HIV Aids - Counterfeit Drugs and Pharma

Author

Counterfeit Drugs and Pharma

GMCarter

2005-11-23, 10:49 am

The attached document is long--but a vitally important read. For
ANYONE that cares about anybody using a pharmaceutical product in
fact--although the effects are more profoundly felt in the developing
world. It speaks volumes to the critical instability that has long
existed but is becoming increasingly worse by shining a spotlight on
the burgeoning growth of "fake" pharmaceutical drugs. Because of
transnational price gouging, generated first and foremost by the
United States' lax attitude and lack of regulation for an industry out
of control and the resultant virtual facilitation of the criminal
enterprise of counterfeiting.

Indeed, the article represents a STELLAR example of how the de facto
privatization of drug discovery has destroyed health care on a
national and global level. Indeed, it is horrifyingly summed up by a
pharma industry individual:

"...In a scathing editorial in April 2005, the online U.S. magazine
PharmaManufacturing.com asked: "Why does the industry continue to shy
away from developing the infrastructure needed to assess the size of
the global problem? The answer is simple: fears of bad publicity and
impacts on stock prices."

The industry is driven by a heady and horrific mixture of fear and
greed. Sadly, the fear is NOT tied to fear of suffering or death but
rather merely the fear that the hungry maw of Greed that drives the
stockholders and parasites of Wall Street may not be sated. "Parasites
of Wall Street"? You bet!

They don't DO anything but skim off the sales and trades that
investors make based on what will give them a good return. And ANY
private industry must be fearful of that power.

This privatized approach has distorted the discovery, distribution and
science of medicine in ways that have only become more and more warped
over the years.

And, like the hideous, lying filthy murdering scumbags in the Bush
Administration and the cronies that support them, this regime must
end.

As the Berlin Wall fell, so must these edifices of killing lies.

And we must have in place the people who will continue to do the work
for good pay that DOES help to save lives. The honorable women and men
who work to discover new drugs, to undertake clinical studies, the
people who GET in those trials, the manufacturers and distributors of
fairly and inexpensively costed medicines, tested under a PUBLIC
health system.

The resources are AMPLY there to do this--and can be dramatically
reduced if license fees, advertising, lawyers and patent disputes
along with the horrific price gouging is taken from the picture.

Who will be hurt? Some miserable fat middle men--but even they won't
suffer so as there are plenty of other opportunities for the private
sector in bubble gum, tennis shoes and co-opted popular music, roided
sports figure and the like to shill and sell.
George M. Carter

http://www.prospect.org/web/page.ww...articleId=10650
Death By Dilution

When fakes of a GlaxoSmithKline anti-malarial drug turned up in
Africa, authorities assumed the drug giant would want to know.
Instead, they learned about a huge, evil trade in fake drugs -- and
about an industry that doesn't want the truth to get out.

By Robert Cockburn
Issue Date: 12.20.05

In Graham Greene's 1949 thriller classic, The Third Man, Harry Lime --
"the dirtiest racketeer who ever made a dirty living" -- peddles
diluted penicillin through the sewers of occupied Vienna. During the
film's famous scene atop the city's Great Wheel, Harry's friend Holly
Martins, played by Joseph Cotten, asks, "Have you ever visited the
children's hospital? Have you ever seen any of your victims?"

"Victims?" replies Orson Welles as Harry, pointing to the tiny figures
moving far below them. "Would you really feel any pity if one of those
dots stopped moving -- forever? If I said you can have £20,000 for
every dot that stops, would you really, old man, tell me to keep my
money -- without hesitation?"

* * *
In Vienna, Virginia, not far from Washington, a database of all the
fake drugs discovered by the world's 18 largest drug companies is kept
at the Pharmaceutical Security Institute (PSI). The data maintained by
the PSI may well hold the key to saving millions of innocent consumers
from ingesting lethal counterfeits of the industry's best-selling
medicines -- but it remains inaccessible to outside inquiries for what
the industry calls "security" reasons. Fake drugs are indeed the
pharmaceutical industry's most closely guarded secret.

But in September 2002, at a conference in Geneva, a man named Emmanuel
Kyeremateng Agyarko made a startling admission. The conference brought
together top government officials, scientists, private investigators,
and the world's biggest drug companies for the first global forum to
discuss the explosion of fake pharmaceutical drugs in a racket
spreading to the West. The media were expressly not invited into the
meeting at the luxury hotel overlooking Lake Geneva.

Speaking up from the audience, Agyarko explained how one month earlier
he had discovered a deadly counterfeit of the children's malaria syrup
Halfan, which had been diluted to 40-percent strength. Halfan is made
by the British drug giant GlaxoSmithKline (GSK). The syrup is a
lifesaver for serious cases in Africa, where a resurgence of malaria
is killing more than a million people a year, 90 percent of them
children under 5 years old.

The fake was discovered on sale in a pharmacy in Kumasi, Ghana's
second-largest city, with a population of approximately 862,000. "It
was atrocious," he recalls of the diluted medicine. "At 40 percent, if
anybody takes it they won't get the desired effect, particularly
children. Any malarial infection that is not properly treated could
easily end up losing the child." As chief executive of the Ghana Food
and Drug Board, Agyarko says he prepared a warning and then called
GSK.

What followed is disputed to this day.

According to Agyarko, corporate staff from GSK's London headquarters
came to his office, took away five bottles of the fake syrup for
testing -- and asked him to withhold any warning. "We were going to
issue a public statement," Agyarko explained, until GSK told him,
"'Please, don't put that in the press. If you do this you will damage
our product.'" He recalls that GSK offered to send in a sales team to
remove fake Halfan from Kumasi if his agency kept the story out of the
media.

" [GSK] raised the issue of a problem with the brand if you go out and
say that there is a batch that is counterfeited ... . They sort of
talked us into accepting the fact that if we did [report the fakes],
it would badly affect the product. I wouldn't want to use the word
'pressure.' We were encouraged to the view that this was not something
that was a large amount."

After his meeting with GSK, Agyarko's agency issued no warning. He
later came to fear that children could have died as a result of that
decision. The company never reported back to him, and he suspected
that fakes were still available. "If it does come up again I would not
hesitate at all to go public on the matter," he says now. "I wouldn't
give [GSK] the benefit of doing it themselves."

Did GSK indeed ask him to withhold the warning? Did children in Kumasi
suffer or die from using fake Halfan? At the time, GSK advertising
featured a photograph of a healthy, smiling African girl to project
the image of a caring company. The corporate Web site opened with the
girl's picture and the GSK mission statement: "Our global quest is to
improve the quality of human life by enabling people to do more, feel
better and live longer." Moreover, GSK depicts itself as an industry
leader in fighting pharmaceutical fakes. "Fake drugs can kill people,"
according to the company's official policy. "Counterfeits deceive
patients."

When I brought Agyarko's story to the attention of GSK's director of
international public policy, Jessica Hughes, the corporate response
was adamant denial. Louise Sibley, then GSK's vice president for
communications, denied that the Kumasi incident ever occurred, and
went further to deny that the company had ever received Agyarko's
alert or his fake Halfan samples. In a corporate statement, she said,
"[W]e were not provided with any samples of fakes by the authorities
in Ghana, nor were any reports of fakes lodged with us."

Informed that Agyarko was sticking to his claim, Sibley promised, "If
there's a misunderstanding I'll run this into the ground." I suggested
that the company's security director, Graham Satchwell, would know
whether GSK had received Agyarko's alert and samples. "I put in a call
to Graham Satchwell, but I think he must be traveling," she later told
me, adding, "I don't think we are going to have anything more to say
on it."

It was simply Agyarko's word against GSK's, and because he insisted
that the company had the only evidence, the controversy might have
ended there. But a pair of Oxford university scientists had reason to
suspect that Agyarko's story might be true. Based in Bangkok,
professor Nicholas J. White and Dr. Paul Newton of Oxford's Centre for
Clinical Vaccinology and Tropical Medicine had been rebuffed by GSK
when they asked about fakes of Halfan syrup for research to assess the
spread of counterfeit malaria drugs in Southeast Asia.

"It's despicable," says the lean, shrewd White, at 54 one of the
world's top malaria experts. "One packet or bottle is the difference
between life and death. Poor people normally invest everything in that
one medicine. You've got one shot and that's it. They often don't know
why they are suffering and their children have died." At the
scientists' request, Agyarko teamed up with them to try to prove that
the company indeed had received his fake samples, and to find out what
GSK really knew about the fake Halfan. White had also asked me to
assist the team's research because I had reported on the racket for
the London Guardian and Times newspapers over a period of almost 20
years. (One night before flying back to Beirut in 1982, I met a
marketing executive from Beecham (now GSK) who asked me to look for
counterfeits of his company's Amoxil antibiotic, which he believed
"the plo was faking." After an investigation that included a
frightening car chase, I learned that everyone on!
all sides of the Middle East conflict was making the stuff because
the trade was so lucrative.)

* * *
Why would a caring company want to stop a warning that could save a
sick child? In fact, had Agyarko uncovered one of the main causes of
the extraordinary spread of fake-drug racketeering? Had the years of
inadequate regard for Third World customers by the pharmaceutical
industry and governments allowed the racket to move out of the
backstreet labs to become a vast criminal enterprise that now accounts
for 10 percent of all available medicines? Agyarko's story offered the
first insight into why the racket flourishes largely unchallenged --
and sparked a demand to break the industry's secrecy.

What began as a hunt for those missing bottles eventually revealed a
murderous global trade in fake drugs targeting the sick, vulnerable,
and poor. It grew into a survey to discover what major drug companies
do -- and don't do -- to warn patients about fakes. Agyarko's missing
bottles were only a symptom of a far deeper state of denial -- and a
clue to the resurgence of malaria in Africa.

* * *
In essence, the global trade in fake drugs operates as a mirror of
legitimate commerce. The producers of fakes sell them to dealers who
infiltrate them into the retail market. Profits flow from the capacity
to counterfeit valuable commodities at very low cost. As the fakes
pass from producers to wholesalers to retail outlets, everyone can
take a profit and yet still deny complicity.

The pharmaceutical industry and the agencies responsible for
protecting the public differ widely on the magnitude of the
counterfeiting problem. The Food and Drug Administration (FDA)
estimates that around 10 percent of all available medicines are now
faked in a racket earning $35 billion a year. The figure exceeds 50
percent in parts of Africa and Asia. The PSI estimate is between 1
percent and 2 percent. Within the industry, however, that figure has
little credibility. In a scathing editorial in April 2005, the online
U.S. magazine PharmaManufacturing.com asked: "Why does the industry
continue to shy away from developing the infrastructure needed to
assess the size of the global problem? The answer is simple: fears of
bad publicity and impacts on stock prices."

Millions of people are left to suffer and die from fake drugs while
the industry denies access to information that doctors say could save
them. The industry insists that its data on fake drugs must be
restricted for security and to avoid public panic. But White believes
that the underlying reason is simply profit. In a chilling assessment
of pharmaceutical-industry ethics, he says, "Their marketing people
must have made the calculations that they are likely to make more
profits by not publicizing than by publicizing."

The Oxford team concluded that most fake-drug data is kept secret
because drug companies fear that publicity will harm sales of
brand-name drugs in a fiercely competitive business. That has been the
industry practice for over 25 years, but the human toll is gradually
emerging. In 2001, China reported that 192,000 of its citizens had
died from fake drugs. White guesses that between 500,000 and 1 million
people die from fakes every year. "I believe that people must have
died in their millions," agrees Dr. Dora Akunyili, the drug regulator
of Nigeria and an associate of the Oxford team. "It is mass murder --
terrorism against public health." To her, companies that conceal fake
drugs are not much better than criminals. "They are [maintaining
secrecy] because of their selfish gain, because they don't want to
lose money," she says.

This month Akunyili, 47, will receive the 2005 Grassroots Human Rights
Campaigner Award in London's Houses of Parliament. The streetwise
doctor cuts a dashing figure with her traditionally colorful Nigerian
costume and hats -- one of which she keeps in her office shot through
by the bullet that creased her scalp when she was caught in a hail of
gangster gunfire.

Only as fake drugs spread into lucrative western markets are drug
companies and governments finally contemplating determined action
against a scheme that the makers of Rolex watches and Gucci handbags
have fought in public for decades. There are two victims of fake
drugs: companies that lose sales and patients who lose their health.
Why don't they work together? GSK's Louise Sibley told me, "It's not
our job to give public-health warnings. We don't make the fakes." Drug
companies pursue fake-drug manufacturers by using their own security
and hiring private investigators to trace and facilitate the closing
of fake-drug factories. By using covert means, the industry avoids any
assessment of its efforts and is accountable to no one.

* * *
The Oxford team's first break in the Ghana case came when Dr. Newton
found a GSK laboratory analysis of counterfeit Halfan syrup in an
obscure Internet technical journal on mass spectrometry. He wondered
whether that syrup came from Agyarko's bottles. The GSK research
center in Britain had made a breakthrough in identifying fake-drug
ingredients -- the chemical "fingerprint" -- in the samples. Their
tests showed that the fake syrup contained no halofrantrine active
ingredient and had two sulfa additives that Newton knew to be
dangerous and should have been made public. But GSK's scientists, who
had quoted Newton's own research on fake malaria drugs in their
report, rejected his request for the source of their fake syrup.
"Analyzing counterfeit products of ours can be a very sensitive issue,
and if I was to give you further information I would need to clear it
with our corporate security and investigations department," a GSK
researcher told him in an e-mail. "The product pres!
ented in the paper was found in Central Africa, but for legal
reasons, I can't be more specific at the moment."

The courteous, donnish White then wrote to Satchwell, the GSK security
chief, asking for the source of the fake Halfan syrup and to know
whom, if anyone, GSK had warned. A reply arrived from the company's
international public-policy director, Jessica Hughes, who refused to
provide answers about the fake syrup but acknowledged "counterfeit
Halfan is present in Nigeria and Sierra Leone."

The Oxford team's hunt moved to Nigeria, the hub of West Africa's
fake-drug trade and a country notorious for corruption and violence.
In June 2002, Nigeria's drug regulatory body, the National Agency for
Food and Drug Administration and Control (NAFDAC), had also alerted
GSK to a discovery of fake Halfan syrup -- two months before Agyarko's
warning. As NAFDAC's chief, Akunyili had issued an immediate public
warning through a system set up to identify fake drugs to patients and
health workers. Every month, in fact, NAFDAC destroys tons of fake
drugs. A typical list includes faked versions of products from the
Pfizer, Hoffman La Roche, Novartis, Unilever, Janssen, Astra Zeneca,
Boots, Hoechst, Pharmacia & Upjohn, and GSK companies.

Akunyili was furious to hear that her Ghanaian colleague Agyarko had
withheld his public warning at GSK's request. "No company would have
the courage to tell me not to publish anything," she says. "We will
still issue a warning even if we find it in just one shop. If you find
any fake-drug product in only one shop you can be sure it is in many
villages ... . People die all the time." She is driven by the death of
her sister Vivienne, a diabetic who received fake insulin. She says
that she herself has been a victim of fake Halfan and Amoxil
antibiotics. There had been no public warning in either case. "I
didn't know that Halfan had been faked," says Akunyili. "Everybody can
be a victim." She joined NAFDAC in 2001 when Nigeria suffered from a
wave of fake drugs comprising up to 80 percent of the market. Now she
is a national hero, known as "Dr. Dora," who publicizes the
counterfeits in schools and villages, roots out corruption, and
travels to India and China to stop the fakes!
at their source.

Eventually the Oxford team learned that GSK had known about a global
trade in fake Halfan since at least December 2000, when Belgian
customs officials seized a vast haul of GSK counterfeits in transit
from China to Nigeria. The Belgian haul included 57,600 packs of fake
adult Halfan capsules, along with more than 15,000 packs of Amoxil and
Ampiclox antibiotics. GSK says it informed the Nigerian health
authorities of the haul. The counterfeiter's trial revealed that fake
GSK drugs were being produced on an industrial scale in factories in
China and Thailand. In all, Chinese investigators seized 43 tons of
fakes of 17 brands made by seven major drug companies, which only
represented a fraction of known output. Chinese authorities say that
in 2001 they closed 1,300 fake-drug factories while investigating
480,000 cases worth $57 million.

White's attempts to publish the Oxford team's findings were rejected
by the leading medical journals -- including The Lancet, the British
Medical Journal, and The New England Journal of Medicine -- and
several U.K. newspapers. But in October 2004, one year after GSK had
denied any knowledge of his fake Halfan discovery, bbc Radio reported
Agyarko's claims. Faced with the broadcast, the company's London head
office reversed position to acknowledge that it had received Agyarko's
alert -- and that it had the fake Halfan syrup bottles all the time.
In a new statement that admitted GSK staff had "bumped into" Agyarko,
the drug giant still insisted that "[a]t no point was any pressure put
on the Ghanaian authorities not to issue a public warning on fake
Halfan."

By then Louise Sibley had left GSK. Louise Dunn, the company's new
vice president for communications, had a new explanation. "There was
some confusion over the interactions with Mr. Agyarko," she said. "The
key point here is that there was no wrongdoing." Neither Sibley nor
Dunn had ever called Agyarko, although Dunn says that he "never
complained to us." She added, "There was no intention to hide
anything. In our view there were minor discrepancies."

Among those discrepancies was the complete disappearance of the fake
Halfan bottles that the company finally admitted receiving from
Agyarko. GSK claims that no trace of the Kumasi fake Halfan sample
survives. "Mr. Agyarko did provide us with a sample of the Halfan,"
says Dunn. "But we don't have any records of the tests. What our
procedure would be now is that absolutely everything gets tested at
the time." She says it is no longer possible to compare the Kumasi
fake to other fake Halfan syrups in Africa, which would be the key to
mapping their source and spread. The disappearance of the critical
evidence also eliminated any chance of using the syrup's chemical
fingerprint to identify possible victims.

As for the fake Halfan syrup whose test results were found online by
Newton, Dunn says that sample came from Sierra Leone. She says that
the company informed the Sierra Leone minister of health about those
counterfeits. But the Pharmaceutical Board of Sierra Leone, which
investigates all fake drugs and issues public warnings, never received
any such information from GSK or the minister of health, according to
the board's director, Michael J. Lansana, who called the omission
"unfortunate." The head of Sierra Leone's Malaria Control Program, Dr.
Sirian Kamara, who works with Lansana to uncover fake drugs, also says
that no warning ever arrived.

Most curiously, the news of Agyarko's fake Halfan alert never reached
Graham Satchwell, then GSK's security director. Asked about the
Agyarko case at a conference in Paris in March, he was stunned. "I
know nothing of that!" he shouted from the conference platform. "If
you are trying to suggest that I would [in] any way conceal anything
that would cause the death of anyone, let alone children, then you are
very mistaken indeed."

Later, Satchwell told me that he had led GSK's anti-counterfeiting
operations, and that he should have received all reports of fake
drugs, including Agyarko's Halfan find. No one at GSK told him about
the Kumasi case or about the attempts to contact him concerning
Agyarko's claims. A former U.K. policeman, Satchwell took personal
risks as an undercover buyer to obtain fake drug samples. He has
testified at congressional hearings on fake drugs. Sir David Hare, the
British dramatist, has lionized Satchwell's integrity in a play
exposing government and corporate negligence. Why was he not told
about the Agyarko case?

"There is a large anti-counterfeit team at GSK," says Dunn, "so the
involvement or noninvolvement of one individual is not unusual or
significant." But Satchwell questions the official GSK version.

"If GSK knows that the [fake] sample was received," he says, "then
they should know who received it and what happened next. If a test was
undertaken, then the results would have been recorded. The department
concerned with doing that were an efficient and organized bunch."
Satchwell was pushing to build up a record of all fake GSK drug cases
to be used for intelligence analysis to trace sources and pathways.
"There are umpteen things you can profile within the packaging and the
product in order to identify counterfeit 'strains.' This was -- and is
-- done."

GSK declined to allow any interviews with Louise Sibley or the GSK
staffers who met with Agyarko. As for Satchwell's comments, Dunn says,
"We have no comment." The company's fake-drug policy states, "GSK
rigorously investigates any case of suspected counterfeiting." But GSK
still refused to answer questions about the actions it took following
the fake Halfan syrup find in Kumasi. And Dunn says she cannot
understand how withholding fake-drug data can harm patients. "I would
like some evidence," she says.

There is no way of finding such evidence -- yet. For "security"
reasons, the industry's fake-drug data is kept confidential at the
PSI, which collates fake-drug discoveries made by the world's 18
biggest drug companies, including Pfizer and GSK, dating back more
than a decade. The institute's stated goals are "protecting the public
health" and "sharing information on the counterfeiting of
pharmaceuticals." Whether it fulfills either is questionable. Dr.
Lembit Rago, director of medicine safety for the World Health
Organization, has been frustrated by the PSI's secrecy. "We've been
discussing it with [the PSI] for a long time," he says, "but they are
not willing to open up the databases. They really don't like [the
idea]."

A PSI spokesman insists that the secrecy is necessary to prevent
criminals from being tipped off before police arrests. But Chris
Jenkins, a founding member of the PSI now serving as an analyst and
associate director at Pinkerton Consulting and Investigations, says
there is an additional explanation. "At the outset, we [PSI] were
against having data online that anyone could interrogate," says
Jenkins, who set up the original psi fake-drug computer data system in
the 1990s, with its access restrictions. "There were also commercial
reasons. If a patient came to harm as a result of a counterfeit
product, the company's good reputation is in danger of disappearing,
together with a loss of confidence in the products. From the company's
perspective, there is then the inherent danger of rival products being
preferred in the marketplace."

Jenkins says that the industry's security regime was designed to
prevent the major drug companies from using fake-drug information to
take commercial advantage of one another.

"The one thing we were trying very hard to do was to keep [data] out
of the hands of the commercial people in any of the companies," he
says. "We always had this possibility, which is why things were
sanitized. One had to produce reports for the CEO, but beyond that it
was kept very close. The only people [in a member company] nominated
to PSI were senior people with anti-counterfeit responsibilities, such
as security directors and IP lawyers. You can imagine trying to get 20
top companies trying to share information, a lot of which was
extremely commercial-in-confidence. The importance of meeting sales
targets is such that you can even find cutthroat competition between
different operating divisions of the same company, let alone between
two companies competing in the same market with similar drugs."

Could that explain why Graham Satchwell never learned of the fake
Halfan in Ghana?

Dr. Sebastian J. Mollo of the PSI confirms that data is routinely
withheld from members. "Since [PSI's] inception, it was recognized
that a great deal of this information would remain confidential and
would not be disseminated. There is proprietary information that
cannot be disclosed, either to peer member companies or to the general
audience."

The industry has turned fake-drug data into a potential weapon against
itself, inadvertantly offering the racketeers a layer of immunity they
never could have imagined. Some companies have, on rare occasions,
issued public warnings, including GSK (and Johnson & Johnson, Serono,
Hoechst, Wellcome Foundation [now GSK], Merck Sharp & Dhome, and
Genentech), but the list is tiny compared with the racket's size.
"Fake drugs should be reported like infectious diseases," says White.
"By not making the public aware you create a market (for fakes). Drug
companies are making it easier for the criminals."

High profits, low costs, minimal legal risks, and little publicity are
drawing crime gangs away from arms and narcotics. High-tech
photocopiers turn out perfect drug packaging for every type of
treatment for heart disease, birth control, meningitis, kidney
disease, cancer, or depression. Out-of-date and damaged drugs get
relabeled for sale, transforming a $22 drug into a $450 drug by
creating a higher dosage label.

Most fakes are made in China, Southeast Asia, India, Russia, and the
Middle East and then infiltrated into the legitimate global
drug-distribution system. What is surprising is how many ordinary
people are needed to make the racket work. Officials and health
workers meant to protect patients are bribed and intimidated to put
fake drugs into a distribution system that is like a sieve. "An awful
lot more [fake drugs] get through than are seized," says Jenkins.
Inside the system, fake drugs are very hard to find and then are often
ignored, even in the United States.

Once taken, a fake antibiotic pill made of rice starch or a vaccine
made of water is virtually untraceable in the body. Victims succumb to
their illnesses, leaving no sign of a crime. In the absence of
investigations, very few victims have ever been unidentified. Its
anonymity has allowed the racket to be ignored and to thrive.

The most vulnerable are malaria victims. The resurgence of malaria now
affects more than 500 million people in Africa. Mosquitoes carry the
disease in a "meal of blood" passed from one human victim to another.
The most dangerous parasite, Plasmodium falciparum, kills more than
800,000 African children under 5 years old annually, according to the
World Health Organization. It is Africa's biggest child killer,
destroying families, health services, and economies. But the role of
fake drugs in promoting malaria is barely ever mentioned.

In November 2005, for example, Bill and Melinda Gates gave $250
million to fight malaria. "It's a disgrace that the world has allowed
malaria deaths to double in the last 20 years, when so much could have
been done to stop the disease," declared the Microsoft billionaire.
"Millions of children have died." Is Gates aware that his generosity
and the efforts of pharmaceutical research-and-development staff are
being diluted by fake drugs? Experts are linking the resurgence of the
disease to the growth of fake drugs, in a terrible cycle of neglect
over the past two decades.

The explosive growth of malaria has created a sales boom for both drug
companies and counterfeiters. "Anti-malarial drugs have now really
become the focus" of the fake racket, says Dr. Allan Schapira of the
World Health Organization's Roll Back Malaria project. "It is murder.
It is incredibly cruel."

* * *
The marketing of fake drugs and the resurgence of malaria are
inseparable. "It kills the voiceless children, who cannot protest,"
explained Dr. Martin Meremikwu of Nigeria's Calabar university at the
launch in October of Gsunate Kit, a new artesunate anti-malarial drug.
"Malaria hardly kills adults, which explains why we don't seem to give
the fight against malaria enough attention. The tragedy is that while
90 percent promptly take drugs when they have malaria, only 15 percent
get 'good' drugs. The fraudulent practice of fake-drug manufacturers,
inappropriate use of the available drugs, and the mutation of the
malaria parasite are responsible for the resistance of malaria
parasite to drugs."

No one has assessed the extent of fake malaria drugs in Africa along
the lines of White's project in Southeast Asia. Anti-malarials are
known to be among the most faked drug types. But the danger does not
stop there. The use of fake drugs is helping the malaria parasites to
quickly mutate to become resistant to new drugs. Akunyili says diluted
fake drugs are "feeding the malaria parasite with little doses" that
build more resistant strains. You don't have to take a fake drug to
suffer its effects. Resistance is accelerated and then spread by
mosquitoes to the next victim. As more patients fall prey so the need
for more drugs grows, encouraging the trade in fakes that fuels the
cycle. Dr Jan Rozendaal, believes that fake drugs were causing most
malaria deaths in 1998, when he was running the European Community
malaria project in Southeast Asia's Mekong region. But such warnings
have gone largely unheeded. This leaves questions about the
effectiveness of any new drugs while th!
e use of fakes is rife.

There is a lot of money to be made in combating malaria. GSK's tests
of an experimental malaria vaccine on children in Africa were greeted
last year with a ringing headline in the London Times: "Malaria
vaccine to save millions of children." Within a month, the British
government had made an unprecedented $5 billion presale for the
still-unproven vaccine (and was criticized by malaria experts for
investing so much in one Western company).

But while a company can be paid billions for a new drug, its patients
have no guarantee of getting the real thing. There is little incentive
to publicize the danger. Vaccines have been faked with tragic results.
The 1995 Niger meningitis epidemic led to the worst known fake-drug
incident, when 60,000 people were given vaccines made by SmithKline
Beecham (now GSK) and Pasteur Merieux before they were found to be
nothing but water. Some 3,000 people died. SmithKline Beecham was
criticized in the French press for failing to take legal action amid
speculation that it feared damaging trade with Nigeria, which had
donated the fake vaccines. No one has been prosecuted.

* * *
Has the pharmaceutical industry made a huge miscalculation by using a
strategy that now harms its own interests as well as its customers?
Without effective laws or close cooperation among companies,
governments, and international organizations, the racket has
metastasized. White and Akunyili want international legislation to end
the secrecy by enforcing mandatory reporting by drug companies of all
fake-drug finds, and for government authorities to investigate and
issue public warnings. "This is not a role for the pharmaceutical
industry which has a serious conflict of interest," says White, who
also wants PSI data opened to health authorities. "The information
kept on PSI databanks could absolutely help limit the number of
casualties from fake drugs. It is entirely preventable."

Akunyili says the next and most difficult step in the campaign against
counterfeit drugs is to identify the victims. In the case of Halfan,
it could be possible to detect the link between the criminal and the
victim by checking the chemical fingerprint developed by GSK against
that of the fake syrup. But is there any will to find the victims?

So far, the PSI has resolutely refused to disclose its data for
public-health warnings.

The pharmaceutical industry, backed by the FDA, is pursuing a
different strategy to stop counterfeiting, such as high-tech covert
markers in drug packaging. But when GSK put holograms on its Halfan,
according to Akunyili, "these criminals faked their hologram." She
believes that consumers represent an untapped pool of highly motivated
"detectives" who could hunt down fake drugs to protect both themselves
and the industry. White agrees that the public should be told which
drugs are being faked without companies revealing sources. Such public
warnings directly attack the racket itself. "When people stop buying
fakes the market dries up," says Akunyili. "Companies benefit in the
long term."

When the racket began to take off in 1982, Hoechst pharmaceuticals
discovered the power of publicity against counterfeits in Beirut,
where wartime conditions had encouraged a plague of fakes. Hoechst
fought back with an advertising campaign warning patients about a fake
of its diabetes drug Daonil. There was no panic and there were no lost
sales. Indeed, Hoechst says it gained credibility, and when its
customers stopped buying fakes the supply dried up. Why don't drug
companies use this vast resource of human intelligence and let
consumers check their own drugs?

Clearly the companies worry that the victims will come back to haunt
the industry -- creating the legal and public-relations disaster the
secrecy was meant to prevent. Chris Jenkins believes that the PSI
could face a legal challenge to open its databases. "Only the PSI has
an overview of the known racket," he says. "In theory, every fake-drug
case reported by the companies should be on there." Pieced together,
the PSI fake-drug data could reveal the scale of the racket and its
human toll through specific companies, drug names, discovery dates,
and locations. Jenkins and other private investigators fear that they,
too, could be held liable for keeping confidential the fake-drug data
they have obtained for pharmaceutical clients.

Such fears have been stimulated by a series of breakthrough court
cases in the United States, which argued that a drug company may be
liable for the safety of its customers if it possesses information
that could save them. It is a question with implications for millions
of patients around the world.

It will probably never be known if any children suffered from diluted
Halfan in Ghana. But in 2002, around the same time that the fake syrup
turned up in Kumasi, prosecutors in a courthouse in Kansas City were
exposing the horrors of fake drugs in America -- and the identity of
their victims.

On December 5, 2002, Kansas City District Judge Ortie Smith changed
the perception of the racket from that of copyright infringement to
mass murder. Pharmacist Robert R. Courtney pleaded guilty to diluting
the cancer drugs Gemzar, made by Eli Lilly, and Taxol, made by Bristol
Myers-Squibb. Courtney made extra money, and at least 17 patients
died. Judge Smith told him, "Your crimes are a shock to the conscience
of a nation, the conscience of a community, and the conscience of this
court. You alone have changed the way a nation thinks." He sentenced
the pharmacist to 30 years in prison.

Investigations by the FDA and the FBI -- of a case that had been the
FBI's top priority until September 11 -- found that since 1992,
Courtney had diluted 72 different medicines, affecting some 400
doctors and more than 4,000 patients. During the hearing Assistant
U.S. Attorney Gene Porter apologized for identifying the victims by
code numbers instead of their names. Noting that they were indeed
persons, Porter read out the names of the 17 women who died without
any warning from Courtney's diluted drugs. They were, wrote Kansas
City Star reporter Mark Morris, "brave women, fighting desperately
against cancers that never seemed to get better, no matter how many
treatments they endured."

What happened next riveted the attention of the pharmaceutical
industry -- and its lawyers.

Victims and surviving families filed hundreds of lawsuits against
Courtney and against Eli Lilly and Bristol-Myers, alleging that the
two companies knew or should have known that Courtney was diluting
their drugs because sales data showed that he sold greater quantities
than he bought. The companies denied any liability and argued that
they had no duty to protect their customers from Courtney's criminal
acts. But faced with the prospect of a legal precedent that could hold
drug companies responsible for fake-drug victims where they had
knowledge of the racket, Eli Lilly and Bristol-Myers Squibb settled
more than 300 lawsuits out of court -- without any admission of
wrongdoing. In February 2003, Courtney's victims received around $71
million in settlement payments from the companies.

What would such an investigation reveal in Kumasi, or a thousand other
African or Asian communities? Whether it is brought about in courts or
through government action, the mandatory reporting of fake drugs would
save potential victims everywhere.

* * *
In the 2004 GSK corporate responsibility report, Chairman Sir
Christopher Gent and CEO Dr. JP Garnier assured stockholders, "Our ten
corporate responsibility principles set the standard for everyone,
since responsible business is only a reality if it is practised by all
employees at all times. ... We invite you to read this report for more
information on all our corporate responsibility principles, and we
welcome your comments and suggestions."

As Holly Martins said, "Have you ever visited the children's
hospital?"

Robert Cockburn is a writer and a former foreign correspondent who has
reported for the Times of London and the BBC.

TheRealConspiracy

2005-11-23, 10:49 am

This is why the entire idea of private Big Pharma needs to be attacked.
Not because the diseases aren't real they are all too real and more the
meds work. Medicine is not like candy bars, it is not a consumer
product. If no one was making money off of the meds than we wouldn't
have fakes and we wouldn't have people who argued that diseases weren't
real. We would just get on with life, when a person got sick he or she
would get treated and move on. Everybody wins, healthy people fuel a
healthy economy, less sick days, less emergancy room visits, etc.

Death

2005-11-23, 12:49 pm

"GMCarter" <fiar@verizon.net> wrote in message

> The attached document is long--but a vitally important read. For
> ANYONE that cares about anybody using a pharmaceutical product

Well that saved me a lot of useless reading, thanks

GMCarter

2005-11-24, 10:50 am

On Wed, 23 Nov 2005 11:13:00 -0600, "Death" <Death@yourdoor.net>
wrote:

>
>"GMCarter" <fiar@verizon.net> wrote in message
>
>
>Well that saved me a lot of useless reading, thanks

LOL. Excellent. If you never use a pharmaceutical product, the world
will have one less itinerant bigot who wants apparently only to die
anyway as he "kills" his own time and life by spewing his
self-destructive, self-hating vitriol.

Best of luck dear!

Death

2005-11-24, 10:50 am

"GMCarter" <fiar@verizon.net> wrote in message
>
> LOL. Excellent. ...
> ...itinerant bigot ...

I see why you worry about the drugs