Foretelling the future - personalised medicine
Envisage Ltd was the firm I founded in the 1990s. We specialised in advising companies and government on the implications of future trends in science and technology.
Back in 2005 we predicted that the UK had the potential to provide personalised medicine through genome technology.
It's taken 13 years for the results to start coming through...
The UK’s 100,000 Genomes Project has hit its target of sequencing the complete genetic blueprints of 100,000 National Health Service patients with cancers and rare diseases.
See : https://www.newscientist.com/article/2187499-uk-dna-project-hits-major-milestone-with-100000-genomes-sequenced/
Here is the original article:
Biotech - idividual genetis blueprints
Dale Pfost is president and CEO of Orchid Biocomputer, in Princeton, New Jersey. He believes UK clinical practice already holds the key to a most important breakthrough in medicine.
Because a visit to the doctor in Britain results in an update to the patient’s database and a computer-generated prescription, many of the ingredients for personalised medicine are in place. Unlike in the USA, a NHS doctor anywhere in the country has access to patient records – a progressive patient history file is updated and goes where the patient goes. Our personal files could tell the doctor much more about us.
A personal genetic blueprint can identify small genetic changes, or variations, that characterise a person's DNA sequence (their genotype). This can predict the potential of an individual to develop a disease based on their genetic (hereditary) factors or identify if an individual was suitable for a certain therapy.
Already some drugs come with information about how they react with our genetic make-up. It’s just that for most people their genetic blueprint hasn’t been read, so we don’t know how they’ll respond to a particular treatment.
Many prominent researchers in biotech believe that medical diagnosis will be the major immediate consequence of the human genome project and advances in our understanding of how cells work.
Oncology is already making great strides in the treatment of certain cancers with drugs like Herceptin. Herceptin treats breast cancer patients who have a genetic mutation causing overproduction of a tumour growth factor receptor (HER2). The development of this drug would not have been possible without specific diagnostic tests to identify HER2 positive patients.
Individual patients can react differently to drugs depending on the rate of their metabolism. A variant of the gene CYP2C9 alters the rate at which Warfarin is metabolised with potentially dangerous consequences. Determining the required dose of the anti-coagulant drug, Warfarin is often a process of trial and error for individual patients who may haemorrhage if the dose is too high. 1.2 million people in the UK will be receiving Warfarin before the end of this decade and it is estimated that up to three hundred thousand of these would benefit from genetic testing to determine the variability of this gene. This is particularly relevant in the UK because Caucasians have a higher variability of this gene compared to other ethnic groups.
COX-2 inhibitors are newly developed drugs for inflammation that selectively block the COX-2 enzyme. Blocking this enzyme impedes the production of the chemical messengers that cause the pain and swelling of arthritis inflammation. COX-2 inhibitors are widely prescribed for rheumatoid and osteoarthritis, but may disappear entirely as a class of drugs because of the associated risk of adverse cardiovascular events, including heart attacks. It is possible that genetic testing might allow such preparations to be used safely among a sub-set of patients identified as not being susceptible to the associated risks.
PTO
Patients could therefore be prescribed clinically relevant treatments, with expected reductions in morbidity and gains in health and quality of life, while the numbers of wasted prescriptions would be reduced.
As well as benefiting patients, targeted medicines could be brought to market more quickly and at lower cost. In recent times, the size and duration of clinical trials needed to prove the efficacy and safety of new drugs has risen steeply. This is because of increasing demands for data by regulators. Dr Paul of Eli Lilly says the cost of bringing a new drug to market has now risen to $1.5b. The average HIV drug cost $479m to bring to market but the average figure for rheumatoid arthritis was $936m.
Genetic approaches to treatment could mean clinical trials becoming more cost-effective by pre-selecting the population taking part, potentially accelerating drug approval. This would also remove the danger of a drug failing its trials because its efficacy was considered poor. It may have been 100% effective for 20% of the trial group, but without identifying those on whom the drug worked, the results merely show an overall 80% failure figure.
In the west, clinical trials are used to identify risks and side effects in the population. It is considered unethical to approve drugs which have not received exhaustive clinical trials. In contrast, traditional attitudes in China are that it would be unethical to deny such patients drugs from which they may benefit. In the UK, breast cancer patients have demanded access to Herceptin before it received final drug approval. We have also seen how UK patients for whom COX2 inhibitors has provided great relief, are reluctant to see the drug taken off the market. Similar argument is prevalent in the US.
From the Daily telegraph 04 November 1999
Drugs giant Glaxo Wellcome [now GSK] gave hope to sufferers of irritable bowel syndrome yesterday, with encouraging trial results of its pioneering treatment Lotronex. In a phase three study involving 623 women, patients reported relief of abdominal pain and discomfort within two weeks. One in five of the population suffers from the condition. If successful, analysts at Morgan Stanley believe Lotronex's annual sales could peak at £950m in 2005, making it one of Glaxo's biggest products.
Following post-marketing reports in the US of serious complications, leading to hospitalization and requiring surgery in some instances, the US FDA recalled Lotronex on November 28, 2000, just 9 months after approval. In June 2001, the US-based Lotronex Action Group wrote this letter to GSK.
Dan Rather has referred to Lotronex as "a miracle medicine". We truly believe it is. Please consider the proposal [for continued marketing of Lotronex] … do the humane thing as people are suffering needlessly.
Medicines prescribed by GPs to an average patient in Britain cost half that of some European countries at around $300 per annum. Once genetic blueprints are available, personalised medicine will be a reality. Drug trials will be faster and cheaper; new drugs will be brought to market and effectively targeted for those who would benefit the most and the cost of treating NHS patients would be reduced. The drug-makers, the health service and the patients all benefit.
Envigage 2005
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