Bad medicine

The global counterfeit market is booming. From handbags to make-up, clothing to medicines the art of counterfeiting has become so sophisticated that counterfeits are often indistinguishable from the real thing. Counterfeiting medicines has become a truly global phenomenon and represents a huge threat to us all. The World Health Organisation (WHO) estimates that up to 10% of the worlds pharmaceuticals are now counterfeits. Counterfeit medicines are designed to deceive and defraud. Unlike clothing, shoes and handbags, counterfeit medicines pose a huge risk and can cause loss of life and injury to its victims. Per year it is estimated that 500,000 people die from counterfeit drug use (WHO). In 2013 in the UK MHRA announced that it had seized £12.2 million of counterfeit and unlicensed medicines and over £26.8 million globally in a week long counterfeit medicines campaign. The issue has become so serious that the MHRA has launched several campaigns such as Operation Panagea to try and target the serious network of criminals that mastermind this complex pharmaceutical fraud. The WHO approximates that counterfeit medicines can be sorted into six groups.

1. Products without active ingredients 32%

2. Products with incorrect quantities of active ingredients 20%

3. Products with wrong ingredients 21%

4. Products with active ingredients but fake packaging 15.6%

5. Copies of an original product 1%

6. Products with high levels of impurities and contaminants 8%

It used to be mainly lifestyle drugs such as Viagra® that were counterfeited but nowadays life saving medicines are being counterfeited too. The WHO reports that the commonest pharmaceuticals counterfeited are hormones, antibiotics, analgesics, steroids and antihistamines as well as lifestyle drugs such as Viagra®, sleeping tablets and antipsychotics. The internet is largely responsible for the huge increase in the counterfeit pharmaceutical trade. The faceless, anonymous medium that the internet presents means that the criminals who are behind the fraud are often protected because they cannot be traced or found. The internet offers a low risk trading place for drugs and medicines where bogus pharmacies and distributors can masquerade as genuine traders.They do so by making themselves look genuine with pictures of pharmacists and stethoscopes, with local phone numbers and addresses. Yet the stark reality is that many are unauthorised traders who sell knock off and counterfeit drugs at discounted prices. They import these drugs from various parts of the world and provide no back up or customer service if anything goes wrong. So why have the general public been happy to buy medicines off the internet? Why do people take such risks? When surveyed, people who brought counterfeit medicines cited the following as their reasons.

1. The internet provides easy access to online medicines

2. They thought the counterfeit medicine was the same as the genuine product

3. It took too long to wait to see a doctor/medical professional

4. They could not afford the genuine article

5. They wanted to be in control of their own medicine supply

6. They didnt want to tell their healthcare provider

Counterfeit medicines are big money. They are easy to make, low risk and vastly profitable. Counterfeiting a drug can be as simple as merely compacting talcum powder and printing a label. And because the penalties are low and the risk of being caught also low, there is no real deterrant. At least if you get caught dealing heroin or cocaine there is a hefty prison sentence to face, or worse still the death penalty. With counterfeits the sentences are short and the risk of being caught pretty low due to the protection afforded by the internet’s anonymity. The UK is a vulnerable market as our medicines are comparatively expensive. A medicine costing a few pennies to make can be sold in the UK for 20-50 times as much. The MRHA had a case recently where 100,000 of a Chinese counterfeit product that cost 25p to make were being sold in the UK for £20 each, a net profit of £1.6million. Cases like this are numerous. 10 years ago counterfeiting was mainly a problem for the developing world. Now it is a truly global problem and one that the UK cannot afford to ignore. The WHO estimates that counterfeits represent nearly 10% of worldwide pharmaceutical sales.

HOW DANGEROUS ARE COUNTERFEIT MEDICINES?

In China it is thought that between 200,000 and 300,000 people die per year either directly due to contaminants in counterfeit medicines or due to lack of active ingredients. The WHO recently estimated that 200,000 of the one million malaria deaths worldwide would be prevented if the drugs used in all cases were genuine. In 1995 fake vaccines killed 2,500 people in the meningitis epidemic in Nigeria. In that same year in Haiti 89 children died as a result of bogus paracetamol syrup that contained cheap, toxic diethylene glycol. But deaths aren’t just limited to developing countries. In Canada a lady died in 2006 after taking fake Zolpidem purchased over the internet. The pills were found to have arsenic, selenium, aluminium, uranium and strontium in them. And in the US in 2004 a gentleman in Chicago bought the anxiety drug Xanax and the painkiller Ultram. He apparently took one of each and woke up three weeks later in hospital having suffered a heart attack and having sustained brain damage. The “Xanax” had four times the amount of active ingredient it was meant to. So far deaths from counterfeits in the UK have been not reported. However many people suspect that this is just a case of lack of knowledge or underreporting and that the problem could exist. Studies from Liverpool University suggest that one in 16 hospital admissions are due to adverse drug reactions. But nobody knows if some of these could be due to counterfeits. What we do know is that counterfeit pharmaceuticals have frequently slipped into the UK legitimate supply chain. Since 2004 there have been 12 cases of recall of medicines where clear evidence has been found that fakes had entered the UK pharmacy and patient supply chain. Drugs included in the MRHA recall were Lipitor, Plavix (anti-paltelet drug), Reductil (obesity drug), Cialis (erectile dysfunction medicine) and Zyprexa (anti-psychotic). The MRHA has a watch list that it publishes of at risk medicines and it works in collaboration with the Royal Pharmaceutical Society to conduct random spot checks at pharmacies and distributors to try and stop fakes making it into the legitimate supply chain. But the real problem is that counterfeit drugs have low police priority, fraudsters face low penalties and the problem is really much larger that we think.

COUNTERFEITS IN AESTHETICS

Perhaps the biggest example of fraud in the aesthetics industry was the PIP scandal of 2010 where there was a violation of regulations by the company who produced the PIP resulting in inferior quality silicone implants entering the supply chain. This was a deliberate attempt to defraud the medical industry by those that knew that the quality of silicone being used was potentially dangerous. 47,000 British women were thought to have had the faulty non-medical grade silicone implants. This was the biggest scare to date for the aesthetics industry and brought about significant questioning into the lack of regulation for cosmetic procedures. Less well publicised but also alarming was the Tritox fake Botox® scandal in the USA. In November 2004 in Florida four individuals almost died after receiving research grade botulinum. They believed they were purchasing Allergan’s Botox® from the medical clinic that they attended. At the time Allergan’s Botox® was the only toxin that was FDA approved in the US. Instead of Allergan’s legitimate Botox®, they actually received a research grade toxin called Tritox that was not suitable for human use. Soon after their injections they developed symptoms of botulism and all four ended up in hospital with symptoms of muscle paralysis. Fortunately they all survived but it led to a huge investigation by the FDA into the persons behind the Tritox company and the 350 doctors and practitioners that knowingly administered the wrong drug.

The distributors of Tritox were sent to jail for six and nine years respectively and the numerous physicians who administered this fake Botox® to over 1,000 patients were fined heavily, had their medical licenses revoked and some served prison sentences. Botulinum toxin is one of the deadliest substances known to man and in its pure form has been grouped with some of the worlds most lethal biological weapons such as anthrax, smallpox and the plague. The masterminds behind this pharmaceutical fraud served time in jail and paid enormous fines because they put over 1,000 people’s lives at risk and profited $1.5million personally from their fraud. Another commonly abused medicine in our industry is hydroquinone. Although it is not technically a straight forward counterfeit issue there is a huge black market for skin lightening creams both in the UK and globally. Hydroquinone is FDA approved in low doses i.e.4% for short-term use under a physicians guidance. However, it is frequently found in over the counter skin lightening creams and is (as a consequence) frequently and often unknowingly abused. In 2000 Hydroquinone was banned from cosmetic creams in the UK. The problem now is that many skin-lightening creams contain hydroquinone but just don’t list it. Around 10-15 million skin-lightening products are sold annually with Japan and parts of Africa being the biggest consumers. Some of these creams contain hydroquinone in high doses but the ingredients are often not listed. This is a huge concern as it simply means that the problem becomes invisible, which is a much more dangerous situation indeed. Unfortunately there is a general assumption that there is some truth in labelling but this is a false assumption for the skin lightening market. Potent steroids such as clobetasol have also been found in numerous over the counter cosmetic skin creams. When applied to the face daily these can thin the skin. But bootleg versions are available all over the UK and around the globe.

SO HOW CAN WE STOP THE PROBLEM OF COUNTERFEITS?

The first thing is to be aware of the counterfeit issue. As physicians we have a duty to protect our patients. We can help educate them about the dangers of internet buying and help them seek out genuine stockists and providers. We can also help patients to report any fake or counterfeit products purchased online by directing them to the MRHA website. The counterfeit problem is a growing one. MRHA, the FDA, Interpol and the pharmaceutical giants such as Pfizer and Eli Lilly are all investing heavily in the fight against counterfeiters. It is not something that can be tackled overnight but awareness is the first step to bringing down the pharmaceutical fraudsters that think nothing of selling the pills that can kill.