The medicines that could kill millions
* 07 September 2006
* From New Scientist Print Edition
* Andy Coghlan
Imagine the outcry if 500 people in a developed country such as the US
or UK died after being given a fake medicine. Then consider that in the
early 1990s a similar number of children died of kidney failure in
India, Haiti, Bangladesh and Nigeria after taking fake paracetamol syrup
contaminated with a toxic solvent. Barely anyone noticed bar their
families and a few doctors.
Their deaths represent just one documented case of a trade in illicit
pharmaceuticals that claims countless lives each year. Victims, mostly
among the world's poorest, unwittingly buy fake medicines that often
contain toxic substances or little or no active ingredients, yet purport
to combat the most common preventable killers, including malaria,
tuberculosis and typhoid.
The scale of the problem is laid bare this month in a review published
in The Lancet Infectious Diseases (vol 6, p 602). In south-east Asia,
for example, half of all medicine sold is thought to be fake, much of it
counterfeit versions of new anti-malaria drugs based on the molecule
artemisinin, which many believe will be vital in curbing the spread of
the disease. In Cambodia, a survey revealed that 71 per cent of the
artemisinin-derived drug artesunate sold is fake, while across
south-east Asia, 53 per cent of artesunate packs sold in 2002 and 2003
were faked, says lead author Paul Newton of the University of Oxford.
"We're desperately worried that these counterfeit derivatives will
follow the real ones into Africa," Newton says. "The very high
prevalence of counterfeit artesunate in Asia has emphasised the
importance of tackling this trade." Unless it can be stopped, he warns,
there is little point in spending vast amounts of money developing new
drugs, as they will only be immediately undermined by ineffective or
toxic counterfeits.
The World Health Organization is so worried by the trend that this
November in Bonn, Germany, it will launch an International Medical
Products Anti-Counterfeiting Taskforce, or IMPACT. The aim is to unite
all parties involved in tackling in the problem, from pharmaceutical
companies, drug regulators and distributors through to Interpol and
customs officers.
Experts fear the trade in counterfeit pharmaceuticals kills more people
and causes more harm than the trade in illegal narcotics. And it isn't a
great deal less lucrative. In 2005, the US Food and Drug Administration
estimated that worldwide sales of fake drugs exceeded $3.5 billion, but
other estimates suggest the figure is 10 times as high. The Center for
Medicines in the Public Interest, a charity backed by the US
pharmaceutical industry, predicts that global sales of fake drugs will
reach $75 billion by 2010 unless the trade is curtailed.
However, no one can yet be sure how many fake drugs are sold. The
pharmaceutical industry first raised the alarm 20 years ago, but law
enforcement agencies, governments and charities that donate medicines
have paid scant attention. As too have researchers. In his review,
Newton found that just 43 academic papers have been published on fake
drugs, only one of which used scientifically acceptable methodology.
What's more, a survey he conducted in Laos revealed that two out of
three pharmacists and four of five consumers didn't even realise fake
drugs existed. The reality is that this trade threatens to undermine
global attempts to combat infectious diseases that kill 14 million
people, 90 per cent of them in developing countries.
IMPACT will initially focus its efforts in five areas:
anti-counterfeiting technology; harmonising legislation; tougher
enforcement; strengthening regulatory agencies; and better publicity
warning consumers about fakes, says co-founder Howard Zucker, who is the
WHO's assistant director-general for health technology and pharmaceuticals.
Strengthening regulatory agencies is key, argues Newton, especially in
the one-third of countries worldwide where they barely function. "If you
don't have a functioning drug regulatory agency, you can't inspect the
drug supply, enforce border checks, prosecute counterfeiters or root out
bribes and corruption."
Zucker agrees this is a priority. "If there's no enforcement, nothing
else has any teeth," he says. So too does the Global Fund to Fight AIDS,
Tuberculosis and Malaria, which spends millions of dollars each year
providing drugs to treat these major diseases. Spokeswoman Rosie Vanek
says the Global Fund has already approved requests for technical
assistance to improve national drug quality-control labs and bolster
regulatory authorities. Vanek also stresses that the Global Fund has
established measures to "ensure to the greatest possible degree the
authenticity of commodities purchased with Global Fund resources".
But Valerio Reggi of the WHO, who will coordinate IMPACT from Geneva,
Switzerland, says it won't be easy to root out corruption, especially in
countries where inspectors are paid so little that it is worth the risk
of taking bribes to turn a blind eye to the trade.
Newton also says that donor agencies must subsidise life-saving drugs so
that the real versions price counterfeiters out of the market. "The key
is to beat them at their own game." This strategy is supported by the
Global Fund, which provides drugs either free or at a small fee.
The pharmaceutical industry is less convinced, however. "As long as the
cost per unit of a counterfeit is lower than the street price of the
real thing, there will be counterfeits," says Harvey Bale, director of
the International Federation of Pharmaceutical Manufacturers. He points
out that paracetamol (acetaminophen) and the antibiotics ampicillin and
amoxycillin are the most widely counterfeited drugs in developing
countries, even though they are also the cheapest.
A number of initiatives are to be unveiled in Germany. One option IMPACT
will pursue is to give each packet of drugs a code number that can only
be read when the seal is broken. The consumer can phone the factory with
the number to check their medicine is genuine. Zucker says the precise
details are secret for now, but will be revealed in Bonn.
Others include off-the-shelf legislation that nations could adopt to
combat counterfeiting, while IMPACT will launch a study to assess the
growing threat of fake medicines sold on the internet, and another to
gauge the scale of counterfeiting in Africa.
Newton warns not to underestimate the counterfeiters, as their
production techniques have become increasingly sophisticated. Often they
include small amounts of the real drug to make them more difficult to
spot than if they contained no active drug. This practice that promotes
the development of drug resistance. "It means that bacteria or parasites
see very low concentrations of the active ingredient, enough to select
for resistance," says Newton. That could mean future generations of
drugs could become obsolete.
Fake packaging is also increasingly sophisticated, says Newton. Some of
the artesunate packs he found in Asia even carried holograms like those
on the originals. "At the moment, the counterfeiters are winning." But
Zucker is more upbeat, and sees the creation of IMPACT as evidence that
there is at last the political and international will to do something.
"My perception is that there's momentum."
Churning them out
In 1995 in Niger, some 60,000 people were inoculated with fake
meningitis vaccine after authorities received a donation of 88,000 doses
of purported Pasteur Merieux and SmithKline Beecham vaccines from
neighbouring Nigeria. The vaccines contained no traces of the true
active ingredient.
192,000 patients in China reportedly died over the course of 2001 after
taking fake drugs. In the same year Chinese authorities closed 1300
factories while investigating 480,000 cases of counterfeit drugs worth
$57 million. In 2004 they arrested 22 manufacturers of grossly
substandard infant milk powder and closed three factories after the
death of more than 50 infants.
In North America, there have been recent reports of various
counterfeits: human growth hormone; atorvastatin, which is used to lower
cholesterol and treat heart disease; erythropoietin, used to alleviate
anaemia; filgrastim, used to treat people who have had either leukaemia
or a bone marrow transplant; and the anti-cancer drugs germcitabine and
paclitaxel.
Antiretrovirals, a long-term drug therapy that helps stop people with
HIV from developing AIDS, are already being faked in central Africa. So
far, counterfeit versions of the drug combinations
stavudine-lamivudine-nevirapine and lamivudine-zidovudine have been
identified.
From issue 2568 of New Scientist magazine, 07 September 2006, page 8-9
http://www.newscientist.com/article/mg19125683.900?DCMP=NLC-nletter&nsref=mg19125683.900
--
"Absolutely Drug less Health Care solution Organization"
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