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.

The spread of a malaria strain that is resistant to artemisinin, the standard treatment, threatens a health crisis in the developing world.

First encountered in Cambodia in 2006, the drug-resistant strain has spread along the Thai-Myanmar border and threatens to spread to India and Africa.

The potentially disastrous problem has been blamed on incorrect use of artemisinin and on counterfeit and weakened versions of the drug.

According to a study published in The Lancet, researchers found that patients in malaria clinics in the affected region were taking longer to recover when treated with combination therapies containing artemisinin.

Artemisinin, derived from a plant source, is the standard treatment for malaria. Its use has resulted in a 30% drop in malaria deaths since 2002.

Professor Nicholas White of the Mahidol Oxford Tropical Medicine Research Unit at Mahidol University in Bangkok, Thailand, said that stronger action by governments and international health agencies was needed to protect the efficacy of this crucial medicine.

“We need considerable support for Myanmar, leadership, better intelligence,” he said. “It’s like fighting a war. We need serious financial support to contain [the drug-resistant strain] in this region, otherwise it is going to spread to India and Africa.

Artemisinin is “the treatment of choice throughout the world” for malaria, he said. “Compared with quinine, it reduces death by a third. We could lose that advantage.”

Malaria, a plasmodium infection spread by the Anopheles mosquito (pictured), kills more than 650,000 people each year. Prevention, rapid diagnosis and drug treatment are all essential for fighting the disease.

Most malaria deaths occur in sub-Saharan Africa, so the spread of drug-resistant malaria to that region could be, as The Lancet notes, “a public health disaster”.

Molecular analysis of the malaria parasites has shown that drug resistance is due to genetic changes. A new drug targeting the adaptive genome is theoretically possible – but preventing the spread of the drug-resistant strand is an urgent priority.

Professor Francois Nosten of the Shoklo Malaria Research Unit in Thailand commented: “Malaria already kills hundreds of thousands of people a year – if our drugs become ineffective, this figure will rise dramatically. If we were to lose artemisinin then we don’t have any new drugs in the pipeline to replace them. We could be going back 15 years.”

The rise in the generics market and the controversy over NICE’s alleged ‘bias’ against expensive new drugs are both signs that the recession is back and pharma is feeling the pressure. Non-generic blogger Maxine Vaccine asks whether the industry can stand the strain.

It’s been a hard month for the pharma industry. February is supposed to be about roses and champagne, but this year it was about closures and real pain. With Merck and AZ announcing job cutbacks and the generics market showing a marked increase, “you’re something special” is not something the industry or its representatives have heard much lately.

Generics are the drug industry’s equivalent of cover versions and remakes: the market is guaranteed and the overheads are low, what’s not to love? Well, frankly, what you save on R&D costs you lose on innovation credibility and the chance to make a medical impact. Even Shlomo Yanai is saying generics aren’t really where it’s at for his company – so it’s official: hitching a ride on patent expiry isn’t big and it isn’t Teva.

But with The X Factor churning out clones like there’s no tomorrow for the music industry (and that’s mostly because there isn’t), the day of the generic has come regardless of whether the industry feels good about it. Where respectable generic manufacturers aim at brand credibility and value-based pricing, some murky (but not Mercky) company in an obscure location will undercut them with cheap and nasty substitutes that have invaded the local formulary before you can say ‘austerity’. Think of it as payback for the CIA.

And as for counterfeit high-cost cancer drugs allegedly being made in Turkey and sold on to Egypt, then to Denmark, to Switzerland, to the UK and finally to clinics and pharmacies in the US... I may be wrong – I thought we said it couldn’t happen here? Face. Bothered? Yes.

And back home, we’ve got the two Sir Andrews – Witty and Dillon – squaring up like the ‘History Today’ professors over NICE’s alleged message to GPs: New cancer drugs? Just say no. Behind the polite sparring, the underlying sarcasm is unmistakeable. Both parties are saying: See that person who wouldn’t know value-based pricing if it wore a T-shirt saying ‘Here comes VBP’? That’s you, that is. But who sent who the Twitter message Back off or we’ll form a committee to modernise your face, our sources have been unable to determine.

After years of horrible fashions we’re about due another Mod revival. That underrated movement had the slogan Clean living in difficult times. That’s something we should all aspire to. In an ugly world, having (and deserving) a good reputation is vital.

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

The discovery of fake vials of cancer drug Avastin in the US has prompted a call by The Lancet for stronger international laws against counterfeiting.

The counterfeit vials of the Roche drug, distributed in the US medical system, contained various laboratory chemicals but no pharmaceuticals.

The case has revealed a complex supply chain involving wholesalers in the UK, Denmark and Switzerland, with a possible source in Egypt or Turkey.

According to the International Journal of Clinical Practice, such global supply chains have resulted in worldwide sales of counterfeit medications doubling between 2005 and 2010 to $75bn.

The Lancet has called for “a binding, international standard for criminalising the manufacture and distribution” of counterfeit drugs to be launched by the WHO and backed up with stronger regulatory oversight and control.

The MHRA, which is participating in the investigation, commented that the counterfeit vials had “incorrect expiry dates and fake batch numbers”.

The manufacture of the fake Avastin was not sophisticated: several organic chemicals were included, but no active pharmaceutical ingredients.

The opportunity for concealment lay in the existing global supply chain. MHRA has stated that the vials were supplied to the US market via a UK wholesaler, buying from a Danish wholesaler, buying from a Swiss wholesaler.

Beyond that, it has been claimed, there may have been an Egyptian supplier and possibly a Turkish source of the vials.

The case reflects the growing risk of counterfeiting to high-cost injectable drugs as well as to oral medications.

Counterfeit and substandard antimalarial drugs are undermining the war against malaria in Africa, a new report has claimed.

Researchers from the Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration warned that drugs with incorrect doses, or with erroneous active ingredients, could increase drug resistance in malaria patients.

The report, which called for urgent action to save millions of lives worldwide, identified two problems: fake drugs being sold fraudulently, and substandard drugs arising from poor manufacturing.

The recommended antimalarial drugs are artemisinin derivatives, used as monotherapy or in combination with other drugs.

The researchers gathered medication data from 11 nations in Africa between 2002 and 2010.

They identified many drugs used to treat malaria that contained erroneous active ingredients, treating the symptoms but not the disease itself.

In addition, they identified drugs with small quantities of the correct active ingredient – sufficient to pass chemical tests, but more likely to cause resistance to artemisinin without benefiting the patient.

Some of the fake antimalarials were traced to China.

Study leader Dr Paul Newton said: “Malaria can be readily treated with the right drugs of good quality, but poor-quality medicines – as well as increasing mortality and morbidity – risk exacerbating the economic and social impact of malaria. Worse still, they encourage drug resistance, potentially resulting in the failure of artemisinin treatments. Failure to take action will put at risk the lives of millions of people, particularly children and pregnant women.”

He also recommended that clinicians fighting malaria rely exclusively on combination therapies, which are harder to counterfeit.

“This research is very worrying and should act as an early warning,” said Dr Jimmy Whitworth, Head of International Activities at the Wellcome Trust. “We have already begun to see the emergence of drug-resistant malaria parasites in South-East Asia; substandard and counterfeit antimalarials and the availability of artemisinin monotherapies threaten to lead to the spread of drug resistance in Africa. If this happens, the effect could be devastating on efforts to control malaria in Africa."

Malaria caused approximately 781,000 deaths worldwide in 2009, according to the World Malaria Report 2010.

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.

A new law has been passed by the European Parliament to stop counterfeit drugs from entering the market.

The directive is designed to tackle the estimated 1% of fake medicinal products currently sold to the European public through the legal supply chain.

The European Federation of Pharmaceutical Industry Associations (EFPIA) welcomed the pan-European measure, saying it is “an important move in achieving greater protection for patients from counterfeit medicines”.

The law covers internet sales, introduces new safety and traceability measures, as well as sanctions against counterfeiters.

Online pharmacy sites will now be required to display a common logo to verify their authenticity and will be linked to a central website in each member state which will be connected to an EU site.

The general public will also be given further details about the risks of buying medicines over the internet.

The legislation also updates current rules and provides for new safety features to be placed on individual packs in order to, “guarantee their authenticity” and for pharmacists to check whether packaging has been “tampered” with.

Member states are instructed to impose a system to prevent dangerous products from reaching patients. The system must permit recalls, and if a product is suspended to present a serious risk to public health, all other member states must be rapidly alerted.

For those found guilty of breaking the new directive, the law states that “sanctions imposed on those who infringe it must not be inferior to those applicable to infringements of national laws of similar nature and importance”.

Marisa Matias, a Portuguese MEP and the parliamentary rapporteur, said that counterfeit drugs are “silent killers” and the absence of a legal framework currently encourages organised crime. She added that in the EU there has been a “huge growth of this criminal activity, with an increase of 400% in seizures of fake drugs since 2005”.

Brian Ager, Director General, EFPIA, says the new law “will require the involvement of all key stakeholders – manufacturers, pharmacists and wholesalers but also patients – to ensure success”.