The Twilight Zone

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Classified drugs, which are potentially dangerous and liable to abuse, have legitimate uses but also turn up on the black market. What does this mean for industry – and how has the internet affected this problem?

Take a look at any list of ‘drugs’ banned in the context of recreational use – or more accurately, abuse – noted by the Home Office, social services or avant-garde novels. They fall into three categories. Drugs made from natural sources – marijuana, opium and magic mushrooms. Synthetic drugs that have no medical function – ecstasy (MDMA) is the classic example. And drugs that have been patented by pharmaceutical companies and released for medical use – that’s all the rest.

Heroin, cocaine, amphetamines, tranquillisers, barbiturates – you name it, doctors have prescribed it and addicts have taken it, with or without prescription, and often with bad consequences. In the past, many psychoactive drugs were shifted from medical sources to the black market via theft or bribery. Today, they are more likely to be manufactured in secret labs in Latin America, the Far East or that odd little house in your street with the blacked-out windows. You might be surprised at how strong the UK pharmaceutical manufacturing base really is.

You may wonder why that’s a problem for industry. When you’re talking about drugs that affect the nervous system – killing pain, inducing sleep or keeping people awake – the subjective factor is important. If a patient knows the drug they get on prescription is also available on the street corner, they may react in various ways. They may decide, on the basis of news or hearsay, that the drug is too dangerous to take. Alternatively, they may decide they want more of it than their GP will provide – and their friends want some too. Either way, the drug’s value chain gets tangled up with barbed wire. It’s not your fault, but that doesn’t mean it’s not your problem.

Two recent events reflect the pervasiveness of this issue. Firstly, the Advisory Council on the Misuse of Drugs recommended that the painkiller tramadol should be made a Class C drug – with penalties of up to two years for possession and 14 years for supply. Tramadol has both opioid and antidepressant properties, making it a potent euphoric but increasing the clinical dangers of overdose.

Secondly, Roche took Valium off the market after fifty years of iconic status as ‘mother’s little helper’. Forty years after patent expiry, the black market had finally pushed the brand into the red.

The only chemistry

The UK’s classification system for ‘dangerous drugs’ is based on the Misuse of Drugs Act 1971, which gave the Home Offie a role in drug licensing by defining the boundaries between legitimate and illegal use of medicines. The Act defined four types of drug crime: unlawful possession; possession with intent to supply; supplying, even if no money changes hands; and allowing your premises to be used for producing or supplying a controlled drug.

The Act also divided controlled drugs into three classes in terms of the penalties for illegal use:

• Class A – up to seven years’ imprisonment for possession, up to life imprisonment for supply

• Class B – up to five years’ imprisonment for possession, up to 14 years’ imprisonment for supply

• Class C – up to two years’ imprisonment for possession, up to 14 years’ imprisonment for supply

An unlimited fine can be imposed instead of, or in addition to, any of these sentences. The law is designed to come down most heavily on illegal manufacturers and suppliers – in other words, the people doing illegally what you do within a legitimate business framework. In practice, of course, it’s mostly the end users who get caught, tried and jailed.

Down at the doctor’s

What should pharmaceutical sales professionals keep in mind when working with controlled drugs? I won’t insult your intelligence by telling you not to break the rules. It’s the things that can happen that aren’t your fault you need to worry about.

Doctors and pharmacists have strict guidelines about using only legitimate suppliers. However – as the recent scandal of counterfeit cancer drugs being found in US pharmacies proved – the pressure to use cheaper suppliers means the audit trail of many drug supplies is extremely complex. If the drug is a controlled one, the threat of illicit sources to the supply chain is much greater.

It’s important to distinguish between ill-effects of drug abuse and potential side effects of legitimate drug use. The negative impact of abuse on a drug’s reputation is considerable – and, in addition, studies of abuse provide genuine insight into the risks and benefits of a drug. So be prepared for that side of things to make your discussions with customers more complex – maybe more difficult, but also maybe more fruitful if you’re well informed.

The internet has made the supply network for illegal drugs both more diverse and more immediate. The user can access a global black market without needing to hang out in dangerous places or carry cash. Every bedroom is a car park now: the black market in drugs has no limits as regards time, place or who is involved.

Be aware of security issues. Andrew Bolan at ABPI comments: “All activities related to the legitimate manufacture, distribution, supply and storage of controlled drugs are subject to the regulations made under the Misuse of Drugs Act. All actors in the legitimate supply chain will hold the appropriate licences and have the necessary facilities and systems to ensure the secure supply of these products to patients, and all these elements are subject to scrutiny and control by the appropriate authorities.

“While every effort is made via these systems to prevent the illicit diversion of these products, the issue of theft is a concern and, despite the best efforts of all in the supply chain, there will always be a risk of such events. The pharmaceutical industry is always willing to work with other partners in the supply chain to seek to enhance the already high level of security that is applied to the movement of controlled drugs.”

Blues run the game

One of the great blockbuster drugs, Valium (diazepam) helped to make Roche a leading global pharma company. While known primarily as a tranquilliser, it has also been used as an anti-convulsant, a muscle relaxant and an anti-depressant. The brand’s popularity among the general public as a means of coping with stress earned it the nickname ‘mother’s little helper’, and kept Valium on the market for forty years after its patent expiry.

However, the addictiveness of Valium soon became notorious, with some experts arguing that it induced serious physical dependency. This, combined with the emergence of SSRIs as more successful anti-depressants, led to diazepam being increasingly used only for short-term sedation, where branded Valium had less commercial traction over generic equivalents.

But users – in both senses – rush in where doctors fear to tread, and ‘blues’ are now a staple of the illegal drug world. Their widespread legitimate use has helped to fuel an illegal supply chain via many forms of theft and fraud. While Roche gave the long-term effect of patent expiry as its reason for taking the brand off the market, it would appear likely that a fuller explanation lies both in Valium’s dwindling legitimate market and in its rapidly growing online illegal market.

Diazepam tablets that look like Valium, thus retaining elements of brand appeal, are being marketed by MSJ Industries, a subsidiary of the Sri Lankan manufacturer J.L. Morison Son & Jones (Ceylon) PLC. Stamped ‘MSJ’, they are legitimate pharmaceutical products, but are being diverted to the black market – where they are known as ‘MSJs’, ‘vals’ or ‘blues’ – in large quantities.

As an example of the information available, Pf found an easily accessible online forum with a thread titled ‘MSJ blue pills (Vals?)’, featuring comments from people around the UK. One forum member offered to supply MSJs at the remarkably cheap rate of £20 for a hundred 10mg pills, or £80 for 500. Others commented:

• “I took two of them last night meaning it should have been a 20mg dose. But these two I took sent me well off.  It was like I had just taken 60mg or something. Couldn’t move.”

• “the msj are from sri lanka mate. they are the real mccoy. due to no standards and/or no quality control means that some msj tabs have 8mg-28mg per pill. i hope this helps you.”

• “msjs are the best valium about beat roche hands down”

 These words leave you wondering what ‘controlled drugs’ really means. For the pharmaceutical industry, that’s not a comforting thought.