Tudor Reilly Blog

United pledge to combat diseases of ‘neglected people’

2012-02-07T11:11:00.000Z

In the largest co-ordinated effort to date the 30 January saw some ofthe most influential organisations join forces at the Royal College ofPhysicians to accelerate progress towards elimination or control of 10neglected tropical diseases (NTDs) by 2020.

The US, UK, UAE governments, Bill & Melinda Gates Foundation andthe World Bank began cooperative movements along with 13 pharmaceuticalcompanies. FiereceBiotech reports the pledge willbring a unique focus to defeating conditions such as Guinea worm disease,sleeping sickness and blinding trachoma, while controlling Chagas disease andriver blindness. There is potential to improve 1.4 billion lives worldwide.

Present at the event was Sir Andrew Witty, CEO of GlaxoSmithKline, who said,“Many companies and organisations have worked for decades to fight thesehorrific diseases. But no one company or organisation can do it alone. Today wepledge to work hand-in-hand to revolutionize the way we fight these diseasesnow and in the future.’’

It seems the loud complaints of charities and developing countriesconcerning the lack of investment in tropical diseases have finally impactedthe consciences of the drug industry who historically have preferred to investin more profitable Western ailments, such as irritable bowel syndrome.

Yet, as the Financial Times documents, the drug industry will alwayshave its sceptics. Bernard Pécoul, head of Drugs for Neglected DiseasesInitiative, cautioned that all the NTDs could not be treated equally and wouldrequire further commitments to research and development; while Caroline Ansteyfrom the World Bank said “These are not neglected diseases but diseases ofneglected people”; highlighting the fact that drugs alone would not solve theissue.

Sceptics aside, this effort - guided by the World Health Organisation(WHO) - includes promises to sustain or expand existing drug donation programmes;sharing expertise and compounds to accelerate R&D, and donations of morethan US $785 million to ensure medicine reaches patients. Companies will donateon average 1.4 billion treatments each year to those in need.

The London Declaration onNeglected Tropical Diseases also called on companies to pledge new levelsof collaboration. Already, this has made for an unusual companionship betweenrivals: Johnson & Johnson, Pfizer and Abbott who will be developing amacrofilaricide, anti-worming pill to tackle river blindness and lymphaticfilariasis.

Dr Margaret Chan (Director General of the WHO) said last week: “Withthe boost to this momentum being made today, I am confident almost all of thesediseases can be eliminated by the end of the decade.”

A webcast of this event can be viewed at www.UnitingToCombatNTDs.org

Authored by Lisa Stevens

Riddling Alzheimer’s disease

2012-01-24T16:07:00.000Z

Alzheimer’s disease (AD) is a growing threat to the world’s ageing population and is atopic of fascination for the mass media and public alike – whether in the press(The Daily Mail 23 Jan), TV shows (Greys Anatomy) or film (The Iron Lady). And the scientific community isundoubtedly racking its collective brain to find potential treatments with clinical.trials.gov listing over 1000registered clinical trials in AD as of January 2012.

The need fornew treatments is certainly present: in2010 there were an estimated 35.6 million people with dementia worldwide. Alzheimer’sDisease International estimatethat by 2050 this will increase to over 115 million people. According to the Alzheimer’s Study Group report, of these patients, 16 million could be in the United States,costing the government healthcare system over one trillion dollars if noeffective treatments are found.

Yet,despite the considerable efforts, effective treatments remain elusive. Justlast week, Pfizer/Medivation ended the development of a potential candidatefollowing another failed Alzheimer trial (see Health News Daily). And it won’t be the last.

Scrip suggeststhat there is a pending crisis, with investors shying away from Alzheimer’s dueto the many unanswered questions around the disease: how do we diagnosepatients accurately? Can we change the disease progression? What is thepotential for reimbursement?

Nevertheless,small victories are gradually being achieved. BioCenturyreports today that CHMP has adopted a final qualification opinion for a newbiomarker allowing its use in patient selection for clinical trials.

No need todespair yet then. And as the press reports today: reading, writing andpuzzle-solving can help stave off the disease. Let’s hope the academiccommunity can follow these steps to unravel the riddle that is Alzheimer’sdisease!

Authored by Juliet Burns

Rare Treatments for Rare Diseases

2011-12-22T14:15:00.000Z

Rare diseases, such as unusual hereditary conditions and some less common forms of cancer, affect many more people than most of us would imagine. In the EU, diseases are defined as rare if they afflict no more than five in 10,000 people. But put that in the context of more than 6,000 rare conditions so far identified and the total numbers affected - including the families of those that suffer from them - and we are well into the millions in the UK alone.

But, despite the millions of dollars spent worldwide on developing new therapeutic drugs, the treatments approved to tackle these rare conditions remain pathetically few. The biggest obstacle to improvement is money. Most drugs are licensed for use in conditions where the drug manufacturers are both able to recruit enough patients into clinical trials and where the products will yield enough sales to justify running those trials in the first place. So, people with rare diseases find their access to effective medication either limited or non-existent.

The first genetic condition ever identified, Alkaptonuria (or AKU) is a case in point. It's over a hundred years since AKU, more commonly known as black bone disease - for the discolouration and damage it causes to the bones and cartilage - was identified. Yet there has never been an effective treatment for it and people with AKU, who see the symptoms appear typically in their 20s and 30s, suffer chronic health problems that often lead to destruction of the cartilage and early joint replacement surgery.

A relatively small number of people with AKU have been identified in the UK (around 70) but experts, who describe the disease as a severe form of arthritis, to which it's closely linked, believe there's a much larger number who are living with AKU undiagnosed.

This month, the AKU Society - a small UK patient charity supporting those with the condition - launched a campaign to raise funds for a late-stage clinical trial of a drug that does promise a treatment for AKU. It could in turn give hope to some of the eight million in Britain who suffer from osteoarthritis, to which AKU is closely linked.

Dr Lakshminarayan Ranganath, co-founder of the AKU Society and one of the country's leading experts on the condition, says "Anything we can do to understand AKU will undoubtedly help us to understand other forms of arthritis."

The drug nitisinone, which is already marketed for another hereditary condition has been shown in previous clinical trials to relieve AKU patients' symptoms but because of the estimated £5m costs of mounting a late-stage clinical trial and the relatively small patient population, no organisation has yet put up the funding.

Taking the drug over this final development hurdle would create the first ever treatment for AKU, as well as a better understanding of osteoarthritis and its potential treatment - a hugely significant benefit in an area of unmet medical need. Some well-funded organisation, ideally a pharmaceutical company, should put the money up for the trial. Research into rare conditions such as this one really shouldn't be left to charity.

Authored by Peter Coe

Recently published in The Huffington Post UK

AstraZeneca paves the way for UK research

2011-12-09T16:02:00.001Z

It appears that AstraZeneca was well ahead of David Cameron on the dayhe announced his Life Science initiative.

With the unveiling of his Strategyfor UK Life Sciences, the British prime minister argued the need for newmodels of working between universities, hospitals and pharmaceutical companies.This, he claimed “would place the UK at the forefront of medical research nowand in the future.”

Turn the page of your newspaper that day and you would have found that AstraZenecaare already beginning to do just that. As reported in The Daily Telegraph andthe Financial Times, in a revolutionary move that could see the development ofseveral new treatments, AstraZeneca has opened its doors to allow full and freeaccess for UK researchers to more than 20 of its experimental drugs.

New research findings will be owned by the relevant academicinstitutions, with AstraZeneca retaining the rights to the chemical compositionof the compounds. The company has stopped developing all of these compounds,many rejected as the market was too small or because the treatments felloutside AZ’s areas of interest.

It’s a radical move and a pioneering effort to boost medicaladvancement. The AstraZeneca initiative will allow researchers to examinecompounds – many still on patent – and could broaden the potential of drugsthat would otherwise have been neglected.

The chance to be more open and co-operative is a growing trend andclearly supported by David Cameron’s incentives. Sir John Savill, MRC chiefexecutive said it is ‘win, win, win’ where the connections between AstraZeneca,academics and patients will be firmly fused.

Authored by Lisa Stevens

Swap pills for health solutions

2011-11-21T11:29:00.008Z

A bill so big you can see it from space. Bigger than the decades-old bill that created the system the current bill is intended to replace. Two descriptions of the Health and Social Care Bill, a controversial set of proposals designed to overhaul the UK’s unwieldy and overly-bureaucratic NHS. After a rocky few months, the bill is at committee review stage in the House of Lords. Reformers hope it will reach royal assent in spring 2012 and become law soon after. This raises two questions. Once all the necessary amendments are made, what bill can we expect to emerge in a few months’ time? And what can the pharmaceutical industry do to prepare for it?

Companies can do little to influence the answer to the first question; the passage of the reforms is now in the hands of the peers. But the recent Wellards Annual Conference, held in London on 9 November, showed that there are plenty of experts willing to have a stab at answering the second. A day of presentations and discussions, aimed primarily at pharmaceutical marketing and other customer-facing professionals, underlined two new strategic priorities: the need for proactive engagement with an enlarged group of stakeholders and a shift from selling drugs to providing broad healthcare solutions.

The first priority is to recognise the stakeholders. The few constants in the new system will be patients, health providers and the Department of Health; virtually every other component of the UK healthcare landscape will change. Some 250 clinical commissioning groups (CCGs), member organisations led by GPs, will take over work currently carried out by primary care trusts and regional strategic health authorities. Monitor, the independent body that regulates NHS foundation trusts, will become an economic regulator responsible for overseeing access and competition in the NHS. Health and wellbeing boards (HWBs) will co-ordinate and integrate services and develop strategic-needs assessments. And there will be a shift from centralisation to localism. Come 2013, local governments will take on a long list of public health responsibilities, including dealing with key disease areas such as mental health.

Some companies have seen these changes coming and been quick to adapt. David Rogers, chair of the Local Government Association Community Wellbeing Programme Board, said he had been approached by firms asking how best to work with local government. A recent pharma roundtable discussion, organised by the HFMA, an association representing NHS accountants and finance directors, showed that drugs companies are willing to share ideas with influential new stakeholder groups. A few years back, pharmaceutical sales and marketing teams were already talking about key account management as an effective way of working with NICE and other payer groups. It would not be much of a leap to do the same in their interactions with local governments and HWBs.

The second strategy, rethinking traditional sales approaches, may have more of an impact. Senior NHS managers are tired of seeing sales reps trying to sell pills and fancy gadgets. They are frustrated that a health service that claims to be primary care-led ends up dealing with so many patients admitted to hospitals as emergencies. They are crying out for solutions so that patients stop using A&E departments as their first port of call. How to achieve this? NHS officials argue for the creation of holistic disease-management pathways, integrating diagnostics that can be used at home, the most appropriate pharmaceuticals, self-monitoring and management by patients, and better use of smart telemedicine tools.

These ideas are gaining currency among policymakers the world over. Barack Obama’s health reforms in the US have placed a premium on the ability to deliver cost-effective health solutions across the entire treatment spectrum. In its two most recent Progressions thought-leadership reports, Ernst & Young has promoted guiding principles that it calls “Pharma 3.0”. These include the need for pharma companies to focus on health outcomes, for example by forming non-traditional partnerships with firms outside the life sciences space.

Delegates at the Wellards conference also heard some frank admissions about where the NHS needs to change. One area is cultural: the rules of the NHS have created a culture of risk-aversion rather than risk-taking. This will hold back a system that desperately needs to get into better shape. Jim Easton, national director for improvement and efficiency at the Department of Health, admitted the NHS is often scared to back new ideas and timid when it comes to disseminating or adopting innovation.

Other reforms will be structural. Senior NHS officials are already speaking the corporate lingo of the pharmaceutical CEO. Dr Gordon Coutts, chief executive of Colchester NHS Foundation Trust Hospital (himself a former Lilly and Schering-Plough man), talked about weighing up market penetration versus market expansion, competition or collaboration, and vertical or horizontal integration. Dr Coutts is on a quest for efficiency that will lead to a shortening of patients’ length of stay in hospital. He also wants to implement just-in-time principles (used to superb effect in the car-making industry) in his hospital’s supply chain.

Under intense pressure to adapt, most big pharma companies have spent the past few years re-engineering their organisational structures. They could be a fount of knowledge for an NHS undergoing upheaval. In addition, the drugs industry is shy of neither risk nor failure; the two have always been integral to the pharmaceutical R&D model.

Conference chair Alan Jones was probably only half joking when he told a room full of pharmaceutical professionals: “The NHS is full of people who don’t like you.” If companies were to share with NHS managers their expertise in re-engineering large bureaucratic organisations and innovation through smart risk-taking, they could go a long way towards overturning such ingrained negative attitudes.

Authored by Pete Chan

Pay-for-performance refunds – an ethical minefield?

2011-11-11T17:17:00.006Z

Roche pharmaceuticals recently announced its plans to launch a pay-for-performance scheme in Germany for its best-selling drug, Avastin, in an effort to increase cost effectiveness. The scheme means that hospitals and clinics would be reimbursed for the cost of Avastin if it fails to halt the progression of cancer in a patient during the first few months of treatment. The monthly cost of Avastin treatment in Germany varies between €3,000 and €6,000 depending on the indication, so the amount of money to be saved by prescribers is potentially vast.

Although there are no contracts in place yet, Roche says it is hoping that this scheme will mean Avastin being available to all those who can benefit from it.

But it’s clear that German insurers are wary of the scheme. The AOK (which represents about a third of insured patients in Germany) explained in Scrip Intelligence: "We are sceptical because the refund of the drug cost will go to the hospitals, even though they are paid by the Krankenkassen [insurers]. The hospital would be paid extra for the product and would profit from failure of therapy."

Currently in Germany, products and treatments are supplied directly from the company to the hospital and then reimbursed by insurers. Issues of who should be receiving refunds and when can be overcome by well-written contracts but the real ethical concern lies in the doctor-patient relationship.

Patients trust their doctors to act in their best interests at all times but this scheme potentially incentivises the use of a particular treatment when it may not necessarily be the best course of action - and potentially exposes them to a therapy which can cause serious side effects with no benefit to their condition.

Prescribers may be tempted to try a treatment that won’t cost their clinic anything if it doesn’t work (and they could even make a profit from if the AOK’s suspicions are correct), than choose another treatment route which isn’t refundable.

To prioritise financials over the needs of a patient is, of course, highly unethical and no professional worth their salt would admit to taking this tack; but in a climate where healthcare budgets are being cut at all levels this kind of scheme is bound to have an effect on prescribing behaviour.

Authored by Rachel Penniston

Golden opportunity for the NHS to innovate

2011-10-18T16:16:00.000+01:00

In these turbulent times, the last thing the world needs is more uncertainty. So UK ministers could at least breathe a sigh of relief last week as attempts to get the NHS reform bill dropped or subjected to more rigorous external scrutiny were defeated in the House of Lords. The controversial Health and Social Care Bill will establish an independent NHS Board to allocate resources and provide commissioning guidance. It will increase GPs’ powers to commission services on behalf of patients. It will also abolish primary care trusts and strategic health authorities, as part of measures to cut administrative costs.

The next step is for a House of Lords committee to conduct a line-by-line examination of the bill, beginning on 25 October. Perhaps peers were persuaded that a motion to have the bill referred to a select committee could have had “grave implications” for the legislation becoming law next year. Perhaps they saw through the brinkmanship and recognised the NHS as an out-dated and overly bureaucratic system in desperate need of surgery. Or perhaps they wanted to demonstrate that healthcare reform, a political hot potato in any country, is one area where the UK can succeed, setting an example for other Western governments whose efforts have all too often failed.

Senior Labour figures have dug in their heels. The FT reported that they might resort to filibustering tactics, a common strategy in US politics, to get their way. Labour officials complain there’s not been enough serious debate about the level of private healthcare that hospitals will be allowed to provide or on the extent of bureaucratic reform. They also want clarification of the relationship between the Health Secretary and the NHS. Expect to see fireworks as the debate rumbles on.

Optimists see a golden opportunity for the UK to adopt innovative practices that have worked in other countries. The Center for Connected Health, a forward-thinking US organisation, aims to “move healthcare from the hospital and doctor's office into the day-to-day lives of patients”. It encourages patients to wear sensors that monitor and transmit information about their well-being to doctors. Telehealth and other clever technologies that allow remote monitoring and diagnosis would surely be less of a drain on the UK’s public purse.

Entrepreneurs and healthcare professionals in emerging markets are experts in frugal innovation. Leading Indian hospitals have positioned themselves as focused factories, leveraging economies of scale and employing specialists to increase productivity. If these innovations have worked in emerging markets’ healthcare systems, why not try them in the cash-strapped healthcare systems of the West? This model already has the backing of large multinationals. GE calls it reverse innovation.

And back in May, the ABPI, the UK trade association, said that embracing innovation in the NHS would help to deliver better patient care. The language was familiar but the ABPI’s message was clear. The association said it was “essential that all the bodies responsible for implementing NHS reforms have an obligation to foster the use of innovation in the NHS. If the NHS is too slow to embrace new technologies, there will be missed opportunities to improve healthcare, and it is patients who feel the loss most."

Another danger is that if it is too slow to adopt new technology and innovation the NHS will itself become a loser. So while the health bill’s passage into law is far from certain, one reason for optimism is that the next series of debates should now remain on track.

Authored by Pete Chan

Drug relief for rare diseases

2011-10-05T15:10:00.000+01:00

The UK Health Secretary, Andrew Lansley sweetened his party conference speech yesterday on the state of the National Health Service by announcing a programme to give doctors better information on drugs that can treat rare disease. The initiative promises at least some relief to long-suffering patients whose doctors are unable to provide them with unlicensed or off-label medication, or who are unaware that drugs even exist.

One obstacle to treatment lies with the UK’s National Institute for Clinical Excellence. NICE doesn’t normally appraise drugs outside their licensed indication, which means they can’t be recommended for use on the NHS. Consequently, doctors often lack the evidence or knowledge they need to make an informed decision. But many rare conditions, including rarer cancers and auto-immune conditions, can be treated with drugs outside their licensed indication.

Under the Lansley initiative, the Department of Health will commission expert assessments of the evidence on the use of off-label medicines that can inform doctors’ and patients’ choices.

As well as the NICE problem, the deeper-rooted issue is that most drugs are licensed following clinical trials that the drug manufacturers only commission when they’re sure they can recruit enough patients to take part - and where they will garner enough sales to justify the investment. Rare, or orphan, diseases typically don’t make the cut.

A total of some 7,000 rare diseases have been identified, affecting hundreds of millions people worldwide and while the overall problem is huge, the individual diseases affect tiny numbers of people. Currently, only 200 out of the 7,000 have approved treatments.

Authored by Peter Coe

A UN talking shop or real action?

2011-09-26T16:46:00.000+01:00

Finally after a decade the United Nations (UN) has met, for only the second time, to focus on disease. This historical moment was granted to the issue of non-communicable diseases. Once widely assumed to be products of an industrialised society the UN has now recognised these killers as a worldwide epidemic. Cardiovascular diseases, cancers, chronic respiratory illness and diabetes are now proving themselves more deadly in the developing world than infectious diseases such as HIV and malaria, with the exception in a few parts of Africa. Also included within non-communicable diseases are reproductive, neurologic and psychiatric disorders.

It is a sad fact that many cases of non-communicable disease are a product of tobacco use, alcohol consumption, unhealthy diet and lack of physical activity. The two-day summit ended with a declaration calling for a multi-pronged campaign by governments, industry and civil society focusing on curbing these risk factors, to be established by 2013. Influential leaders have proposed ideas which could see increased tax on tobacco consumption, a decline in food advertisements aimed at children and other measures aimed to promote a healthy lifestyle. A need for global co-operation, universal national health coverage along with assistance to developing countries was also highlighted.

Secretary-General Ban Ki-Moon described this as a ‘public health necessity’ accusing certain individuals in industry of risking public health to protect their own profits. Good nutrition took centre stage and corporations profiting from selling food to children were urged to act with integrity.

The addition of non-communicable diseases to the international agenda has delighted all who work in the field. Marilyn Gentry President of the World Cancer Research Fund (WCRF) stated ‘...we are pleased to see a real understanding that while personal choice is important, the environment people live in also influences their ability to make the kind of healthy choices...’. Yet many have questioned whether change will happen without measurable objectives, which were absent from the declaration.

Authored by Lisa Stevens

The Silly Season

2011-08-25T16:32:00.000+01:00

August 2011 and it seems that our MPs are not the only ones on holiday. Developments in the healthcare industry are few and far between and journalists are itching for the winter months when the next seasonal flu epidemic can once again take centre stage.

Sensational headlines have included ‘Woman’s addiction to lettuce showed she had cancer’, ‘Infertile men may be able to ‘’grow their own sperm’’’ and ‘Coffee sunscreen may ward off skin cancer and wrinkles’.

At face value, common sense suggests these stories are a bit silly but let’s consider the content. Take the first story. Elsie Campbell believed her obsession for lettuce was just a passing fancy but when she began munching her way through four a day it was the tip of the iceberg for husband Jim. Cravings are often associated with pregnancy and can indicate deprivation of certain nutrients. After some research Mr Campbell discovered that lettuce contains the nutrients selenium and sulphoraphane, nutrients that your body can be deprived of when fighting cancer.

Not quite so silly now, in fact perfectly plausible. Elsie did indeed have cancer and as it has disappeared, leading to a full recovery, so have her cravings. Is there anything wrong or less newsworthy with a little light-heartedness? Elsie’s story sends a powerful reminder: we should listen to our bodies and not automatically dismiss the ‘silly’ things in life.

Mr Campbell has now created a website, questionmyhealth.com, designed to identify nutrient deficiencies that may be caused by something more serious, saying ‘‘Some chronic diseases, like diabetes and Alzheimer’s can take 20 years to develop, but your body can give you a clue to what you are dealing with early on if you know what to look for ... everything has to have a cause and effect.’’

Authored by Lisa Stevens

Unappealing result!

2011-08-02T09:59:00.000+01:00

Mr Tom Condliff, a 62-year-old, morbidly obese (BMI 41) former policeman, is clearly a shining example of medication adherence, medication that has stripped away his quality of life by causing weight gain and co-morbidities that require him to take a shocking 28 different pills a day. It’s not terribly surprising he’s housebound and feeling depressed.

It is well-documented that adherence to medication in people with diabetes is a major issue. Diabetes is a self-managed, chronic disease and relies on the patient to not only take their medication but also alter their lifestyle. Mr Condliff has done both and also made an informed decision as to how he wants to manage his disease.

So, this shining example of adherence has been dismissed by the Court of Appeal because he is not fat enough for a gastric bypass. The North Staffordshire PCT “grappled with difficult ethical and practical questions”. Maybe if all parties involved had just followed national guidelines or even taken some advice from a few of the patient groups that deal with such issues on a daily basis, they wouldn’t have had to grapple at all. It all could have been spelled out as easily as the The National Obesity Forum (NOF) did on their website: “The NOF is bound to inquire what is the purpose of NICE [the National Institute of Clinical Excellence] if the courts are going to run a coach and horses through its guidance? Mr Condliff, who has several co-morbidities brought about by his weight, qualified for surgery when he had a BMI 35.”

I wish Mr Condliff good luck at the Supreme Court and hope he will get the correct outcome next time.

Authored by Tanya von Ahlefeldt

Flipping back to the future: the power of the presenter

2011-07-22T17:04:00.000+01:00

Think of a slide presentation and what springs to mind? Grey suits and faceless boardrooms with matching blank faces? I don’t think many people associate slide presentations with creativity and sparkle – regardless of rainbow colours and technical wizardry. Slides are often used as a showcase for everything the presenter knows about the subject, along with everything they think they know about design. And how often do slides resemble pages of a book – with presenters insisting on reading out every word, despite glazed expressions from the audience?

The failure of many slide presentations seems amazing in an age where we are constantly bombarded with highly sophisticated, creative design. Yet as Lucy Kellaway commented recently on ft.com: it’s difficult to remember even a single slide that has been presented to us – and when presentations are memorable it’s usually because of the presenter’s skill rather than the slides.

The Anti PowerPoint party (APP) is a new political party in Switzerland whose goal is to make the average presentation more exciting and interesting. ‘The solutions are there, but nobody pays attention to them’ states their website. APP believes that the solution is to use a flipchart because “the effect of the illustration is not being created by the result but by the act of creating it.”

Effortless effort

APP’s views reinforce the power of spontaneity and interactivity during a presentation. Of course, slide presentations are a blank canvas and any shortfalls are not due to the software itself but to both the creators and presenters. The best presentations may look effortless but will doubtlessly have involved significant thought. TED talks epitomise the value of passionate, knowledgeable speakers who ignite their subject and engage their audience.

As Lucy Kellaway states: The human voice, especially when connected to a brain that has done some thinking, and a body that has done some rehearsing, can be a wonderful, memorable thing.

As with everything in healthcare communications, substantial effort and expertise translate into effortlessness – and effectiveness.

Authored by Jacqui Brommell

You’ve got mail

2011-07-07T08:30:00.000+01:00

Authored by Peter Coe, 7th July 2011

Every so often there’s a flurry in the press as someone prominent sounds off over the vast amount of time we all consume sending and receiving emails, particularly at work. A few years ago the EasyJet founder, Sir Stelios Haji-Ioannou got so fed up with it, he tried to ban his staff from sending emails for days at a time. The manoeuvre burnished his media profile but, not surprisingly, the ban didn’t last long.

The curator of the TED conferences, Chris Anderson created a fresh flurry recently with a blog calling for a 10-point email charter. Whether a charter’s really going to catch on is arguable, but simply suggesting it from his influential vantage point will help restore sanity – and forethought - to our business and personal communications.

My favourites among his top 10 contenders are these:

• Respect recipients' time (ie: keep emails as short as possible)
• Be easy to process (ie: crisp sentences, unambiguous questions)
• Choose Clear Subject Lines. Here are some that don't work:

- Subject:
- Subject: Re: re: re: re
- Subject: Hi!

• Short does not mean rude
• Think before you ‘cc’ or hit ‘Reply all’ (ie: do they really need to know?)

The excellent FT columnist, Lucy Kellaway suggested programming inboxes only to accept brief e-mails. Anyone sending her a rambling one would get an automatic reply saying: “Your e-mail was too long. Lucy Kellaway’s inbox will only accept messages of up to 100 words. The remainder of your message is in her junk folder.”

Taking it a step further, only half-ironically I suspect, Lucy also proposed junking any emails containing emoticons or the beloved yet, in my opinion too, hideous and usually superfluous business phrase: “... going forward”.

My tip for keeping business emails short is to banish the thought that you’re embarking on an essay-writing exercise and start each one with the words ‘Next steps:’ – then write the rest of it in bullet points. You can always elaborate it afterwards, and delete the heading, but that may be good enough to send ... and it will take half the time to write.

The end of the Prozac era or the start of something brainy from Roche?

2011-06-16T12:38:00.000+01:00

Authored by Oliver Jelley, 16th June 2011

Scientists have been predicting the end of the Prozac era this week following the publication of a report claiming funding into brain disorders is being abruptly withdrawn.

The paper published on 14 June, 2011, by the European College of Neuropsychopharmacology (ECNP) raised serious concerns about major pharmaceutical companies moving away from the market as well as low levels of EU research funding.

Pharma giants including GlaxoSmithKline and AstraZeneca have pulled out of the area saying research and development into brain research is too expensive and difficult.
Senior neuroscientists David Nutt and Guy Goodwin, authors of the report, concluded: “The withdrawal of research resources is a withdrawal of hope for patients and their families.”
Without doubt neuroscience has been a difficult area of research, measuring the effectiveness of treatments for patients with depression, schizophrenia, multiple sclerosis and Alzheimer’s is like measuring opinions with often unreliable answers.

But why give up on a market the size of 27% of the population of the EU, or 80 million Europeans – Rome wasn’t built in a day. It might take more than ten years to bring a brain disorder drug to market but get it right and the rewards can be plentiful for both the pharma company and more importantly for patients.

One global pharma player that isn’t ignoring brain disorders is Roche, which is making major efforts in the field. The drug giant is fully committed to finding new treatments and believes now is the time to invest in the area.

Roche believes the answer is no longer one size fits all – based on this principle the company is looking into pharmacology that can help it break down and target specific molecular pathways.
This is encouraging news for patients and gives hope that one day this arena will have more answers than questions.

The Final Frontier - negotiating the blood-brain barrier

2011-06-03T10:46:00.000+01:00

Authored by Aemilia McDonnell, 3rd June 2011

Roche Genentech believes that it has found a way of passing an engineered antibody through the blood-brain barrier. The barrier is one of the greatest problems in the treatment of neurodegenerative diseases; it works as a very selective firewall to the brain, allowing small molecules to pass through but denying access to larger molecules such as antibodies and antibiotics.

Scientists at Genentech have engineered an antibody which attaches itself to a receptor that carries iron to the brain. As the brain needs iron, the barrier also allows the antibody to pass into the brain.

The discovery has particularly exciting implications for the treatment of Alzheimer’s disease, which affects 35.6m people worldwide, according to Alzheimer’s Disease International. To date, Alzheimer’s drugs which target the amyloid proteins that form in the brains of patients have required delivery in huge doses as so little is able to pass into the brain.

In August of last year, Eli Lilly abandoned late-stage studies of semagacestat, a potential Alzheimer’s drug, when it was found that it did not slow disease progression and actually worsened patients’ ability to function in daily life. FierceBiotech suggested that this could be disastrous for all drugs in the class, but Genentech’s discovery seems to imply otherwise. The breakthrough could mark the beginning of a new age in the treatment of neurological diseases such as Parkinson’s, schizophrenia and autism, providing relief for many millions of sufferers.

The long and the short of a brave new world?

2011-05-18T09:46:00.000+01:00

Authored by Matt Foster, Wednesday 18th May 2011

In February last year, we blogged about the discovery of a gene sequence that suggests some people are genetically programmed to age at a faster rate than others (read How we age, 8 February 2010, by Peter Coё). This week it was announced that a Spanish company has developed a test called Life Length that can predict how long you may live based on this gene sequence, or more specifically, the length of your telomeres. These are end sections of chromosomes that fray over time and become shorter when they replicate until the cell itself eventually dies. Scientists claim that the longer your telomeres are the longer you will live - as the rate at which you age biologically is slower than those with shorter telomeres, who age faster. The test could be made available over the counter in the UK for £435, but the news has been met with divided opinion in the scientific and medical ethics communities.

Steve Connor of The Independent reported that there are two schools of thought. Some scientists question whether this information is useful and if the predictions are reliable. In contrast medical ethicists warn of wider philosophical dangers of knowing when we are going to die: “We need to avoid the fatalism which says that I’m going to die on a certain date so why should I give up smoking or bad foods,” said medical ethicist Piers Benn. But beyond the philosophical implications, there are more tangible ones in the shape of insurance companies potentially using the results of the test, or the government making funding decisions for vulnerable groups. Josephine Quintavale from the pressure group Comment on Reproductive Ethics suggests such tests could be used to marginalise the elderly. But is this somewhat Orwellian view a real possibility?

In 2005, Rupert Jones of The Guardian reported on the government’s extension of the moratorium with the Association of British Insurers on genetic testing by insurance companies. This occurred at the time when targeted therapies such as Roche’s blockbuster breast cancer drug Herceptin had recently been developed and biomarkers such as HER2 could be identified by simple genetic testing. The moratorium was a response to the public’s fear that people would be discriminated against, leading to several consequences including potential employers refusing to offer jobs to the genetically challenged.

This agreement is set to last until November of this year, by which time Life Length may be available in every local pharmacy. So perhaps resistance to the new test is a little more than unfounded scaremongering. Could we perhaps see the emergence of a genetic underclass, to whom doors would be shut due to the short length of their telomeres?

Given the oral clear

2011-04-28T15:19:00.000+01:00

Authored by Matt Foster, 28th April 2011

Recent news that an oral compound fingolimod has been launched in the UK for multiple sclerosis has been welcomed by both patients and physicians.

Fingolimod represents more than just convenience. Selina McKee of Pharma Times also observes that many patients fail to respond to injections and are still not eligible for infusion therapy under National Institute for Health and Clinical Excellence (NICE) guidelines. Until now this group was left with limited treatment choice.

Multiple sclerosis (MS) is a debilitating autoimmune disease of the central nervous system (CNS) in which the immune system incorrectly attacks healthy nerve tissue. As sufferers are often young adults between the ages of 20 and 40, the media has named it ‘yuppie flu’, with speculation being raised that stressful careers play a part in the development of the disease.

Currently, the standard treatment is beta interferon, which works by regulating the functioning of the immune system. Beta interferon requires either an injection or intravenous infusion given in a hospital setting, which interferes with an MS patient’s ability to manage their disease conveniently.

Studies found that fingolimod halved the chances of relapsing, which is extremely good news for patients. And makers of the drug Novartis are keen to point out to NICE that the potential health savings could amount to over £3,000 for each MS relapse that requires hospitalisation. Good news for a National Health Service (NHS) needing to make cost savings and improve patient outcomes. But is fingolimod a silver bullet for patients?

Fiona Macrae of the Daily Mail reported on research that has identified the biological target GM-CSF, which may be the ‘driving force’ behind MS and could lead to the development of a drug that ‘could stop the disease in its tracks’. The research was carried out on mice, but the investigators are optimistic about improving the outlook of MS in people. Could GM-CSF radically change the face of the disease? The Mail reports that without the target, MS does not develop, and when it is ‘mopped up’, symptoms are greatly eased, even in brains that have experienced an accumulation of damaged nerves.

We have yet to see whether mopping up excess GM-CSF will work in people, but the future is looking much brighter now for the 100,000 people in the UK who suffer from MS.

A gleam of light through the cloud of confusion

2011-04-04T18:01:00.000+01:00

Research by an international team of scientists has revealed five gene variants that increase the risk of contracting Alzheimer’s disease. It takes the number of identified genes linked to Alzheimer's to 10 and throws an intriguing new light on a condition that afflicts 300,000 people in the UK alone and is forecast to double over the next generation as the population ages.

The new genes are thought to be responsible for three specific disease mechanisms that could become targets for treatment: the way the body deals with fat and cholesterol; the mechanism by which brain cells process big molecules (endocytosis); and the working of the immune system.

The research, partly-funded by the Alzheimer’s Society and led by Professor Julie Williams (BBC) of Cardiff University, predict that if the effects of all 10 could be eliminated the risk of developing the disease would be cut by 60%.

So is Alzheimer’s largely inherited? “It’s an accumulation of risk factors,” says Professor Williams. “Some are genetic, some are life-style-related. If you get enough of them, you will develop the disease.”

The team, whose findings are published in Nature Genetics, aren’t promising early relief for those living with the condition. It’s likely to be 10 to 15 years before drug therapies will be available for those carrying the genes – or recommendations to others to change their lifestyle. In that time, researchers will have much work to do to gain a fuller understanding of exactly how these disease mechanisms work so targeted therapies can be developed.

Learning from the heart

2011-03-29T17:10:00.000+01:00

Authored by Matt Foster, Tudor Reilly, 28 March 2011

Several large meta-analyses have highlighted the benefits of statins used for secondary prevention of cardiovascular disease (CVD) ie: for people with a past history of it. Though there has been some debate over statin use in primary prevention (for people with no past history), current National Institute for Health and Clinical Excellence (NICE) guidance is supportive and was recently bolstered by a favourable Cochrane review published in February 2011.

This ability for statins to reduce the risk of CVD saves patients’ lives and helps to curb a yearly economic cost to the UK estimated at £29bn, the bulk of which results from hospital in-patient care. It now seems this clinical prevention model may be applied to breast cancer too. According to a consensus paper published in The Lancet Oncology on 28 March, oestrogen-blocking drugs like tamoxifen can help prevent the disease in high-risk women (one in ten women in the UK).

Speaking to The Times this week, Professor Jack Cuzick of Queen Mary University of London, who participated in the paper, said: “There’s always been this feeling that drugs to prevent cancer [as a strategy] seems very strange. But the cardiologists have been doing this for decades. If you went to your doctor with high blood pressure and he said: ‘Come back in a year and we’ll see if you’ve had a heart attack’, you’d sue him.” So will tamoxifen do for breast cancer what statins have done for CVD?

The media have been keen to point out the side-effects of tamoxifen and similar drugs, which The Daily Telegraph cited as blood clots and womb cancer. The Daily Mail mentions that women taking these drugs are also at risk of experiencing hot flushes. But, as Professor Cuzick pointed out, the benefits outweigh the risks: “Approximately, for every ten breast cancers you prevent, you might cause two endometrial cancers.”

Primary prevention, though, is not for everyone. In CVD, NICE recommends that widespread use of statins in people with low CV risk (ie: below the NICE primary prevention threshold of 20% or greater 10-year risk of developing CVD) is not supported by existing evidence. In breast cancer, the risk is measured by a mammographic reading of breast density. So, if these risk thresholds are met, it would make sense to pave the way for tamoxifen to be indicated for primary prevention in high-risk women.

The reaction from patient groups is balanced and cautious. A statement published on the website of Breakthrough Breast Cancer said: “It is vital that we find effective ways to prevent breast cancer, especially in women with a high risk. However, as preventative therapy may have negative side-effects it would not be appropriate for everyone.” The key here is common sense. If statins have successfully prevented CVD, why can’t a similar strategy apply to oncology? If we learn from drugs for the heart, we may help lower the risk of one in ten women developing breast cancer. For a cost of £240 a year per patient, tamoxifen used in primary prevention may mean fewer prescriptions will be needed for drugs used to treat breast cancer, some of which can cost the NHS tens of thousands a year for an individual patient. This should be welcome news for the NHS, which is tasked with finding £20bn worth of efficiency savings over the next three years.

Apples and pears are crushed

2011-03-16T14:57:00.000Z

Authored by Jacqui Brommell

Capturing the public’s imagination with memorable, relevant and effective educational visuals is surely one of the most effective weapons in the fight against cardiovascular (cv) disease. But, while knowing if you’re an apple or pear shape may be useful when shopping for clothes, it’s not so useful when predicting risk of first-onset cv disease, according to a study published in The Lancet.

The study involved almost 222,000 people in 58 prospective studies across 17 countries – and its findings contradict the popular belief that where the body stores fat is more important than the amount of fat. Apple-shaped people, who store fat around their stomach and so have a high waist-to-hip ratio, were previously thought to be more vulnerable to heart disease and strokes than pear shapes, who carry fat below the waist. For example, a large multinational retrospective study had previously concluded that apple shapes have three times greater risk of a heart attack than those with general obesity.

These new findings underscore the value of thorough, long-term prospective studies in establishing medical facts. A combination of BMI (body mass index) and waist-to-hip ratio was revealed to provide only about a quarter of the extra predictive information provided by total and HDL cholesterol. The authors, the Emerging Risk Factors Collaboration , concluded: “BMI , waist circumference and waist-to-hip ratio, whether assessed singly or in combination, do not importantly improve cardiovascular disease risk prediction in people in developed countries when additional information is available for systolic blood pressure, history of diabetes, and lipids.’

As noted by the researchers, national and international guidelines provide conflicting recommendations about the value of fat measurement in predicting cv risk. Yet despite this, the apple and pear analogy and its relation to health seems to have gathered huge momentum with the public, perhaps because it is easily understood and visualised.

Of course, carrying excess fat is a well-established health risk – wherever the fat is. But now that this prospective study has established that lipid levels are a more important cv risk factor than where fat is stored, perhaps we need to shift the public’s attention away from apples and pears into a new universal `fat’ image. Or, we could replace the apples and pears with user-friendly lipid icons – each representing a level of cv risk. Who knows what names we might be calling each other soon!

Fortune favours the BRAF

2011-03-02T09:41:00.000Z

The $935 dollar purchase of hot Californian biotech, Plexxikon by Daiichi Sankyo is a reassuring sign of life in the challenged biotech sector. It’s also a reaffirmation of the value of genome research that once appeared to promise so much and then delivered so little.

The deal value, approaching one billion dollars, is high for a company with just 45 employees, but less surprising when you recall the excitement generated last year around the publication of trial data for its lead compound aimed at skin cancers.

Plexxikon’s PLX4032 is an oral, targeted drug designed to inhibit the BRAF cancer-causing mutation that occurs in about 50 per cent of melanomas and about eight per cent of all solid tumors. In August, researchers announced in Nature that nearly all melanoma patients enrolled in their Phase II trial demonstrated some response, while 81 per cent of patients had tumor shrinkage of at least 30 per cent. By any clinical trial standard, it was an astonishing result.

And it wasn’t just the tabloid media who were excited. Normally sober commentators were right there with them. The BBC Today programme’s science correspondent likened Plexxikon’s discovery to ‘cancer’s penicillin moment’. Sir Mark Walport, director of the Wellcome Trust, which played a key role in producing the first human genetic blueprint, proclaimed on the programme that ten years on from the sequencing of the human genome, its benefits are starting to be demonstrated "on a grand scale".

Plexxikon are not alone in striking gold. Gilead agreed to buy Calistoga in a $600m deal only last week. It just shows that even in these hardest of hard times for the drug hunters, with the way strewn with once bright stars now laid low, there is always hope.

What does the Pfizer closure really mean?

2011-02-14T13:55:00.000Z

Pfizer attracted the headlines in recent weeks after announcing that it will be closing its UK research centre in Kent (read the release here).

Opinions vary as to what the closure means. The UK Opposition was quick to point out a wider political implication, claiming the decision showed the government had “no strategy for growth”. The European Union research and innovation commissioner, Máire Geoghegan-Quinn told the Financial Times that the site closure should be a “wake-up call”, pointing out that “the public and business R&D expenditure in the UK was below the EU’s overall standard”. Despite this, there are other musings that actually big pharma isn’t the place to be looking for R&D in the first place.

Following rumours that Pfizer may open another of its Centres for Therapeutic Innovation (CTI) in London (Scrip Intelligence), perhaps the latter holds some weight. Although not an R&D plant in the same sense, this may be an idea of what is to come in the scientific world: partnering with academic institutions rather than having in-house R&D. This kind of partnership aims to increase innovation, in a market where the simple things have already been done - and so, blockbuster discoveries are increasingly rare.

Due to the accidental nature of some of the big discoveries (including Viagra, discovered at Pfizer’s closing site in Kent), Boston.com is suggesting a further innovative approach to R&D: using the power of social media to give researchers access to real time observations in a bid to “harness communal wisdom”. However, as FiercePharma points out this could be difficult to implement from a regulatory angle.

Although a site closure is never pleasant, it does not necessarily hail the demise of R&D in the UK, it may just be the beginning of a new era, in which a more flexible framework for innovation is the answer to address 21st Century diseases.

The Risky Business of Reform

2011-01-19T09:47:00.000Z

With the publication of the Health and Social Care Bill today (19 January) the media are in a frenzy, reporting on the dissenting voices emerging since the coalition government announced the most radical healthcare reforms in the history of the National Health Service (NHS).

The Daily Telegraph ran a headline stating that opposition MPs likened the ‘rushed reforms’ to tossing a grenade. The Daily Mail examined what it calls ‘the gamble that David Cameron is taking with our health’. Andrew Lansley is accused of spearheading what some Labour MPs describe as ‘reckless decision making’ that will cause ‘institutional upheaval’. But the Prime Minister is adamant: we are in desperate need of change and our health system must be modernised. The question remains whether this strategy will do more harm than good.

The main criticism stems from the central plank of the reforms, which gives GPs responsibility for buying health services and managing the NHS in place of the Primary Care Trusts (PCTs). But GPs themselves have argued the upheaval that will be caused is unnecessary, that instead of abolishing PCTs GPs could simply have taken them over with the same results.

Several unions including the British Medical Association (BMA) are worried that, with GPs being given such powers to cherry-pick health services, there will be increased competition between the public and private sectors, and that the extreme pace and scope of the reforms are risking patients’ lives ‘by putting cost before quality’, as the BMA chairman, Hamish Meldrum put it in a joint letter to the Times.

The government is under extreme pressure to find £20bn in efficiency savings within the NHS and the restructuring is meant to create management savings through the PCT’s removal. But this move appears to many as a reckless way to go about it, potentially putting patients at risk. One example of the potential catastrophe that may unfold is the threat to the country’s cancer networks, made up of key staff who have been told their jobs are now at risk.

As reported in The Guardian, Mike Hobday of Macmillan Cancer Support said: “Cancer treatment will get much worse and more patients could die earlier… unless the expertise that networks have is retained”. If you will allow the mixed metaphor, I’m reminded of what Confucius may once have said: “do not use cannonball to kill fly”. And if efficiency savings are the fly in the ointment of the NHS, the government could run the risk of damaging patient outcomes.

All this, when Andrew Lansley claims the reforms will put patients first by offering greater flexibility. Ironically, this flexibility could be at the cost of key NHS staff whose expertise is crucial to treating patients. It would appear this is a risk the government is willing to take. As The Daily Mail reports, it is a gamble, but great leadership requires great risks to reap great rewards. So let’s hope that what is being risked is not the wellbeing of those most in need of care.

Chill forecast for Britain's NHS in 2011

2011-01-05T22:59:00.000Z

The year 2011 will be a defining year for Britain’s National Health Service (NHS). The country’s healthcare system, with a proud boast of delivering health services to patients free-at-the-point-of-care, will be 63 years old. It will also be running an annual budget of more than £100 billion.

The NHS employs an astonishing 1.7 million people. Of these, 120,000 are hospital doctors; 40,000 general practitioners (GPs), 400,000 nurses and 25,000 ambulance staff. The organisation’s own website points out that only the Chinese People’s Liberation Army, the Wal-Mart supermarket chain and the Indian Railways directly employ more people.

No one argues that the NHS has grown since its launch in 1948 to become the world’s largest publicly funded health service. And most concede its claim to be the most egalitarian and most comprehensive health service in the world. Where the consensus breaks down is over its future and whether it can continue to do as much as it is doing – and more – at an ever increasing cost to the UK taxpayer. Its eye-watering budget has been reached by an average annual increase over its lifetime of four per cent more than the inflation rate.

The UK Health Secretary, Andrew Lansley is leading the argument for radical change, setting out his boldest plan – to hand responsibility for most health services in England to GP practices - within weeks of taking office.

The coalition has pledged to protect the health budget from the severe cuts that have already hit all other government departments. But it’s also determined not to allow the annual inflation-plus increase to continue.

In response, Dr Hamish Meldrum of the British Medical Association said recently "There is no doubt that 2011 will be an exceptionally testing time for the NHS, patients and the profession ... With efficiency savings of at least £20 billion being sought in England alone, the Government is pushing ahead, at break-neck speed, with an unnecessarily ambitious programme of reform."

While a report before Christmas from think tank, Civitas, warned patients could suffer "rationing and the return of long waits" because managers will be preoccupied with restructuring the NHS.

Prominent voices will continue to be raised loudly against the reform programme and there is no doubt pain will be felt throughout the system. The truth is, not only is unrestrained NHS growth unaffordable and reform well overdue, but even more reform is inevitable as the cost and complexity of modern health provision gets ever greater.

An early Christmas present for big pharma

2010-11-30T16:28:00.000Z

Blog authored by Juliet Burns, Tudor Reilly

Biosimilars and how to best regulate and approve them has been the matter of much debate in recent years, especially in light of patent expiries on a number of blockbuster biologics in the next five years. Although regulators have the right to approve biosimilars, until this week, there have been no concrete guidelines.

Finally, the European Medicines Agency has issued guidance on biosimilars that necessitates a much lengthier and more costly process than that needed for generics, and could almost be deemed half way between the rigorous regulations new drugs are submitted to and the milder ones of generics.

The EMA reason that “the focus of the biosimilarity exercise is to demonstrate similar efficacy and safety compared to the reference product, not the patient benefit per se, which has already been shown for the reference product” Unlike generics, biosimilars are much harder to make. Slight variations in the production of biosimilars can make a huge difference to the final product: a hugely complex molecule.

Imagine using Jamie Oliver’s slap dash approach to cooking on one of Heston Blumenthal’s creations – it may still be tasty, but it’s not the same, and in the pharmaceutical industry, being almost as good just isn’t enough.

As a result, clinical trials will be needed to show that a biosimilar has “highly similar” effects to the product it is emulating, which will incur greater costs for producers. Manufacturing will be limited to a small group of large companies who can afford to invest, and indeed Teva Pharmaceutical Industries is already testing its version of Roche’s Rituxan.

So good news for some major pharmaceutical companies like Roche and Abbott Laboratories, not least because the high costs involved in producing copies will mean biosimilar pricing will only be 20-30% lower than that of their originals, compared to up to 90% lower costs for generics.

Alzheimer’s disease: The greatest medical challenge of our time?

2010-10-07T15:51:00.000+01:00

The latest report from Alzheimer’s Disease International makes sober reading. The report estimates the total worldwide cost of dementia to be US$604 billion. “If dementia care were a country”, it states, “it would be the world’s 18th largest economy”.

Alzheimer’s is often described as the public health challenge of our time, not only because of its economic impact but also because of the challenge in finding effective treatments. Pharmaceutical companies have invested significantly in R&D but to date with little success.

In June, the struggle to address the issue of Alzheimer’s disease prompted the Coalition Against Major Diseases (CAMD) to publish a database of information from failed clinical trials conducted by J&J, GlaxoSmithKline, AstraZeneca, sanofi-aventis and Abbott Laboratories, in the hope that a problem shared is a problem halved.

Recent reports of failed compounds, such as Lilly’s semagacestat, which was halted in August (read the press release here), have raised concerns that researchers are not taking the right approach. On 1 October 2010, BioWorld called for a new research paradigm and a change in the way clinical trials into Alzheimer’s disease are recruited and conducted.

The article speculates that the hypotheses behind current research – amyloid deposition and tau hyperphosphorylation being the most accepted - are arbitrary. Russell Katz, Director of the US Food and Drug Administration’s Division of Neuropharmacological Drug Products, said that "the great fear is that maybe amyloid has nothing to do with the disease".

Ray Woolsey, Chief Executive of the Critical Path Institute, which oversees the CAMD, claims that pharma companies are running into a stone wall with research into Alzheimer’s: “We really believe drugs are failing because we honestly don't understand the disease” (Wall St Journal, 11/06/2010). Another theory is that drugs are failing because they are being tested on patients whose brains are already too damaged by Alzheimer’s disease (Reuters, 21/09/2010).

Whatever the reason, it is clear that the need for a solution is becoming increasingly urgent, as an ageing population leads to rising incidence and soaring costs of patient care. The pharma industry, government, and healthcare charities need to work together to raise awareness, promote early diagnosis, and increase the resources available for research into the disease that could become “the most significant health and social crisis of the 21st century” (The Guardian, 21/09/2010).

Vending machines for medicines

2010-07-22T11:09:00.000+01:00

Blog authored by Jacqui Brommell, Tudor Reilly.

If UK pharmacy legislation changes to allow remote supervision of pharmacies, it may not be long before patients could collect their medicines as if they were chocolate bars – from a vending machine.

PharmaTrust’s MedCentre device, due to go on trial in a small number of UK hospitals later this year, combines automated delivery of medicine with a live audio visual link to a pharmacist. The device automatically checks prescriptions and selects, labels and dispenses medicines from the machine, with a pharmacist controlling the process remotely and offering real-time patient advice via telephone and video link-up. PharmaTrust say that the MedCentre can “dispense over 2,000 different medications, is 100% remotely pharmacist controlled and audited and can put 24-hour pharmacies anywhere without the time, distance, language or costs of traditional pharmacies.”

But why are convenience and speed so often seen as the ultimate factor where medicines are concerned? Why are patients impatient when waiting a few minutes in a pharmacy for a cocktail of medicines to be safely dispensed – despite being more than happy to wait indefinitely in a coffee-shop queue? In my view vending-machine-style dispensing reinforces the view that patients should grab their medicines and run.

As a pharmacist, I believe that there’s no substitute for having regular direct contact with patients, taking the time to fully explore all aspects of medication and ailments, and picking up on hints such as body language that may only be apparent if the patient is present. Building relations and trust with patients paves the way for them to fully utilise the skills and knowledge of the pharmacist.

Despite this technology seeming to satisfy legal requirements and include all necessary professional checks, I can’t help agreeing with Michael Thompson, editor PJ Online, that “it just doesn’t feel right....it is a step on the road towards reducing medicines supply to a pure commodity transaction.”

Advances in Alzheimer’s research that promise to defeat dementia

2010-07-14T16:35:00.000+01:00

Existing therapies for Alzheimer’s disease (AD) only address symptoms – there are no available treatments that slow the progression of the disease or target underlying causes. Alzheimer’s Disease International estimates that AD affects approximately 30 million people worldwide and this is expected to rise to over 115 million by 2050. With an ageing population and increasing economic burden of the disease, demand for treatments is high and research into Alzheimer’s is a potentially lucrative business for the pharma industry. A host of pharma companies have committed to research into AD, including Lilly, AstraZeneca, and Pfizer.

The search for an AD treatment is well-documented by mainstream media. In the last week a number of breakthroughs have made headlines and a recent study by the Institute of Psychiatry at King’s College London was front-page news in The Daily Telegraph. Scientists measured levels of a protein called clusterin in the brain and found that patients with high clusterin levels went on, years later, to develop high levels of the plaques in the brain that have been linked to Alzheimer’s. This suggests that the level of clusterin in the bloodstream can be used as an early indicator of the disease and that a simple blood test could be developed that would allow doctors to predict the likelihood of a patient going on to develop the disease.

Last week The Daily Mail reported that researchers at the University of Texas Southwestern have discovered a compound that boosts the production of cells in the brain and could improve memory. The drug, known as P7C3, could be developed as a single daily pill with the potential to address the underlying cause of AD.

However, the search for new treatments is not without risk. Recent late-stage failures, such as Pfizer/Medivation’s Dimebon (see Tudor Reilly blog, 8 March 2010), have led investors to tread carefully, leaving the industry under pressure.

A recent Reuters article claimed that in the United States alone $172 billion a year is spent on caring for AD patients. There is no doubt that AD represents a significant unmet medical need and a potentially profitable therapeutic area for the company that finds the silver bullet. So, it’s not surprising that pharma, biotech and academia are investing substantial resources into understanding the disease and searching for potential treatments.

Pharma’s drug pipeline still in trouble – but not everyone’s a loser

2010-06-30T19:44:00.000+01:00

There was more confirmation this week, if any were needed, that Big Pharma’s R&D pipeline is in trouble.

A study from CMR International noted a near doubling of the failure rate of drugs in late-stage development between the periods 2004-6 and 2007-9. CMR estimated that for every 12 drugs entering pre-clinical research, only two make it to Phase III and just one is submitted to regulators for approval. And even that figure may be optimistic.

There was an up-tick in new drug launches to 26 last year, from 21 in 2008, but that was still little more than half the peak level seen in 1997.

Jane Sharples at CMR, commented “There is a real problem with innovation. The science is getting more difficult, and companies really need to understand how a product works in order to succeed".

Whatever the reasons, the failures come at a huge price to pharmaceutical companies. Failure of a drug candidate in late-stage (Phase III) clinical trials can mean hundreds of millions of dollars of R&D investment burnt for zero return. So it’s no wonder we have heard from more than one Big Pharma player this year that they are narrowing the range of their R&D in a bid to cut costs.

Among the losers, though, there’s always a winner to buck the trend. Shire, for one, can expect a major boost in sales after the European Medicines Agency authorised the use of its experimental drug, Vpriv to treat Gaucher’s disease; a rare genetic disorder that causes abnormal amounts of fats to be stored in the body.

As an orphan drug, Shire can be guaranteed a high price for Vpriv. Genzyme, until now the only provider of a treatment for Gauchers with its drug, Cerezyme has been recovering its R&D investment with sales of $200,000 to $300,000 per patient.

Partnering with patients in clinical trial design

2010-06-16T11:14:00.000+01:00

There is much speculation surrounding the role of patients in the clinical trial process. Should patients and patient organisations play a role beyond that of research subjects? If so, to what extent can patient organisations be helpful to pharmaceutical companies? Funded by the European Commission, PatientPartner is a project that aims to answer some of these questions.

The project began in May 2008, with the aim of analysing the role of patient organisations in clinical trials and ultimately developing best practice guidance for patient groups and clinical trial investigators on how they can best work together. After two years of research, the project is yielding some interesting results. The best practice recommendations and tools to facilitate patient partnership in clinical research will be presented at the final European workshop in Brussels in December 2010.

In late 2008, PatientPartner conducted a survey of 205 national patient organisations across Europe on their involvement in clinical trials. According to the project team, this is the only survey to date that has made an inventory of the experiences of patient organisations in the clinical trials context. Only 11% of respondents had no experience of being involved in clinical trials, while over 79% had been involved in trials at more than one level – either as a research subject; an information provider for patients; an advisor, reviewer, or co-researcher; or as a driving force for the trial. In contrast, and perhaps not surprisingly, the pharmaceutical industry appeared wary of patient involvement, preferring patient organisations to assist with recruitment or providing information to patients, rather than taking an advisory role.

However, the survey did not indicate how successful the partnerships between patient organisations and pharmaceutical companies has been, which is a key piece of the puzzle in developing best practice guidelines for the industry. Perhaps the next stage of research should focus on this aspect of patient-pharma partnerships.

The project’s initial findings can be found on http://patientpartner-europe.eu/en/home.

Finding a way through the UK clinical maze

2010-06-07T09:30:00.000+01:00

Blog authored by Julie Walters, Tudor Reilly.

Clinical trials in the UK have been criticised for being expensive and time consuming. Over the past few years, the National Health Service has been working hard to change that view. A recent conference in the UK heard from those trying to streamline the recruitment of patients into NHS clinical trials.

Dr Louise Wood, Head of NHS Research Infrastructure, said that the step change came with the establishment of the National Institute for Health Research (NIHR) in 2006. This enabled a framework of biomedical research units to be established across England, each with its own centre of expertise. So now if a pharmaceutical company is looking to recruit patients into a trial for advanced lung disease, then try the Royal Brompton and Harefield NHS Foundation Trust; if it’s cardiovascular disease, go to Sheffield, London Bristol or Leicester; Nottingham for respiratory disease and so on.

At the heart of this clinical web, sits the NIHR Clinical Research Network, designed to act as a single point of contact, referring industry to the right place and speeding R&D approvals. See www.crncc.nihr.ac.uk/index/industry

Delegates heard that the jury is still out on the results but it’s a step forward in the NHS being recognised as an international centre for research excellence.

Creating synthetic life

2010-05-26T15:04:00.000+01:00

The news of Craig Venter’s ‘creation’ of synthetic life has hit headlines across the world this week. And while the tabloids have mostly taken the sensationalist tack of ‘Frankenstein lab creates life in a test tube’, the scientific significance deserves cooler examination.

Quoted by the BBC, Venter compares his achievement to the industrial revolution; and it’s no wonder that he hopes this is the case. With collaborations already in place with fuel and pharmaceutical companies, like a $600 million contract with Exxon Mobil, the J. Craig Venter Institute could potentially make trillions of dollars through this development.

While the results undoubtedly show a breakthrough in the creation of a synthetic genome (read the paper published in Science here) it is questionable whether this experiment really heralds a new era in biology.

Scientists like Steen Rasmussen, of the Center for Fundamental Living Technology, claim that Venter’s approach is the wrong way up for ‘creating life’. Rasmussen believes that to truly create a synthetic life you must start from the bottom up - to assemble life, including the hardware, unlike Venter’s team who used a natural cell to house their synthetic genome.

There are other scientists, like James Collins at Boston University, who don’t believe Venter’s cell represents the creation of an artificial life form at all; preferring to view the result as an organism with a synthetic genome, rather than a synthetic organism.

We’ll have to wait and see whether we are now living in a new era of biology, if genetic engineering has been transformed, or if the second industrial revolution is just around the corner. But despite the doubts of some in the scientific community it’s clear that commercial concerns are right behind the endeavour and eager to invest.

Difficult decisions in healthcare

2010-05-19T13:51:00.000+01:00

Blog authored by Julie Walters, Tudor Reilly.

Sir Mike Rawlins was on good form this week as he spelled out how the NHS makes its funding decisions. As Chair of the National Institute of Health & Clinical Excellence (NICE), it falls to his team to balance the effectiveness of new treatments against the cost.

When he started in 1999, NICE had no office and no staff. 11 years on, it has an annual budget of £35 million and a staff of 270.

Sir Mike told an audience at the Royal Society of Medicine in London that spending on healthcare per person in the UK was what you would expect – about 10% of gross domestic product (GDP) – but that we still had a long way to go in terms of improvements.

Recent refusals to fund new cancer drugs had attracted headlines but despite what you read in the Daily Mail, he said, around two-thirds of all NICE decisions have recommended full use of new treatments. However, “pharmaceutical companies can no longer expect the NHS to pay premium prices for drugs with limited health benefits.”

“The NHS has finite resource and we must base our decisions on the best evidence available,” he added.

Legally, the way NICE assesses value is strictly defined. In coming years, that may need to evolve, he hinted, as new drugs for conditions such as Alzheimer’s disease are assessed. For example, the current formula does not take into account the cost of carers having to give up work to look after a relative with dementia. The true cost of healthcare is certainly an evolving debate.

Newron setback highlights vulnerability of biotech

2010-05-12T09:55:00.000+01:00

The plummeting share price of Newron Pharmaceuticals highlights the vulnerability of European biotech, which has seen a number of companies collapse over the last 12 months due to lack of funding and poor clinical data. Newron’s phase III failure for ralfinamide in neuropathic pain resulted in a 55 per cent nose dive in share price to an all-time low (see the charts at Reuters.com).

The setback will mean restructuring and job cuts, according to Newron spokesman Martin Meier-Pfister. However, Newron does have the advantage of an additional phase III candidate partnered with Merck Serono – safinamide, in development for Parkinson’s disease. The treatment is expected to be filed for approval in 2011, and this, along with five compounds in early and mid-stage development, gives Newron “continued potential for growth and value generation” according to CEO Luca Benatti (read Newron’s press release here).

So will Newron manage to weather the storm? Newron displays three key criteria that, according to our research, make biotechnology companies attractive to investors: data, management and partnerships. Late-stage data is critical accompanied by strong safety data. The management team needs to be driven, committed and visible, with experience of big pharma and ideally some commercial experience. Existing partnerships with pharmaceutical companies are also a key factor. Investors want returns – and good data, a strong management team, and profitable partnerships demonstrate that a biotech, like Newron, could recover.

Hard times for Britain’s health service

2010-05-05T18:47:00.000+01:00

Despite promises from all the leading political parties to protect healthcare spending, it looks likely that the UK’s National Health Service (NHS) faces painful cuts in services – regardless of the political colour of the new government after this week's general election.

The NHS budget for England alone in this financial year is £102 billion, a figure reached after record growth of more than 6% a year since 2000. That’s growth well in excess of the UK inflation rate and driven principally by the nation’s ageing population, an epidemic in obesity and the rising cost of new technologies and medicines. And in these austere times, everyone agrees that that trend has to stop.

It transpires that, even before the UK election campaign was underway, NHS managers had laid plans to cut not just beds but also hundreds of doctors and thousands of nurses, in an attempt to balance hospital budgets that will no longer be allowed to outstrip inflation.

So far, the campaign rhetoric has identified a reduction in “waste and bureaucracy” in the NHS – the multiple layers of management – as the source of cost reduction. The reality is that those managers who survive the cull will soon face tough choices on which frontline services also survive. The least of it will be that more district hospitals will close and specialist services will continue their migration towards regional centres of excellence. But the cuts will almost certainly go further as the tax-payer funded system simply can’t afford every expensive new drug and every state of the art technology.

While party leaders have vied with each other to promise better access to cancer specialists and the best available drugs, there are mutterings too from the election trail that physicians should take every opportunity to prescribe generic drugs over their branded counterparts. And don’t tell me they’re only talking aspirin.

South Africa goes to war on HIV-AIDS

2010-04-27T19:35:00.000+01:00

The South African president, Jacob Zuma’s launch on Sunday of a huge HIV counselling and testing campaign (HCT) is a welcome and radical contrast with the approach of his predecessor, Thabo Mbeki. It’s also a highly visible sign of the new administration’s commitment to tackling the scourge of AIDS-related disease in the world’s worst-affected country.

Mr Mbeki, remember, spent much of his presidency questioning the link between HIV and AIDS and refusing government funding for anti-retroviral drugs – supported by a health minister who at one point advocated a diet of beetroot, lemon and garlic as an alternative treatment.

Despite the Mbeki government’s reversal of that policy as long ago as 2003 - under duress from the courts - and the roll-out of an anti-retroviral programme, it’s estimated nearly six million South Africans, one in eight, are now HIV-positive and that up to 1,000 die every day from AIDS-related conditions.

Mr Zuma’s HCT programme aims to provide testing for 15 million people, almost a third of the population, over the next 14 months.

Almost as significant as the programme itself, though, was the president’s willingness to declare publicly his own (HIV-negative) status, following a recent test, which should help to demolish the taboo around talking about HIV.

Strikingly, Jacob Zuma’s announcement also contained confirmation that cases and deaths from Malaria in South Africa were down by 90% in 2009 compared with the year 2000. With the new HCT programme, there are grounds for hope that South Africa can go some way to match these achievements in the fight against AIDS.

Personalised healthcare shows promise

2010-04-19T11:23:00.000+01:00

Blog authored by Julie Walters, Tudor Reilly.

This week saw promising results for personalised healthcare in lung cancer, the number one cause of cancer deaths in men and women.

Researchers at the University of Texas M.D. Anderson Cancer Center have successfully completed a Phase II clinical trial called BATTLE (Biomaker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination), the results of which were presented at the American Association for Cancer Research in Washington DC at the weekend.

Results suggest that patients prescribed treatment with existing drugs based on their tumour biomarkers benefit more than patients whose treatment is not based on tumour biomarkers.

Scientists have known for some time that not all tumours are the same – but it has taken years to begin to understand which tumours would respond best to which treatment.

The study’s co-principal investigator Roy Herbst said the results were “an important step towards personalised medicine and marks a paradigm shift for clinical trials”.

Pharmaceutical industry leaders attend launch of D3

2010-04-12T10:13:00.000+01:00

Blog authored by Julie Walters, Tudor Reilly.

Around 200 leaders from the pharmaceutical industry, venture capital and academia attended the launch of the Drug Discovery and Development Unit (D3) at the Italian Institute of Technology (IIT) in Genoa on Friday.

Roberto Cingolani, Scientific Director of the IIT, welcomed guests to the 30,000 square metres of newly equipped lab space, including nanobiotechnology and neuroscience, which now employs nearly 600 scientists from 38 countries.

Daniele Piomelli, Director of the D3, said D3 would be focused on discovering new drugs in pain, inflammation and dementia and is looking to partner with external collaborators to advance key projects.

The launch event, entitled PharmaFuture 2010, heard leaders from the pharmaceutical industry predict that the future of new medicines would depend on collaborations between academia, biotechnology and industry.

“The key way to move forward in drug discovery and development is to have good interconnectivity”, Bill Burns, the newly retired Chief Executive Officer of Roche Pharmaceuticals, told delegates.

“No single institution is doing all of the right things, so partnerships are crucial to the development of innovative new medicines. The industry needs to harness science from hybrid groups like the D3, who are working in an inspired way to advance the discovery of new drugs in important therapeutic areas.”

Sergio Dompé, President of Italy’s pharmaceutical industry association, Farmindustria, encouraged local industry to form collaborations to further drug discovery.

“Here in Italy we have extremely skilled scientists who have great ideas, but we face a challenge in getting new R&D projects off the ground,” he said. “Collaborations between industry and academia, such as the model employed here at D3, are crucial to the success of the Italian pharmaceutical industry”.

Breast cancer screening: The jury is out

2010-04-06T10:30:00.000+01:00

The debate on the value of the NHS breast screening programme is ongoing following research published last week from the Wolfson Institute of Preventive Medicine at Barts and the London School of Medicine and Dentistry.

Breast cancer is the most common cancer in women in the UK. According to the UK Office for National Statistics, over 38,000 new cases were diagnosed in 2007. Almost 10,000 women died of breast cancer in the same year. The NHS breast screening programme provides free mammograms every three years for all women in the UK aged 50 and over, and the programme screens almost 2 million women each year, at a cost of £75 million.

The research, part-funded by Cancer Research UK, shows that breast cancer screening saves lives – approximately 1,400 deaths each year are prevented because of the NHS screening programme. However, critics claim that there is a minimal difference in the death rates of women who have mammograms and those who do not. A further drawback to consider is the fact that scientists are currently unable to distinguish between threatening and non-threatening tumours, meaning that in the UK, 2.3 women in every 1000 receive treatment for cancer that is not harmful (statistics from the Wolfson Institute’s research). These cases of unnecessary treatment are described as over-diagnosis, referring to forms of cancer detected through breast screening that are so slow-growing they would probably not affect the patient in their lifetime, and would not otherwise have required treatment.

A report published in the Telegraph discussed the example of ductal carcinoma in situ, which often remains symptomless, claiming that “half of women diagnosed with DCIS go on to have a breast removed”. The question therefore is – do the benefits of breast screening outweigh the costs associated with over-diagnosis, including hospital time and resources and the stress of false diagnosis and unnecessary treatment?

The Wolfson researchers think so. They studied data from the UK Breast Screening programme over a 20 year period and compared it with data from a randomised trial involving 80,000 women in Sweden. Their findings suggested that in the UK, for every woman aged 50-69 who is over-diagnosed, two lives will be saved – a statistic that cannot be ignored. The World Health Organization promotes screening programmes, sharing the view that “early detection in order to improve breast cancer outcome and survival remains the cornerstone of breast cancer control”. It’s a complex issue, but it seems that if more lives are saved, the programme should continue, as long as women are well-informed of the risks.

Who pays for spin-outs?

2010-03-30T09:46:00.000+01:00

Who should pay for the commercialisation of publicly-funded research? That was the debate at last month's BioTuesday, the Oxford Biotech Network's monthly clan gathering.

Understandably keen to spread the risk from the technology transfer organisation alone was Linda Naylor of Isis Innovation - the tech transfer arm of Oxford University, which alone has spun out over 70 companies.

Linda noted there had been 54 Oxford spin-outs since 2000, with a total external investment of £266m, the bulk of that being second round funding from institutions and venture capitalists. The future lay, she suggested, in a shared risk environment where funding came from many sources, including universities, research councils and trusts, industry and government.

Sceptics on the fringes of the meeting, though, were asking whether Britain's universities were trying to commercialise their projects far too early and focusing on numbers of spin-outs at the expense of value created.

Markets welcome healthcare reform

2010-03-23T11:48:00.000Z

Blog authored by Julie Walters, Tudor Reilly.

Not perfect but certainly welcome. After months of uncertainty and daunting odds, US President Barack Obama has secured the healthcare reform for which he had long battled. And although some of the details have yet to become clear, the markets have responded positively. Shares in many US healthcare companies rose after the announcement, trading on greater certainty and a cautious welcome from industry.

PhRMA, the US trade body representing pharmaceutical research and biotechnology companies, said “the important and historic vote in the House will help to expand health care coverage and services to tens of millions of Americans who are uninsured and often forced to forego needed medical treatments.

“Our commitment to help pay for health care reform will require all of our companies to make some difficult choices moving forward – on top of already losing more than 150,000 jobs since 2007 because of the recession and other economic factors.”

According to the Financial Times, the final version of the bill came close to the one that drug companies had supported, accepting additional costs of more than $80bn over the next few years, while fending off measures that would have capped prices of drugs or exposed them to greater competition from generic rivals.

Social media lessons from Sanofi-Aventis

2010-03-15T09:13:00.000Z

If you work in a pharmaceutical company that - like most - is cautious about using social media of any kind, you may have good reason this week to continue to avoid dipping your toes in the Facebook or Twitter waters.

Sanofi-Aventis has been left feeling the brunt of patient power after an apparently unhappy cancer patient posted on the company’s Facebook page images of her permanent baldness, allegedly caused by the company’s anti-cancer agent, Taxotere.

The 8th March post from Ann Adams on Sanofi’s Facebook Wall accompanied by a photo said: "Good morning Sanofi, I had your drug Taxotere and as you can see from my photo this is what my scalp looks like 4 years later. Do you have any comment to make?"

The company blocked Ann Adams from posting further comments to the Facebook page, only to find that days later its VOICES Facebook page had been flooded with messages. Under a post entitled “Soon the world will know your dirty little secret”, many have posted messages about Taxotere and permanent hair loss.

One post said: “Stop hiding the truth about how your drug Taxotere can cause permanent hair loss in women.”

The messages appear to have now been removed from the Facebook pages.

But some are now questioning the authenticity of these posts. Pharma blogger John Mack has suggested that the messages could be from a disgruntled employee, a competitor or even a law firm. “This attack smells to me like an organised campaign designed by professional PR people who might be employed by a law firm” he says. He calls for the company to respond to the posts and the allegations. “S-A sure is getting a lesson on how to handle social media communications! What it needs to do quickly is to get vitalised, organise its response, involve its legal and PR people, communicate ... and educate themselves about social media so that they better serve their FB community!”

The entire affair reminds us that when it comes to consumers and the public having their say, constraints and rules don’t seem to apply. It’s OK to name-drop a brand if you’re a consumer having a rant. But it’s a bit tricky to use the same vehicle to defend your product (see Tudor Reilly Blog, Big Public little Pharma, 28th July 2009).

Alzheimer's disease and the search for the silver bullet

2010-03-08T17:04:00.000Z

Last week brought a disappointing blow to the development of new treatment options for Alzheimer’s disease when Medivation and Pfizer’s Dimebon (latrepirdine) failed the Phase III CONNECTION trial. Results from the CONNECTION study showed that Dimebon didn’t meet its primary and secondary efficacy endpoints and failed to differentiate from placebo, sending Medivation’s stocks crashing by more than 65%. There was a lot of positive anticipation before the results were released; the Phase II trial had shown that a three-times-daily 20mg dose of Dimebon preserved function in patients at or near their original levels on entering the trial across all key aspects of Alzheimer's disease; specifically memory and thinking, behaviour, activities of daily living and overall function. (Medivation press release)

Dr Mark Smith, a consultant to Medivation and professor of pathology at Case Western Reserve University, said he expected the CONNECTION trial results would not be as good as the Russian trial but even replicating 50% of the original results would be meaningful to patients. (Financial Times)

In the UK alone there are nearly 685,000 people living with some form of dementia. This is expected to rise to 940,000 by 2021, and 1.7 million by 2051, according to the Alzheimer’s Society.

With an ageing population, the prevalence of diseases like Alzheimer’s can only rise and while current therapies can alleviate symptoms there are no available options to stop its progression.

The next treatment expected to announce Phase III results is Johnson&Johnson’s bapineuzumab, a humanised monoclonal antibody targeting β-amyloid, followed closely by Lilly’s solanezumab which is currently in Phase III trials. Both of these agents work by clearing existing β-amyloid deposits from the brain or by hindering their formation. The dominant view is that other processes considered hallmarks of Alzheimer’s occur downstream from β-amyloid plaque formation.

There is a lot of scepticism surrounding Alzheimer’s treatments, with few patients continuing treatment long enough to see any real benefits. Quoted in the Financial Times, Dr Gary Kennedy, director of the division of geriatric psychology at Montefiore Medical Center in New York, said “We’re not close enough to the cause of this illness to get the silver bullet. People have to be really cautious about this.”

Despite the lack of definite causality, there are hopes that we will one day have a therapy to treat the underlying disease, not just the symptoms of Alzheimer’s. Meanwhile, symptomatic therapies, such as Aricept, Namenda and Exelon, remain important and are likely to remain the mainstay of treatment.

Turning scientists into entrepreneurs

2010-03-01T10:13:00.000Z

Blog authored by Julie Walters, Tudor Reilly.

News that the UK’s Royal Society is putting its research fellows through a Business of Science programme at Imperial College Business School is welcome news. The journey from Albert Einstein to Bill Gates can be a long one.

Most biotechnology companies are started by scientists who are passionate about their research. But a company will need a lot more than passion for science if potential drugs are to make the journey from bench to bedside.

Bill Gates once famously said: “If I was down to my last dollar, I’d spend it on public relations.” Unfortunately, public relations or PR is often the last thing scientists think of when they launch a company. First, rightly enough, comes the three big Ms: management, money and markets. But increasingly, PR is next on the list, to help build and guard reputation.

There are still some who think that the science should speak for itself. The only flaw in that plan is that most people, including investors, don’t understand the science. I’ve heard investors complain that they had to watch a pitch presentation several times before they understood the potential application. The company in question was lucky to have found a patient investor! Most won’t be so lucky.

PR builds and maintains credible and sustaining relationships with investors, business partners, potential consumers and regulators. And in the beginning that can mean helping management to define a message and a story that can be understood by the outside world. Not an easy task but one that has to be done – the earlier, the better.

Scientists unlock the secret of ageing

2010-02-22T10:10:00.000Z

Last week a team of researchers from Newcastle University and the University of Ulm, Germany, claimed to have discovered the biochemical pathway involved in ageing, unlocking the secret of how living cells grow old. This discovery could have significant implications for research into age-related diseases, such as heart disease and diabetes. These findings come hot on the heels of the identification of a gene which determines how quickly people age, reported in Nature Genetics earlier this month (read Peter Coë’s blog on the discovery of this gene, “How we age”, 8 February 2010).

The research, published in Molecular Systems Biology, hypothesised that cells become senescent (a state in which cells stop dividing and their tissue shows signs of deterioration) due to a feedback loop triggered by a DNA damage response. In other words, when a cell detects serious damage to its DNA - which occurs naturally from the wear and tear of life – it sends distress signals to the brain, triggering the cell’s mitochondria to produce free radicals which in turn reduce its ability to support tissue regeneration and repair.

An article published in the Financial Times described how Thomas von Zglinicki, leader of the research team and Professor of Cellular Gerontology at Newcastle University emphasised the need for caution with further research into cellular senescence. “It is absolutely essential to tread carefully in trying to alter processes that cause cells to age, because the last thing we want is to help age-damaged cells from breaking out to become malignant”, he said.
Nevertheless, this discovery has great potential for improving our understanding of diseases linked to cellular senescence, such as atherosclerosis and diabetes.

Patient Voice

2010-02-15T10:37:00.000Z

Blog authored by Julie Walters, Tudor Reilly.

Last week’s Economist Pharma Conference in London heard how patients are helping to shape future treatments.

Jon Achenbaum of Bayer Healthcare Diabetes Care shared two examples of how patients have been involved in the design of two new treatments.

The first, Contour USB, is a new way to monitor blood glucose levels – a glucometer on a thumb drive. The second is a monitoring device for kids called Didget that plugs into a PlayStation.

Diabetics need to proactively manage their glucose, Jon told delegates, so there is a real motivation for patients to have a say in how they do that.

The new patient-centric ideas resulted from a visit by an innovation team from Bayer which spent five days in a diabetes clinic to understand more fully how patients manage their condition and to hear their ideas.

Living up to the maxim “the best way to get a good idea is to start with a lot of ideas”, the Bayer team came back to HQ with hundreds of new possibilities. They were then whittled down to the best few, which went forward for development.

“If you were a patient, who in this room would not like to be involved in the solution?” asked UCB’s CEO, Roch Doliveux in the same panel discussion as he talked of the sea change taking place in the corridors of power. “In the past,” he said “we’ve talked at patients, not with them” but that had changed. Among other things, patients had helped UCB engineer a new syringe, designed by patients for patients with rheumatoid arthritis.

How we age

2010-02-08T13:49:00.000Z

The journal Nature Genetics reports scientists have identified a gene sequence that suggests some people are genetically programmed to age at a faster rate than the rest of us. It’s the first time a link’s been found between DNA and human lifespan and it raises the hope of drugs that could prevent the biological deterioration behind age-related conditions such as heart disease and cancer.

The promise and fascination of this area of research was highlighted by last year’s Nobel Prize for Medicine, awarded to three US-based scientists who identified both how our chromosomes are protected by telomeres and the enzyme that makes them.

The telomeres are end sections of chromosomes which act like the plastic tips of shoelaces and stop them from fraying. The problem is they shorten each time they replicate and eventually are so short that replication becomes impossible and the cell dies forever.

The latest study has observed that a variant of the gene determines not only how long the telomeres are when someone is born but also how quickly they shorten. Professor Nilesh Samani of the University of Leicester, one of the study leaders, found a common sequence of DNA in 45% of the 3,000-strong trial group was strongly linked to a person’s biological age. The majority of the population don’t carry copies of the variant and don’t appear to age as fast.

Professor Samani said: "It is the first step to understanding why people age. Once we have a full understanding we should be able to manipulate it in a manner to influence how someone ages."

All of which suggests that in the longer term it may be possible to extend the life spans of those who carry the gene variant.

In the meantime, those of us who test positive as young adults can expect a prescription for cholesterol-lowering drugs - and the familiar encouragements to exercise, eat healthily and avoid smoking.

Converting skin cells to working neurons

2010-02-01T12:42:00.000Z

This week Nature published the results of a study into the conversion of skin cells to working neurons conducted by a team at Stanford University School of Medicine. (Read the results here)

Interviewed on Nature’s podcast Marius Wernig could hardly believe what his team had achieved. The team’s discovery turns epigenetic regulation on its head.

Traditional thinking around epigenetic regulation saw it as a one-way process: pluripotent embryonic stem cells give rise to all other types of cells in an organism. This idea was thrown out when Dolly the sheep was cloned from adult cells.

The thinking after Dolly was that cells had to be converted into the pluripotent stage and could then be coaxed into transforming into a different type of cell. The Stanford team feel that this is an unnecessary detour on the road to cell conversion.

Wernig’s team took skin cells and actively and directly induced them to become a completely different cell type, in this case, neurons. There was no detection of pre-existing neurons, glia, or neural progenitor cells in the original sample but after twelve days 20% of the cells had developed neuronal morphology. An incredibly fast transformation. Not only this, but when put in a petri dish with original brain cells, these induced neuronal (iN) cells formed fully functioning synapses and integrated into a neural network.

It is the repercussions of this research that really matter. One application could be in implementing these cells in the treatment of neurodegenerative diseases where brain cells are destroyed. These results also indicate that we will have the ability to take skin cells from patients with neurological problems and very quickly convert them into brain cells to study them in vitro. Capturing diseases such as Parkinson’s and Alzheimer’s in the petri dish for the first time.

Obesity surgery on the NHS: The postcode problem

2010-01-25T09:13:00.000Z

At a conference last week, The Royal College of Surgeons of England spoke out against access to weight-loss operations on the NHS, such as stomach bypass, stomach stapling and gastric bands, describing them as “inconsistent and unethical”. Guidelines issued by NICE in December 2006 aimed to standardise treatment in England and Wales, but these guidelines are not compulsory, which leaves the decision-making to local primary care trusts (PCTs) and puts patients’ lives in the hands of a “postcode lottery”.

According to the Royal College of Surgeons, around one million people in the UK meet the NICE criteria of eligibility for obesity surgery (read the criteria here), yet only 4,300 NHS weight-loss operations were carried out in 2009. The delay in treating these patients is costing the NHS an estimated £7.2 billion per year. A survey of UK bariatric surgeons conducted prior to the conference found that some primary care trusts are refusing to commission any obesity surgery at all, and approximately two-thirds of respondents said that in their centres patients who are eligible under NICE guidelines are frequently refused surgery.

Quoted in the Royal College of Surgeons press release, Mr Alberic Fiennes, President-elect of the British Obesity and Metabolic Surgery Society said “...to limit surgery to the most severely obese is unfair and short-sighted and against basic professional ethics...”. So why are PCTs resisting these ops?

Speaking on BBC Radio 4’s Today programme, David Stout, Director of the NHS Confederation’s PCT Network, argued that PCTs decisions on obesity surgery are dependent on competing priorities in the local area, such as cancer, mental health, or maternity. An article in The Daily Telegraph quoted Professor Mike Larvin, Director of Education at the Royal College of Surgeons, who believes it is budget pressures that are leading PCTs to avoid paying for obesity surgery: “In many regions the threshold criteria are being raised to save money in the short-term meaning patients are being denied life-saving and cost-effective treatments”.

Incontestable evidence that weight-loss surgery is both cost-effective (with surgery costs recouped within three years) and the only proven successful method of treating the morbidly obese suggests that leaving the decision in the hands of PCTs is not an effective long-term fix. The issue needs to be addressed, and The Royal College of Surgeons of England is calling for the Department of Health to develop a long-term strategy which ensures that all patients have equal access to treatment.

The future of partnering

2010-01-19T16:40:00.000Z

Blog authored by Julie Walters, Tudor Reilly

The biotech-pharma partnering conference that is BioBusiness opened in London today with a panel discussion with three industry heavyweights: Tony Rosenberg of Novartis, Dan Zabrowski of Roche and John Goddard of AstraZeneca.

The topic was the success – or not – of partnering over the past 10 years and predictions for the future.

John Goddard told the 200 delegates that he believed three themes would define the next 10 years: innovation, the increasing demands of payers and emerging markets.

“In 10 years, we won’t be calling them emerging markets,” he said “as they will be bigger than the US.”

Tony Rosenberg said pharma’s future would continue to depend on successful external collaborations though denied that pharma could rely becoming just a distribution and marketing organisation without its own R&D. “The ability to judge these external opportunities is key so we need an internal innovation engine,” he said.

Dan Zabrowski said Roche was placing an increasing focus on emerging technologies and had created a group within Roche Pharma Partnering to carry these forward. He added that Roche would continue to be aggressive in terms of the number of transactions signed and expected to match, if not beat, the 100 deals signed in 2009.

For more information, visit the conference website.

It’s JP Morgan time

2010-01-11T11:45:00.000Z

Blog authored by Julie Walters, Tudor Reilly

The zoo that is the JP Morgan Healthcare conference starts in full swing this morning in a crowded hotel in central San Francisco. Anyone who is anyone in pharmaceutical and biotechnology deal making and investment will be there.

More than 300 companies are expected to deliver presentations to more than 3,500 investors . If you’re looking for cash in biotech, this is the place to be.

So far, over 80 companies have put out press releases just on the fact that they’ll be presenting at what is universally acknowledged as the most important event in the healthcare investment calendar.

Thankfully, you can follow some of the action by webcast – here’s a list of many of the key events: http://www.eventnewscenter.com/shows/show/407-jp-morgan-28th-annual-healthcare-conference-2010?page=1

2010-01-06T18:00:00.000Z

The steady increase in cancer survival rates is good news for many of us but it’s not without problems for doctors and their patients. While the number still alive in the UK at least five years after initial diagnosis has climbed to 1.25m, a leading charity has highlighted today that cancer survivors often go on to struggle with other serious illnesses.

Macmillan Cancer Support, a UK charity, says many patients and doctors don’t appreciate the lasting impact of the disease and its treatment and that this has led to long-term neglect of some patients. All cancer patients, it says, should be advised about possible long term side-effects and other health problems that may develop long after their treatment.

Depending on their type of cancer, survivors may subsequently experience weight gain, memory loss, bowel problems, and bone and heart disease - often as a result of the cancer treatment. The terminal condition of Hannah Jones, the 13-year-old who refused a heart transplant in 2008 before eventually changing her mind, resulted from drugs she had been taking since contracting leukaemia as a little girl.

Macmillan says some doctors aren’t aware of the possible long-term effects of cancer and its treatment, so patients don’t get the support they need. It estimates that some 250,000 patients who are alive at least five years after diagnosis have chronic health problems.

Macmillan and the UK’s cancer tzar, Professor Mike Richards seem agreed that next steps should include a personalised care plan for each patient that looks beyond the end-point of their original cancer treatment.

Happy, healthy Christmas time...

2009-12-21T09:04:00.000Z

Work commitments met? Check. Christmas tree dressed? Check. Gifts bought and wrapped? Check. Half a stone of weight gained? Um...check. This year most of us will get more than we planned for this festive period – piling on the pounds. Following the feast over the holidays, the New Year will doubtless see many of us hitting the gym, detoxing and counting our calories. There’s a good chance that health foods and diet pills such as GSK’s over-the-counter weight loss pill Alli (orlistat) could enjoy a rise in sales following the Christmas period. New Year resolutions will see people quit smoking, drink less alcohol, and become more active.

Aside from being a time to indulge and relax, the festive period is for some a very difficult time of year. Mental health charities and NHS Direct offer advice for people who are prone to feel anxious or lonely over the holidays while NHS Trusts have set up free helplines to provide reassurance and support.

UK Charity the Depression Alliance says the Christmas and New Year period is a difficult time for thousands of people, particularly those affected by depression. Many older people also find it a difficult time of year. Age concern estimates that one in three people over the age of 55 dread the Christmas period because of loneliness, health issues, money concerns and depression. The charity has also published shocking data on fuel poverty and winter deaths in the UK, showing a rise across all regions for December to March 2008/09 compared with 2007/08.

Flu viruses will also hit hard this Christmas time. Cases of swine flu (H1N1) in particular are predicted to rise as thousands of relatives travel oversees to visit one another.

But we can all take the Christmas health warnings a little too far. Researchers at Monash University in Australia believe that Father Christmas is a health and safety disaster. His obesity, drinking and dangerous driving send out the wrong messages, the researchers say. Writing in the in the BMJ they declare: “Given Santa’s fame, he has considerable potential to influence individual and societal behaviour—and not necessarily for good. Santa is a late adopter of evidence based behaviour change and continues to sport a rotund sedentary image.” Perhaps a slimmer, healthier Santa Claus would give them Christmas cheer?!

Pharma looks to emerging markets to get ahead of the game

2009-12-14T11:35:00.000Z

Over the next decade, the emerging economies of Brazil, China, India, Mexico, Russia, Turkey and South Korea are expected to experience the most rapid growth in demand for medicines and pharmaceutical companies are looking to broaden into these new horizons in more ways than one.

Last week saw a number of companies vying for increased presence in emerging markets. In London, Abbas Hussain, Head of Emerging Markets at GlaxoSmithKline, outlined the company’s strategy to expand through sales of generics, vaccines and patented drugs, as well as pursuing acquisitions and alliances (read the FirstWord report and the Daily Telegraph article).

Elsewhere at its annual meeting US-based Eli Lilly & Co announced the creation of an emerging markets business unit with China being the company’s key priority (read press release).

Pfizer has repeatedly stated that growth in the emerging markets is one of its top priorities, and in recent weeks has made headlines for pursuing deals in India (Reuters: India’s Cipla in generic supply talks with Pfizer), China (Forbes: Pfizer, Crown to study cancers common in Asia), Brazil (PharmaTimes: Pfizer beaten in battle for Brazil’s Neo Quimica) and Japan (Reuters: Pfizer to launch generic drugs in Japan).

This shift in focus is unsurprising. The traditional major pharmaceutical markets of the United States, United Kingdom, Western Europe and Japan are slowing down, with the contribution to global growth from these areas forecast to drop to 16 percent by the end of 2009 according to IMS Health.

Meanwhile, economies in the emerging markets are becoming stronger and disposable income is rising, leading to an increase in lifestyle diseases such as diabetes and high blood pressure. According to IMS Health, the seven “pharmerging” markets of Brazil, China, India, Mexico, Russia, Turkey and South Korea will be worth $155-$185 billion by 2013 (read the Pharmaceutical Executive feature).

Spending on health where it matters

2009-12-07T17:39:00.000Z

As Britain’s finance minister, Alistair Darling is set to reveal this week how he plans to cut the UK’s huge borrowing requirement, the eye-watering £13 billion pound IT project for the country’s National Health Service (NHS) looks like a prime casualty. It’s argued the patient benefit will be too small to justify this huge investment and few beyond the IT consultants are arguing otherwise in these straitened times.

In contrast, the Cinderella of NHS provision in the UK - mental health - seems finally to be getting the recognition it deserves. The Department of Health's New Horizons report published today has announced a tripling of funding committed to research on depression, schizophrenia and other aspects of mental health from about £50m a year to £150m as part of an ambitious vision for 2020.

The report rightly argues that much more effort is needed to understand the underlying roots of these illnesses. Apart from the misery experienced by those who are affected by depression or schizophrenia, it has also been found that sufferers have significantly increased risks of developing cancer or having heart attacks in later life. People with depression or schizophrenia are also likely to have worse outcomes than others when they contract other serious illnesses, such as arthritis or diabetes.

Key to realising the vision in my view are: the development of more effective drugs that offer the chance of a cure; that a person’s physical and mental health are treated with equal importance by health service providers; and that all people with mental health problems and their families - not just the most seriously ill - will have access to the high-quality support they need.

Increasing numbers of patients join online communities to Talk Health

2009-11-30T09:15:00.000Z

Guest blog from Deborah Mason, Founder, TalkHealth.

When you consider that the World Wide Web only became commercially available in the mid 1990s you realise just how much our lives have changed in such a short space of time. From booking flights and ordering groceries to keeping in touch with friends and family, the Internet is intrinsically part of our lives.

Health is one area where the Internet has had a huge impact. People use it to find information about all aspects of their health, often before making an appointment with their GP. It is this proactive approach by patients that’s led to an increase in patient focused websites providing both information and much needed support.

According to an article from BBC Health*, people searching online for health advice often reject sites giving high-quality information in favour of those with a human touch. Researchers found that sites including personal stories to which the reader can relate are favoured over drug company sites. Many are drawn to sites where they can read about the experiences of other people who have the same or similar problems.

This is certainly true of my own experience. It was my daughter’s battle with severe atopic eczema and a lack of emotional support that led me to start my first TalkHealth site, TalkEczema in 2000. The site fills the gap that health professionals can’t necessarily fill; the desire for patients living with the day-to-day difficulties of specific health problems to band together and form communities so they don’t have to suffer alone. Being able to access a wealth of information in one place, talk to others who know exactly what you’re going through and learn about products and treatments that may help are some of the many reasons why patients keep joining sites like TalkEczema.

For more information visit http://www.talkhealthpartnership.com/

*Source: ‘Personal’ health websites sought, BBC Online, 7 March 2007

Industry stars honoured at Scrip Awards 2009

2009-11-23T09:26:00.000Z

November 18th saw the Who’s Who of the pharma and biotech industry gather for the 2009 Scrip Awards ceremony in London. Hosted by broadcaster Gavin Esler, the awards saw a wide range of entries from small biotech and big pharma alike.

In spite of the financial downturn, it was an evening to celebrate the industry’s achievements in the past year – the best partnership alliance, product pipeline, management team and licensing deal of the year were all honoured.

Amgen and Novartis each won two awards, while Abbott, Schering-Plough, Sirtris, Archimedes, GlaxoSmithKline, Hikma Pharmaceuticals and Quintiles also received gongs.

Licensing Deal of the Year went to ThromboGenics, BioInvent International and Roche for their collaboration in the development and commercialisation of an early-stage anti-cancer antibody, which the judges thought was a natural extension of Roche’s oncology franchise.

The lifetime achievement award was given to Professor George Poste CBE, acknowledging his four decades of work in the fields of academia, industry and government. During his career, Professor Poste has published more than 350 research papers, has brought 31 drugs, vaccines and diagnostics to market as President of R&D at SmithKline Beecham, and served on several government panels in the UK and US. Even after retirement, Professor Poste continued his contributions to the industry, designing and building the Biodesign Institute at Arizona State University. He was awarded a CBE for services to the development of biosciences in 1999.

A second award recognising excellence in leadership was Executive of the Year, which went to Miles White, Chairman and CEO of Abbott, for having “completely re-invigorated the organisation” during his 25-year career at the company.

As well as awards for R&D and leadership, the Scrip Awards highlighted some other important trends in the industry. The award for Best Company in an Emerging Market was given to Hikma Pharmaceuticals of Jordan, a fast-growing company in the Middle East and North Africa region. The Corporate Social Responsibility award went to GlaxoSmithKline for its “Big Pharma as a Catalyst for Change” programme.

For a full round-up of the winners, visit the Scrip World Pharmaceutical News website.

US praise for NHS

2009-11-16T09:10:00.000Z

After a barrage of US political attacks on our “socialist” NHS system, the latest opinion piece to come from the Big Apple ranks the NHS as one of the best primary care systems in the world.

Only a few months ago, British health professionals were mounting a defence of the NHS after US conservatives condemned the system – presenting it as a terrible example of healthcare and a reason why Obama’s reform plans should be opposed.

Yet a US survey of over 10,000 primary care physicians in 11 developed countries has rated the UK top in several categories, with the US lagging far behind.

The report, by New York think tank The Commonwealth Fund, found that the UK was the only country where most doctors (51%) felt healthcare quality is on the up, having improved in the last three years. In contrast, just 19% of US doctors felt quality of care in their country had improved over the same period.

The UK was also the least likely to report long waiting times for patients to see specialists – just 22% of UK doctors raised this as a problem, compared to 28% in the US and a horrific 75% in the worst-ranked countries of Italy and Canada.

And despite the fact that the US has the highest per capita spending on health in the world – and nearly 2.5 times more than the UK – it seems just 46% of their doctors keep electronic medical records, compared to over 90% of UK GPs.

The UK also performs much better in terms of after-hours care. Most UK doctors (89%) said their practices had facilities in place after hours, compared to just 29% in the US.

Perhaps US doctors simply don’t have time to give this level of care because they are too busy dealing with the bureaucracy of insurance claims. Nearly half of their doctors report the time they spend sorting out insurance restrictions to medications or treatments is a major problem.

In our socialist UK system, this is only a problem for 6% of doctors.

US comes close to healthcare reform

2009-11-09T10:11:00.000Z

All eyes move to the Senate in Washington over the next few days after the House of Representatives passed the healthcare reform bill championed by President Obama. http://news.bbc.co.uk/1/hi/world/americas/8348941.stm

Having sat in on some of the Senate debates in the past couple of weeks, it is an extraordinary testament to the determination of the Obama administration that a result – albeit a close one – was achieved amid such passion, anger and a barrage of confusing statistics.

After a week in Washington, it was difficult to know who to believe.

We heard the Democratic Party Whip, Senator Dick Durbin from Illinois defend the reforms claiming that the republicans have no better option and that the reforms would “liberate people, families and businesses from healthcare they can’t afford.”

We also heard Republicans giving astronomical figures as to the true cost of the reforms. The UK’s NHS was held up as the worst example of publicly-funded healthcare: the unacceptable face of socialism.

The debate continued day and night on 24-hour news channels, with the Obama camp and Fox News slugging it out like an old married couple in their entrenched, polar opposite positions.

So a result is a welcome surprise. Let’s hope the Senate also comes to a conclusion in the days ahead.

Hot off the press at Ausbiotech 2009

2009-11-02T10:26:00.000Z

Approximately 1,400 delegates and 1,800 participants from 26 countries worldwide gathered in Melbourne last week for Ausbiotech 2009, the premier Australasian biotechnology conference.

The focus of the conference was on the sector’s emergence from the global recession, with key emphasis on the success of Australian R&D and the improving financial performance of the Australian biotech industry.

Media coverage surrounding the conference highlights the promise of Australia as the ‘next big thing’ in biotech. Robert Gottliebsen from The Business Spectator described how “Australian junior pharmaceutical companies have been making world-breaking discoveries”, and Mr Jon Mowles, Sector Specialist for Life Sciences for UK Trade & Investment, acknowledged Australia’s importance to the global biotech industry in a press release: “The UK government has recognised the ever increasing global stature of Australia in biotechnology – now ranked sixth in the world – and sees great potential for further partnerships...”.

This year, the conference hosted its largest UK delegation ever, with representatives from 19 companies, academic and government institutions attending and a satellite session hosted by UK Trade & Investment showcasing the latest developments in research out of the UK.

Another key theme emerging from Ausbiotech 2009 is Victoria’s position at the forefront of innovation in Australia, which sparked two widely-covered stories. In his opening speech, Australia’s Minister for Innovation, Gavin Jennings, announced that regulatory processes for multi-site clinical trials will be relaxed from mid-November, and also highlighted the findings of a Deloitte report suggesting that Government investment in the Australian biotech industry over the last decade has created thousands of jobs and contributed to the strength of Australia’s economy (read the stories in Australian Life Scientist and Science Alert).

The other stories causing a buzz in the media were the results of two Big Pharma sponsored awards presented at the conference. The Ausbiotech-Roche 2009 Excellence Award for contribution to the biotechnology industry by an individual went to CEO of ChemGenex Greg Collier, whilst the award for contribution to the biotechnology industry by a company went to Acrux. The Ausbiotech-GSK Student Excellence Awards included regional awards as well as an overall national winner, Tony Carlisle from Flinders University in South Australia.

Overall, Ausbiotech 2009 was characterised by positivity, opportunity, increased confidence in the market, and promise that the Australian biotech sector will bounce back.

2009-10-26T08:27:00.000Z

Is being healthy its own reward?

Last week saw considerable controversy over the world’s heaviest man potentially being airlifted to hospital at considerable cost to the NHS. Paul Mason, 43, eats 20,000 calories of food a day – eight times the official adult male average of 2,500 and has spent most of the past eight years in bed.

Paul’s care costs UK taxpayers approximately £10,000 per year and he needs daily carers to feed and bathe him. The decision to use any means necessary to bring him to hospital for a £20,000 operation to save his life caused outrage amongst many who thought that Paul has brought this problem on himself through his poor diet and inactive lifestyle and doesn’t therefore deserve to be airlifted in an RAF Chinook or transported in a modified ambulance. I don’t know whether those looking in, who don’t have a disease, can really understand what the patient is going through.

But the big question for me is where exactly do we draw the line on so called self-inflicted conditions? Do we stop treating overeaters, drug addicts and smokers or do we have to accept that all of these conditions have underlying causes that some people simply can’t overcome and that we all have a duty to pay for?

Maybe there are no NHS brownie points for being healthy but surely health it is its own reward?

Lessons in motivation

2009-10-19T09:20:00.000+01:00

To be “the world’s greatest living explorer” it appears only one thing is necessary: Motivation. You need to be motivated, and your team needs to be motivated too.

Speaking at the London Business Forum last week to an audience of 400, Sir Ranulph Fiennes OBE made it all too clear that in life, whether it be big business or polar expeditions, it’s the people that matter. You need to have the right people from the start. And you need to choose your team based on their motivation. “You can teach skills. You can’t alter characters”, he said.
So what exactly motivates this 65-year old expedition leader to keep going, after enduring heart bypass surgery, a heart attack, and the amputation of all five fingers on his left hand as a result of “one mistake in 30 years”? In his case, exploring is a profession – just like any other job, Fiennes half-joked that it helps to pay the gas bill. But he has also raised more than £40 million for UK charities over the years. Sir Ranulph’s competitive streak also shines through. He faces these challenges to beat his rivals – to be the first.

Although leading a polar circumnavigation of the earth may seem a far cry from running a business, many of the lessons Sir Ranulph learned along the way can be transferred to the day-to-day operations of modern businesses. The importance of motivation, strong leadership, and teamwork, as well as the value of choosing the right people for the job up front. The stark reminder to any leader that the moving ice doesn’t wait for democratic conversations. Finally, Sir Ranulph’s admission that the lesson he has learnt the most from over 30 years of expedition leading is to listen.”You have two ears and one mouth”, he said, “and you should listen twice as hard”.

Changing face of media

2009-10-12T08:53:00.000+01:00

Guest blog from Michele Parisi.

The steady demise of traditional media in the United States – particularly local, daily newspapers – has many people wondering about the future of news and news delivery. Will we all be consigned to accessing news exclusively on-line? Without city-based papers, who will provide local news? Will some new model emerge to fill the void left by shuttered publications?

Until very recently, the answer to all of these questions had to be “it’s too soon to tell.” But fortunately for the fourth estate (and those of us who believe the world benefits from a wide variety of timely news sources), it appears ingenuity and opportunism will once again prevail to ensure a long – albeit somewhat altered – future.

One particularly interesting trend is the proliferation of non-profit news organisations – which rely on funding from grants, foundations and other non-profit organisations rather than traditional advertisers. To date, these include the Washington Independent, the Kaiser Family Foundation’s Kaiser Health News and the Voice of San Diego , which is filling local news holes created by shrinking newspapers in California’s fourth largest market. And just last month, financier Warren Hellman announced he was working with public broadcaster KQED, UC Berkeley's journalism school and possibly The New York Times to create a nonprofit news organization that would help shore up local news following the decline of the San Francisco Chronicle and other daily papers.

“Citizen-“ and “crowd-sourced” journalism have also demonstrated significant promise as means to ensure continued access to comprehensive national and local news. The Huffington Post and Examiner.com – both of which outpaced NYTimes.com in growth during the past year – are two examples of (so far) successful outlets that rely on unpaid, local subject experts to contribute news. While some question the reliability and quality of news derived from individuals who are not always trained, professional journalists, there is no denying the fact that these outlets have generated a good amount of high quality content – content that provides information and perspectives that would otherwise be absent.

Finally, while some of us are still reluctant to forfeit the familiarity and “physicalness” of a real newspaper for content scrolling on a computer screen, there are practical and informational benefits to the online versions of traditional newspapers. At a recent biotechnology industry event exploring the topic of social media, Los Angeles Times health writer Shari Roan noted that the paper’s web site now carries 10 times the content found in the hard copy. This gives Times reporters the chance to cover and comment on stories that they otherwise couldn’t touch.

These aren’t the only creative solutions helping to ensure both local and national news remain accessible and current. We’d love to hear about others that you find important or interesting.

Make mine two GPs!

2009-10-05T08:47:00.000+01:00

Hurrah! At last it looks like something will be done to make visiting a GP in the UK more convenient.

Plans unveiled by Health Secretary Andy Burnham on 17 September suggest that the current postcode-restrictive system will be dropped in favour of allowing people the freedom to choose their GP.

Busy career types will be able to choose a surgery close to where they work, limiting out-of-office time for routine appointments, while harried parents can opt for GPs near their children’s school.

Not only will this give people far greater flexibility in their primary care, the suggestion is it will boost healthy competition; if patients are given the freedom to choose, GPs offering poor service will suffer the consequences.

As usual, the devil’s in the detail and this has yet to emerge. Choosing a GP is all well and good but if you work two hours away from home and therefore opt for a surgery near your office, what happens when you’re really unwell?

Is it greedy that I want to have two GPs? I’d like one near work for those day-to-day appointments and one near home for when I’m feeling miserably sick – close enough so I can get away with throwing a coat on over my pyjamas and scooting down the street to the surgery.

The obvious implication of allowing work-friendly GP registration is that surgeries in busy cities could be over-run at lunchtimes and immediately after work. But given a bit of planning and shift work is that really so terrible? After all, if there’s a need for additional lunchtime cover at busy central surgeries, it might suit doctors with children. They could work part-time, school-friendly hours and enjoy a bit of family balance.

Alternatively, if that all sounds far too complicated, couldn’t we simply reintroduce Saturday surgeries and allow weekday workers to book routine appointments in their free time?

2009-09-28T11:23:00.000+01:00

An unacceptable conflict of interest?

Few industry observers or insiders would seriously argue there aren’t conflicts of interest when pharmaceutical companies conduct clinical trials on their own drugs. The estimated cost of bringing a new drug to market after all is now well in excess of one billion dollars and rising. And that average masks the huge cost to pharma of the compounds that don’t make it, particularly when they fail late in development.

So, unarguably, companies have a vested interest in success. But does that make the conflicts of interest created, for the companies funding the trials and the investigators who lead them, unacceptable? The editor of the BMJ, Fiona Godlee certainly said as much when she addressed an industry audience in the Great Oxford Debate at the Oxford Union last week.

“You can get the results you want” she told them. “We have a vast literature that we cannot trust, littered with lies and distortions.” “We should stop drug companies being involved in the evaluation of their own drugs.”

Dr Godlee was backed in the debate by Ben Goldacre, the Guardian’s Bad Science columnist, who exclaimed “Enough of you are bad enough, enough of the time that something must be done!”

Some ideas for an alternative approach were offered by the pair – including the Italian model of a 5% surtax on pharma to pay for head-to-head independent trials – but few in the audience were convinced that this sort of measure would anywhere cover the cost of future trials or that non-pharma trials wouldn’t face their own conflicts of interest.

Perhaps unsurprisingly, the audience voted down Dr Godlee’s proposition by nearly four to one.

Women to drive the future of the Economy?

2009-09-21T09:12:00.000+01:00

Women represent the largest market opportunity in the world, but despite their dominant buying power, many companies focus their marketing efforts towards men and fail to explore how they might meet women’s needs, according to a report in this month’s Harvard Business Review (The Female Economy, p 46-53). Michael J Silverstein and Kate Sayre of Boston Consulting Group argue that companies that tailor products and services for women beyond “making it pink” will be positioned to win when the economy starts to pick up.

The 12,000–women survey shows that women make the decisions on 94% of home furnishings, 92% of vacations, 91% of homes, 60% of cars and 51% of consumer electronics. As a market, women represent a bigger opportunity than China and India combined, the report states. The industry that is least in tune with women and their needs? Financial Services. Healthcare follows close behind, with survey respondents reporting dissatisfaction with hospitals and doctors. In the US, women generally pay more than men for health insurance, the report notes.

Opportunities to better serve the needs of women in healthcare are huge. Back in the early 1980s, PR firm Burson-Marsteller virtually invented the term women’s health when they worked with Wyeth Ayerst’s hormone replacement therapy Premarin, launching a range of products, information and services around the brand.

It seems strange that almost 30 years on we are still talking about women as an underserved market.

Fighting the pharma flab

2009-09-14T08:59:00.000+01:00

The tireless management guru, Tom Peters was in feisty form and laying into big pharma on his latest UK tour this month.

“The big pharmaceutical companies haven't become muscle-bound”, he told his London audience. “They’ve become FLAB-bound,” buying smaller companies to defend themselves but slowing themselves down in the process.”

On the same theme, he laid into The Economist, one of his alleged favourite publications. “Big is Back”, they trumpeted on a recent cover “which is nonsense!” Peters continued.

The Economist’s thesis is that corporate giants were on the defensive for decades but now they have the advantage again. Few industry observers or insiders would be quite so bullish about big pharma right now with evidence of retrenchment everywhere and morale clearly suffering from the threat of more to come.

Streamlining teams, collapsing reporting structures and, dare I say it, finding smart ways of reducing the number of internal meetings are just a few ways of fighting the pharma flab. But for those who survive, might they do better to heed how the other half lives; particularly the mean and lean biotech stars - and savvy outsiders, like Tom Peters?

Stick to the rules

2009-09-07T09:14:00.000+01:00

The healthcare headline in every paper last week was Pfizer’s $2.3bn settlement for the illegal marketing of four drugs for uses which had not been approved by regulators. This amounts to the largest healthcare fraud settlement in US history.

In a further blow to the drug giant’s reputation, Pfizer was also accused of paying bribes and offering lavish hospitality to doctors in return for prescriptions of the four drugs in question:
Bextra (valdecoxib), Geodon (ziprasidone), Zyvox (linezolid) and Lyrica (pregabalin).

The story certainly captured media attention, running in UK nationals such as the Daily Telegraph, The Guardian and the Daily Mail, as well as leading business journals Business Week and The Wall Street Journal.

What does this mean for Big Pharma?

Some believe that the US Department of Justice is setting a precedent for other pharmaceutical companies. Business Week described the fine as a “pointed warning to other drug companies that it plans to come down hard on the industry for fraudulent marketing”. Indeed, earlier this year Eli Lilly was slammed with a $1.4bn fine for the illegal marketing of its antipsychotic Zyprexa (olanzapine) (read the story on CNNMoney.com). Are these penalties just the beginning?

A New York Times exposé published earlier this month on Forest Laboratories’ 2004 marketing activities for Lexapro (escitalopram), alleging that the company made payments to doctors in order to encourage them to prescribe the drug, criticises marketing practices among Big Pharma: “The pharmaceutical industry… has also used its marketing muscle to successfully peddle expensive pills that are no more effective than older drugs sold at a fraction of the cost”.

One thing is clear - in an industry with such strict regulation, pharma companies can’t afford to bend the rules. While the financial impact of fines such as Pfizer’s may be minimal for companies generating billions of dollars in drug sales each year, the reputational damage - in an industry which already struggles to win the trust of the consumer - is far greater.

What next for Kennedy’s cause?

2009-09-02T08:24:00.000+01:00

"For five decades, virtually every major piece of legislation to advance the civil rights, health and economic well-being of the American people bore his name and resulted from his efforts", said President Obama last week in tribute to the late Edward Kennedy. While positive tributes for Mr Kennedy flooded the media, most carried an undertone of concern that a very heavy blow has been dealt to the US healthcare reform process.

The media mood has suggested one of the passing of an icon and the end of an era but optimism may yet be boosted by the feeling that the US must reform its healthcare system as a tribute to a man who described universal healthcare as the cause of his life.

Today, the principal cause of personal bankruptcy in the US is medical debt and an estimated 50 million Americans don’t have any insurance cover.1 This has led to political parties, industry and insurers at least coming to the agreement that change is needed, unfortunately, they just can’t agree on how to implement it.

Debates have centred on cost, how to avoid the evil of the NHS and on ensuring that those who already have good cover don’t lose out. The FT offers some calm and balance to the argument by suggesting what’s really important is understanding why the overall results achieved by the US healthcare system continue to be so low compared with the amount of funds spent and in comparison to other developed nations (could it be the quality of care provided to the uninsured?).2

As congress prepares to reconvene without Kennedy on September the 8th, it remains to be seen whether Obama can find a replacement of similar passion and stature to help steer his plans through. Let’s hope so.

1. http://www.nchc.org/facts/coverage.shtml
2. http://www.ft.com/cms/s/0/4cecb8e4-88d9-11de-b50f-00144feabdc0.html?ftcamp=rss&nclick_check=1

Are tweets just twittering?

2009-08-25T09:43:00.000+01:00

Is there a point to Twitter or is it just a forum for meaningless posts, allowing people to update their status, converse with friends or simply add dull comment to other users’ tweets? According to research undertaken by market research company Pear Analytics earlier this month, 40% of tweets are just “pointless babble”.

The US firm took 2,000 tweets over a two-week period from 11am to 5pm and captured tweets in half hour increments. They found that 40% of tweets were babble and 38% were conversational, while only 9% had some pass-on value. The remainder of the tweets were classified as being self-promotion or spam. Another finding from the study was that younger users prefer other social media tools, such as Facebook, over Twitter because they want to select who they connect with and who they email.

Regardless, it seems the popularity of Twitter is growing. There are even those who tweet beyond the grave, with comedian Bob Monkhouse tweeting to raise money for prostate cancer, the disease he died from in 2003. His Prostate Cancer Research Foundation’s Twitter site has a growing following.

Meanwhile in the UK, lovers of Twitter have been using the forum to defend the NHS following attacks by US republicans on our health service. The debate raged at #welovetheNHS - with members of the public, ministers and the prime minister, Gordon Brown declaring their loyalty to the NHS.

Media silly season

2009-08-24T09:19:00.000+01:00

August is holiday time. It's also known as the media's silly season: that time of year when a story that normally wouldn't get any media coverage can indeed make the front page. All the decision makers are on a beach in Sardinia. No decision makers, no events, no news - so the media can get a little desperate for stories.
Take the case this week of the latest health scare from the World Cancer Research Fund (WCRF): giving children processed meat can increase their risk of cancer, screamed the headlines. "Ham sandwiches too dangerous for children." In fact, any meat that has been smoked, cured, salted or had preservatives added.
Nicely timed, the story was issued in a press release right in the middle of the holidays (17 August 2009). To make it irresistible, it angled the story at children, despite no research having been carried out in children (only adults), and mentioned packed lunches in the top line of the press release just ahead of the new school year. The media went for it hook line and sinker. WCRF's spokeswoman made it onto BBC Breakfast, BBC Online, The Daily Telegraph, Sky News and the Daily Mail to name but a few. Only when you read the small print of the press release did you realise the research was actually published in November 2007!
Nothing like old news in August.

Cashing in on swine flu

2009-08-06T19:02:00.000+01:00

Australian biotech CSL has become the first company to start human trials of a swine flu vaccine (Scrip, July 31st). The company looks set to earn around US$247 million if the trials are successful.

Other firms are set to follow hot on CSL’s heels in the bid to set us free of swine flu - Novartis, Sanofi-Pasteur, Baxter and GSK all have H1N1 vaccines in their pipelines. And some companies are already reaping the benefits of the pandemic. Roche’s Tamiflu and GSK’s Relenza are being stockpiled around the world while manufacturers of tissues, disinfectants, soaps and hand wash are rubbing their super-clean hands with glee: shares of hygiene group Byotrol have risen following increased interest in its range of hand and hard surface sanitisation products (The Times, August 6th).

“Out-spamming Viagra”

Last month it was reported that counterfeit Tamiflu was “out-spamming Viagra” (CNN, July 3rd) as fraudsters try to cash in on the pandemic, prompting the UK Royal Pharmaceutical Society to warn on its website that people should be advised “not to buy medicines from unknown sources or respond to spam e-mails offering to supply Tamiflu or Relenza”.

But while some are making money from the outbreak, the UK Government has spent more than £2.4 million on a public awareness campaign. Do we really need to be told not to sneeze all over one another and be bombarded by tips on how to maintain good basic hygiene such as hand washing? A website, hotline and advertising campaign have been launched to tell us: “catch it, kill it, bin it”...is this really money well spent? As if that wasn’t enough, the government has spent a further £155 million on stockpiling flu vaccine. It’s a shame that half of this won’t actually reach us by the time the second, more dangerous, wave of the pandemic hits at the end of this year (Telegraph, July 29th).

Big public, little pharma?

2009-07-28T09:21:00.000+01:00

The pharmaceutical industry has long been portrayed as the big, bad giant bullying helpless consumers, but has the rise of social media put the boot on the other foot?

When it comes to exploiting the considerable potential of social networking sites, such as Twitter or Facebook, drug companies are understandably constrained by regulatory shackles.

And rightly so – social media has the potential to reach millions, extremely quickly. It wouldn’t be appropriate for a pharmaceutical company to use a 140-character tweet to push a drug to consumers, even if this was legal. This approach wouldn’t wash: social networks are seen as the domain of the public, and overt brand ‘advertising’ is more likely to generate anger than win consumers.

But when it comes to consumers having their say, constraints and rules don’t seem to apply. It’s OK to name-drop a brand if you are a consumer having a rant. But it’s a bit tricky to use the same vehicle to defend your product.

As consumers, we all enjoy hating the corporate giant, and love it when tiny, powerless David is seen to beat huge, strapping Goliath. And this doesn’t just apply to the pharmaceutical industry – it’s true across all industries.

However, the popularity of social media means that David is no longer small and powerless – in fact, in the online wrestling ring, the odds seem stacked in David’s favour. Where once consumers were limited to boycotting products or writing letters of complaint if companies let them down, social media now gives them a giant soapbox – just consider how effective a punishment was dished out to United Airlines for their shoddy handling of a traveller’s guitar (Independent, 24 July 2009: http://bit.ly/KmxXW).

Which is great if consumers use their powers fairly – but who is regulating the public and making sure they don’t abuse their power?

“The lunatics have taken over the asylum”

2009-07-22T09:27:00.000+01:00

Replied Jenni Lloyd, social media strategist at NixonMcInnes, when asked whether social media was simply a fad at a webinar: Monitoring the social media conversation from Twitter to Facebook on 21 July.

Recognising this shift in audience-controlled content, pharma companies have started sticking their tentative toes into the social media waters with Boehringer, Novartis, JNJComm, Roche and AstraZenecaUS all tweeting.

When it comes to sites like PatientsLikeMe.com, a social networking site that allows patients with life-changing diseases to chat, there is a clear place for pharma at the table: together, researchers and pharma can gather information and learn how these diseases act in the real world with a view to improving the lives of patients. However, should pharma use social media as part of a direct marketing strategy, they could run the risk of being considered misleading, annoying or fraudulent and end up losing their audience.

The jury is still out on Novo Nordisk’s branded Twitter page called @racewithinsulin, which promotes its prescription insulin drugs Levemir® and NovoLog® through the tweeting of one of its patients. However, its review as “Sleazy Twitter Spam” by Pharma Marketing blogger, John Mack, clearly signals the immediate and sometimes negative repercussions of social media marketing.

Obsessed with dementia?

2009-07-15T09:19:00.000+01:00

Does the media have an unhealthy obsession with Alzheimer’s disease? It seems that wherever I turn, dementia-related headlines flash alarmingly from the page.

Perhaps it is simply a reflection of our own morbid fascination with this devastating disease. Inexorably, we are drawn to stories about a terrifying descent into a confused, child-like dependency.

Or perhaps it is something more rebellious – a scientifically-justified uprising against nanny’s advice to cut out the food, drink and activities we love because they are bad for our health.

For, if we examine some of the research that’s hit the headlines recently, it all seems to be confirming that a little of what we fancy is actually good for us...

In fact, having a regular curry with a few sociable glasses of wine or beer, finished up with a satisfying cup of coffee could actually help to prevent us from getting Alzheimer’s. (BBC, 3 June 2009: http://bit.ly/9QUQK; Telegraph, 13 July 2009: http://bit.ly/sjxdY; C4, 6 July 2009: http://bit.ly/12oxeS)

Throw in a bit of nookie afterwards and you’re sorted, it seems. (OK, the real research may have been suggesting it is the social interaction between middle-aged married couples that helps to protect them from the onset of Alzheimer’s.) (BBC, 30 July 2008: http://bit.ly/128Vw9 )

And if you do find yourself single, there’s no need to panic: a rendez-vous with Super Mario could be all you need. A new four-year study is assessing whether playing certain video games can help slow the effects of ageing. (Time, 11 July 2009: http://bit.ly/jgTbG)

If all that fails and you succumb to the worst of it, you’ll just have to join the queue at the fake bus stop they’re installing at care homes these days to give residents a ‘sense of purpose’. (Daily Mail, 26 May 2009: http://bit.ly/QMmxA)

Poor old men

2009-07-10T09:18:00.000+01:00

The news this week that scientists have grown synthetic human sperm from stem cells for the first time must have been met with smug, knowing smiles from the fairer sex and mild panic from the hunter-gatherers. (The Times, 8 July 2009: http://bit.ly/10KoeH)

And is it just me, or does it seem that Britain is particularly obsessed with ridding itself of the male species?

After all, it was here in the UK, on 25 July 1978, that the world’s first successful test-tube baby was born, taking us our first step forward in the race to remove men from the reproduction process. (20th Century History: http://bit.ly/KVgCr)

We’ve also been battling hard to crow-bar more women into traditionally male jobs, such as building and plumbing. We earmarked around £20m for training women to work in construction leading up to the 2012 Olympics, and last year Equalities Minister Harriet Harman also announced controversial changes to the law which gave women workers positive discrimination rights. (BBC, 14 June 2006: http://bit.ly/k49rg; Telegraph, 26 June 2008: http://bit.ly/wrqig)

We’re even reviewing whether we should be sending our girls into front-line battle... (BBC, 24 May 2009: http://bit.ly/AbeSh)

Perhaps this is all sensible forward planning, and simply a way to ensure we’re ready to manage without men if we’re forced to – after all, research has suggested that the male Y chromosome is dying and could one day run out. But given that it’s likely to take around five million years, we might be a bit ahead of ourselves. (Mail, 21 May 2009: http://bit.ly/DdNcK)