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Emerging danger

No longer do lifestyle drugs remain the sole attraction for counterfeiters targeting the UK

A story did the rounds in the press, some years back, of an elderly lady who had been walking her dog in a park when she was mugged; the thief (a pretend dog-walker) making off with her handbag.

When the police enquired as to the nature of the stolen bag's contents, the victim apparently beamed and noted that, as chance would have it, on that particular day it had contained practically nothing, except for one of those poop-a-scoop devices which had been deployed earlier and hence was very much full of 'contents'. Now that's comeuppance.

In a similar vein, one might forgive the attitude that it could be just as deserving for anyone involved in counterfeiting medicines to be attacked in the park by a schizophrenic whose fake medicine (unbeknown to them) was under-strength, essentially ineffective and consequently highly dangerous. Sadly, this scenario is not metaphorical; unlikely maybe, but the threat is absolute.

Much has been written about counterfeit medicines weaselling their way into the hands of UK pharmacists and patients; however recent events have taken the Medicines and Healthcare products Regulatory Agency (MHRA) and the pharma companies it protects to tipping point, in terms of the need for measures to interfere with counterfeit production mechanisms, enhance identification capabilities and remove some of the impetus driving the 'demand'. This latter point concerns initiatives to raise risk awareness among members of the public who choose to buy prescription-only medicines via the internet, which they do currently and increasingly for myriad reasons.

In addition, there is ñ certainly from the patient's point of view ñ the sickening development that counterfeiting is starting to permeate therapy areas which ought, by the rights of elemental moral probity, to be left sacrosanct. Within the last four months, spurious copies of Plavix (sanofi-aventis and Bristol-Myers Squibb's anti-platelet medicine), Casodex (AstraZeneca's prostate cancer therapy), Zyprexa (Lilly's antipsychotic for schizophrenia) have all for the first time physically, if unknowingly, been put into patients' hands by our country's regulated supply chain.

The emergence of fake 'lifestyle' drugs (though clearly erectile dysfunction and uncontrolled obesity, for example, are perceived as beyond the 'lifestyle' tag by sufferers) is appalling enough, yet the hazards imparted from phoney cancer, cardiovascular and neuropsychiatric medications reflects a darker, more profound level of turpitude rooted in an utter disregard for the value of life.

There's handbag theft for a few quid and then there's risking life for profit; both are detestable, but the latter is worth an 'eternity-class' perch on the middle prong of the fork of hell. In this life however, it is down to the MHRA, the police and the country's judicial powers to catch and prosecute those responsible ñ a job which has become significantly tougher during 2007, and which for a time will get still tougher.

Caught red-handed

"I'm confident that we'll get to the bottom of this," says Mick Deats, head of enforcement and intelligence at the MHRA, on the most recent, and most worrying violations. "We take the issue of counterfeits in the regulated supply chain very seriously, it's a huge priority and that's why you've seen immediate police and legal action in relation to the recent incidents."

Pharmaceutical Marketing spoke to Deats in November last year, when he expressed satisfaction that legislation was sufficiently strong and his team at the MHRA, several of whom are ex-police staff, were geared up to tackle the counterfeits problem head on. Progress made in seeking the prosecution of those behind the practice includes a trial, running since January 2007 at Kingston Crown Court, of nine individuals. It is anticipated to draw to a close fairly soon, but continues currently.

We also have a number of trials coming up later this year of individuals that have been involved in the supply, or insertion, of counterfeits into the UK supply chain, and in relation to the latest incidents [Plavix, Casodex and Zyprexa] three people have been arrested so far. We've also had a wholesaler licence suspended in connection with that enquiry.

He adds: This is being investigated thoroughly. We're working with our counterparts all over Europe, and wider, where excellent co-operation takes place in these investigations.

On November 22 2007, the MHRA will host the Combating Counterfeit Medicines Seminar in London, where international medicine regulators, law enforcement personnel, pharmaceutical manufacturers, wholesalers and patient safety groups will hear experts explain the UK strategy and how it dovetails with international efforts. This is the largest event of its kind undertaken by the MHRA and shows gravitas as efforts in the counterfeit battle are ramped up. The UK is a lucrative market for counterfeiters, and though we had planned to do a seminar before the recent incidents, I feel that it's even more important to do so now, admits Deats.

Removing online impetus 
The focus of most current anti-counterfeiting strategies, however, is aimed at the online market, where Joe Public can buy his prescription medicines from the comfort, and danger, of his own home. To those in and around the pharma industry, plus actually most people in the country, this is tantamount to leaping from an aeroplane wearing a parachute bought online and delivered 'ready for use'. No-one checks the parachute before it's too late, the jumper simply hopes it'll be okay because the website said it would be. You couldn't possibly trust it; yet, people do.

We've done a lot of work on the internet side of the issue. We've been carrying out operations, we've had the media with us several times a year, international counterparts have also come over to observe the action we take against counterfeit drug websites and those running them, says Deats.

Websites have been shut down, products seized and people prosecuted. Civil action has been taken against the perpetrators, who typically end up with the minimum of a caution, though ñ where evidence is sufficient ñ they frequently get the opportunity to see the inside of a court room.

Yet the key question remaining is surely this: how can the impetus behind people buying prescription-only medicines online, and hence the 'marketplace' and main inlet for fake products to be introduced to the UK, be diminished or even eliminated? Without buyers, the peddler's core raison d'etre becomes null and void.

Reports have suggested that up to half of all Viagra samples sourced from the internet are counterfeit, so if we could eliminate the impulsion to buy online, would it not serve to pull the rug out from under a notable part of the enterprise?

What about a public awareness campaign, which goes beyond the odd article written by the broadsheets ñ which in any case focus notoriously not on the message to patients but on the perceived weaknesses in the regulatory system and the figures behind the business of counterfeits? Something like a printed patient information leaflet that is distributed through doctors' surgeries, or even an awareness campaign through the media.

We have considered that [printed leaflets] says Deats, and it may be something we need to consider again in the future. The idea of talking directly to people through a television or broader media campaign might be too easily dismissed, due to concerns over cost and production time. Yet consider the current 'It's 30 for a reason' campaign against speeding in residential areas. It makes a powerful impact on television and while it cost GBP 2.1m (partly because it uses special effects technology and is aired at prime time), it would be possible to deliver a simple message at a fraction of that cost, maybe on the radio or through another direct-to-public communication medium, paid for with funds from a special MHRA pot into which every stakeholder in patient welfare and anti-counterfeit efforts had contributed.

If only 100 contributors split the cost, even GBP 2.1m becomes a manageable GBP 21,000, while in the case of an anti-counterfeits communication there would be no requirement to spend anywhere near that much in the first instance. Indeed, what price, or value, can you put not only on the safety of patients but also on the restoration of trust in the regulatory system and UK pharma?

Technological safeguards
Coupled with talking openly to the public about the dangers of procuring prescription medicines online, technology plays a crucial role in the physical prevention of counterfeit products penetrating the regulated, offline supply chain. Discussion of which technologies are effective and provide an appropriate benefit for the spend is currently prolific, with radio-frequency identification (RFID) technology and 2D barcoding at the centre of debate.

Identification of a fake drug by visual examination alone is now almost impossible, even for experienced wholesalers and prescribing doctors who handle medicine packs every day of their working lives. Without a forensic inspection, few clues exist in the search to confirm authenticity. There may be something odd in the taste or smell of the medicine, or the way in which a tablet breaks up when crushed that might indicate changes from the manufacturer's intended composition. It is a grey area, however, which is why many pharma firms employ a tiered security system, protecting best the products in their portfolios most attractive to counterfeiters ñ ie, widely prescribed international products, popular 'lifestyle' medicines and those generating high revenue.

In the absence of an official list of 'approved' security technologies for pharmaceutical products, RFID seems to be at the fore of discussion. We were the first pharmaceutical company to implement a comprehensive RFID technology programme in the US early last year, by shipping Viagra which incorporates a passive radio frequency device encoded with a unique electronic product code into its packaging, a Pfizer spokesperson explained. This allows pharmacies and wholesalers to authenticate our original product and, eventually, may enable the ability to track and trace products throughout the US distribution channel to the pharmacy level.

This move has elicited strong support from the Food and Drug Administration (FDA) as a means of deterring counterfeiting, and Pfizer is currently extending the RFID programme to incorporate its painkiller, Celebrex. The company has, like others, introduced more sophisticated 'tamper-evident' packaging on products in Europe, and sees the European Federation of Pharmaceutical Industries and Associations (EFPIA) proposal for a 2D barcoding technology an an effective solution.

The MHRA says it has no plans to work with the Department of Health in whittling down a list of rubber-stamped technologies that might be applied universally. Deats notes: There isn't any agreement for regulating and stipulating the route to take in that regard, but there's a lot of debate, particularly about RFID. We're interested in it, but there's now a much wider debate on whether that technology is ready, and whether it will be able to do what's required of it.

Seal of safety

In September 2007, a nationwide programme is expected to be rolled out whereby all online entities claiming to be trustworthy e-pharmacies will need to display a logo on the site which will attest to consumers the integrity of their credentials. Following a successful 20-pharmacy pilot, the Royal Pharmaceutical Society of Great Britain's (RPSGB) internet pharmacy logo will appear on all bespoke online pages.

There will be no point in fakers duplicating the design as the logo is interactive, clicking through to the authorised registration information for a particular online medicines supplier, as verified by the RPSGB. Inclusion in this list denotes that an online operation is bound by the same code of ethics that govern the day-to-day running of standard, bricks and mortar, high street pharmacies. To support the extension of the programme around the UK's online pharmacies, a national media/public awareness campaign will begin early in 2008.

There are so many online pharmacies now that the public isn't sure what's legitimate and what's not, says the RSPGB. [With the new logo,] consumers will have a safer way to buy, knowing that medicines are coming from a registered pharmacy.

Overall then, will we see a successful pincer movement deployed to bring counterfeiting to its knees before it escalates still further? The combination of new security technologies plus, notably, the benefits to be gleaned from a high-profile public awareness campaign, might diminish both the opportunity and ability for counterfeiters to operate. We wait also to see what becomes of those caught and prosecuted by the authorities. With luck, the judicial system will send them down and make an example of their conduct as a strong deterrent to others. If we don't get them in this life, a white-hot poker hopefully awaits them impatiently in the next.

The Author
Rob Skelding is a freelance pharmaceutical and healthcare journalist

9th August 2007

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