BBC News says we are a step closer to microchips that can be “implanted under a patient’s skin to control the release of drugs”.
The news was based on a study that tested the use of advanced microchips containing tiny drug reservoirs that can be remotely triggered to release medication into the body. Creating workable drug-release chips has long been a goal of researchers, as it could help people take the correct dose of vital medicines such as insulin.
In this particular trial, reported to be the first of its kind, eight women were given the chips filled with a drug to combat osteoporosis. The drug, teriparatide, is normally delivered by daily injection, but researchers found that using the chips produced similar physical results to injections. Also, there were no toxic or adverse events, due to either the microchip or the drug, and all the patients reported that it did not impact on their quality of life.
This study throws up a range of possible uses for microchip-based drug delivery, which could one day be used for the treatment of wider conditions that require frequent, scheduled dosing, particularly where standard treatment is through injection.
However, much more testing of the technology will be needed to firmly establish its safety, and to see whether there could be wider applications. One key consideration though, would be whether the use of this advanced technology can actually prove better or cheaper than the use of injections.
Where did the story come from?
The study was carried out by researchers from MicroCHIPS, Inc, (a private company producing medical microchips ; the Harvard Medical School; Case Western Reserve University; On Demand Therapeutics, Inc, and the Massachusetts Institute of Technology. It was funded by MicroCHIPs, Inc.
The study was published in the peer-reviewed scientific journal Science Translational Medicine.
The results of this study have also been presented at the annual meeting of the American Association for the Advancement of Science (AAAS .
The story appeared on the BBC and a number of newspapers, including the Daily Mail, the Daily Mirror and The Independent.
Most of the coverage of the story was good. However, alongside The Independent’s main article the newspaper featured an opinion-based section discussing potential uses of the device, including allowing psychiatrists to trigger doses in schizophrenic patients when they resist injections of medication. There is a distinct difference between using medical devices to structure the delivery of medication and using them to force people to take medication against their will.
It seems unlikely that medical groups would find this theoretical use to be ethically acceptable, and it should be noted that the treatment of mental health problems was not assessed in the study or in other coverage.
The Independent also used a photograph of a distressed man huddled on the floor wearing no shoes, intended to illustrate schizophrenia. While the condition can certainly involve periods of acute problems and distress, it seems to a rather extreme and particularly negative depiction of someone with schizophrenia.
What kind of research was this?
This was a small cohort study of a drug delivery microchip, implanted under the skin. The microchip contains tiny drug reservoirs and can be programmed to wirelessly release discrete doses of a medication.
This particular study used the drug teriparatide, prescribed by specialists only for the treatment of severe osteoporosis (bone weakening . It is normally delivered by daily injection and given for a maximum treatment period of two years only.
The researchers aimed to see whether the drug released from the device had similar ‘pharmacokinetics’ (adsorption, distribution, metabolism and excretion and biological effects to the drug administered by standard injection. They also monitored how reliable and reproducible drug release from the microchip was, and if there were any side effects of the implant.
This was the first clinical trial of this microchip. As the researchers state, further development is required to ensure proper operation of implanted devices, and devices containing more reservoirs will be needed if the device were to provide regular doses over one or more years. In addition, before this technology becomes available, it will have to be tested in larger, controlled trials.
What did the research involve?
Eight women with osteoporosis, aged between 65 and 70, were recruited for the study. The drug delivery microchip was implanted under the skin, just under the waistline. The devices were implanted for four months. Eight weeks after implantation, the microchip started releasing daily doses of teriparatide for a period of 20 days. Blood samples were drawn regularly to monitor the pharmacokinetics and to determine levels of bone markers. A safety assessment was also performed.
After the 20 days of drug release from the device, the researchers administered the osteoporosis drug by injection, and again took blood samples, so that release from the microchip and from the injection could be compared.
What were the basic results?
In one patient, feedback from chip indicated that the drug was not being released. The results from this patient were excluded.
Drug released from the microchip in the seven other patients had similar pharmacokinetics to drug administered by injection, and bone markers indicated that drug released from the microchip increased bone formation as expected. However, the effectiveness of medication released from the microchip was not compared to the effectiveness when given by injection.
There were no toxic or adverse events due to the device or drug. Patient response to the implant was also favourable, stating that it did not impact upon their quality of life.
How did the researchers interpret the results?
The researchers concluded that the programmable implant was able to deliver teriparatide at scheduled intervals, with pharmacokinetics similar to injections ‘without the pain and burden of daily injections’.
Conclusion
This study was a small clinical trial, performed in eight women, of an implantable microchip-based drug delivery device. It found that the microchip could deliver the osteoporosis drug teriparatide with similar pharmaceutical properties to injections, including adsorption, distribution, excretion and metabolism by the body. There were no toxic or adverse events due to either the microchip or the drug, and the patients all responded favourably to the implant, stating it did not affect quality of life.
Larger controlled trials comparing this device with conventional injected teriparatide would be needed to confirm the safety and efficacy findings. Furthermore, trials may need to assess use of the chip over a longer period - on prescription, teriparatide may be administered by daily injection for up to two years.
The findings also suggest that this microchip-based drug delivery device may have the potential to be used for the treatment of wider conditions that require frequent, scheduled dosing, particularly where standard treatment is through injection. However, much more testing of the technology will be needed to see whether there could be wider applications.
Analysis by Bazian
Links To The Headlines
Dawn of the age of wireless medicine. The Independent, February 17 2012
'Wireless medicine' helps solve one of doctors' biggest problems - getting patients to take drugs. The Independent, February 17 2012
New microchip will let doctor administer drugs into your body over the phone. Daily Mirror, February 17 2012
'Pharmacy on a chip' gets closer. BBC News, February 17 2012
Links To Science
Farra R, Sheppard NF, McCabe L, et al. First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip. Science Translational Medicine. Published online February 16 2012
Wasted medication is costing the NHS millions every year – including £20million for the NHS across South Central England – local health chiefs have revealed.
This potential money wasted on unused or partially used medicines could pay for:
- 785 more nurses, OR
- 20,000 more treatment courses for Alzheimer’s, OR
- 1,319 more treatment courses for breast cancer, OR
- 5,393 more hip replacements, OR
- 20,811 more cataract operations
A campaign aimed at reducing unnecessary waste launches today across the eight PCT areas which comprise the NHS South Central Strategic Health Authority. The campaign asks patients to;
- Only order what they need;
- Return their unwanted medicines to their pharmacy for safe disposal and;
- Take their medicines with them when they go into hospital.
GPs and pharmacists across Berkshire have joined together in a bid to inform patients about their treatment and to help patients understand more about their medicines and the options they have.
One of the main concerns is repeat prescriptions, which are ordered and collected by patients but then not used. It is estimated that £90 million worth of unused prescription medicines are retained in individuals’ homes, across the UK, at any one time1. Around half of all do not take or use their medicines as prescribed
[i]. This can occur for a number of reasons, including:
- patients not believing the medicine is necessary;
- possible side effects;
- fitting taking or using medicines into daily routines;
- choosing between medicines if patients’ feel they are taking too many, and;
- cutting down or stopping medicines they have been taking for a long time.
Posters and leaflets will be displayed in pharmacies and GP practices to raise awareness of medicine waste among both patients and carers. In addition to this a high profile bus campaign which will run across the South Central region. Further information may also be found on the national website
www.medicinewaste.com
Notes to Editors
The latest report by the Department of Health estimates that £300 million is wasted on unused medicines across England.1
NHS South Central comprises NHS East Berkshire, West Berkshire, Buckinghamshire, Hampshire, Isle of Wight, Oxfordshire, Portsmouth and Southampton.
[1]Department of Health, Evaluation of the Scale, Causes and Costs of Waste Medicines, November 2010
Dr David Buckle, Medical Director at NHS Berkshiresaid: “Everyone involved in prescribing, dispensing or reviewing medicines needs to make sure that patients are involved in making decisions about their treatment and that more medicines are taken as recommended.
“Unwanted drugs in the home may mean that patients are not getting the benefit they could be from their medicines. It also represents a large amount of waste. We want patients on repeat prescriptions to think about what they are ordering and only ask for what they need and are running out of. Any other medicines can be dispensed when needed at a later date, as once medicines have been dispensed, they cannot be recycled”
The latest report from the Department of Health (Nov 23rd 2010 cited Medicine Usage Reviews as a potential way to reduce waste. In 2011, NICE (National Institute for Health and Clinical Excellence issued new guidelines to healthcare professionals on how to involve patients in making decisions about prescribed medicines and reduce the number of people not taking or using their medicines correctly.
Carol Trower, Chief Executive Office, Berkshire Local Pharmaceutical Committee, said: “There are a number of reasons why medicines are going to waste; including people no longer taking or using the drugs. Others may be put at risk if unwanted medicines are left in the home.
"If anyone has any unused medicines at home we're encouraging them to take them back to the pharmacy for safe disposal and have a chat with the pharmacist about their medicines on how to use them more effectively."
The campaign will encourage patients to have regular reviews of their medicines and to discuss any issues they may have with taking their medication with their GP or pharmacist.
Anyone with unwanted medicines can return them to their local pharmacy where they will be disposed of safely.
[i] Department of Health, Evaluation of the Scale, Causes and Costs of Waste Medicines, November 2010
Today, Sandoz Canada’s reputation lies in tatters after chronic problems at its state-of-the-art plant on Montreal’s south shore caught the eye of U.S. regulators. Much of its production is halted as it tries to fix the problems, leaving pharmacists and health-care providers alarmed at what could be months of shortages of injectable medications that treat everything from nausea among cancer patients and abnormal heart rhythms to endometrioisis.
Last week, Sandoz told Canadian health-care providers it would discontinue certain products and temporarily suspend production of other injectable products on the heels of a scathing “warning letter” from the U.S. Food and Drug Administration three months ago that criticized the plant’s “ineffective quality system.”
Pfizer is weighing plans to raise about $3bn this year through a part-flotation of its animal health division, as the drugs giant examines the best way to spin off a business valued at as much as $18bn.
The pharmaceuticals group, the world’s second largest by market capitalisation, has been talking to bankers about arranging an initial public offering that would look to place up to 19.9 per cent of the unit’s shares in the autumn, in what is known as an equity carve-out or partial spinoff, people familiar with the talks said.
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