Fearless pharma blogger Maxine Vaccine asks whether That Cyclist is a scapegoat for our unease over the role of drugs in our everyday lives.

This week’s public loser by 2,173 miles (the length of the Tour de France) is the disgraced cyclist whose name we’re all sick of. His two-part ‘confession’ to Oprah Winfrey broke down the uneasy truce of non-admission and non-belief between him and the public. Instead, we had a carefully staged fessing up ritual that invited audiences to doubt both his full veracity and his regret.

If he’s as well versed in pharmaceuticals as we can now assume, it’s surprising that LA didn’t go the pharma CEO route and hide behind lawyers, arranging a settlement iron-clad in gagging clauses and insisting the truth is too complex for us to comprehend.

Reactions to the LA statement from cyclists and sports fans have been bitter. Take this comment from Barry Richardson on the BBC website: I tried to understand this alien being, the harrowing picture of his cancer struggles always haunting me as I saw him tear the peleton apart, and spit venom at those who suspected he was cheating. And now, I still love cycling, but in a different way. It's like being divorced but knowing deep down you will always love someone... and it hurts. A lot.

Why so much disillusionment? It’s not just the sense of sporting propriety having been mocked. It’s the deadpan realpolitik of his stance: he did it to reach the “level playing field” of all the other dopers out there. It’s like he wants to take the Tour de France down with him – and even the UKIP cretins would baulk at such vandalism.

But some of that apocalyptic prospect was built into the charges levelled by the US Anti-Doping Agency, who called LA’s cycling career “the most sophisticated, professionalised and successful doping programme” ever exposed in sport. Like Watergate, this scandal is not about one infamous person: it’s about the erosion of honesty in respected professional organisations and systems.

Another source of distress is the sheer sophistication of the doping methods. LA had blood transfusions to increase his oxygen uptake – not new in sport or in other trials of endurance, but still a long way beyond the furtive necking of a few uppers.

But it’s not only those deeply involved in the world of cycling who find the LA story troubling. Even for those of us who gave up cycling when old enough to drive (the back seat of a bicycle offers limited romantic possibilities), the episode leaves a bad taste in the mouth. It’s the taste of medicine.

Competitive sport may be the only profession where taking drugs to improve your performance is not acceptable. In the midst of our technically and chemically mediated lives, sport is framed as a return to the innocence of a younger life, and a younger world, where we relied on our unaided (but trained) bodies and minds for everything.

Let’s put that in a modern working context. In the last few years I have taken the following drugs specifically to enhance (or enable) my performance at work, either directly or indirectly: nicotine, caffeine, paracetamol, phenylephrine, guaifenesin, dextromethorphan, aspirin, ibuprofen, codeine, valerian, loperamide, menthol, loratidine, cortisone, fluoxetine and diazepam. There may have been others. The first two were purchased in general shops; the last two were prescribed; the rest were bought OTC from a pharmacist. Nearly all of them are banned in athletic sports.

In all other jobs you take medicines if you feel tired, if you are upset, if you feel sick, if you have a cold, a cough, a sore, a headache, period pains, backache or worries. You might even take medication when you feel fine – just to make sure you stay that way. But if your job is sport (though interestingly, football is an exception), you have to suffer whatever ails you without medical relief – or go on forced sick leave.

Is that fair? Are we making sporting professionals suffer unnecessarily in order to maintain a fantasy of some Elysian fields where young men and women run, jump, throw, swim, cycle and dance without access to the routine meds the rest of us rely on? How much longer can we keep sport in a state of innocence the rest of modern life doesn’t even want? Perhaps we can’t and never could.

But would I have a blood transfusion to make me a better key account manager? Sorry, but no. That’s the paradox of LA. He’s put more effort into cheating than most of us do into playing by the rules.

Prescribing costs fell last year as measures to reduce the amount spent on medication began to have an impact, new data shows.

Figures from the Information Centre show there was a reduction in spending by a third of a per cent compared to 2010.

The Department of Health praised the efforts of doctors in reducing medicines spend but said further progress could still be made in this area.

Research found that a total of 962 million prescriptions were dispensed in community pharmacies in England last year at a cost of £8.831bn.

However, this total was down on the £8.834bn spent 12 months before.

The reduction in overall spend followed a reduction in the mean net ingredient cost of the average prescription falling from £9.53 to £9.16. Reduced drug tariff prices and smaller payments to pharmacists also contributed.

NHS spending on drugs fell in 2011 due to patent expiry affecting a number of major products – and 2012 will see the trend accelerate.

The NHS in England spent £8.81bn on prescription drugs in primary care last year, compared to £8.83bn in 2010, according to the NHS Information Centre.

This fall, which reflects pressure on GPs to reduce their drug budgets, contrasts with the previous trend of drug spending increasing by 3–4% each year.

Therapy areas where the NHS pharmaceutical market was strongly affected by patent expiry in 2011 include cardiovascular care and CNS disorders – while diabetes care showed a new trend towards the selection of cheaper drug classes.

Cardiovascular drugs showed the steepest drop in sales: from £1.51bn in 2010 to £1.35bn in 2011. A major factor in this was the generic erosion of the anti-platelet drug Plavix from Sanofi and BMS, revenues from which fell from £46m to £12m.

By contrast, NHS spending on Pfizer’s statin Lipitor increased by £5m to a massive £310.8m – but that blockbuster will fall over the patent cliff in May, with wholesale shifting of GPs to generic versions expected.

The NHS spent £1.95bn on drugs for CNS disorders last year, but this therapy area is facing major generic erosion due to the recent patent expiry of AstraZeneca’s antipsychotic Seroquel and Pfizer and Eisai’s Alzheimer’s drug Aricept, which between them cost the NHS £170m in 2011.

In diabetes care, growing demand and the impact of new treatments is balanced by growing cost pressure forcing a retreat to older and cheaper drugs.

On the one hand, spending on Novo Nordisk’s new injectable GLP-1 drug Victoza increased from £9.6m to £21.9m last year, while AstraZeneca’s new oral medicine Januvia saw its revenue rise from £27m to £45m.

On the other hand, NHS spending on Novo Nordisk’s fast-acting insulin NovoRapid fell from £63.4m to £62.7m last year, due to pressure from the National Prescribing Centre to switch to the cheaper isophane insulin.

The UK pharmaceutical market thus faces both generic erosion and a new trend towards the choice of drug classes that reduce costs, but may not represent the standard of care.

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.

Barack Obama has outlined a number of measures aimed at tackling the prescription drug shortages in the US.

The President has signed an Executive Order directing the FDA to broaden the knowledge of potential medicine shortages and has asked them to exercise regulatory reviews to help prevent future shortages.

The Order also states that the FDA should work with the Department of Justice to examine whether prescription shortages have led to illegal price gouging or stockpiling of medication.

“This is a problem we can't wait to fix,” said the President. “The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety.”

Previously, the FDA has only had the power to direct drug makers to inform them of the discontinuation of a medication when it is available through a single manufacturer. The Executive Order now states that the Agency can take further action, asking drug manufacturers to provide adequate advance notice of discontinuances or other actions that could lead to shortages.

The Order also requires the FDA to review new manufacturing sites, drug suppliers and production changes.

A statement from the White House said: “While the causes and many of the solutions are outside of the FDA's authority, including the need for additional manufacturing capacity in the private sector, the Administration will continue its ongoing work with manufacturers and other stakeholders to help address drug shortages.”

It is estimated that typical grey market vendors mark prices up by an average of 650%, as a results of prescription drug shortages.

In recent years the German government has introduced a series of reforms designed to radically cut the costs of drugs. With VBP being considered here in the UK, Dr Arnim Jost explains how these measures have affected pharma companies in Germany.

As the biggest pharmaceutical market in Europe and a price reference point for other European markets, success in Germany has always been essential for pharmaceutical companies. However, recent changes in legislation have combined to make Germany an increasingly tough challenge even for the pharmaceutical originators delivering innovative new drugs.

Germany was one of the last countries in Europe to allow pharmaceutical companies to determine prices. Now, with an estimated goal of cutting €2 billion from pharma spending, that is changing, with even new drugs facing tough value assessments before prices are set. With the UK Government considering the adoption of VBP, with fees negotiated on the scienti­fic assessment of a drug’s clinical value, once the Pharmaceutical Price Regulation Scheme expires in 2013, the impact of this change in Germany will be keenly watched by pharmaceutical companies in this country.

Price pressure

Since 2007 and the introduction of GKV-WSG (Gesetzliche Krankenversicherung-Wettbewerbsstaerkungsgesetz), which allowed public insurers the chance to negotiate discount agreements with pharmaceutical companies for generics and off-patent products, companies have seen prices erode.

These public health insurers represent 90% of the population of 82 million, and hence have signi­ficant influence. Over the past twenty years there has been significant consolidation of these organisations, from 1,100 in 1990, to 226 in 2008, and 155 today.

Within the next three to five years that number is set to fall further to just 50. For pharmaceutical companies this consolidation is a double edged sword: there are fewer organisations to target and understand; but each insurer has a far greater buying power and can drive ever stronger discounts across the market.

Price pressure increased in 2010 with the GKV ÄndG (Gesetzliche Krankenversicherung-Aenderungsgesetz), which demanded mandatory discounts for non-reference price products to increase from 6% to 16%, and introduced a retroactive price freeze for all non-reference price products from 1 September 2009 until 31 December 2013, a move expected to save €1.15 billion, according to Policy.io.

Innovative overspend

At this time, pharmaceutical companies were at least allowed to set prices for innovative new products after a drug’s introduction to the market. However, this changed in January 2011, in response to €32 billion spent on medicines by the public health insurers in 2009, creating a signi­ficant deficit.

With the Health Minister claiming innovative drugs were responsible for the overspend, a new law was passed which limits the amount that pharmaceutical companies are allowed to charge for new prescription drugs.

AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) demands pharmaceutical companies provide a value dossier within three months of the product launch, demonstrating the medicine’s cost and bene­fits. If a new drug is found to have additional medicinal benefits, its price will be negotiated between the manufacturer and the insurers within a year.

However, maximum prices – reference prices, in Germany called “festbetrage” – will be set for drugs which do not have any additional benefits over an existing drug.

Evidence based

The implications for pharmaceutical company market access strategies are significant. Market access has now shifted towards justifying the price, towards conducting cost benefit analysis and evidence based medicine. Of course, for the first three months of any product’s life there is little opportunity to undertake evidence based assessment.

Companies in Germany are, therefore, now involving business units, including sales and marketing, up to 12 months before a product launch to create cost benefits dossiers and prepare the value arguments for the medical and pharma-economical experts within the regulatory bodies G-BA (Gemeinsamer Bundesausschuss) and IQWIG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen).

Companies now need access to greater depth of information regarding the decision makers within G-BA and IQWIG to determine the on-going strategy for this value-based assessment.

Indeed, this process requires far greater information resources – from therapy data, to information about comparable products and product costs. Pharmaceutical companies must now analyse the entire health chain, from diagnosis through therapy to rehabilitation to assess and demonstrate the true potential value of the new product.

They are not, however, as yet able to work effectively with hospitals to ensure drugs are used appropriately in order to achieve the expected benefits. Unlike the UK, where the NHS is being actively encouraged to co-operate with pharmaceutical companies to promote research, innovation and better practice, in Germany the boundaries between health provider and pharmaceutical company are still strong, with hospitals looking to optimise their own working practices without pharmaceutical co-operation.

Clinical autonomy

At primary care level, meanwhile, clinicians have limited opportunity for any strong decision making. Whilst the UK is now pushing hard to reinvigorate the role of clinicians within the health service, clinicians in Germany continue to lose decision making power. GP prescribing is strongly led by the discount agreements between pharmaceutical companies and the public insurance companies: if a prescription does not reflect the agreement, it will be automatically substituted by the pharmacist when it is fulfilled – unless the GP has specifically requested no substitution.

Similarly within secondary care, there is a lack of clinical empowerment. Many hospitals are part of purchasing groups, which has increased buying power, but limited the decision making options for both individual doctors and hospital pharmacists.

However, there are signs of a new level of interaction between pharmaceutical companies and health care services in Germany on the joint development of innovative services. Whilst in the past pharmaceutical companies were constrained from negotiating contracts direct with hospitals or doctors to deliver such services, over the past two years there has been a evolution towards more integrated healthcare contracts that have evolved beyond basic discounting towards shared risk models based on the joint delivery of services – most notably within diabetes.

Moving forward

Given the emphasis on the reduction of drug prices across Europe, the evolution of cost saving on pharmaceuticals within the German market is notable for any similar sized market place, such as the UK. From initial focus on generics, with reference pricing and discount agreements to the impact of AMNOG on the new chemical entities, every aspect of the pharmaceutical market has been affected.

Indeed, despite the market size, this new price point has resulted in companies deciding not to launch new products in the German market due to the problem this would create across Europe with reference pricing: get it wrong in Germany and a pharmaceutical company could end up with an unsustainable price point in many other countries.

The biggest test for pharmaceutical companies in Germany in the coming months will be to understand the challenges created by AMNOG and to determine how best to create the value dossiers. To date, only one product, Merckle Recordati´s Pitavastatin, has passed the examination of the G-BA, but without the approval of a pre-price, there’s only the allocation of a reference price – so the industry has no real evidence of how this process works, or how successful companies will be.

However, with 15 products currently under review, this model will become far clearer in coming months. Market access strategies must be supported by a new depth of information relating to this value-based decision making, most notably granular visibility of the key influencers within G-BA. Armed with this insight, pharmaceutical market access teams will be able to refine their information analysis and determine how best to disseminate the value message to the market.

Dr Arnim Jost is General Manager, Germany, and VP REGION D-ACH, for Cegedim Relationship Management.