycerine from CTC to Pharval, Port-au-Prince,
Haiti.
6. February 1995(1): shipment of glycerine from Rotterdam harbour to company
Pharval, Haiti.
7. It is not known where the second shipment of glycerine(2) was sold.
The barrels of glycerine(1) were stored in Rotterdam harbour for several
months, in which period Vos BV could have had a chance to test the
glycerine. The certificates for the glycerine changed owners several times,
each time the certificates were copied to a new header of the next company.
On the certificates contents were changed, the certificates contained no
signatures, stamps, neither batch-numbers. On the other hand it was clear
that the glycerine was meant to be used for medicinal use, on the
etiquette's on the barrels was noted: GLYCERINE 98 PCT USP.
Follow-up
American lawyers, in co-operation with a Dutch and a German lawyer, work on
this case in order to compensate the Haitian company, and the Haitian
parents whose children died form the poisoned glycerine. In the last half of
last year there have been no results for these lawyers. The reasons for
this: unclarity on who is responsible for the death, unclarity on the trade
of the glycerine, unclear laws or no laws at all. In the Netherlands this
case resulted in parliamentary questions to the Minister of Health three
times already. Each time the answers were unsatisfactory. The last round of
questions focused on why the Ministry of Justice didn't prosecute Vos BV,
and on new guidelines for quality control of raw materials for medicines. In
the Dutch ministry of health there are plans for proposing new guidelines
for quality control of raw materials for medicinal use.
General analysis
These tragedies keep on repeating itself over and over. These are clear
examples of the consequences of uncontrolled commerce. When the involved
companies were aware of what they were doing, which still remains to be
proven, this is the most cruel form of organised criminality. And it this is
all possible through lack of control on the quality of raw materials for
medicinal use.
Of course the Haitian company, Pharval, should have tested the glycerine.
But in this case, like in many other cases, the company was relying on the
etiquette coming from the Dutch company. Made in Europe
equals quality, was the reasoning. The most important problem is that
companies in developing problems have many difficulties in testing. There is
a great lack of reliable information on the quality and the operation of
medicines.
Solutions
The main principle for solutions is that not only the substance is exported,
but is accompanied by reliable and independent information. Solutions should
be kept simple and cheap and are possible on both sides of the trade-line.
For the buyer in developing countries it should be made easy and affordable
to acquire independent and reliable laboratory tests locally. On the
exporting side it is necessary to enforce legislative measures for raw
materials which are used for medicinal purposes. Our proposal is to apply
the WHO certification scheme on the raw materials as well, and at the same
time enhancing the scheme itself by increased attention by inspectorates and
customs.
Interested?
Please contact me if you're interested to know more. I'm interested in
getting into contact with people who:
- have experienced, or know, other examples which underline the need for action.
- have other suggestions for solutions as mentioned above, and can support
me in further elaborating these concepts for solution.
Best greetings from Amsterdam,
Mark Raijmakers
Co-ordinator Programme on Pharmaceuticals
Wemos Foundation
P.O. Box 1693
1000 BR Amsterdam
The Netherlands
TEL +31-20-420.22.22
FAX +31-20-620.50.94
E-mail: wemos@antenna.nl (work)
E-mail: markadam@worldonline.nl (private)
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