Monday, February 20, 2012
Drug releasing microchip passes the first test in humans
It sounds like something out of a sci-fi movie: A patient visits a doctor's office and, after a brief surgical procedure, walks away with a microchip under her skin that delivers medication in precisely timed and measured doses.
That scenario doesn't seem so futuristic anymore. Researchers at the Massachusetts Institute of Technology (MIT) announced today that they have successfully completed the first trial of a drug-releasing microchip in humans.
The results were published on the website of the journal Science Translational Medicine.
The pacemaker-sized microchip devices, which were implanted near the waistline of seven 60-something women in Denmark, worked as intended, releasing up to 19 daily doses of an osteoporosis drug that ordinarily requires injections. The implants proved safe, and tests revealed that they delivered the medication as effectively as once-a-day shots.
Health.com: How to fight osteoporosis
The devices won't be ready for mainstream use for at least another four years. But the researchers say the technology will ultimately enable people who take injectable drugs for conditions such as multiple sclerosis and rheumatoid arthritis to swap their needles for microchips.
Other drugs that could potentially be delivered in this manner include chemotherapy, fertility hormones, and vaccines, they say.
"It's almost like 'Star Trek,' but now it's coming to life," says study coauthor Robert Langer, Jr., Sc.D., an institute professor at MIT's Koch Institute for Integrative Cancer Research, in Cambridge, Massachusetts.
Langer, a chemical engineer, came up with the idea for the drug-delivery device about 15 years ago, while watching a TV show on how microchips are made in the computer industry.
Langer and his colleagues at MIT worked on the idea throughout the 1990s, and published the first paper on their research in 1999. That same year, Langer cofounded a privately held company, MicroCHIPS, Inc., to license the technology from MIT and commercialize the device.
Health.com: Injecting yourself 101
Here's how it works: Microchips containing tiny reservoirs of concentrated, freeze-dried medication are secured to the surface of a titanium housing, which also contains a wireless transmitter that communicates with a small portable computer. A surgeon implants the device via a one-inch incision, in an outpatient procedure requiring local anesthesia only.
Each reservoir on the microchip holds a single dose of medication and is sealed by a thin metal membrane. When instructed by the computer, the implant sends an electrical current through a membrane and melts it, allowing body fluids to flow into the reservoir and the powdered drug to diffuse into the body. (The melted metal resolidifies on the chip and is not released.)
In the recently completed trial, the microchips were loaded with Forteo (teriparatide), a drug used to build bone mass in postmenopausal women with osteoporosis. The study participants carried the implants for a total of 103 days, and received medication on 20 of those days. Overall, the devices successfully released 94% of the doses as planned.
Health.com: 11 foods for healthy bones
One implant malfunctioned due to a faulty microchip circuit, but the researchers caught the problem thanks to the wireless transmitter, says Robert Farra, the president and CEO of MicroCHIPS.
"The on-board diagnostics allowed us to identify right away...that the drug could not be released," Farra says. "There were no safety concerns to the patient and we decided not to include [her] in the study, as our study objective was on safety and efficacy."
The study participants were reportedly untroubled by the device. "They found the implants pretty much acceptable," Farra says. "They could not feel the device once it was implanted, and they all indicated they would be willing to repeat the procedure."
The fact that several of the women said they forgot about the implant once their incision healed is a "good sign," says John T. Watson, Ph.D., a professor of bioengineering at the University of California, San Diego. Watson adds, however, that the microchip system may not be for everyone.
The quality of life of people who take injectable medications "varies very broadly," says Watson, who coauthored an editorial accompanying the study. "Some people say 'I just don't want an incision' -- so they could opt out easily and elect another approach. On the other hand, there would be some people who would say 'I want this' because [they] want it to be forgettable, sort of like a pacemaker."
Health.com: Prescription drugs that lead double lives
More research and fine-tuning will be needed before the device can even be tested in full-fledged clinical trials, Watson says. The researchers need to establish that it's durable and reliable, for instance.
Langer and his colleagues say their implants could be used for brief stretches of 30 to 90 days (to administer pain medication after an injury, say), or for periods of up to a year.
"We think 365 doses is very manageable with the design that we're working on," says Farra, noting that MicroCHIPS is currently developing a one-year Forteo implant.
S. Louis Bridges, M.D., the director of clinical immunology and rheumatology at the University of Alabama at Birmingham, in Alabama, says microchip devices could be a boon for people -- such as rheumatoid arthritis patients -- who require regular injections or intravenous infusions.
Health.com: Alternative therapies for rheumatoid arthritis
"Patients tend to do OK, but there are some that absolutely hate [injections]," Bridges says. Some patients complain that the medicine burns, and some experience so-called injection site reactions in which the surrounding skin becomes red and swollen, he explains.
Patient comfort and convenience aren't the only potential benefits of microchips, Farra says. The automatic dosing ensures that people receive the medication exactly as prescribed, so doctors and patients don't have to worry about skipped or inconsistent doses, he says.
CNN
EARLIEST GOSPEL OF MARK FOUND
A New Testament professor is setting the world of Bible scholarship on fire with his claim that newly discovered fragments of early Christian writings could include a first-century version of the Gospel of Mark, from the same century in which Jesus and the apostles lived.
Daniel B. Wallace of the Dallas Theological Seminary made the stunning announcement during a Feb. 1 debate with Bart Ehrman at the University of North Carolina Chapel Hill on whether we have the wording of the original New Testament today.
“If this Mark fragment is confirmed as from the first century, what a thrill it will be to have a manuscript that is dated within the lifetime of many of the original followers of Jesus!” Wallace said. “Not only this, but this manuscript would have been written before the New Testament was completed.”
Wallace says seven New Testament fragments written on papyrus had recently been discovered – six of them probably from the second century and one of them probably from the first. He expects further details to be published “in about a year.”
“These manuscripts now increase our holdings as follows: we have as many as eighteen New Testament manuscripts (all fragmentary, more or less) from the second century and one from the first. Altogether, more than 40 percent of all New Testament verses are found in these manuscripts. But the most interesting thing is the first-century fragment.
“It was dated by one of the world’s leading paleographers. He said he was ‘certain’ that it was from the first century. If this is true, it would be the oldest fragment of the New Testament known to exist. Up until now, no one has discovered any first-century manuscripts of the New Testament. The oldest manuscript of the New Testament has been P52, a small fragment from John’s Gospel, dated to the first half of the second century. It was discovered in 1934.”
Wallace’s interest is focused on the portion from Mark’s Gospel.
“Before the discovery of this fragment, the oldest manuscript that had Mark in it was P45, from the early third century. This new fragment would predate that by 100 to 150 years.”
Craig A. Evans, professor of New Testament at Acadia Divinity College, says the find may indeed be of very great importance.
“If authenticity and early date are confirmed, this fragment of the Gospel of Mark could be very significant and show how well preserved the text of the New Testament really is. We all await its publication,” Evans told the Christian Post.
Others agree.
“Any find that gets us a quarter-century or so closer to the time the original gospels were written would be highly significant, even sensational,” Andreas Kostenberger, senior professor of New Testament and biblical theology at Southeastern Baptist Theological in Wake Forest, N.C., told Baptist Press.
“Of course, in part the significance of the discovery depends on the size of the fragment, not to mention the verification of the date. There have been previous reports of discoveries of early Mark or other gospel manuscripts that did not check out at closer scrutiny, so it is certainly appropriate to maintain scholarly caution until the full data are known and available to public scrutiny. For example, some scholars got burned when they prematurely accepted so-called ‘Secret Mark,’ which turned out to be a forgery.”
When asked about the trustworthiness of what Mark really wrote if we don’t possess an actual original copy of his manuscript, Kostenberger said, “The fact is that the earliest manuscripts of all or parts of Mark that we do have show remarkable consistency and stability. And none of the minor variations between different manuscripts affect any major doctrine of Christianity at all.
“Of course, there is no way to prove positively one way or another what might have happened during the period between the original writing of Mark and the first available copies. Knowing what we do know about the care with which ancient Jews as well as early Christians took to preserve the original wording of what they believed to be authoritative and sacred writings – in fact, the very words of God – inspires a high degree of confidence. First the apostles, and then those after them carefully guarded the reliability of the eyewitness testimony to Jesus contained in the four canonical gospels.”
WND
Ancient Biblical Gardens Bloom again
An ancient royal garden has come back into bloom in a way, as scientists have reconstructed what it would've looked like some 2,500 years ago in the kingdom of the biblical Judah.
Their reconstruction, which relied on analyses of excavated pollen, reveals a paradise of exotic plants.
The luxurious garden had been discovered at Ramat Rahel, an archaeological site located high above the modern city of Jerusalem, about midway between the Old City of Jerusalem and Bethlehem. This site was inhabited since the last century of the Kingdom of Judah (seventh century B.C.) until the early Muslim reign in Palestine (10th century), a period that saw many wars and exchanges of power, with the garden evolving under each civilization.
Since excavators discovered the garden, they could only imagine its leafy, flowery inhabitants. That is until now.
The garden relied on an advanced irrigation system, which collected rainwater and distributed it using artsy water installations, including pools, underground channels, tunnels and gutters.
These water installations ended up being the key to the team's new discovery; the researchers found grains of pollen that likely got trapped in plaster when the installations were renovated and the plaster still wet. The result was preserved pollen grains.
In samples dating back to the Persian period (between the fifth and sixth centuries B.C.), the team found grains from local fruit trees, ornamentals and imported trees from distant lands.
"This is a very unique pollen assemblage," study researcher Dafna Langgut, a pollen expert at Tel Aviv University, said in a statement.
For instance, they found evidence of willow and poplar trees, which would have required irrigation to survive in the garden. They also found pollen associated with ornamentals, such as myrtle and water lilies; native fruit trees, including grape vine, common fig and olive; and imported citron, Persian walnut, cedar of Lebanon and birch trees. The researchers think the ruling Persian authorities likely imported these exotics from remote parts of the empire to flaunt their power.
The team suggests these imported plants had a lasting impact on the region and Judaism, said Oded Lipschits of Tel Aviv University. Take the citron tree. It made its first appearance in Israel in this garden, and since has worked its way into Jewish tradition. The citron, or etrog, is one of the four species of plants used at Sukkot, a biblical holiday.
Livescience
Alert level raised for remote Alaska volcano
The Alaska Volcano Observatory has raised the alert level for Kanaga Volcano in the remote Aleutian Islands.
Scientists on Saturday said possible explosive activity and a likely ash cloud indicate new unrest at the volcano, leading it to raise the volcano alert level from normal to advisory.
The observatory says volcanic tremor was detected at about 6:23 a.m. Saturday. The unrest indicates a possibility for sudden explosions of ash to occur at any time, and ash clouds exceeding 20,000 feet above sea level may develop.
Ash clouds above 20,000 feet from Alaska volcanoes are a threat to trans-Pacific air carriers.
Kanaga Volcano is located about 1,215 miles southwest of Anchorage in the western Aleutian Islands.
Alaska News
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