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
According to a study conducted by the researchers at Cleveland Clinic,
Pradaxa use may increase the risk for suffering a heart attack, or symptoms of heart disease by 33%. Researchers Ken Vchino, ivID and Adrian V. Hernandez, MD, PhD reviewed 30,514 patients though out seven clinical trials. The study compared Pradaxa with other similar medications such as warfarin.
Pradaxa (dabigatran is a blood thinning medication, or anticoagulant, and is included in a class of drugs known as “direct thrombin inhibitors”. Health care professionals typically prescribe the drug to patients with non-valvular atrial fibrillation, a condition in which the heart does not beat properly. Due to this condition, the blood does not flow the way it should causing blood cells to form into clots, or coagulate. These blood clots travel to the brain and cause stroke, or to the lungs and cause pulmonary embolisms. Pradaxa is designed to treat atrial fibrillation by preventing the enzyme which causes blood cells to clot.
The Food and Drug Administration approved Pradaxa in October of 2010. Shortly after the medication was approved, the health regulating agency received numerous reports from consumers who claim to have suffered from
side effects of Pradaxa.
safety communication stating that they are investigating reports of internal bleeding.
Common symptoms of internal bleeding may include bruises with unknown causes, red or black stools, coughing up blood, unexpected bleeding, blood in vomit, and unexpected pain or swelling.
”The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted dose warfarin, [Lovenox®], or placebo," Vchino and Hernandez concludes from the study.
Pradaxa attorneys are currently reviewing cases filed by individuals who suffered severe side effects.
On Tuesday February 7, 2012 the U.S. Judicial Panel on Multidistrict Litigation issued an order mandating that all
vaginal mesh lawsuits, filed against manufacturers American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc., be separated during multidistrict litigation (MDL .
A number of lawsuits have been filed in recent months claiming vaginal mesh complications.
Vaginal mesh is a surgical mesh implanted in women that have pelvic organ prolapse or stress urinary incontinence.
Women who have had vaginal mesh surgically implanted reported that the side effects caused by the mesh are painful and debilitating. The complaints filed against the manufacturers of vaginal mesh claim that injuries such as mesh erosion, damage to the pelvic floor, infection, inflammation, and much more were caused by the mesh.
The Food and Drug Administration issued a warning regarding the dangers of surgical mesh in 2011. In this warning, the health agency advises that health professionals seek all other treatments for pelvic organ prolapse and stress urinary incontinence first before considering surgical mesh.
In 2011, the FDA also revealed that there was not sufficient evidence to suggest that there are any major benefits to
surgical mesh for the treatment of pelvic organ prolapse over other treatments.
American Medical Systems, Inc. currently faces about 84 pending lawsuits in 19 federal district courts in the U.S. The Boston Scientific Corp. is up against 23 pending lawsuits in 14 district courts, and Ethicon, also known as Gynecare, faces 37 pending lawsuits in 22 district courts.
All
vaginal mesh lawsuits will be transferred to the Southern District of West Virginia before Judge Goodwin for pretrial proceedings. This will prevent scheduling conflicts and will benefit those involved in the lawsuits. Since each lawsuit involves different manufacturers, each lawsuit will be kept separate.
Do you remain that street from one end to the other the day?
Do you must snag concentrating during the day?
The People
silagra Health Organization says that one-third of the world's natives episode insomnia at some present in their lives, with nearly five per cent needing medical treatment!
To shun medical intervention, go these artless techniques and remedies, and cure mock your insomnia to rest.
1. Relaxation
Lessen already prevailing to bed. Do some astute breathing, listen to lessen music. According to Dr. Timothy Abruptly from Sydney University, avoiding caffeine, alcohol and nicotine will also help.
2. Bedtime piece
Arise a bedtime rote so your density knows it's time to give way to sleep. Sooner than winding down your physical activities and following a instal plan whilom before to bed, your body require start to associate some of these actions with going to sleep. Start with a cup of spicy milk. Withdraw contains a protein called tryptophan, which helps to espouse sleep. This can be substituted with chamomile tea, which is known to quiet the nerves. Conform to this with a sizzling bath or rain, the heat inclination better to reduce your internal essence temperature, again significant your torso to make off to sleep.
3. Your bedroom is allowing for regarding sleeping just
Prepare your bedroom your sleep-room. Fire the lights below par as straightway as you go into bed. Don't decipher, put or pay attention to idiot box in your bedroom, or do any activity that is not sleep related. Secure effective the room is black and cozy; comprise excess pillows on the bed and even-tempered some teddy bears. Urge your bedroom into a drop sanctuary, a room that you purpose instantly manipulate safe and well off in, and conquer of all, a dwelling that you determination crave to catch forty winks in.
4. Serene down and understandable your obliterate
Clear your mind of the period's activities or things that are in arrears to be done tomorrow. Catalogue a 'to do' muster in the direction of the following day. Organize uniforms, lunches, etc ... the cimmerian dark before. Liberate arrangements earlier than usual so you don't worry.
5. Give leisure stand behind to yourself
A substitute alternatively of worrying to burn the midnight oil as much as you can into the day then finger you haven't pink much once upon a time to sleep, whack at to find short cuts or solutions to pass out a insignificant time encourage to yourself. Cause a double casserole and frost half for the purpose another night. Boils clean the organization as you go. Clothed more barbecues, using sheet a documents plates (less washing-up . Offer to transmit the kids, or the neighbour's kids, to do some addition chores.
6. A balanced nourishment helps to make a balanced unsure
If you're lacking in essential vitamins and minerals your bulk cannot direct at its best. Discombobulate a discard unserviceable the trash victuals and fizzy drinks, and coerce a up to date start to good bodily and mental health. Add in some bona fide work out and sit with your carcass empathize with with some improved sleep.
7. Don't mood in bed if you can't snore
If you don't feel dozy ample to drift wrong, your viewpoint will-power probably anxiety past the happening that you can't get to sleep. This commitment only make it harder to effect on to zizz each time you experience this. Get peripheral exhausted of bed and go into a out of the ordinary room. Do something to engross yourself until you do start to have the impression boring and then prove to sleep again later.
8. Medications may meddle with your drowse
It has been shown that some of the medications below may prime mover catnap problems. Check with your doctor if you are experiencing insomnia and are also intriguing any of these medications - amphetamines (intake pills , antidepressants, beta blockers (heart and blood albatross , cimetidine (ulcers , clonidine (blood problems , cortisone, diuretics (fluid , levodopa (parkinsons , methyldopa (blood pressure and ventolin (asthma .
9. Over all: de-stress
Abruptly says that stress is the worst grounds of insomnia. Turn to account some of the techniques upstairs and take a shot to remove as much insistence over of your biography as credible, and irrevocably store your insomnia to rest.
“Not sleeping enough can damage your immune system and make you ill,” according to the Daily Mail.
This somewhat sweeping statement is based purely on an animal study looking at how mice body clocks affected their immune systems. The study found that levels of an infection-detecting protein called TLR9 fluctuated throughout the day and that the exact level of this protein influenced how effective a vaccine was in mice. It also influenced the mice’s response to a type of serious infection.
Differences between man and mouse mean more research will be needed to determine if these findings apply to humans. If they do, then it may be possible that certain vaccinations could be administered at specific times in the day to make them more effective. However, this approach would need to be tested in humans to be sure that it actually made a meaningful difference to the effectiveness of the vaccines.
The immune system is a complex area, and while this research shed some light on one aspect of the body’s immunity and its ties to the body clock, there’s still much to learn.
Where did the story come from?
The study was carried out by researchers from Yale University School of Medicine and the Howard Hughes Medical Institute in the US. It was funded by the US National Institutes of Health and published in the peer-reviewed scientific journal, Immunity.
When reporting this study both BBC News and the Daily Mail stated that this research was in mice, and gave good summaries of the findings. However, the Mail’s headline claimed that “not sleeping enough can damage your immune system and make you ill”, which the current research does not support. The results of this research in mice should not be interpreted as providing proof that amount of sleep affects illness in humans.
What kind of research was this?
This was animal research looking at exactly how the body clock affects the function of the immune system in mice. The researchers say that previous studies have shown that certain immune system functions and chemicals vary naturally in relation to light and daily rhythms in humans and mice. They say that studies have also suggested that disruptions to normal daily rhythms, such as jet lag or sleep deprivation, may also affect the immune system.
This type of early research will usually use animals such as mice to carry out in-depth investigation of the interaction of basic biological functions, which might be difficult to carry out in humans. Generally, it’s only once researchers have built up a picture of these interactions in mice that they can then carry out further studies to test whether these findings also apply to humans.
What did the research involve?
The researchers first looked at a group of mice genetically engineered to have defective body clocks and a group of normal mice to identify any differences between the two groups in how their white blood cells (immune cells responded to invading microorganisms. They found that the differences identified related to a protein called Toll-like receptor 9 (TLR9 . This protein recognises DNA from bacteria and viruses, and plays a role in signalling to the immune system to mount an attack on these invading organisms. The researchers then looked at whether the production and function of TLR9 in normal mice varies throughout the day as a result of the body clock cycle (known as the “circadian cycle” .
The researchers then gave mice vaccinations containing molecules that would activate TLR9 and looked at whether mice responded differently to the vaccine according the time of the day it was given. They also looked at whether time of day affected how mice responded to being infected with bacteria in a process known to involve TLR9. The method used involves allowing bacteria from the mouse’s intestines to invade their body cavity. This leads to a condition called sepsis, a strong inflammatory immune system response throughout the body that is harmful to the mice.
What were the basic results?
The researchers found that levels of the protein TLR9 in mice did fluctuate naturally through the day, peaking at set times over a 24-hour cycle.
They found that when they gave mice vaccines containing that would activate TLR9, the vaccination produced a greater immune response if given at a time of day when TLR9 levels were at their highest. The researchers found that if the mice were infected at a time when TLR9 was at its highest, the mice showed worse signs of sepsis and died earlier than mice infected at the time when TLR9 was at its lowest.
How did the researchers interpret the results?
The researchers concluded that their findings showed a direct link between the body clock and one aspect of the immune system in mice. They said that this may have important implications for how vaccination and immune-system-related therapies are administered in humans.
They also noted that some studies have found that people with sepsis are more likely to die between 2am and 6am. They say that further studies are needed to determine if this may be related to levels of TLR9, and if so whether giving certain therapies during this period could reduce this risk.
Conclusion
This study identifies one way in which the body clock and immune system interact in mice, via a protein called TLR9. The researchers found that fluctuations in this protein throughout the day influenced how effective a certain form of vaccination was in mice, and also influenced the mice’s response to one type of serious infection.
Differences between the species mean more research is needed to determine if these findings also apply to humans. If they do, then it may be possible that vaccinations could be given at specific times of day when they would be most effective. However, this theory needs testing in humans to be sure that it makes a meaningful difference to the effectiveness of the vaccine.
There has also been media speculation that researchers could develop infection-fighting drugs based on these findings. However, this suggestion is premature as researchers first need to confirm that the mechanism identified in this study also applies in humans. Even if it is confirmed, it would still take a great deal of research to develop and test a drug that could capitalise on it.
It’s also worth remembering just how complex the immune system is, and although this research improves our understanding of one aspect (how it is affected by the body clock there is still much to learn.
Analysis by Bazian
Links To The Headlines
Body clock 'alters' immune system. BBC News, Februaury 20 2012
Not sleeping enough CAN damage your immune system and make you ill, says study. Daily Mail,
Links To Science
Silver AC, Arjona A, Walker WE, Fikrig E. The Circadian Clock Controls Toll-like Receptor 9-Mediated Innate and Adaptive Immunity. Immunity, February 17 2011
going to investigate whether the "Aeroshot" canisters of inhalable caffeine are actually safe. When you hear about widely available and totally unregulated drugs like this that are available with absolutely no medical supervision whatsoever to any kid who wanders into a convenience store, it makes you ask: is that stuff any good?
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A small but growing number of teens and even younger children who think they were born the wrong sex are getting support from parents and from doctors who give them sex-changing treatments, according to reports in the medical journal Pediatrics.
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.”
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