Vending machines for medicines

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

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

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

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.