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
A new drug aimed at treating Alzheimer’s disease (AD may have deleterious side effects, according to the scientist who discovered the compound’s molecular target. Northwestern University cell and molecular biologist
Robert Vassar warns that a drug designed to inhibit BACE1, an enzyme that aids in the development of the amyloid plaques that are characteristic of AD, may also stop the enzyme from performing a crucial neuron-mapping function in the brain. Vassar’s group
cloned and characterized BACE1 in 1999.
Vassar recently showed that mice devoid of BACE1 had olfactory neurons that were improperly wired to the olfactory bulb. This is worrying, Vassar said, because in the hippocampus, as memories are formed, neurons are continually reborn and connections reconfigured, making BACE1?s organization role hugely important. Thus, drugs like the BACE1 blocker that is now in clinical trials could impair memory.
“Let’s proceed with caution,” he said Saturday at the annual meeting for the American Association for the Advancement of Science. “We have to keep our eyes open for potential side effects of these drugs.”
“It’s not all bad news,” Vassar added. “These BACE1 blockers might be useful at a specific dose that will reduce the amyloid plaques but not high enough to interfere with the wiring. Understanding the normal function of BACE1 may help us avoid potential drug side effects.
Vassar is publishing the results of the recent mouse study that points to the potential problem with inhibiting BACE1 in the journal
Molecular Neurodegeneration
.
Davis was a convicted murderer who was put to death by the State of Georgia as punishment for the crimes of which he was found guilty. Like so many other death row inmates who were wrongly convicted of—and sometimes even executed for—crimes they did not commit, Troy Davis may well have been innocent. There was no physical evidence proving his crime, and many of the eywitnesses upon whom Davis' conviction depended later recanted their testimony, citing undue pressure from prosecutors to finger the person they had apparently already decided was responsible. In the end, however, whether or not Troy Davis was guilty or not is merely salt in the wound of a far bigger outrage.
The Catholic Church officially opposes capital punishment. This doctrine is in the same vein as those opposing abortion, birth control, and physician-assisted suicide: church doctrine dictates that life begins at conception and is a gift from God. Consequently, it is beyond the scope of any soul, no matter how high the earthly authority, to terminate a human life. It does not matter if it is legal, and it does not matter if the rationale is to relieve suffering: the taking of life is God's department, not ours.
Yet in the middle of September, as opposition to the impending execution of Troy Davis reached a fever pitch and a singular opportunity presented itself for the Church to not just call for an act of mercy, but support a key element of doctrine, the United States Conference of Catholic Bishops was
silent as the grave. Yes, some local Catholic bishops in Georgia did support the conscience of their doctrine by calling for a reprieve, but the USCCB, the organization most responsible for lobbying and policy advocacy on behalf of the Holy See here in the United States, sat idly by. The execution of a possibly innocent man was not enough to stir the bishops into action. But birth control? That's a different story altogether.
The directive of President Obama's Health and Human Services Department that requires employers to cover the cost of contraceptive prescriptions was met with
outrage by the USCCB. Never before, they argued, had citizens been forced to pay for things that violated their religious conscience. Not that the Church would have been forced to cover the cost of contraceptives: churches who objected receive an exemption under the directive. The Bishops even
rejected a compromise that allowed women who work for affiliated organizations, such as nonprofits and hospitals, to obtain contraceptive coverage directly from an insurer, as opposed to through their employer. Apparently, preserving the "religious conscience" of an insurance company was ground that these bishops simply would not cede.
One could commend the bishops' commitment to principle if it were based on any sincerity. Unfortunately, that seems not to be the case. Our tax dollars subsidize executions in every state where they are conducted, as well as pay for the wars and occupations that offend a true Catholic conscience, yet these bishops will not lift a finger to stop the execution of one possibly innocent man, let alone work to prevent their believers from paying for these egregious violations of doctrine.
Yes, the hypocrisy is shameful, and it serves as yet another reminder that in this mean-spirited age, the only doctrines that conservatives deem worth standing up for are those that punish and impede, rather than those that demonstrate any inkling of compassion and mercy.
“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
No comments:
Post a Comment