The NHS is placing too much emphasis on ‘breakthrough drugs’ rather than on diverse and incremental innovation, according to the ABPI.

An updated report on pharmaceutical innovation commissioned by the UK trade association warns that by focusing on unique medical solutions, the NHS risks narrowing the scope of medicines.

ABPI Chief Executive Stephen Whitehead (pictured), launching the report, commented: “I fear for the future of UK medical research.”

The Many Faces of Innovation was commissioned by the ABPI from the Office of Healthcare Economics, updating a 2005 report commissioned by EFPIA.

As well as providing new case studies, the updated report places pharmaceutical innovation in the context of the UK health economy of 2012.

The report attacks the dichotomy between ‘breakthrough’ and ‘me-too’ products, arguing that innovation can be incremental – especially where ‘stratified’ medicine is concerned.

In addition, innovation has several dimensions: it could bring “advances in health gains”, “cost savings in health services” or “advances in patients’ and/or carers’ convenience”.

Finally, medical research benefits from multiple companies tackling the same problem – so it’s not helpful for there to be only one ‘winner’.

The report implicitly criticises NICE for assuming that each medical problem has one ‘best’ solution and that ‘value’ has a single metric.

The forthcoming medicine pricing negotiations will mark a watershed for the industry, Whitehead said: “If we minimise the reward for innovation in the UK, then our manufacturers will go abroad. Our industry, our economy, and our healthcare system will suffer – UK patients will suffer.”

Siemens Healthcare Diagnostics has partnered with two pharmaceutical companies, ViiV Healthcare and Tocagen, to develop diagnostic tests alongside targeted drugs for HIV and cerebral cancer.

As ViiV Healthcare is a joint venture of Pfizer and GSK focused on HIV treatment, the partnership represents a collaboration of leading pharma and medtech companies.

It also signals major company investment in ‘stratified medicine’, where drugs targeting narrow patient groups are developed alongside ‘companion diagnostics’ to identify suitable patients.

Siemens CEO Michael Reitermann said the new projects would “align Siemens with new classes of therapies tailored to the individual”.

ViiV Healthcare will partner with Siemens for clinical trials of its first-in-class CCR5 co-receptor antagonist Celsentri (maraviroc) and investigate the commercial prospects of a diagnostic test to assist in patient selection.

Celsentri was licensed in 2007 in Europe and the US as a treatment for CCR5-tropic HIV. It is currently in a phase III study to establish its efficacy in combination with darunavir/ritonavir.

The planned trials will put the combination head-to-head with the combination of Gilead’s Truvada and darunavir/ritonavir.

US company Tocagen will partner with Siemens to produce diagnostic tests to support clinical trials of Tocagen’s viral gene therapy Toca in two forms, injectable Toca 511 and extended-release Toca FC tablets, in treating primary brain cancer.

For diagnostics companies such as Siemens, gaining access to the companion diagnostics market – which is already worth $1.5bn – depends on collaboration with pharma companies.

Bioscience holds out the prospect of medical breakthroughs that can transform our lives – but it has to contend with traditional fears about ‘interfering with nature’. Maxine Vaccine asks whether fear itself might not be the greatest danger.

Everybody’s talking about biotechnology and its implications for medicine. Even the UK Government, hardly the brightest light on the Christmas tree, recently identified stratified medicine as a crucial area for medical innovation. The idea that drugs can be tailored to the specific genetic characteristics of a patient group is powerful and opens up a new vision of ‘personalised medicine’.

But with that comes the familiar fear among doctors and patients that the new therapies are ‘interfering with nature’. It’s a fear that runs through the history of medicine. Before the invention of the microscope, some doctors who argued that diseases could be spread by ‘germs’ were hounded out of their profession. Body fluids are ‘natural’ – how could they possibly pose a danger? The argument ‘it’s not natural’ has been used against hygiene, antiseptics, antibiotics, vaccines, transplants, transfusions, hormonal treatments...

But that’s all long in the past, you might say. These days we’re enlightened, we have evidence, we don’t listen to superstition. Well... maybe. Back in 1998 a doctor fabricated evidence that the MMR vaccine caused autism. He has now been convicted of fraud, but thousands of doctors believed him. Only this year, a critical analysis of the Million Woman Study by scientists who are not clinicians concluded that it had failed to prove a causal link between hormone replacement therapy (HRT) and increased risk of breast cancer – a causal link that had been broadly accepted by the medical profession across Europe and the USA, despite the persistent voices of a sceptical minority.

Is it just possible that where biopharmaceuticals are concerned, a significant proportion of clinicians are primed to believe scare stories because, at a deep level, they suspect that such therapies are ‘against nature’? Where HRT was concerned, after all, many thousands of women had been enabled to continue successful midlife careers without being nudged by the menopause and its traumatic sequels into early retirement. How could that be right?

Many people – and doctors are not only not immune to this, they may be more prone to it than patients – are driven by an uncritical reverence for ‘nature’s way’ to fear and resist the changes we can make to our own lives as our scientific knowledge develops. The recent decision of a European court to deny patents to medical therapies developed from stem cell research shows that the power of fear is still sometimes greater than the will to heal.

Of course there are valid fears about potential harm arising from science and technology. But the danger lies in the abuse of scientific knowledge for purposes of exploitation and social control. Where valid questions need to be asked about the ethics of medical science, those are not questions about the dangers of scientific knowledge. They are questions about us.

The European Medicines Agency (EMA) has published draft guidelines on the assessment of stratified medicine for cancer, including the use of biomarkers and companion diagnostics.

The proposed changes reflect the growing relationship, both clinical and commercial, between genetic analysis and the development of drugs (such as Herceptin) that target patients with a specific genotype.

The revised EMA guidelines on Evaluation of Human Anticancer Medicines guidelines include new disease-specific guidance on lung cancer and prostate cancer and revised guidelines on blood cancers.

They also emphasise the value of exploratory studies to establish the “technical/quantitative reliability” of biomarkers, and to maximise the application of companion diagnostics.

In addition, the methodology of phase III trials using progression-free survival or disease-free survival as a key outcome is reviewed.

The Evaluation of Human Anticancer Medicines guidelines were first adopted in 1996. They cover all stages of clinical drug development for the treatment of cancers. Disease-specific guidance was introduced in 2010.

The consultation on the revisions will run until May 31, 2012.

Now more or less recovered from the festive break, Maxine Vaccine looks forward to the creative and rewarding possibilities of partnership (strictly in the business sense).

January is the worst month of the year. Back at work, no money, not much daylight, freezing rain and the memory of a festive break that was one long hangover. More breakups happen in January than in the rest of the year put together. It’s enough to drive you to drugs – not the ones you sell, of course, because you already know how rubbish they are.

But never mind! The pharma industry is glowing with thoughts of partnership and fruitful collaboration. Valentine’s Day has come a month early. That nice Mr Cameron said that for the UK to become the world’s leading hub for life science research and development, industry and the NHS need to work ‘hand-in-glove’ to find new solutions to the world’s pressing health problems.

If you listen carefully, you can just hear a faint harmonica playing in the cold January wind, and that supernatural twelve-string guitar weaving its spell. Hand in glove... It’s like being a teenager again. But is it true? Does the sun shine out of our pipeline? Does it really all depend on how near you stand to me? (Having shared hotel lifts with too many hungover male pharma reps in the past, I devoutly hope not.)

This week, Merck CEO Kenneth Frazier (I would) declared: “The future of the industry is going to be more partnerships.” He noted that the use of combination therapies for viral and other conditions made partnership between pharma companies necessary. The company intends to augment its pipeline through acquisitions, he said. “Typically, for Merck, the sweet spot has been earlier rather than later.” I was always a first-date girl myself.

Also this week, Roche CEO Severin Schwan (I also would) said the company was looking to acquire innovative products in the rapidly growing field of stratified medicine, where targeted drugs are developed alongside diagnostics that can select patients with the right genetic profile. Roche’s 2008 $3.4 billion purchase of diagnostic company Ventana “would certainly be a size, if the right opportunity came up, that we would look at,” he said. Just remember to send a photo to my phone.

The good life is out there somewhere, so stay on my arm you little pharma... but we know how that song ends. And if the Queen is dead, you can’t expect much in the way of royalties. Still, keep in touch. And have a good year.

Note: the views of Maxine Vaccine are not necessarily those of Pharmaceutical Field.

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.