[Pharm-policy] bad blood

[Wilbert Bannenberg]

Attached the Bad Blood story as published by Stern 26 October 2000.
Copied as fair use.

-----
[Stern Magazin, Germany, 26 October 2000; translation by Stern;
www.stern.de/magazin]

Bad Blood


Regardless of a contamination with HIV, hepatitis or bacteria unscrupulou=
s
pharma-dealers trade their dangerous goods worldwide. The victims are
numerous: up to 30.000 people per year are affected by risky blood-produc=
ts
of African origin.

Fikile Ncube has a damned dangerous job: She's a prostitute. She works th=
e
streets of Harare, the capital of Zimbabwe. Over one fourth of the adult
population in Zimbabwe is HIV-positive. In no other country has such a
large proportion of the population been infected with the AIDS virus. And=

in Harare, the rate of infection is the highest. =

The women who earn their livelihoods with sex on these streets are expose=
d
to the highest risk of infection - no one in the world is more at risk th=
an
these women. =


Fikile Ncube, the prostitute from Harare, donates blood regularly. =

Today her friend Tawona Khosa isn't coming along. She's still too
weak after having given birth to a baby a month ago. Her second
child. Again, the father is a john. "But normally we don't do anything
without a condom", claims Fikile Ncube. As always, she assures the
nurses who go through a questionnaire with her that she does not
have more than one sex partner. As always, they believe her. Fikile
Ncube has been donating blood since 1994. Back then she was a
schoolgirl and began accompanying white foreigners to their hotel
rooms. Sometimes they asked for a blood test. That's why Fikile
Ncube became a blood donor at the National Blood Transfusion
Center. A blood donor card is worth a lot to a john. =


Every time blood is donated, one half liter of blood flows through a
hose into a plastic bag - a very dangerous liquid considering that not
only AIDS, but also Malaria and Hepatitis are extraordinarily
widespread in Zimbabwe. Up to 70 such plastic bags are harvested
per day from one single collection point. The semi-private National
Blood Transfusion Service is one of the few well-organized institutions
in Zimbabwe, which even the WHO (World Health Organization)
considers a model for other poor countries. And it's a lucrative
business, too. Blood donation busses criss-cross the country,
drawing immense quantities of blood, amounting to 80,000 liters per
year. The collectors separate the red blood cells from the plasma.
The red blood cells are used by Zimbabwe's hospitals for surgery. The
plasma is used in the pharmaceutical industry as raw material in the
production of medicine. The only catch is that in Zimbabwe, there is
no blood derivatives industry. =


Vija Sai (name has been changed) is 46 years old. Up until 3 years
ago, he was a successful businessman in Hyderabad, the owner of
three small factories which produced agricultural machinery parts.
That's about 7,000 air kilometers from Zimbabwe, in another country,
on another continent. Hyderabad has a population of eight million and
is in the middle of India. Vija Sai has never been to Africa. And yet,
his destiny is tightly interwoven with this far-off land. "Vija was a
strong man", says his wife, Mary Elizabeth. "He worked 365 days a
year for both the company and his family." Now he's collapsed in a
chair as if he'd just crossed the finish line of a triathlon, when in fac=
t
he, with the help of his children, only dragged himself from the dining
room into the living room. =


The life of the factory-owner Vija Sai changed on August 7, 1997. " I
hadn't been feeling well for days. My wife urged me to go to the
hospital here in Hyderabad, to New Citi Hospital." A needle was stuck
into the patient's left arm. A transparent liquid trickled into his veins=
.
"My arm started to itch incredibly after only a few minutes." Sai tore
the tube from his arm. He started shivering and fainted. It took the
doctors ten hours to stabilize his condition. Vija Sai left the hospital =
a
sick man after just one week. He had to sell his factories; his wife
sold all of her jewelry. Soon his children will have to provide for him. =


In India, even rich patients such as Sai was before he was treated,
don't really have a chance of proving that their doctors or the hospitals=

are at fault. The Sai family fought for three years, if not for
compensation, then at least for an explanation regarding Vija Sai
sufferings - to no avail. It wasn't until the family read an article in
their
local newspaper, the Deccan Chronicle, that they began to
understand. In the article, stern asked the readers of Hyderabad for
help in the investigation of a pharmaceutical scandal. Stern was also
looking for a woman named Surinder Kaur. "You mentioned the name
of a medication in this article: Albupan. When I read that, things
began to fall into place", said Vija Sai. "I swear that Albupan was
what they had injected back then."

Yet, not even Vija Sai knows anything about
Surinder Kaur. Where is Surinder Kaur? =


It was her case that brought stern to India.
The contents of a fax were leaked to the
magazine in which her name is mentioned.
A very unusual fax. The sender is Dr. Jagan
Mohan Reddy, a doctor at the Apollo
Hospital in Hyderabad. The Apollo is a very
expensive private hospital. The recipient of
the fax is the sales representative of
"Panacea Biotech" in Hyderabad, one of the
largest pharmaceutical firms in India.
Albupan was one of Panacea Biotech's most successful products in
the 1990's. Reddy sent the following hand-written fax on September
16, 1996: " My patient, Mrs. Surinder Kaur, was injected Albupan
20% 100ml bottle (bottle no 99503) on 16/9/96. She developed severe
chills & hypotension (sic reduced blood pressure) when it was infused
and on examination of the bottle it was found to have black particles
floating in it." The same medication injected into Vija Sai, the same
reactions. How is Surinder Kaur doing today? =


In the meantime, Dr. Reddy has been promoted to head of the
gastroenterology department at the Apollo Hospital. " I cannot
remember such a case," says Reddy. The shivering, the black
particles, the fax - all forgotten? Reddy studied medicine in England
and knows what his western colleagues face when they are made
liable for a mistake. " That would be inconceivable here. According to
Hindu tradition, a corpse has to be burned after 12 hours. Thus all
evidence is destroyed." Then he laughs. "And the Surinder Kaur case
will be very, very difficult to investigate." There must at least be
patient records at the hospital. "Sorry", says the director of the
hospital, "we don't have any records for a Surinder Kaur here." Her
whereabouts remain a mystery. There are many indications that she
has died. =


The problems with this medication were no secret to the doctors of
Hyderabad. The nephrologist Dr. C.M. Habibulla of the Gandhi
Hospital, which is one of the three largest hospital in the city, talks
openly because he is retired now: "Yes, it's true: we had many
problems with Albupan. Many, many people died." =


During the 90's, the Indian firm Panacea Biotech sold Albumin
products under the trade name Albupan. Albumin is a protein found in
blood. In the form of medication, it is given to patients to stabilize
their circulation - an important standard treatment administered in
many hospitals. But Panacea was not the manufacturer of the
compound. The labels of the 100 ml bottles read: Manufactured:
Albovina GmbH, Austria, Distribution excl. Albugam AG, Switzerland.

Blood trade is a global business. The red gold is no different from any
other commodity in that the raw material is extracted from poor
countries. Rich industrial nations then process the material and sell
the finished products at a higher price. The path of the plasma which
is the base material for the medication that was injected into the veins
of Surinder Kaur and Vija Sai was a long one and one of many. Stern
retraced one of these blood paths. One such path started in
Zimbabwe, in the "National Blood Transfusion Service" (NBTS) with
low-risk donors but also with prostitutes like Fikile Ncube. From
there, the blood was taken through South Africa, Switzerland and
Austria and finally to India. In Hyderabad alone, hundreds of patients
were treated with this dangerous compound. At least 47,000 doses of
the maleficent cure were delivered to the Indian subcontinent. Yet
India was only one of many recipients. From Vienna, Zurich or Paris
the contaminated blood products were disseminated into many parts
of the world, namely to China, South America, Turkey and various
African countries. =


We will never be able to conclusively determine how many patients
have been harmed by this global blood scam. According to company
documents made available to stern, at least one tone of albumin was
produced from plasma originating from dubious sources. At least
80,0000 vials were filled and sold. "Each unit represents an extreme
health risk for the recipient," says Gottfried Kollmann, an
internationally recognized expert on blood derivatives who reviewed
the case on behalf of stern. On average, two to three doses were
administered to patients in developing countries. Everything indicates
that the medication was actually administered. It is thus to be
assumed that globally, the gigantic sum of 30,000 people was treated
with this highly dangerous substance. One of the largest
pharmaceutical scandals in history. =


Neither the guardians of the WHO in Geneva nor the health ministry
officials in the affected countries ever noticed anything. Victims are
only bewailed in countries where patients can not defend themselves
against pharmaceutical corporations, or where lawsuits against
doctors are hopeless or are not even admitted by the courts. The
blood dealers counted on and abused the weakness of their possible
victims. The blood path efficiently followed the weak points of
governmental inspection points. =


Who are the blood pushers? They operated their network from the
world's upper crust neighborhoods. They helped themselves to blood
not only from southern African countries but also from other dubious
suppliers who peddled questionable stuff - old stock or plasma that
had already been rejected by reputable customers - onto the market
at cheap prices. To pull this deal off, a well-versed team was formed
in which each player had his field of expertise. =


Mike Archer from Durban, South Africa, procured raw material. He
owned a number of firms in South Africa. Wolf Brandenberger from
Zurich and the American Joe Schulman were in charge of global
sales. Wolf Brandenberger's companies are: "Wolf Brandenberger
Resources AG" (WBAG Resources) and "Albugam AG". Schulman
operated through the company "Atlantic Business Organization" in
San Diego. Procurement and Sales were thus taken care of. Now the
trio required a producer who would process the plasma. Franz Dachs
from Gallneukirchen, an Austrian Village in a valley near Linz, was
licensed by and registered with the Austrian Health Authorities for the
production of blood derivatives. His company was Albovina GmbH.
The four had known each other for decades and had worked together
from time to time in different formations and under various company
names. All four had notorious reputations in the blood trade business.
The Swiss publication Schweizer Illustrierte had already warned the
public about the head honcho, Wolf Brandenberger in 1975. He had
offered a journalist purporting to be a plasma buyer an "older stock for
half of the price." The "stock's" shelf life had expired years ago. But
the African blood was doubtlessly their deadliest coup. =


It all started in the 70's. The countries in southern Africa organized
blood transfusion centers in order to secure sufficient reserves for
their wars and civil uprisings. As it is normal around the world, the
plasma was separated from the red blood cells. The red blood cells
can be used for a maximum of 35 days. In order to be prepared for
emergencies, the supply therefor needed to be refreshed
continuously. The separated yellow plasma, however, has a shelf life
of one year when it is kept at a temperature of -25C. Thus, these
African countries were producing lakes of plasma. =


For the pharmaceutical industries in rich countries, plasma is the raw
material for many types of medication. It needs to be fractionated,
that is fragmented into its components. Of particular importance are
both the coagulants from which medication for hemophiliacs are
manufactured and Albumin which is used to stabilize blood
circulation. This is what makes plasma a valuable commodity. The
current price for a liter of plasma is about 170 German Marks. =


Southern African countries started to make money with their waste
product. The sale was regulated for everybody by the "Natal Blood
Transfusion Service", a non-profit organization in Durban. And that is
exactly where Mike Archer, the "supplier" of the gang, worked for
almost 30 years as head of international marketing. =


Once the danger of AIDS was recognized in the 80's, nobody wanted
to buy plasma from Africa. Most countries outlawed these imports.
Soon, the blood pushers from South Africa found themselves with an
ever increasing supply of plasma and ever decreasing bank account
balances. That's when they conceived their plan: They forged the
documentation for and the labels on the plasma containers. And thus
human plasma became "bovine plasma". The advantage in doing this?
Importing animal products is quite simply less stringently regulated.
But soon their cover was blown in Belgium, and one of the partners
received a one-year prison sentence.

 Europe had become too risky a market for
 them. They stuck to the relabeling swindle,
 albeit in a more sophisticated form. In 1995,
 Mike Archer trans-shipped plasma to Wolf
 Brandenberger in Zurich via Guernsey Island
 in the Channel. The documents and labels
 now read: "For Diagnostic Use Only". In
 contrast to therapeutic plasma, diagnostic
 plasma is only used for scientific purposes
 and not for the treatment of patients. As with
 bovine plasma, diagnostic plasma is not
 subjected to restrictive import regulations-
 hence the old labeling trick. =


Brandenberger passed them on to Franz Dachs' company, to
"Albovina" in Gallneukirchen near Linz. Franz Dachs, the
manufacturer, had a license to produce blood products without which
he would not have been able to obtain legal certification of tests as
well as for the quality and origin of the compound. And without these
certifications, the sham would not have been possible. =


Dachs did not dirty his hands with the dangerous slush and left its
processing, the fractionation, to small pharmaceutical shops in
Lithuania, Bratislava or in Zagreb. These shops did not question which
research facilities might be using thousands of liters of diagnostic
material when mere drops are sufficient for experimental purposes -
the global diagnostic plasma market is minuscule. =


For the American blood peddler Joe Schulman, Dachs was also of
decisive importance. On July 7, 1995 Schulman wrote Dachs: "New
business: We have the possibility to export to China 10,000 vials of
20% 50 ml per month, but we need some kind of registration. Can we
use the certificate from Austria you have sent in March?" =


The fractionated plasma went to its next stop, to the Israeli "Bio-Lab
Company", which produced the final product. Nobody had any
illusions as to the quality of the goods. In a fax sent from Dachs, the
Austrian, to Wolf Brandenberger AG, he very openly states:" It is
clear, and that is known to all partners, that the original plasma does
not comply with international requirements." There must have been a
further glitch because the Israelis noted in a fax to Franz Dachs, that
the supplied material was "very, very pyrogenic", that is highly
bacteriologically contaminated. If something like this ends up in a
human's circulatory system, the body reacts with fever, chills and
dramatic circulatory shocks - the symptoms from which Vija Sai and
Surinder Kaur had been suffering. =


Reputable pharmaceutical companies destroy pyrogenic plasma
products immediately. Bio-Lab in Israel nevertheless attempted to
save the harmful plasma, to de-pyrogenize it. After their ethically
questionable process, the fraudsters at Bio-Lab disregarded the most
basic hygiene measures during bottling. Therefore, they did not notice
that old dirt had charred inside the vials during their sterilization
process. The solution was filled into these commercial 50-milliliter
vials, which are used for normal medication. Black particles now
floated in the final injectionable solution. It is in this condition that=

they sent the end product to their customer, Franz Dachs in Austria. =


Diagnostic material in vials from Israel with black particles in it?
Trying to trick the Austrian customs agents with that a second time
was too dangerous even for Franz Dachs. That's why he left it in cool
storage in the duty-free zone of Vienna airport- outside of Austrian
territory. Now he could take all the time in the world to forge the
necessary documents: His license allowed him to issue certificates
that documented results of comprehensive testing. The only problem
is that that these tests never took place. With certificates of origin
taken from his bottom drawer, he turned African plasma material into
Austrian products. And so the diagnostic material had become
medication. Since it purported to be made in an EU-country, it was of
particular value. 100 ml of Albumin cost around 100 US Dollars in the
global market. Mike Archer had bought the plasma for 25 US Dollars
per liter. A value increase of nearly 400 percent. =


Wolf Brandenberger's job was to sell the goods all over the world. But
now it was officially medication for people. International WHO
regulations demand a complete documentation of each and every
blood donation. This regulation includes details such as the donor
number, day and place of donation as well as the signature of the
quality inspector who attests to the proper handling of the donation. In
addition, each donation needs to be tested for HIV and Hepatitis. =


All of this precision is necessary because medication made out of
blood is injected directly into the bloodstream. The bloodstream is
where the human organism is most vulnerable. The slightest
contamination can be lethal. It is for this reason that serious
pharmaceutical companies have a zero-tolerance policy where their
blood derivative products are concerned. The least doubt in origin or
quality results in immediate destruction of the material, even if no
objections have been raised. As a safety measure, serious
businesses quarantine deep-frozen blood from first donors for half a
year without it being processed. Then the donor is asked to give blood
a second time, which is then tested. With this method a "diagnostic
gap" can be bridged. A donor could theoretically have been infected
with a virus just hours before his first transfusion. At such an early
stage of infection, the contamination could still be too small for a test=

to register it. Only when the second test is also negative will the first=

blood donation be processed. In case a donor does not appear for the
second donation, the initial donor plasma is destroyed. Correct
procedure is very involved. And very expensive. =


Whether Mike Archer's blood deliveries from southern Africa were ever
properly tested, and if so with which method and what results were
achieved remains unknown to this day. However, what is clear is that
Mike Archer ordered his suppliers to pour the plasma into normal
five-liter containers just like the ones that can be purchased from any
do-it-yourself store. It was only the contents of these containers that
were probably tested, but the contents were so diluted that the
concentration of possible viruses would have made it virtually
impossible to detect anything abnormal. This swindle method is
called "pooling". Mixing plasma in this manner without single donor
testing beforehand is illegal in both Europe and the US. =


Had everything been done by the book, then the material that was
being sold would have been accompanied by comprehensive
documentation of donor sheets and test results -this documentation
that would not give rise to questions. Of course the blood pusher gang
didn't have the required paperwork. That's why they had to work as a
team using their imaginations to fabricate these documents at a later
point in time. Since none of them knew what proper documentation is
supposed to look like, they had to do quite a bit of faxing amongst
each other. For example in the spring of 1995:


 February 8th, 95: Dachs' secretary to
 Brandenberger's secretary: "Can you please
 give me the name of the quality inspector in
 South Africa. I have to mark approximately
 200 pages with it!!!" =

 May 18th, 95, Mike Archer to
 Brandenberger's secretary: "Please send
 me a draft copy of the exact information you
 require for the Certificate of Origin. We will
 try to find a way that will not compromise
 either WBAG (sic Brandenberger) or
 Montpelier (sic Archer). =

 May 19th, 95, Mike Archer to Dachs: "What
 do the following mean
 1. Donor number
 2. Bleed number
 3. Control
 Please will give you me another sample
 donor list=85 so that we can look exactly the
 same as your plasma." =

May 29th, 95, Mike Archer to Dachs: "Dr. Seidel's name has been
printed but we will have to sign for her so the "pp" has had to be
included and some one else in my office will have to sign for her=85
must we sign every sheet?" =

After some fancywork, the documents with negative test results and
the manipulated signatures of quality inspectors appeared to be
authentic. And so it was sent on its way. The gang of venerable
pharmaceutical professionals spread as many as 80,000 venomous
doses around the globe. The scam worked without any problems. Not
even the Office for Blood Safety at the WHO in Geneva ever picked up
on it. Jean Emmanuel, the head of this department, had even directed
a blood transfusion center. And by sheer coincidence, it was the
National Blood Transfusions Service (NBTS) in Harare, Zimbabwe. In
this position, as he confirmed to stern, he met with Mike Archer from
Durban several times. "All exports of any materials by the NBTS,
Zimbabwe, undergo a strict system of approval by exchange control
authorities and is done with the knowledge and approval of the
Ministry of Health and Child Welfare (MOH & W), Zimbabwe" is Jean
Emmanuel's defense to all accusations. Why exports from
Zimbabwe? With this statement, Jean Emmanuel is saying that he
exported blood from the country with the highest AIDS rate. This man
is the world's highest-ranking blood protector. And since the plasma
collected in Zimbabwe is so immaculate, Jean Emmanuel, the blood
boss at the WHO, declared his ex-employer a model for other
countries. The institution he built up in Zimbabwe is to be replicated
by other nations. =


Had Franz Dachs not been such a lousy businessman, the
charlatanery perpetrated by himself, Archer, Schulman, and
Brandenberger would have gone on forever. With the loot from the
plasma deal, the Austrian attempted to expand production capacity in
Eastern Europe. He leased machinery from a small business in his
neighborhood, from "Rendita Leasing". The owner was Heinz Joksch.
That was Dachs' decisive mistake, because Joksch was not a
member of the venerable fraudsters but a simple businessman.
"Dachs tried to cheat me with the leasing rates, "explains Joksch. "In
any case, he did not pay. That was a threat to the livelihood of my
business." Dachs was broke because he had overextended himself in
Eastern Europe. =

In order to save his money, Joksch secured shares in Albovina from
Dachs and fired him, the director. Now, all Joksch needed was a
replacement for Dachs, someone who was licensed to trade blood.
George Maiwald had the required certification and got the job. Joksch
reported: "Maiwald and I were sitting in my office one November
evening in 1996 trying to put some order into the filing chaos. At
some point during the evening, we began to grasp the kind of filth that
had been going on. First it made me sick. After all, this was out of my
league." Maiwald was mortified as well: "It turned out that I was an
expert in a company which basically specialized in fabricating just
about anything under the pharmaceutical sun. The entire stock was
completely unsuitable for pharmaceutical use." =

Heinz Joksch contacted Wolf Brandenberger, who had previously
obtained a twenty-percent ownership interest in Dachs' company from
him. Brandenberger immediately flew to Linz. "We met in the airport
c
offee shop," says Joksch. "And what does this guy do? He offers me
100,000 dollars if I keep my mouth shut." Joksch could have kept
quiet and participated in the lucrative business. There was no need for
him to worry about the police or health authorities finding anything
wrong since "nothing is ever checked in this business anyway. Any
hot-dog stand is inspected more rigorously than a pharmaceutical
business." If Joksch went to the police, both his money and his
livelihood would be at stake. He did it anyway. On December 18,
1996 he called Johann Kurz, who is in charge of biological medication
in the health ministry in Vienna. =

The very next day, Kurz inspected the offices at Albovina and the
cooled storage house in airport duty-free zone. "The things we saw
there left us dumbfounded," said Kurz. "Five-liter plastic containers.
The tops were covered with frozen plasma crusts." Someone must
not have been particularly careful. The plasma was thawed and
examined by Gerhard Beck an expert with the Federal Office for
Pharmacology. In his report, he states: "it smelled like dead dogs."
He determined that: "the containers were not suitable for transport
and were not sealed properly and that microbiological contamination
and plasma precipitates indicated repeated interruptions in the
freezing chain." Put simply, the stuff Dachs wanted to make medicine
out of had already begun to decompose. Furthermore, the experts
found Hepatitis and AIDS viruses in the stinking slosh. The whole
catalogue. You couldn't ask for more. Gerhad Beck recommended
"that the material be disposed of with safety precautions." Hazardous
waste. =

Since then, since the end of 1996, the Austrian authorities have been
trying to bring the scandal to light in its entirety. However, the
estimated 30,000 possible victims are not Austrian, nor are they
EU-citizens according to the current results of the investigation. The
prosecutor in charge in Linz assigned the investigation to the
Gendarmery in the town of Gallneukirchen. "Our village Gendarmes
are in this knee-deep," says Heinz Joksch. "But they don't know very
much about it. It took them all of one year just to grasp what it's all
about. And of course the "village Gendarmes" never traveled to India
in order to find the victims. Yet without victims, Dachs' or
Brandenberger's worst case scenario would be prosecution for public
endangerment or transmission of contagious diseases. Stern's
research in Hyderabad turned the case around completely: With the
case of Vija Sai, the accusation could lead to an accusation of
reckless physical injury, with Surinder Kaur it could be reckless
manslaughter. =


Heinz Joksch - the man who risked his livelihood when he blew the
whistle - is being investigated by the prosecutor in Linz. =

Wolf Brandenberger denies all accusations. Yet he went to prison.
But only for one night, from November 24th to 25th, 1999. In the
meantime, Swiss police and customs officials as well as officers of
the medical inspection bureau of the Canton of Zurich searched his
offices and his apartment. They confiscated hundreds of documents.
Whether Brandenberger kept all incriminating evidence of the Africa
blood scam for the prosecutors three years after Franz Dachs' cover
was blown is not known at this point. =

Franz Dachs denies all accusations. He has still not been indicted for
his blood peddling. If and when a trial will be brought against him is
unclear at this point in time. What is clear is that he is already
running a new business, "Biotech Engineering", in his hometown. =

Joe Schulman denies all accusations. Joe Schulman continues to run
his company, the "Atlantic Business Organization" in San Diego, as if
nothing ever happened. =

Mike Archer denies all accusations. He remains unscathed as well.
He is still active in the blood business. On March 25th, 1999 the
South African Authorities issued a permit to him; to import further
blood supply from Namibia and Zimbabwe to South Africa - "serum for
diagnostic laboratory use". At the same time he received a permit to
export 10,000 liters of blood products from South Africa. It is not over.=

So, somewhere in the world, at this very moment, Mike Archer's
shipments from the most dangerous of sources are on the loose.
Where the plasma is and what will become of it, nobody knows. =



Rico Carisch, Walter W=FCllenweber