Mark Townsend, crime correspondent
The Observer, Sunday 4 January 2009

Counterfeiting gangs based in China are producing sophisticated copies of the world’s bestselling pharmaceuticals. In 2008 an estimated 8m of these potentially deadly pills found their way to NHS patients. The health of millions of people is at risk

They were made in China, labelled in French and then shipped to Singapore. They ended up in Liverpool and from there were sold straight into the heart of the NHS. As the criminal investigation continues into how a fake consignment of Zyprexa, an anti-psychotic treatment prescribed for schizophrenia, infiltrated Britain’s healthcare system last year, evidence is mounting that sophisticated counterfeiting syndicates are increasingly targeting Britain’s network of high-street chemists, hospitals and GP surgeries.

Figures collated for the first time reveal that British border officials seized more than half a million counterfeit pills destined for the NHS and high-street chemists last year, an amount equal to the quantity of counterfeit drugs found in the whole of Europe in 2005. So vast is the scale of the threat from fake medicines that public confidence in the NHS could be "completely undermined", according to legal experts. Health officials also warn that the health of millions of Britons is potentially at risk.

More than £3m of fake life-saving medicines for ailments such as heart disease and cancer were intercepted by customs officials and the Home Office border agency in the first 10 months of 2008. Three consignments were each larger than 100,000 pills.

In response, customs has upgraded tackling the trade in fake medicines to "high priority", the same urgency devoted to targeting heroin and cocaine dealers. Interpol recently revealed it was investigating reports that profits from counterfeit drugs are funding terrorist groups, including al-Qaida. Others warn that smuggling counterfeit drugs into Britain’s healthcare network could prove to be a terrorist weapon in itself.

Read the rest of this article on fake drugs in Britain.

by Jeremiah Norris

Ministers at the World Health Assembly in Geneva next week will be spending unprecedented amount of money for fighting diseases in Africa. The US Congress has just committed $50 billion over the next five years to combating HIV/AIDS, TB and malaria, while the Global Fund for these diseases will probably add $25 billion. This is a lot of money and a lot of talking. But what won’t be discussed is the fact that many of the drugs that will be bought will end up doing AIDS, TB and malaria patients more harm than good.

Part of the problem in poor countries is the alarming amount of fake drugs . In 2007, the WHO reported that 30 per cent of all medicines sold in Africa were counterfeit, "killing thousands". An Indian pharmaceutical association said this week that 20 per cent are fakes in India itself while the OECD says India supplies 75 per cent of the world’s fake and sub-standard drugs.

The WHO established the International Medical Products Anti-Counterfeiting Taskforce in 2006. The problem, however, is not limited to outright fakes. IMPACT needs to turn its gaze towards sub-standard drugs manufactured in Africa and Asia that rarely meet the very high standards of safe and effective medicines. Nor are they tested by independent regulatory authorities.

If an AIDS, TB or malaria drug is sub-standard, it allows the virus to mutate and drug resistance to develop. This will eventually make the drug useless for the entire population and even fatal.

The outrage is that the Global Fund and WHO have been knowingly promoting sub-standard drugs.

When procuring drugs, the Global Fund follows WHO guidelines so the Fund’s "Option C" rule allows the procurement of drugs that have not been reviewed and tested by a credible regulator (such as the US Food & Drug Administration). These are "investigatory" drugs, which no doctor in a rich country would ever prescribe because of the risk to patients and of drug resistance.

When the WHO and the Global Fund approved Option C, they reasoned it would allow them to buy from mainly Indian companies at a cheaper rate than branded generic (copied, off-patent) and patented drugs.

But what they skimped on price, they lost in quality: According to a February 2007 report by the Global Fund, half the drugs purchased under Option C did not comply with the Fund’s Quality Assurance Policy.

Read the rest of this article on what is being done to combat fake drugs here .

Millions of patients worldwide are swallowing pills that are either substandard or fake and this can kill them.

This warning comes from the World Health Organization (WHO) that recently called for an immediate global action against the growing epidemic of fake and substandard medicines that are flooding the market, silently killing millions of unwary consumers in the process.

WHO said this problem is present in all countries, especially those with weak drug regulation control and enforcement. In the United States alone, the Center for Medicines in the Public Interest projects counterfeit drug sales will reach $75 billion in 2010, a 92 percent increase from 2005.

The problem with fake generic drugs is that they often fall short of their brand name counterparts since they lack the proper clinical studies showing their safety and efficacy. In the past, generic products were not required by law to be tested for bioequivalence and therapeutic equivalence, posing a threat to consumers. In the rush to save money, patients often purchased these products without considering whether they worked or not.

"We see this happen often because there are many generic drugs in the market and we’ve heard patients complain that they aren’t benefiting from one generic drug to another," according to Dr. Ricardo Fernando, a diabetologist and president of the Institute for Studies on Diabetes Foundation.

To determine its bioequivalence, a generic drug is tested for its bioavailability or the rate and extent of the drug that reaches the general circulation from an administered dosage form. Ideally, generic drugs should be bioequivalent and therapeutically equivalent to the branded products before they can be substituted for the latter.

Experts say that while generic drugs may be pharmaceutically equivalent, they aren’t necessarily bioequivalent to brand name or innovator drugs since this can be affected by numerous factors like manufacturing techniques, the raw materials and other ingredients used, patient variations in absorption power, the pH (or acidity) of the gastrointestinal (GI) tract, the user’s age, sex, weight, disease status, and interactions with other substances including drugs and food.

Read the rest of this article on the problems associated fake drugs .

The deadly scourge of fake drugs: counterfeit drugs, which are not only ineffective in treating illnesses but can and do actually kill patients, now form 25% of all medicines in the developing world. The menace is increasing in Africa, as Tom Nevin reports.

According to the World Health Organisation (WHO), 25% of all medicines in less developed countries (LDCs) are counterfeit. In some countries, the prevalence is far higher.

The report Counterfeit medicines in less developed countries: problems and solutions by the International Policy Network’s (IPN) executive director Julian Morris and health programme director Philip Stevens says the majority of counterfeit medicines originates in LDCs, including the bogus drugs that end up in the US and European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . “Much of the debate surrounding counterfeit medicines to date has focused on how to prevent them seeping into the supply chain of developed country markets,” they say.

Statistics assembled by Morris and Stevens make frightening reading:

* Counterfeit medicines comprise 40% to 50% of total supply in Nigeria and Pakistan

* Some products in China have a counterfeit constituent of 50% to 85%

* Some 37% of antibiotics and anti-malarials on the WHO essential drugs list in Nigeria and Thailand are substandard

* A recent survey by the WHO of seven African countries found that between 20% and 90% of all anti-malarials failed quality testing.

“In spite of a lack of hard data, it is clear that counterfeit medicines are not confined to a handful of therapeutic classes,” the IPN researchers say. “This is especially true in LDCs where the range of fakes on the markets encompass treatments for a diverse range of conditions and ailments.” The top five counterfeited medicines in the Philippines, considered representative of the global trade, are blood pressure tablets, anti-asthma drugs, analgesics, anti-diarrhoea treatments and vitamin pills. Other favourites for counterfeiting include drugs for treating anaemia, HIV, schizophrenia and growth promotion hormones.

Such medical consumables as non-sterile syringes and gauze, and even substandard electronic medical equipment are also on the counterfeiters’ list.

Read the rest of this article here.