A BBC investigation has exposed nine London pharmacies that sold prescription-only drugs, including powerful sedatives, for cash.

Undercover reporters were sold sedatives (Valium and temazepam), opiates (Oramorph), antibiotics (amoxicillin) and Viagra for much higher prices than the cost of a prescription.

The BBC’s Inside Out programme has led to calls for stronger controls over pharmacies, which legally can provide such drugs without a prescription only in an emergency.

The easiest of the drugs to obtain by this illegal route were Valium (diazepam) and amoxicillin.

All of the illegal drug sales provoked concern from medical experts:

• Diazepam and temazepam are highly addictive and fatal overdoses are common.

• Oramorph (a bottle of which was purchased by a journalist for £200) is a potent oral form of morphine.

• Antibiotics are widely over-used, leading to poor patient response and the development of antibiotic-resistant disease strains.

• Viagra is dangerous for patients with cardiovascular disease.

Sedatives such as Valium are not controlled as strictly as opiates, but are widely linked to addiction, abuse and overdose.

There is concern that the overlapping regulatory roles of MHRA and the General Pharmaceutical Council (GPhC) may be leading to poor control over some widely prescribed drugs.

The GPhC has the power to cancel a pharmacist’s right to practise, but does not compile a list of pharmacies known to have sold drugs illegally.

In the first of a new series Pf editor John Pinching prescribes a double dose of feature films in which pharmaceuticals have made memorable cameos. This month the line up includes a daft hospital caper and everyone’s favourite heroin addiction yarn.

Trainspotting (1996)

The goodwill, joy and relentless optimism of Danny Boyle’s momentous Olympic opening ceremony made Trainspotting seem like a distant memory – a brilliant germ festering in the darker echelons of the director’s CV. This heroin laced, quintessentially Scottish gem from the mid-nighties remains Boyle’s masterpiece. It managed brilliantly to combine bold cinematic shots, with the raw intensity of independent films, while juxtaposing pure fantasy with sobering realism. The film’s primary focus is a group of heroin addicts, imprisoned by their all-encompassing addiction.

Its central protagonist, Renton, and his hopeless companions, ‘Sick Boy’ and ‘Spud’, will do anything to get a fix. If this means striking a deal with AIDS and cancer patients for their pharmaceutical drugs, then so be it. This insatiable appetite for weird drug cocktails prompted the following memorable piece of narration, “We took morphine, diamorphine, cyclozine, codeine, temazepam, nitrezepam, phenobarbitone, sodium amytal dextropropoxyphene, methadone, nalbuphine, pethidine, pentazocine, buprenorphine, dextromoramide chlormethiazole. The streets are awash with drugs that you can have for unhappiness and pain, and we took them all. Fuck it, we would have injected Vitamin C if only they’d made it illegal.”

Renton then insists that middle class consumers of pharmaceutical drugs, like his mother are, in their own “socially acceptable way, also drug addicts.”

As his habit reaches a nadir, Renton takes a massive overdose and ends up being revived in a destitute hospital corridor by exasperated and world-weary staff – a far cry from Boyle’s somewhat misty eyed NHS view this summer.

Carry on Matron (1972)

Granted, there haven’t been many hilarious comedies about the contraceptive pill, but this, is a notable exception. The ‘Carry On’ team’s usual highly sophisticated tapestry of innuendo, surfaces in the familiar surroundings of an NHS hospital and, naturally enough, medicinal madness ensues.

The man with ‘a face like an unmade bed’, Sid James, plays the ringleader of a hapless gang, intent on stealing medication and selling it on the black market (like the pre-internet equivalent of those nuisance ‘Viagra’ emails).

In order to infiltrate the hospital, and find out where supplies of ‘the pill’ are kept, Sid convinces his son, Cyril (Kenneth Cope) to masquerade as a female nurse. There are awkward consequences, such as being repeatedly molested by Terry Scott (Dr Prodd) and having to get changed in front of another woman. Eventually the scam is exposed by alert patients in the maternity ward. When threats are made to call the police, however, the gang finally reveal that Cyril is a man, and the feuding sides reach an agreement to keep their dirty secrets!

The film’s other notable performances come from Kenneth Williams – whose pomposity is matched only by the weirdness of Charles Hawtrey – and Hattie Jacques, who never tires of her role as ‘matron’. Meanwhile, Barbara Windsor, Jackie Piper and Valerie Leon provide the ‘skirt’.

The erectile dysfunction drug market is shaped by the parallel needs of consumers and industry, with both demanding faster and more reliable performance. Maxine Vaccine explores the fine line between medicine and desire.

This week’s most exciting drug news was the FDA approval for Stendra (avanfil) from Vivus: an erectile dysfunction drug that can take full effect within 15 minutes.

Stendra is the youngest and studliest member of the Viagra family (PDE5 inhibitors), all of which have generic names ending in ‘fil’. Whether that is a play on ‘phile’ (lover) or, more crudely, on ‘fill’ is a question for chemists. It definitely has nothing to do with Phil Mitchell.

The greater speed of action of Stendra prompted urologist Dr Ira Sharlip to make the slightly double-edged comment: “Quick onset of action is important to men.” He added that Stendra would appeal predominantly to ED sufferers “whose opportunities for sexual activity are more casual”.

The new kid in town has the classic side-effects of the PDE5 inhibitor family: headache, lack of sensation, insomnia. But it doesn’t have the rare side-effect observed with Viagra of blue-tinged vision – about which Dr Sharlip said:

“Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don’t care about it.”

Perhaps it just reinforces their sense of living in a blue movie.

But is the impatience of male patients to get it on resonating with the sales professional’s hard-on for the next customer – leaving the clinician as the odd one out in the commercial three-way?

Let’s be honest about this. ED drugs restore reliable sexual functionality to men in whom age and/or circulatory problems have made such functionality unreliable or impossible. They are clinically suitable for men who are in late middle age or old age or have certain medical conditions.

They are not clinically suitable for young and healthy men who want to have more sex for longer, to have sex while drunk or stoned, or to be able to make porn films or imagine they are doing so. Yet that is the natural ‘market’ driven by their brand positioning as performance-enhancing products rather than as medicines helping to restore normality.

The ambiguity of the Viagra brand – is it a medical product or a consumer sex aid? – is reflected in the online market that exists for stolen pills or counterfeit versions of the drug. Just how big is that market? Well, this week it was reported that British fraudster Martin Hickman has been ordered to pay back £14.4 million earned by selling fake Viagra online.

The investigation – one of the biggest ever undertaken by the MHRA – uncovered more than 30 bank accounts scattered around the world, with customers across Europe served via a website hosted in Germany but run by Hickman from his Staffordshire home.

The pharmaceutical industry makes no money from counterfeit drugs – and indeed, it loses custom since those customers will not seek prescriptions. But the question the industry has to ask itself is: does its brand positioning create images and expectations that help to drive a black market in fake drugs?

Remember: a sales rep can do it all night, but only a key account manager can make your breakfast in the morning.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Pfizer continued to suffer from generic exposure on its former cholesterol blockbuster Lipitor in Q1 2012 after overall sales and earnings both dropped.

Reported revenues fell 7% to $15.4bn and net income decreased by nearly a fifth (19%) after sales of Lipitor fell by almost half (42%) to just under $1.4 billion.

Ian Read, Pfizer Chairman and CEO, said he was “pleased” with the results after witnessing growth in “certain brands” and “key geographies”.

Biopharmaceutical sales decreased 8% to just over $13bn as revenue for Lipitor in the US dropped by nearly three-quarters (71%) to $383 million.

Sales of Prevenar 13 dropped by 6% to $941m, Xalatan fell by 42% to $227m with Novasc also recording a fall in revenue by 6%, compared to the same period last year.

The news was better for Lyrica up 16% to $955m, whilst Enbrel earned $899 million outside the US and Viagra generated a 6% rise in sales to earn $496m.

As a result of the losses, Pfizer has adjusted its revenue guidance for the full year from $60.5-$62.5 billion to $58-$60 billion.

Frank D’Amelio, Chief Financial Officer, said the adjustment reflects Pfizer’s recent $11.58 deal with Nestlé for its nutrition business. He commented: “We remain on-track to finalise a strategic decision for our Animal Health business this year and continue to expect that any separation of that business will occur between July 2012 and July 2013.

“Further, this quarter we continued to prudently allocate our capital by returning over $3.3 billion to our shareholders in first-quarter 2012, through $1.6 billion in dividends and $1.7 billion from the repurchase of 77 million shares.”

A new, more rapid-acting erectile dysfunction (ED) drug that is currently being assessed by the EMA has gained FDA approval.

Stendra (avanafil) from Vivus can take effect within 15 minutes, phase 3 clinical trials with over 1350 patients have shown.

The newest addition to the class of ED drugs that includes Viagra, Levitra and Cialis, Stendra is targeted more at patients who engage in casual sex.

The FDA approval is the first gained by US company Vivus, which has licensed the US marketing rights to Stendra from Mitsubishi Tanabe Pharma of Japan.

Stendra will be available in three doses, all of which have been shown to provide statistically significant improvements in erectile and sexual function.

Like other phosphodiesterase type 5 (PDE5) inhibitors, Stendra improves penile blood flow – but it offers a faster action than its rivals.

The drug’s side-effects are characteristic of PDE5 inhibitors: headache, flushing and cold symptoms. However, Stendra clears the body more rapidly than other drugs in its class.

Dr. Ira Sharlip, Professor of Urology UC San Francisco, commented: “Quick onset of action is important to men.” He noted that Stendra was likely to appeal most to ED sufferers “whose opportunities for sexual activity are more casual”.

A marketing authorisation application for Stendra was accepted by the European Medicines Agency (EMA) on March 26.
“The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED,” said Francesco Montorsi, Director of the Urology Research Institute in Milan, Italy.

“The comprehensive results from the development program suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market.”

Pfizer is working with a property consortium to fill its recently-closed Sandwich facility with life science companies.

The Discovery Park site, where Viagra was developed in the 1990s, will become an Enterprise Zone leased to multiple life science companies for R&D.

Pfizer itself will lease some of the facilities, where 650 of its employees still work following the closure of the main facility in 2011.

The site provides about 280,000 square metres of accommodation, including many specialist life science laboratories.

According to a Pfizer spokesperson, the company “has entered into a period of legal exclusivity with a consortium led by London & Metropolitan and financed by a major European institutional real estate investor for the sale of the Discovery Park campus in Sandwich, Kent.

“This announcement is a positive milestone in the transition of Discovery Park to becoming an R&D led multiple-use campus with Enterprise Zone status.”

Following discussions with London and Metropolitan, local Conservative MP Laura Sandys commented that the property consortium has a “very clear vision about having a strong life-science park that will attract people internationally”.

Another rainy January, another cold weekend – but if you’ve got some DVDs then you don’t need a friend. Maxine Vaccine offers her personal viewing list of classic films about prescription drugs and the pharmaceutical industry.

There’s no feelgood movie like a thoroughly bitter take on the industry you work for. After a week of board meetings (note to self: improve spelling), blue sky thinking, brainstorming, thinking outside the box and fighting to the death over the last Jaffa cake, nothing turns that frown upside down more effectively (or more cost-effectively) than punching the air as big pharma takes a left hook from the film industry. So on the way home, stop off at Blockbuster, the Chinese takeaway and the off-licence, then settle down for a long Friday night.

Here’s my recommended list of the top 10 films dealing with the drug industry, its products and its customers. I’ve listed them in chronological order so you can make up your own mind which is the best. Enjoy – and remember: love may be the most potent drug, but all the others have a better risk-benefit profile.

Dr Ehrlich’s Magic Bullet (1940) – controversial biopic starring Edward G. Robinson as Paul Ehrlich, the doctor who found a cure for syphilis. It’s thanks to the drug industry that we don’t still have the horrible diseases and fears of the Victorian age. And what thanks do we get?

Drugstore Cowboy (1989) – a bunch of addicts cut out the middle man and raid small-town pharmacies across the USA, coming up with more good ideas for off-label drug use than [that’s enough – HSP legal team].

The Fugitive (1993) – after his wife is killed, a man discovers he was the target for a drug company hit due to his exposure of its illegal marketing. Incredibly far-fetched and offensive to all right-thinking [that’s enough, no need to overdo it – HSP legal team].

Requiem for a Dream (2000) – dual narrative draws parallels between heroin traffic and the prescription of amphetamines to lonely housewives by crooked doctors drumming up business for the city hospital. Grim.

Prozac Nation (2001) – intelligent young woman finds her career derailed by depression. SSRIs may not be the answer, but they help her to start asking the right questions.

Equilibrium (2002) – in an oppressive future, emotion-numbing drugs are compulsory for all citizens. The title is a clue to this film’s target.

The Constant Gardener (2005) – a medical researcher and an aid worker try to blow the whistle on illegal drug trials in Africa, and are murdered horribly (believe me) at the order of a drug corporation. No comment.

Charlie Bartlett (2007) – cool kid sets himself up as high school therapist and sells prescription drugs to his classmates. Andrew Lansley’s favourite film (allegedly).

Love and Other Drugs (2010) – the yummy Jake Gyllenhaal displays his trademark big and lasting smile as a mid-90s pharma rep who breaks every code of conduct (including some you didn’t know existed) while selling Viagra.

Contagion (2011) – heroic doctors struggle to develop a vaccine that can save humanity from being wiped out by a deadly virus. American anti-vaccination conspiracy theorists didn’t like this film, though how they saw it through their tinfoil hats is a mystery.

Maxine has a very busy social life and lots of blogging to do, but could probably find a window on February 14^th if you’re at a loose end.

Santa’s little helper Maxine Vaccine offers some festive thoughts on the good, the bad and the ugly in the world of pharmaceuticals.

This week’s most eye-catching pharma news is that the leader of a Texan counterfeit drugs outfit who smuggled thousands of fake Viagra and Cialis pills into the US from China and sold them online was jailed for 13 months and ordered to pay $140,000 in restitution to Pfizer and Eli Lilly.

In the USA, Viagra pills are sold legitimately for about $20 each – but the bogus pills were sold for half that. However, they probably did work in the most literal sense. Bill Donnelly, Pfizer’s chief of anti-counterfeiting for North America, commented that drug counterfeiters “are more likely to put too much active ingredient” so that “people will buy it again”.

What the counterfeiters ignore is the regulatory framework that ensures product safety and consistency. Given that Viagra can cause violent headaches and nausea, and is dangerous for anyone with a heart condition, only an idiot would take even the real thing without a prescription.

But there are quite a few idiots out there. Over four million counterfeit Viagra tablets were seized worldwide in 2010.

Of course, you’re not an idiot, and there won’t be any counterfeit drugs in your Christmas stocking. But this is a good time to reflect on what the pharma industry does well and what it’s capable of getting wrong.

This year we’ve seen progress towards the development of a vaccine against HIV infection, while the impact of anti-retroviral drugs has seen rates of HIV infection begin to fall worldwide.

Intensive R&D in the cancer therapy field has seen the evolution of a long-term condition treatment model for a disease that, in previous generations, had few survivors.

The UK government has highlighted the potential of stratified medicine, using genetic analysis to develop targeted drugs, to transform healthcare and create major commercial opportunities for UK life science companies.

While the swine flu vaccine may, in retrospect, have been overused, it’s good to know that the industry came up with a rapid solution to what could in theory have been a much greater problem.

So why do thousands of people click ‘like’ at every scandal story involving a pharma company? If pharma were a person its Facebook relationship status would vacillate between ‘single’ and ‘it’s complicated’. What’s wrong?

For a start, before the advent of ‘designer drugs’ every illegal drug on the black market was developed as a pharmaceutical product. Heroin, amphetamine, cocaine, barbiturates, tranquillisers – they were all on prescription once, and some of them still are. Addiction is something the industry, the medical professional and the public are still learning about.

The Verve song ‘The Drugs Don’t Work’ was indeed about chemotherapy, not narcotics – and there’s another reason drug companies are unloved. Drugs don’t always work, because people and their diseases are not predictable. Every patient is unique, and we ignore that at our peril. Medicine is not about spreadsheets and statistics, it’s about the human body – which nobody can control.

The trouble with drugs is that people see them as quick-fix solutions to problems that have complex causes. Instead of recognising that any drug can affect only certain narrow chemical parameters, increasing this and reducing that, shifting the balance of a complex dynamic system, we continue to look for ‘magic bullets’. That’s as much a problem with patients and doctors as with suppliers – but we get the blame, and we may sometimes deserve it.

The pharma industry’s future doesn’t lie in more blockbuster drugs, in corporate branding, or in NLP. It lies in consultation and the sharing of knowledge, in open innovation, in honest engagement between professionals with different areas of expertise. Only bad sales professionals try to get around the customer’s knowledge. Good sales professionals engage with it and add to it.

Drugs are imperfect. People are imperfect. All we can do is make connections, identify problems and work together towards solving them. The more we can do that, the less pain there will be.

Or maybe I’ve just opened the sherry a few days early.

Have a great Yuletide break and I’ll see you next year.

Pfizer has won its battle against Teva Pharmaceuticals over the patent rights for Viagra.

The US District Court for the Eastern District of Virginia ruled in favour Pfizer in a patent infringement case preventing Teva from gaining generic approval of Viagra until 2019.

Amy Schulman, Executive Vice President and General Counsel for Pfizer, says it is important the court recognised “the validity and enforceability” of the patent.

Analysts recently predicted that extended exclusivity for the ED drug could raise earnings for Pfizer by 3% annually between 2013 and 2018.

Teva had planned to start selling a generic alternative of Viagra next year after one of Pfizer’s patents expired. But the Court’s decision, which is still subject to appeal, ruled that the exclusivity extends for another eight years.

Litigation against other generic manufactures hoping to exploit the same patent at Teva remain pending, Pfizer says, although no trials are scheduled in for these cases.

“Protecting the intellectual property rights of our innovative core is critical,” said Amy Schulman.

By Industry Insider

The portrayal of 90s pharma in the film 'Love and Other Drugs' has no doubt had many a compliance manager cringing on the edge of their cinema seat. Our man on the inside offers his thoughts.

I somehow knew that one day our noble profession would finally get the public recognition for the enormous contribution that our beloved industry, and us as drug reps in particular, make in improving the health of the nation!

Art definitely imitates life in Love and Other Drugs, the recent Hollywood release which ostensibly is a typical formulaic romantic comedy, but also gives a pretty accurate portrayal of the role of a drug rep working for Pfizer in the heady and unregulated days of the 1990s. The film is a loose adaptation of the book, Hard Sell – The Evolution of a Viagra Salesman with Jake Gyllenhaal in the lead role as Jamie Randall, a good looking and libidinous salesman who takes to drug repping like a duck to water!

Having been sacked from his job selling electrical goods in a retail outlet as a consequence of a romantic liaison with a colleague in the stockroom, we see Jamie secure a job as a trainee rep with Pfizer, via his brother who has some connections with the company sales management. It always has, and always will be, ‘not what you know, but who you know’. Nepotism has always been quite an important currency in pharmaceutical sales and probably always will.

We witness Randall’s Pfizer induction and his navigation through his training course, some corporate indoctrination, product training and role plays, concluding with him being given a sales territory promoting Zithromax and Zoloft in Ohio, but not before we see him sleep with the Head of Training which undoubtedly would have helped secure his sign-off with top marks!

His new territory buddy is Bruce, a real industry veteran and highly cynical career rep, who shows him the ropes in his fledgling career. It was these aspects of the film that I found both amusing and very representative. We see them driving round together, Bruce maniacally coaching him as they prepare to meet some customers at a local health centre and impress upon his student the huge importance of meeting his call rate and sales quotas. A final dose of encouragement from the old hand as they rummage in the boot of a car full of branded giveaways, and then it’s the blind panic of that first ever real doctor interaction by way of a car park call, as Jamie tries to accost a doctor with a Pfizer umbrella and pen whilst giving a couple of stilted and over-rehearsed product benefits.

This truly made me smile as I reminisced about some not dissimilar episodes from my past a long, long time ago, in some surgery car park, somewhere in the UK. The film’s resonance with me continued with scenes of a small living room of a flat, littered with box upon box of company literature and freebies – who hasn’t experienced this very real intrusion into one’s private space? As the film progresses we see Jamie rapidly develop in to quite an accomplished and highly successful drug rep, often through learning some harsh lessons of the job as he picks up the necessary ‘tricks of the trade’. The ability to schmooze a surgery receptionist by any means possible is certainly something he adapts to quickly, especially after he suffers the chagrin of sitting in a crowded waiting room and watching another rep waltz through with a few smooth platitudes to the lady at the desk and straight in to the doctor’s consulting room. His annoyance is compounded by the knowledge that the aforementioned rep is both his major competitor, the Prozac rep, and also is one of Lilly’s star performers.

As Jamie uses his undoubted charm and persistence he soon begins to break down the barriers and realise the power of good relationships with his customers and the importance of a very liberal attitude in giving out masses of samples to them as an inducement to prescribe. There are many scenes with him and other reps socialising with doctors in bars and restaurants and also we watch the hype and excitement as he and Bruce learn of the imminent launch of Viagra and the realisation that they could be about to sell a potential blockbuster and earn a lot more money in bonus. Naturally a few slightly clichéd scenes follow centring on jokes about erectile dysfunction, including Jamie himself taking a blue pill and suffering long-term effects. That said, I maintain that the film is amusing and pretty accurate and the leading actors play it well and Gyllenhaal is very credible indeed. It’s also a nice bit of free publicity for Pfizer.

This film is no Citizen Kane and will not get any Oscar nominations. I’m not a film critic, but I did enjoy Love and Other Drugs and I honestly feel anyone who ever has been, is currently, or wants to be a pharmaceutical rep, will too.

One final thought for you to ponder. I recent poll on the Pf website asks which decade was the best time to be a sales representative. When I last looked it was the 90s that had the most votes. I opted for this decade and if you watch this film, I think you might as well!