Fake drugs

[Guest guest]

Another mail from Rakesh Khera 86:

Dear All ,

I am sending a subject non Urological but of immense value to all of us. The

subject if true and I

believe it to be true is really frightening. it is better to be forewarned

and give it some thought. I

do not know how many of you will think it as a gimmick played by the western

world. I do not

know. But read on.

There are two parts taken from different articles

1.

Banned All Over, Available in India

Etoxic, an environmental group based in India, lists drugs that have been

banned in the EU

and/or USA, but continue to be sold in India.

ANALGIN: This is a pain-killer. Reason for ban: Bone marrow depression.

Brand name: Novalgin

CISAPRIDE: Acidity, constipation. Reason for ban : irregular heartbeat

Brand name : Ciza, Syspride

FURAZOLIDONE: Antidiarrhoeal. Reason for ban : Cancer.

Brand name : Furoxone, Lomofen

NIMESULIDE: Painkiller, fever. Reason for ban : Liver failure.

Brand name : Nise, Nimulid

PHENYLPROPANOLAMINE: cold and cough. Reason for ban : stroke.

Brand name : D'cold, Vicks Action-500

PIPERAZINE: Anti-worms. Reason for ban : Nerve damage.

Brand name : Piperazine

QUINIODOCHLOR: Anti-diarrhoeal. Reason for ban : Damage to sight.

Brand name :Enteroquinol

2.

The medicines that could kill millions

Andy Coghlan

The New Scientist

Volume 191, Issue 2568 , 9 September 2006, Pages 8-9

The trade in fake pharmaceuticals is undermining efforts to tackle the

world's biggest infectious

killers

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.

Victims, mostly among the world's poorest, unwittingly buy fake medicines

that often contain no

active ingredients

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 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.

A survey in Laos revealed that two out of three pharmacists and four out of

five consumers didn't

know fake drugs existed

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 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.

One recommendation is to subsidise real versions of drugs so that they price

counterfeiters out

of the market

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.

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 Kline

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.

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. "