With 3D printing, doctors can now create better bone implants at less cost than with conventional implants.

An 83-year-old woman suffering from a lower jaw infection became the first person to receive a jaw implant manufactured with a 3D printer. Infections such as hers are normally remedied with reconstructive surgery, but doctor’s deemed the procedure too risky because of her age and health. Instead they turned to LayerWise, a company that specializes in 3D printing of metallic structures.

Titanium powder was melted with a high-precision laser into layers guided by a computer model of the jaw. The computer model was digitally divided into 2D layers and printed at 33 layers per millimeter. The 3D printing made it possible to create an implant that just as intricate as the real thing. With articulated joints, cavities that foster muscle attachment, and grooves to guide nerve and vein regrowth, the new jaw was an intricate piece of hardware. It normally takes several days to make a custom implant, but the 3D printed implant took just a few hours to print. After the implant was made it was treated with a bioceramic coating by Cam Bioceramics BV. The surgery to attach a jaw implant normally takes around 20 hours. But because the printed implant fit so well surgeons were able to attach it in just four hours. A shorter surgery makes for a shorter recovery. The patient was able to go home with her new jaw after only four days. Normally recovery takes weeks. She was able to speak a few words after waking up, and the following day she was able to swallow again. Being made of titanium, the new jaw weighs 107 grams or about a third heavier than the patient’s own jaw. The doctors think she’ll adjust easily.

The implant is treated with a bioceramic coating prior to implantation.

The new method was made possible by research performed at the Biomed research group at the University of Hasselt in Belgium and researchers at four other universities. The surgery was performed last June but is only now being announced. Later this month the patient will undergo a follow-up surgery to remove healing implants which have served as place-holders for the patient’s teeth. After they’re removed, false teeth will be screwed into their place.

The structures that can be produced by the layer-by-layer materialization of 3D printing are practically limitless. By comparison, creating medical implants with conventional metalworking is time-consuming, expensive, and the implants don’t match the original as well. Last year an orthopedic surgeon used a 3D printer to make bone models from CT scan images that doctors could use to prepare for surgeries. Others are trying to push the medical implant envelope by printing organs! It will be a while before our bodies’ organic material will provide us a reliable ‘ink,’ says Ruben Wauthle at LayerWise, citing many biological and chemical issues that are yet unresolved. Even so, 3D printing could be a major boon for medicine in the near future. No doubt others will adopt printing for jaw and other types of bone replacements. The patients will be better off, and hospitals will save time and money.

[image credits: LayerWise]
images: LayerWise

SkyLight co-founders Andy Miller and Tess Bakke.

The SkyLight is really a simple device derived to solve a simple problem: how to keep your smartphone still enough to take high quality photos through a microscope. Watching other people holding their cell phones up to their microscopes, SkyLight co-founder, Andy Miller, realized that he wasn’t the only one in search of a low cost and easy way to take pictures of microscope images. I recently had the joy of chatting with Miller and fellow co-founder Tess Bakke about how the SkyLight came to be, and how they think it will impact research, medicine and education.

The SkyLight is essentially an adapter that fixes a smartphone to a microscope. Using the phone’s camera to peer through the eyepiece and snap photos, you get images that are practically indistinguishable from images taken with professional microscopy cameras. The big difference is that conventional microscope cameras can cost hundreds to thousands of dollars, while the SkyLight is just $60. Of course, you’ll need a smartphone too, but you probably already have one in your pocket.

The SkyLight adapter consists of a movable platform that the smartphone fits into, and a base that locks onto just about any microscope eyepiece. After connecting the smartphone to the eyepiece, you adjust the platform position to align the camera correctly, and adjust it up and down for focus. Lock it up, and you’re ready to take pictures.

“I was building a microscope in college,” Miller tells me casually, as if microscope-building was as normal as joining the chess club, “and I was trying to attach a telephone to that microscope and I realized, well, it’s fine if I can attach one cell phone to one microscope but it would be pretty feasible to have a universal adapter that would allow me to attach any phone to any microscope.”

Miller likes to build microscopes, but there’s a purpose behind his geeky pursuit. While studying bioengineering and global health at Rice University, he designed and built the Global Focus microscope – a simple, affordable microscope that can be built for areas of the world with limited resources. With off-the-shelf lenses and mirrors, an LED flashlight for a light source, and running off batteries, the microscope could take bright field and fluorescent images and cost only $240 to make. Right now there are 20 prototypes being tested in the US, Central America, and Africa.

Not too shabby: a 10X image of esophageal cells taken by an iPhone 4S.

As the Kickstarter page confesses, “Now he’s bent on making meaningful change through design.” The SkyLight is a simple idea that could have profound results. Connecting a cell phone to a microscope not only saves money, but in a developing country, it makes the difference between quality care or not. Don’t have a pathologist in your rural Kenyan village? No problem. Just send the images to the hospitals in Nairobi. SkyLight can literally bring together innovative solutions such as the Global Focus microscope and the $80 IDEOS Android smartphone, which 350,000 Kenyans had scooped up as of this past summer, to extend the reach of much needed quality healthcare.

The idea for the SkyLight came to Miller while building the cheap microscopes in Africa. The lack of resources available there forced him to create a general design. “How do you make it work with anything you might have?” He made a product that would work with any cell phone. Had he been in the US and had all the resources he needed, Miller expects the adapter he’d have come up with would have been specifically built for an iPhone and only an iPhone, or a specific microscope together with a specific phone. The tightened constraints in Africa forced Miller to make a more general use device, and it’s all the better for it. The SkyLight can work for different phones and different microscope with different kinds of eyepieces. And even though they’re focusing on microscopes at the moment, the team expects that SkyLight will eventually be used to mate smartphones with other types of cameras such as spotting scopes, the telephoto cameras used by birders. Check out their gallery of images here.

Think you could tell the difference between images taken with a phone and conventional camera? While they haven’t rigorously compared the images taken by their smartphone with images taken by conventional microscopy cameras, they’ve already passed the eyeball test. As Miller tells me, the Kickstarter page “received the most attention from…doctors, pathologists who want to do doctor-to-doctor consult.” Some physicians actually contacted the group and asked that they take pictures of samples. They took the pictures with an iPhone 4S with a resolution of 8-megapixels. After posting the pictures on their website they were contacted by multiple pathologists who told them that it’s good enough for them to make diagnoses.

The SkyLight won the Proto Labs Cool Idea! Award in the program’s inaugural year. According to their website, Proto Labs is the “world’s fastest” maker of CNC machined and injection molded parts. Their Cool Idea! Award is aimed at producing high quality prototypes for startup businesses that might not have the resources to follow through on a good idea. In a press release about the award, Proto Labs cited how SkyLight enables researchers, clinicians and educators to communicate in new ways by combining tools already available to them. Winning the award was a key achievement for SkyLight’s mission to make the adapter available to those who need it. The mold that Proto Lab has created lowers production cost and makes it more affordable. The SkyLight was listed on Kickstarter for $60, but Miller and Bakke hope to work with an NGO in the future and offer the adapter for even less.

Bakke emphasized SkyLight’s social enterprise aspect, mentioning their 5 to 1 promise: for every five SkyLights they sell they’re going to donate one to schools or other places like a local health program that could use them.

We shouldn’t forget that the camera in use is still a phone. Miller and Bakke point out that SkyLight could be used live; that is, you could connect a collaborator with a live view through your microscope all the while having a conversation.

“Can you move it a little to the left…great, now zoom in.”

As an easy and inexpensive way to generate and share images, SkyLight is an ideal telemedicine tool. Wanting to explore SkyLight’s potential, the company has sending their prototype to telemedicine researchers to tap their imaginations. At the same time they’re encouraging apps developers to come up with apps to improve image-based smartphone telemedicine and telediagnosis capabilities. Miller mentioned one app that would be universally useful would be an app that pushes images directly to a server, and labels and organizes them. That way people wouldn’t have to email or text themselves every image they want to keep.

Right now the adapter is still in its testing and production phase, but they expect SkyLight to be ready around the first of March. When that happens there will be no shortage of takers. Their first production run will be aimed at filling Kickstarter orders and getting feedback for improvement.

Kickstarter is great for turning great ideas into real tools. SkyLight’s goal was to raise $15,000. They ended up with over $22,000. I have no doubt that these two, enthusiastic young people and the SkyLight will get a lot of attention in the coming months. All they did was find a way to combine technologies that already existed, showing us once again you don’t need to reinvent the wheel to create something useful.

[image credits: SkyLight]
images: SkyLight

The man of the hour. UCLA's Steven Schwartz and his team partially restored vision to two patients by injecting stem cells into their retinas.

Macular degeneration had left Sue Freeman, 78, legally blind. She couldn’t go for a walk by herself, she couldn’t go shopping or even cook by herself. Another woman, age 51, was suffering from Stargardt’s macular dystrophy, which causes the loss of cells located in the pigmented layer of the retina called the retinal pigment epithelium. Also legally blind, she was unable read the large letters on an eye chart used to test people with compromised vision.

In July of 2010 doctors injected retinal cells derived from human embryonic stem cells into one eye of each woman in the hopes that they would regrow the cells needed to see. A couple weeks after surgery Freeman improved her visual acuity score from correctly identifying 21 letters (20/500 vision) to 28 letters (20/320). She could once again pour a glass of water without spilling it, read her own handwriting, and – to the chagrin of her husband – take notice of all the improvements that needed to be done on rental properties that they own.

The other patient, who wishes to remain anonymous, could only detect hand motions prior to surgery. Two weeks following surgery she began counting fingers. She also improved from identifying zero letters on the acuity chart to correctly recognizing five. She woke up one morning and looked at the armoire in her bedroom. “It has a lot of detailed carvings and I thought wow, I was missing those before,” she told CNN.

Both patients continued to show improvement in the treated eye four months after surgery and did not show any adverse side effects. Importantly, the eyes that did not receive stem cells did not show improvement. The patients were also given immunosuppressants to prevent their bodies from rejecting the foreign tissue.

The trial was led by Steven Schwartz, an opthalmologist and chief of the retina division at UCLA’s Jules Stein Eye Institute, and the results were published in The Lancet. Although the results are extremely promising, Dr. Schwartz is quick to temper enthusiasm over the trial. Only two patients were treated, after all. Many more will need to be successfully treated before the procedure can be accepted as a robust option. He justified publishing the study after only two patients given the amount of interest in the field. Qualifying the study further, Dr. Schwartz cautioned that the improvement in eyesight for one of the women could be a placebo effect.

Pigmented epithelial cells were grown from embryonic stem cells prior to injection.

The stem cells were treated before being injected into the patients’ eyes. Researchers at the company that had provided the stem cells, Advanced Cell Technology, had induced the cells to become retinal pigment epithelial cells. The procedure, which included the injection of about 50,000 cells, took half an hour. The team received stem cells from Advanced Cell Technology, which had gotten them from an embryo stored at a fertility clinic. The couple who’d produced the embryo decided not to use it and then donated it to the company. After stem cells were derived from the embryo it was destroyed. The hope is that in the future stem cells will be taken from embryos without the need to destroy them.

The stem cell treatment gives new hope to the blind. Macular degeneration is the leading cause of vision loss among the elderly. When the light-sensitive photoreceptors of the macula degenerate people can no longer bring objects into focus. Stargart’s muscular dystrophy, or Stargart’s disease, is a common cause of vision loss among children and young people. Right now there is no treatment for Stargart’s disease, and while drug injections, laser treatment and diet alteration can slow the progression of age-related macular degeneration, it is also considered incurable.

Others are working towards a stem cell cure for macular degeneration. In 2010 researchers successfully grew a retina in the lab from human embryonic stem cells. It was the first time a 3D tissue was produced from stem cells. Curing macular degeneration is an ideal target for stem cell treatments. The number of cells needed is low compared to, say, regrowing the neurons of a damaged spinal cord. Unlike other cells in the retina, cells of the retinal pigment epithelium don’t need to form synapses to work. Lastly, the retina’s immune environment is more tolerant, thus decreasing the need for immunosuppressants.

Pharmaceutical giant Geron Corporation used to represent one of the best chances for making stem cell treatments a reality. But recently after the company had begun human trials on their promising cell line that allowed paralyzed mice to walk again, they dropped out of the stem cell game altogether. If the UCLA trial results hold, it could entice more companies like Advanced Cell Technology to invest in stem cell research. According to a commentary on the trial, when Geron ended their trial it left ACT and Dr. Schwartz and his colleagues as the sole group treating patients with embryo-derived stem cells. That’s not good enough. Let’s hope the trial not only brings the world into focus for its patients, but also brings the potential of embryo-derived stem cells back into the focus of medicine.

[image credits: UCLA Jules Stein Eye Institute, CNN and The Lancet]
image 1: Schwartz1
image 2: Schwartz2
image 3: stem cells

Modern healthcare is sick, but Dr. Daniel Kraft knows a little something about the cure. At the 2011 TEDMED conference in San Diego, the stem cell researcher gave a great overview on the emerging trends which are poised to play a big role in how medicine develops in the decades ahead. Mobile platforms, 24 hour at home monitoring, artificial intelligence, social networking, massive data collection, crowd-sourcing – Kraft expounds upon them all with his characteristic charm and humor. He even explains how lessons learned from aviation (checklists, simulations, heads-up displays) could help transform healthcare. With $2.4 trillion spent on medicine in the United States alone, there’s a huge incentive to make the industry faster, smarter, and more efficient. Kraft’s TEDMED presentation is a great guide to how humanity can make that happen. Don’t miss it below:

If you find yourself wanting to learn even more check out Dr. Kraft’s recent Q&A with Singularity Hub. Or think about attending the exciting FutureMed Executive Program at Singularity University in February, headed by Kraft and featuring some amazing innovators in the field of medicine.

[screen capture and video credit: TEDMED]

Due to the overuse and misuse of antibiotics, the prevalence of drug-resistant Mycobacterium tuberculosis is growing.

This is scary.

A report out of India identifies four new cases of tuberculosis that are completely resistant to drug treatment. They gave all four patients, ages ranging from 20 to 57, the full first-line and second-line batteries of drugs. The first-line included four to five drugs and the second-line five to six drugs for the patients. The drugs had no effect.

When study co-author Zarir Udwadia from the Hinduja National Hosptical and Medical Research Centre in Mumbai, spoke to the New Scientist he sounded like he was reading a script from a Hollywood movie. “It’s estimated that on average, a tuberculosis patient infects 10 to 20 contacts in a year, and there’s no reason to suspect that this strain is any less transmissible. Short of quarantining them in hospitals with isolation facilities till they become non-infectious – which is not practical or possible – there is nothing else one can do to prevent transmission.”

Udwadia says mismanagement of the multi-drug resistant strain by both the government and private care givers is to blame. The emergence of people with strains resistant to some or all drugs, however, is simply a natural and inevitable consequence of antibiotic use. But while we should brace ourselves for similar reports in the future, places like Mumbai have plenty of room for improvement if they want to stem the tide.

The 110,000 people in India with multidrug-resistant tuberculosis are cared for by private practitioners. In a survey of 106 of them located in a Mumbai suburb, Udwadia concluded that only five private practitioners gave the proper prescription to multi-drug resistant tuberculosis patients. In fact, the four patients in the current study underwent analyses to determine prior treatment. The test revealed that three of the four had received “erratic, unsupervised second-line drugs, added individually and often in incorrect doses, from multiple private practitioners.” The patients received treatment from an average of four different physicians in an 18-month period in a desperate attempt to rid themselves of tuberculosis. According to the report, neither the prescription practices nor the qualifications of these private physicians is regulated.

And then there’s the cost. It costs just $20 to treat a patient with conventional tuberculosis. The drugs used to treat patients with the multidrug-resistant strain run between $2000 and $12,000.

Tuberculosis has already been a challenge for India. A World Health Organization report estimated that 110,132 multidrug-resistant tuberculoses cases arose India in 2006, accounting for 20 percent of worldwide cases. The report cites insufficient lab capacity as a major barrier to controlling the disease.

The four patients are the fourth group in recent years to have been found with completely drug-resistant tuberculosis. In 2007, two cases were reported in Italy. In 2009, 15 cases were reported in Iran. If this is a trend, and it’s probably prudent to assume it is, the world should be on guard. In particular, some countries of the former Soviet Union. What the WHO calls a “serious and widespread epidemic,” about 35 percent of all tuberculosis cases in these countries are multi drug-resistant, and about fifty percent are resistant to at least one drug. Also troubling is China with the second highest proportions of drug resistance. In 2006 China accounted for 25 percent of worldwide multidrug-resistant tuberculosis cases. In 2009, the United States reported just 113 cases of multidrug-resistant tuberculosis.

While multi-drug resistant tuberculosis is on the rise in some areas, the conventional disease is being treated effectively. Last year the WHO reported a drop in global tuberculosis cases from 9 million in 2005 to 8.8 million in 2010. Deaths also dropped from 1.8 million in 2003 to 1.4 million in 2010. Between 1990 and 2010 the death rate decreased 40 percent. In 2009, 87 percent of reported tuberculosis cases were cured.

Which makes the India cases all the more disheartening. Again antibiotics misuse rears its ugly head. Antibiotic use leads to antibiotic-resistant bacteria. The susceptible bacteria is killed off while the resistant bacteria live to proliferate and infect another day.  Minsk, Belarus recently topped the charts when 15 percent of their multidrug-resistant population was shown to be extremely drug-resistant. There are some antibiotics used specifically to treat people with multidrug resistant tuberculosis. When those drugs are misused, the patients become resistant to even them, and become extremely drug-resistant. In 2007, about a dozen people in South Africa were diagnosed with extreme drug-resistant tuberculosis. They were sent on their contagious ways because the hospital didn’t have isolation wards.

So, where does this leave our highly interconnected world? Clinics haven’t actually run out of drugs just yet. Clofazimine and thioacetazone are two drugs that could potentially be used to treat the new form of totally resistant tuberculosis. The major drawback, though, are the drugs’ side effects. Clofazimine can cause discoloration of the skin, causing some patients to become depressed. In two cases, the patients committed suicide. And thioacetazone can cause the skin of people with HIV to peel off.

Another solution under consideration are sanatoriums, institutions in which patients and their immune systems do battle with the disease, quarantined safely away from the public. If that sounds familiar to you it’s because it was the best method for curing tuberculosis in the 19th century, long before antibiotics were discovered.

It wasn’t long ago that the WHO summarized the growing problem of anti-microbial resistance by saying, “The world is on the brink.” Well it certainly feels that way. An important question that, from where I’m sitting isn’t asked enough, is what really can be done about drug resistance? Tighter regulations and improved clinical practices will only slow the progression. Perhaps instead of focusing our efforts to stop their spread through policy, we should prepare for the inevitable and confront the daunting task of developing new antiobotics and new techniques to fight this terrible disease.

[image credits: Youth Ki Awaaz, Science Daily, and the World Health Organization]
image 1: India
image 2: Tuberculosis
image 3: graph

Yoshiki Sasai's group induced embryonic stem cells to grow into the three-dimensionally complex pituitary.

Chalk up another part of the body that can be grown from stem cells – at least in mice. Scientists in Japan have induced mouse embryonic stem cells to form a pituitary in the lab. The team’s success not only holds promise for people with pituitary defects, but it’s another of just a few examples in which stem cells have been coaxed into a complex, three dimensional structure.

The pituitary is often referred to as the “master” gland of the endocrine system, as it secretes hormones that control the hormones secreted by other endocrine glands. It’s formation during embryonic development is closely tied to the hypothalamus, another important endocrine structure located close by at the base of the brain. The challenge to the Japanese researchers was to maintain the proper developmental environment for the nascent pituitary outside the brain. It was a complex challenge. They added hypothalamus tissue to the mix so that the stem cells would receive guiding signals from it, but the brain obviously consists of much more than these two areas. In order to “trick” the pituitary into thinking it was still in the brain, they also added several growth-inducing molecules including Sonic Hedgehog (it was discovered by a graduate student back when the game was popular) that are required for proper development in the brain. It worked. In just a couple weeks, the new structure not only looked like a pituitary, it produced all the major molecular markers that a normal pituitary produces. For the icing on the cake, the researchers placed the lab-grown pituitary into mice which had their own pituitaries destroyed. A week after transplantation, the mice showed increased blood levels of hormones produced by the pituitary.

The study was led by Yoshiki Sasai at the Riken Institute in Japan and was published in Nature.

The same researchers had previously used embryonic stem cells to from layers of the brain cortex.

The pituitary hormones regulate important physiological processes such as growth, puberty, and reproduction. A dysfunctional pituitary can lead to deficits in these hormones, which in turn can lead to disorders such as stunted growth, hypothyroidism, and infertility. Combined pituitary hormone deficiency affects about 1 in 3,000 to 4,000 live births. And although hormone-replacement therapy can be effective for many, it does not return hormone levels to their normal levels.

But don’t expect doctors to start replacing dysfunctional pituitaries with ones grown in the lab anytime soon. Most importantly, we’ll first need to see if the procedure can be repeated with human embryonic stem cells. And even now questions remain regarding the lab-grown mouse pituitaries. Embryonic stem cells differentiated in the lab don’t always run the course to full maturity. The pituitary in the current study still looks like the pituitary from an embryo. Only time will tell whether or not it can develop to an adult pituitary. But even if we can’t start swapping out dysfunctional pituitaries, the lab-grown structures should be a valuable tool for researchers studying pituitary defects. They can be looked at under a microscope and labeled with molecular markers, lending themselves to analyses far more difficult to perform in whole animals.

It could also pave the way for future stem cell research. The pituitary’s development in the study, as it is in normal development, was dependent on molecular signals sent from the hypothalamus. Now that the researchers have established that it is possible to run this inductive process, they have opened the door for the induction of even more complex organs in the lab.

The victories for regenerative medicine just keep on coming. Last year a group at UC Irvine in California successfully grew a retina from human embryonic stem cells. Like the pituitary, the retina needed to be grown with a specific three-dimensional organization in order to function properly. The starting clumps of stem cells required no intervention from the scientists to become retinas. The cell-to-cell communication during “development” was all they needed. Sasai’s group also induced embryonic stem cells to form a retina this past spring, although theirs was grown from mouse cells.

The group is currently working to improve transplantation of pituitary tissue in their mouse model. They’re also working on methods to repeat the experiment with human stem cells. Sasai expects it will be about three years to create a human pituitary. When they do, the field of regenerative medicine will be that much closer to its holy grail of growing all organs in the lab and transplanting them into humans.

[image credits: RIKEN]
image 1: cortex
image 2: Sasai

Thanks to surgeon Mark Frame, 3D printers can now read CT scans and produce bone models at a fraction of the previous cost.

While necessity is the mother of invention, frustratingly high costs can motivate us to ask if there’s another way. Mark Frame, an orthopedic surgeon in training, came up with a new way to make bone replicas that help surgeons plan their procedures. Not that anything was wrong with the replicas they had, but at hundreds or even thousands of pounds apiece, Frame searched for a cheaper way to get the same result. His first production, a plastic bone of a patient’s arm, cost just £77. And everything he needed was right there on the Internet.

Monklands Hospital in Scotland where Frame works typically enlists a bone prototyping shop at a local university to make their models based on CT scan images. They’d put in for a model of a patient who’d fractured his arm. Because of costs they ordered a truncated portion of the bone. The sub-optimal model still cost them more than $1,200.

How Frame came to find a way to make a complete model for £77 is due in no small part to his enthusiasm for “any new tech or gadgets.” In particular, he “couldn’t fail to have noticed this upsurge in talk about 3D printing,” he blogged on the website for Shapeways, the Netherlands-based 3D printing company he used to make his models.

But, as 3D printers don’t normally handle CT scan images, Frame had to find a way to convert the images into a format the printers could use. And, of course, the final product had to be just as precise as those surgeons normally use. To accomplish this he used OsiriX, an image processing package specific for the kinds produced by imaging equipment, such as CT scanners. As OsiriX is open source software that runs on mac OS, Frame was able to use it free of charge. He then used a program called MeshLab – also open source, and free, for Mac – to clean up the image and make them medical quality. Finally, this image was sent to Shapeways for printing. Seven days later the model bone arrived in the mail. All for £77.

The CT scan used for the model shown above.

Verification showed that he had indeed made an identical copy of the real bone. And not only did the model prove a valuable anatomical guide, the hard plastic used to cast the model, Frame found, was great for practicing procedures with the actual drills, saws, and screws they used in operations.

“All in all Shapeways has opened up rapid prototyping to everyone no matter what the budget,” he writes in the blog.

They’ve since gone on to make a model of an entire pelvis, which cost them £150. With the old method the models themselves would sometimes cost just as much as the procedure, and so they wouldn’t make them. With Frame’s method cost becomes a non-issue.

What do veteran orthopedic surgeons at Monklands Hospital think of the trainee’s scheme? Not only at Monklands but surgeons at hospitals in the West of Scotland have asked for his help in ordering models. The more models, the less change of a complication during surgery. Frame has actually written up the procedure and has submitted it to the World Journal of Science Technology so that surgeons worldwide can benefit and save lots of cash. In these times of budget cuts and struggling hospitals, it’s sure to get real popular real fast. And if you don’t feel like bothering with the paper, Frame and colleagues have started a company that makes the models for you. Just send 3D-OM your CT scan and they’ll send you back your model. Heck, it’s so cheap now, if you’ve got a CT scan you might just want to get the model for fun.

So yet another part of our world – and our bodies – is forged from a 3D printer. Toys, robots, sculptures, even human kidneys. I wonder what imaginative people like Mark Frame will think of next. And maybe there’s a lesson to be learned here. Maybe, instead of simply following the status quo we should ask ourselves if there are better ways to get something done. Frame didn’t invent anything, he just had the creativity to bring together existing technologies in a new way. What new uses and technologies are sitting under our noses right now, waiting for us to merge disparate instruments into a new, unitary whole. One thing’s for sure, we have a lot to work with.

[image credits: Shapeways]
images: Shapeways

Do you really need all those pills? Some researchers say dietary supplements help only those who need them, and don't make healthy people healthier.

“Don’t forget to take your vitamins?”

That healthful reminder from mom may soon become a thing of the past. While dietary supplements remain popular in the US, a continuous stream of studies are casting increasing doubt that the widely-accepted benefits are real. Researchers and regulators are taking notice, and some are beginning to deliver a different message.

Two studies published earlier this month are the most recent examples. One takes aim at vitamin E, the other at multivitamin supplements for women.

The Selenium and Vitamin E Cancer Prevention Trial (SELECT) put to test the common “wisdom” that vitamin E lowers men’s risk for prostate cancer. A total of 35,533 men in the US, Canada, and Puerto Rico, received one of four treatments: vitamin E, selenium (an essential mineral thought to lower the risk of cancer when taken with vitamin E), both together, or a placebo. They found that taking vitamin E actually increased the risk for prostate cancer. Taken together with selenium, however, seemed to mitigate the increased risk that comes with taking vitamin E.

Bottom line, though, is that taking vitamin E or selenium – or both – did not reduce risk of prostate cancer.

The Iowa Women’s Health Study assessed the health affects of vitamins and minerals in over 38,000 older women. With a maximum follow up of about 20 years, the study showed that taking common vitamins and mineral supplements was actually associated with an increase in mortality rate, compared to women who did not take supplements.

We have to keep in mind, though, that studying the effects of vitamins and supplements is tricky. People don’t just eat them one at a time. The subjects in the SELECT trial took their vitamin E along with their normal diet. Other vitamins and minerals can interact with vitamin E in complex ways that researchers are far from understanding. So studies that try to parse out the effects of a single supplement have to be taken, pardon me for saying, with a grain of salt.

But while any single trial is not conclusive, a pattern emerges when one takes a broader view, according to Marion Nestle, New York University professor of nutrition, food studies, and public health. “The better the quality of research, the less benefit [supplements] show,” he told the Wall Street Journal. “It’s fair to say from the research that supplements don’t make healthy people healthier.”

There's nothing like the real thing.

Others agree. The Office of Dietary Supplements, part of the National Institutes of Health, says that while vitamin C has long been a popular remedy for the common cold, research shows that, for most people, vitamin C does not reduce the risk for getting a cold. On the other hand, taking too much vitamin C can cause diarrhea, nausea, and stomach cramps. And while taking vitamin B-6 and B-12 is commonly thought to reduce risk for cardiovascular disease, the data is not conclusive. In a 2006 statement, the American Heart Association said “evidence is inadequate to recommend…B vitamin supplements as a means to reduce cardiovascular disease risk.” There’s no disputing that calcium is important for bone health, but efforts to show it reduces the risk of cancer and heart disease have fallen short. And taking calcium supplements can increase risk for kidney stones.

Early studies suggested beta-carotene decreased risk for lung cancer. But two large studies published in 1994 and 1996 showed that smokers taking beta-carotene supplements were actually more likely to develop lung cancer than smokers who didn’t take the supplement. A follow up to the studies was performed in 2004. It concluded that beta-carotene was harmful to those at risk for lung cancer, even though the subjects hadn’t taken the supplement for years.

But that doesn’t mean all of us should stop taking our vitamins. For those with specific deficiencies or the malnourished, supplements are a necessary part of the diet. It’s recommended, for example, that pregnant women take folic acid. Folic acid is important for the kind of rapid cell growth that occurs during pregnancy. Taking it helps reduce the risk of birth defects.

Large studies that evaluate supplements, such as SELECT, are rare. In fact, many supplements remain untested, not only for their effectiveness, but for their safety as well. The FDA has a separate set of regulations for supplements than they do for drugs or “conventional” foods. According to these regulations, the “manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed.” The FDA is responsible, however, for taking action if a supplement has adverse effects once people start taking them.

Sounds arse-backwards if you ask me. But no one’s asking me, and the fact is the supplement industry is big business. According to a National Health and Nutrition Examination Survey report published earlier this year, in 2006 about half of Americans were popping at least one supplement a month. In 2010 the supplement industry raked in $28 billion in sales, a 4.4 percent increase from 2009. Despite the growing number of studies that show a given supplement doesn’t work, people continue to take them.

Joseph Fortunato, chief executive of supplement retail giant GNC Corp., is quite okay with that. The Wall Street Journal quotes Fortunato from a company conference call transcript: “The thing you do with [reports of studies] is just ride them out, and literally we see no impact on our business.”

That may soon change if the National Center for Complementary and Alternative Medicine (part of the NIH) and other health institutes have their way. The growing body of data that consistently fails to show benefits has prompted them to push for more studies that explore how nutrients work – a body of knowledge that is surprisingly lacking.

So what do we do with all this uncertainty? If you’re considering taking a dietary supplement, get informed. Read up and talk to your doctor. But as professor Nestle says, it might be a waste of money for people without specific deficits. The best way to get the vitamins and minerals you need? The old fashioned way: a balanced diet.

[image credits: Johns Hopkins Bloomberg School of Public Health and Dietary Supplements For Health And Fitness]
image 1: pills
image 2: balanced

GlaxoSmithKline's Joe Cohen celebrates a phase 3 clinical trial success that makes his vaccine likely to be the first to be distributed to Africa by 2015.

Joe Cohen didn’t know much about malaria when he agreed to head the vaccine research program at a company that was called Smith, Kline & French. The company had just completed an early stage trial for a malaria vaccine – a trial in which the vaccine had been shown to protect just one out of a group of volunteers. That was 24 years ago. The company’s name has since changed to GlaxoSmithKline, and the now 68-year old Cohen has just seen his vaccine cut the chances of catching malaria in half for thousands of African children. So promising are the results that the World Health Organization has uncharacteristically indicated to GSK that it could approve dispersal of the vaccine to African countries as early as 2015. If it does the malaria vaccine will become the world’s first.

The vaccine, called RTS,S or Mosquirix was March 2009. By January 2011, three doses of RTS,S reduced the risk of malaria in 6,000 children between 5 and 17 months old by about 50 percent. The trial is still ongoing, but the initial data was so striking the researchers published the result. It appeared in a recent issue of the New England Journal of Medicine.

A total of 15,460 children from seven African countries are enrolled in the study. They’re broken up into two age groups: 6 to 12 weeks old and 5 to 17 months old. Data from the babies 6 to 12 weeks old are expected to be obtained by the end of the year, and the entire trial is expected to be completed in 2014. If all goes well the vaccine could begin distribution the following year.

Malaria is caused by Plasmodium parasites which are spread to people through bites of Anopheles mosquitos.

Each year nearly one million people die of malaria. Most of the victims are babies and young children in Africa, accounting for about 20 percent of all childhood deaths in the country according to the World Health Organization. The malaria parasite is transmitted when carrier mosquitos bite and the parasite enters the blood stream. From the bloodstream it goes to the liver where it multiplies. The newly spawned parasites eventually re-enter the bloodstream where they infect red blood cells and cause fever, body aches, and sometimes death. Cohen’s vaccine stimulates the body’s immune system to stop the parasite from multiplying in the liver.

Just as the vaccine shows promise at this early stage, it has shown drawbacks as well. The children receiving it developed meningitis at a higher rate than those receiving other malaria vaccines. “There seems to be no plausible explanation for this, and it may well turn out to be a chance finding, but it cannot be ignored,” Nicholas White, Professor of Tropical Medicine at the University of Thailand, wrote in an editorial about the report. The treated children also showed an increased risk of convulsions and seizures compared to the control group that did not receive the vaccine. Prof. Nicholas suggested that this might be a real effect, “reflecting the reactogenicity of this highly immunogenic vaccine.”

As Cohen’s 24-year slog attests, developing a vaccine against a parasite is tough work. A recurring hurdle in the field arises from the fact that parasites are more closely related to human cells than are bacteria and viruses. Often a drug that kills the parasite kills human cells too. Another challenge is the complexity of parasites. Scientists often don’t know what part of the parasite structure to target. The success of Cohen’s vaccine lies in its ability to stimulate the immune system with several molecules for a multi-pronged attack. Even so, the vaccine’s 50 percent success rate is lower than common vaccines for which an 80 percent success rate is standard.

The vaccine is the product of a public-private partnership between GlaxoSmithKline and the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative, and was supported by the Bill and Melinda Gates Foundation. A number of other researchers are also working hard to develop their own vaccines for malaria, but RTS,S is the closest to becoming deployed and saving lives. Although the current report makes the vaccine’s path to widespread treatment an inevitability, Cohen hasn’t forgotten the hard times that got him here.

“There were many ups and downs, and moments over the years when we thought ‘Can we do it? Should we continue? Or is it really just too tough?’” he told Reuters. For the near million people that die from malaria each year, it’s a good thing he didn’t quit. The trial still needs to be completed, but if the results remain the same it’ll be a triumph for world medicine. And an example of how a determined will can triumph over daunting odds.

[image credits: nuranews, reuters, and gates foundation]
image 1: mosquito
image 2: cohen
image 3: malaria

Microscopes? That's so 2010. The lenseless ePetri dish just made one graduate student's day a lot easier.

A camera-attached laboratory microscope: $2,500.
An imaging chip, a smartphone, and some Lego blocks: $400.

Scientists at Caltech, out to ruin microscope manufacturers, have built their own device to monitor cells growing in a Petri dish. The device – which they call an ePetri dish – does away with the normal habit of taking the Petri dish out of the incubator and inspecting them under a microscope. Instead it takes images of the entire dish surface over time from inside the incubator. Without ever disturbing the cells they’re trying to grow, researchers can now take these cell growth “movies” and replay them whenever they want.

With the ePetri system, cells are grown on a CMOS image sensor – the kind found in common digital cameras. A smartphone placed above the sensor provides – via a commercially available app – a scanning spot of light that sweeps back and forth across its LED screen. Legos provide an enclosure that the smartphone rests on (no Lego NXT needed here). The contraption sits inside the incubator while a wire connects the sensor to laptop outside. Pictures are taken by the sensor and transferred to the laptop. With the ePetri system, scientists no longer have to remove the cells from the incubator but can simply look at the laptop images. Less manipulation makes for better cell health and reduced risk of contaminating them.

No microscope necessary. The ePetri system was able to track stem cells change over time with sub-micrometer resolution..

It also cuts down on work. Peering through a microscope limits visual range to a very small section of the Petri dish. Because ePetri scans the entire dish at a resolution of about half a micrometer – plenty of mag to see single cells. With the ePetri system scientists have the option of viewing the entire culture at once or zooming in to visualize single cells. And the continuous scanning capability means they get to watch their cells change in realtime.
Michael Elowitz, a professor of biology and bioengineering at Caltech and a co-author of the study, thinks ePetri is a game changer. “It radically reconceives the whole idea of what a light microscope is,” he said in a press release. “Instead of a large, heavy instrument full of delicate lenses, [we] have invented a compact lightweight microscope with no lens at all, yet one that can still produce high-resolution images of living cells.”

A lab member prepares an ePetri dish in the following video. He does his best not to speak, but I’m sure he’s very excited.

Elowitz and his colleagues gave ePetri a test run by using it to monitor the growth of stem cells. With it they were able to track the cells as they differentiated across the entire dish surface – an extremely labor-intensive and time-consuming undertaking with the use of a single microscope. They published the study recently in the Proceedings of the National Academy of Sciences.

Beyond monitoring cell growth, the ePetri scientists envision using the system to monitor other devices such as lab-on-a-chip tools. They also think doctors could use the system to test bacteria samples right there in the office instead of sending them out to a lab for testing. Currently the team is looking to make the ePetri dish a self-contained system by giving it its own small incubator. Of course, if they use anything but ziplock bags and soda cans it simply won’t be as cool.

[image credits: Proceedings of the National Academy of Sciences]
[video credits: caltech via YouTube]
images: ePetri
video: ePetri

Rite Aids in Detroit are getting chat rooms with which customers can video chat with doctors or nurses for medical advice. The doctors can even tele-prescribe over the Internet.

You got your shopping list: coffee, toothpaste, Tums, and…a doctor’s consultation about your lower back pain? Rite Aid is now your one-stop-shop for everything pharmaceutical, including expert medical advice on prescriptions or any other health-related questions you might ask your primary doctor. Chat rooms are already being installed at Rite Aids Detroit in which you can connect with doctors and nurses through the Internet for one-on-one video consultations. Now the doctors themselves are over-the-counter, and you don’t even need health insurance, just a credit card. Technology continues to make health care more convenient and accessible, and to reshape the clinic as we know it.

Inside the private chat rooms, customers will pay $45 to talk to a doctor for ten minutes. After describing symptoms they’ll receive feedback from the doctor and even a prescription if necessary, which they can then immediately fill. And they can choose to speak to a general practitioner or a specialist such as a psychologist or dermatologist. Nurses are also available for consultation free of charge. Staffed by OptumHealth, the company that also supplies the chat rooms, nurses can provide the customer with basic health information and assist them on appropriate care options. If they’re not comfortable with video chat, patients can choose to chat by typing or talk over the phone. The exchanges are automatically recorded and the recording can be sent off to the customer’s primary doctor to maintain continuity.

The “virtual” clinics are part of the OptumHealth’s NowClinic Online Care services. Rite Aid and OptumHealth’s efforts make health care more convenient. And if the chat rooms are convenient enough customers can still use NowClinic 24/7 by going to www.myNowClinic.com/RiteAid. Of course, it’s also very convenient for Rite Aid to have people in their store who have fresh prescriptions that need to be filled.

The following video is a tutorial demonstrating how to use the NowClinic.

The virtual clinics are part of a growing trend to make healthcare more accessible through technology. Rite Aids in Detroit are the first to receive the NowClinics, but BlueCross BlueShield has a similar system in five different states through which patients are able to gain immediate online access to doctors within the company’s network. Additionally, there are a number of websites such as healthcaremagic.com, goodhealthnyou.com, and askadoctornow.com that have doctors online, ready 24/7 to give advice to paying customers.

And OptumHealth doesn’t want to stop there. Chuck Grothaus, Senior Director of Corporate Communications told Singularity Hub that there are plans to “include some remote diagnostic capabilities including the ability to measure and share blood pressure information, among other things. We are still researching and developing what these tools will entail.”

It's the next step, you know it!

Some customers, however, might be resistant to this trend towards virtual care, or to taking advice from a doctor they’ve only “met’ ten minutes ago. But a study published earlier this year shows that virtual health care can be as good or even better than old fashioned visits to the doc’s office. The study compared traditional health care monitoring and total internet-based monitoring of a group of HIV positive patients. While neither the physical or psychological healths showed differences between the two groups, the patients monitored through the “Virtual Hospital” felt they had better access to clinical information.

Virtual doctors are just the latest way technology is making it easier for us to stay healthy. We can track our calories and sleep with Fitbit, test our blood sugar levels with our smartphones, and soon we’ll be able to swallow a pill that monitors our internal physiology. But to be clear, virtual visits aren’t meant to replace face-to-face visits but to augment them. An at home, do-it-yourself stethoscope exam probably wouldn’t work. As medical records become increasingly digitized virtual doctors and virtual hospitals will draw closer to true doctors’ office visits, even if they are found at the end of aisle five, just past the toothpaste and hair gel.

[image credits: Academy of Information Medicine]
[video credits: myNowClinic]
image: stethoscope

A new brain chip that allows monkeys to control a virtual hand and sense touch may be the breakthrough needed to give paralyzed patients the protheses control they need.

Scientists have created a brain implant that not only allows monkeys to control a computer with their thoughts, it also allows them to “feel” the virtual objects. The new, two-way, brain-machine-brain interface represents a major breakthrough in the field of neuroprosthetics. Bolstered by the results, the scientists plan to test the technology on a quadriplegic in just three years.

There have been a number of advances in brain-machine-interface (BMI) research in recent years. Implants have allowed monkeys to control computer cursors and even a robotic arm with impressive precision. In the current study, two macaques were trained to control a virtual arm on the computer screen and use it to “grasp” virtual objects. What separates these macaques from past BMI trainees is that, when their virtual hands contacted the virtual objects they were able to “feel” the objects.

The macaques were shown three identical objects on the computer screen. They were trained to pass the virtual hand over the three objects and to choose the one that evoked a sensation. Controlling the hand was enabled by electrodes implanted into the motor cortex, a major part of the brain for movement control. First, the activity of hundreds of neurons in the region is recorded while the monkeys control the virtual hand with a joystick. In this way the computer learns what “left” and “right,” etc. means in terms of brain activity. Then the joystick is taken away, and the monkeys are trained to control the hand with their thoughts.

The sensation indicating the correct object caused by electric stimulation through a return connection from the computer to the brain. These electrodes were inserted into the somatosensory cortex, the part of the brain that senses touch. As the virtual hand passed over the correct object the somatosensory cortex was stimulated. If the monkeys chose the correct object they received a food reward. They learned the task quickly. One monkey showed improvements after nine trials, the other after only four. After mastering the task the monkeys were picking the right object nine times out of ten. This shows that they can sense and object without any stimulation to the skin.

The following video shows the avatar arm in action.

“We don’t know what the animals perceived,” Miguel Nicolelis, neuroprosthetic aficionado and lead author of the study, told Nature, “but it was a sensation that was created artificially by linking the virtual fingers to the brain directly.” The study was published in Nature October 5th.

Managing the two signals – out from the motor cortex and into the somatosensory cortex – proved tricky for the researchers. The two areas are close enough together in the brain that the electrical stimulation in the somatosensory cortex would actually leak over to the motor cortex and disrupt control of the virtual hand. They got around this by alternating between recording and stimulating every 50 milliseconds. Of course, normal brain activity usually doesn’t take turns, but the fact that the monkeys were still able to learn the task means the constrained methodology still worked.

To give prosthetics sensory feedback would be huge. Some labs are currently trying to develop prosthetics with sensory feedback functions. One example relays feedback signals through the stump ending nerve terminals. Due to variability in the health of the stump tissue and severed neurons, this approach is less than idea. The two-way communication of BMBI, straight to the brain’s pristine movement and sensory centers could make feedback a reality. If BMBI can be used effectively in humans – a big ‘if’ – it would surpass current BMIs that up till now have relied solely on visual feedback for control. “If you want to reach and grasp a glass, visual feedback won’t help you,” Quian Quiroga, a neuroscientist at the University of Leicester, UK said in a commentary in Nature. Quiroga, who was not involved in the study, added, “It’s the sensory feedback that tells you if you have a good grip or if you are about to drop it.”

The Walk Again Project exoskeleton will be controlled entirely by thoughts.

With the successful BMBI demonstration, Nicolelis and his colleagues are ready to take neuroprostheses to the next level. The Walk Again Project is a collaborative effort involving many scientists from the world’s leading research centers to, through BMI/BMBI technology, do no less than “restore full mobility to patients suffering from a severe degree of paralysis.” Of course, to achieve such a superhuman feat will require superhero suit. In collaboration with Walk Again, Nicolelis’ lab at Duke University are putting together a “wearable robot” or “exoskeleton” designed to support the patient’s body and allow he or she to move at will. As in the study, electrodes will be implanted to give the patient both movement control and the all important feedback. The electrodes will be chronically implanted in at least five different regions on each side of the brain. Whereas a few hundred neurons were sufficient for the macaques to control their virtual arms, the larger human brain requires that a couple thousand brain cells be recorded for proper movement. It’s a major challenge that the researchers will have to overcome before patients can begin donning the exoskeleton. The electrodes will have to be stable for up to a decade, and then there’s always the risk of infection.

The brain chips – if they work – will be a technological triumph by themselves. Custom designed, the brain chips will be low-power and wireless, transmitting their signals to a processing unit worn on the patient’s belt about the size of a cell phone. That brain activity will then be translated to digital motor signals which will control the actuators across the joints of the exoskeleton. Force and stretch sensors throughout the exoskeleton will signal back to the patient’s brain the whereabouts of his or her joints and limbs. They predict that it would only be a matter of weeks before the patient was used to the suit, off on his or her own, experiencing the world like never before.

It’s an ambitious project, to say the least. The scientists are currently working hard to ready the suit for clinical trials over the next three years. You see, they have a deadline: the 2014 World Cup in Brazil. Nicolelis, a native Brazilian, hopes to test the exoskeleton on a grand stage by having a young quadriplegic Brazilian deliver the opening kick.

[image credits: The Guardian and Walk Again Project]
[video credits: DukeMedicine via YouTube]
image 1: Virtual arm
image 2: exoskeleton
video: BMBI

A new study shows that brain stents add no benefit to stroke patients treated with drugs alone, and they actually increase the risk of death and subsequent strokes.

Brain stents are the latest in treatments for victims of stroke. Cutting edge medicine, they’ve steadily increased in popularity in recent years. Too bad they not only don’t work, but make matters worse.

A stroke occurs when the blood supply to part of the brain is cut off or critically reduced. Brain cells deprived of oxygen and nutrients begin to die within minutes. One way the blood supply can be cut off is if the blood vessel narrows too much for blood to pass. A major health risk following a stroke caused in this manner is yet another stroke in the same region as the first stroke. To prevent another stroke from occurring, doctors have been increasingly using stents to keep the artery open. Every year about 90,000 Americans suffer the kind of stroke that the stents are designed to prevent.

Boston Scientific’s Gateway-Wingspan stent system was approved by the FDA in August of 2005. A catheter on the device is inserted into the blood vessel and inflated to open the blockage. The stent, a metal mesh in the shape of a tube, is moved into the inflated catheter and expanded. The stent remains permanently implanted, keeping the artery permanently open and preventing future blockage at that site.

Seems pretty straightforward. The study that won Gateway-Wingspan its approval seemed pretty straightforward too. In retrospect, however, the study is found to be “small” and “less rigorous.” It was pushed through the FDA under the Humanitarian Use Device Exemption, a kind of fast-track to approval for treatments that target a relatively small number of individuals. The incentive to rigorously test these treatments is diminished. As the FDA explains: “A device manufacturer’s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.”

The current trial, thankfully, does not concern itself with market returns. Called SAMMPRIS for Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stentosis trial, it compared the outcome of patients who had recently suffered a stroke and were treated with either a stent and drugs to those who received drugs alone. They began enrolling patients in November of 2008 with plans of evaluating a total of 764 patients. By April 5, 2011, with only 451 patients enrolled, they had seen enough. The analysis at that point showed that the 14.7 percent of the patients with the Gateway-Wingspan stent plus the drugs suffered another stroke or died 30 days after surgery. Meanwhile, only 5.8 percent of the patients who received drugs alone had a stroke or died in that time. The near 2.5 times increased risk for stent patients was substantial enough for the SAMMPRIS group to stop the trial.

It’s clear from the study that the brain stent makes matters worse for the patient but it is unclear why. One hint may come from the abnormally high amount of hemorrhaging they saw. Placing stents in the carotid artery – the main artery that delivers blood to the brain – rarely results in hemorrhaging. But almost one-third of the patients with intracranial stents in the current study showed hemorrhaging. The authors speculate that the abnormal amount of bleeding could have caused the recurrent strokes. It also suggests that placing stents in the smaller intracranial blood vessels is simply more technically challenging. Not only are they smaller, but they have many more twists and turns compared to the carotid artery. Placing stents in such a tricky location could cause tearing and dislodge bits of plaque or tissue that could clog a blood vessel elsewhere and cause a stroke.

In addition to saving their lives, avoiding the stent could save patients’ some bucks too. The drug regimen costs about $3,400 for the first year. Adding the Gateway-Wingspan ups the cost an additional $20,000. That’s a lot of money to pay for increased risk of death and more strokes.

“Without the trial, this procedure seemed destined to become the standard of care,” H. Gilbert Welch, a professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice, told the Washington Post. “With it, we have another example in which the best medical care is not the most medical care.”

But that’s assuming the study will have an impact on the treatment and prevention of stroke. Again, seems straightforward, but it’s actually quite complicated.

A damning report of coronary stents had only a temporary affect on the stents' popularity.

As an example, let’s consider the most widely used stents, the ones placed in coronary arteries. Coronary arteries supply blood to the heart. When these arteries are blocked – usually by cholesterol-containing plaques – the heart is deprived of blood, oxygen and nutrients. This leads to chest pain, shortness of breath, or, at worst, a heart attack. The use of coronary stents has exploded since they were first used in the mid-1980s. In 2004, over a million patients received coronary stents. Entitled COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation), a 2007 trial sought to determine if coronary stents with drugs offered more advantages than drugs alone in alleviating chronic chest pain caused by blocked coronary arteries. They found no difference in the outcome of the two groups in regards to death, heart attack, and stroke. It didn’t make matters worse, but it didn’t help either. The published study was called a “blockbuster,” Boston Scientific Corp. who makes the coronary stent saw their stock fall, and doctors saw usage of the stent begin to fall off.

For a time.

One month after the study was published the use of coronary stents in the US decreased by 13 percent. “But as the headlines about COURAGE faded, stentings soon began to rise again, and are now back at peak levels of about one million a year,” reported the Wall Street Journal.

Why would health care providers continue stenting despite the evidence that there’s no added benefit above drugs alone? As you might’ve guessed, it’s all about the money.

William Boden, the cardiologist who led the study, told the WSJ: “Most [cardiologists] haven’t voluntarily incorporated the COURAGE criteria into their practice. What’s going to continue to drive practice is reimbursement.” That is, as long as insurance companies continue to cover the coronary stents, doctors will continue to hand them out like candy. Adding to the inertia are patients with a hankering for the devices. Many doctors argued that suggesting to the patient they should take the drugs first, then implant the stents later if necessary, would only make the patients go seek another doctor who will provide the “best” treatment right now.

An important difference between the SAMMPRIS and COURAGE studies is that the former actually showed the stents to be harmful, compared to treating the stroke patient aggressively with drugs. No doubt, as with the COURAGE study, some doctors will find faults with the study. But we can only hope that, over time, data will trump agenda.

[image credits: Boston Scientific and Wall Street Journal]
image 1: Stent
image 2: Graph

One big happy. Unregulated fertility clinics have allowed the number of half-siblings – such as these three – to grow to groups as large as 150.

Imagine finding out you had a half-sister. You might want to contact her, find out where she lives, what she does for a living, and whether or not she likes sushi.

Now multiply that by 150.

At the same time that artificial insemination is a miracle for so many couples who can’t conceive children, it’s also an example of how slack regulation can lead to unhealthy consequences. The New York Times recently reported that a single sperm donor has fathered 150 children, and his fertile seeds of life are still being used to impregnate more women still.

The Waltons would have needed the show’s entire hour to say goodnight.

This particular cohort is one of the largest to be found on the Web-based registry that tracks children born from specific donor numbers – donor identities are kept anonymous. But more and more there are groups of 50 or more half-siblings.

Cynthia Daily, who’s child is among the group of 150 siblings, told the New York Times, “It’s wild when we see them all together – they all look alike.”

Not only is this strange, it’s worrisome.

What if, for example, the donor had a genetic defect that he’s unwittingly – or worse, wittingly – passing on to all of these children? Logically one might think that fertility clinics would disqualify someone who had, for example, a genetic heart defect. But fertility clinics aren’t thinking logically, they’re thinking with their…um…test tubes. The FDA requires that donors in the US are tested for “communicable disease agents and diseases.” Screening includes a medical history interview and tests for infectious diseases such as hepatitis and HIV.

How effective is the screening? Just ask Tyler Blackwell. Curious about his biological father, Tyler and his mother located him and sent him a letter suggesting they might meet. They got no response. Later, the donor’s sister contacted Tyler and his mother – not to help Tyler meet his father, but to tell him there was a good chance that he had a genetic heart defect. Tyler’s biological father had almost died at the age of 43 when his aorta ruptured. Two of the man’s brothers have the disorder, as well as his mother. And by the way, the family has a history of a connective tissue disorder called Marfan’s syndrome. Tyler’s biological father had never told the three clinics at which he donated sperm of his genetic conditions. His sperm has been used to father at least 24 children, yet he was never required to update his medical history with the clinics.

Three half-siblings pictured with their mothers.

“It didn’t occur to anyone to tell us.”
A much more egregious example recently occurred in the Netherlands. A man with Asperger’s Syndrome, a mild form of autism that affects a person’s ability to socialize and communicate effectively with others, was able to donate sperm by lying to a clinic. After telling the clinic that he was perfectly healthy, his sperm was used for 18 months to father at least 22 children. Some of the children are already showing signs of autism. The man had also been previously treated for depression, which is also thought to have a strong genetic component. Inexplicably, the man is still at large and he’s still finding women who will use his sperm for artificial insemination or even by having intercourse with him.

The above examples illustrate the need for better monitoring and more comprehensive regulations. The US has been slow to adopt regulations. While Britain, France, Sweden, and other countries set limits to how many children a single donor can father, no such limit exists in the US. “We have more rules that go into place when you buy a used car than when you buy sperm,” Debora L. Spar, president of Barnard College and author of “The Baby Business: How Money, Science and Politics Drive the Commerce of Conception” told the New York Times.

Because there is no formal registry from which donor offspring can get information or make connections, a Donor Sibling Registry was created by and for the donor-conceived community. Half-siblings that share a mutual desire to make a connection can find each other through the registry. The registry can also potentially be a lifesaver by connecting offspring with their donors, thus giving them access to medical information that fertility clinics can’t be bothered to collect. “There are no rules or regulations about donor identification, testing donors, monitoring numbers of children or medical records.” Wendy Kramer, co-founder of the registry told ABC News. “No one is watching. There are no laws. They don’t keep track.”

Genetic diseases aside, how wise is it to alter the gene pool so rapidly and disproportionately as when fathering 150 children or more? Rare diseases could spread, and then there’s the increased likelihood of accidental incest. As a mother of a donor-conceived teenager told the New York Times, “My daughter knows her donor’s number for this very reason. She’s been in school with numerous kids who were born through donors. She’s had crushes on boys who are donor children.”

Given the industry’s lack of regulation, it’s not surprising that we don’t really know how many children from sperm donors are born per year in the US. Estimates range from 30,000 to 60,000. Although sperm banks ask mothers of donor children to report when a child is born, only about 20 to 40 percent of mothers do.

When Louise Brown became the first baby born using in vitro fertilization back in 1978, the British government charged a committee with the task of recommending regulations for what was sure to become a big international industry. What they produced was called the Warnock Report, named after the philosopher who led the group. The report recommended limiting the number of children a donor father could have to 10. The New York Times points out that “the regulations have become a model for industry practices in other countries.”

Obviously, the US is not one of them.

[image credits: CBC and MSNBC]
image 1: children
image 2: with mothers

New study shows that middle-aged women can improve health in the decades to come by drinking regularly – but moderately.

A new study finds that middle-aged women who regularly drink moderate amounts of alcohol are healthier when they’re older, compared to those who drink heavily or drink very little. It’s yet another study that supports the idea that a drink a day will keep the doctors away, but we have to ask once again if the health benefits come from the [drink itself or other factors.]

Regularly drinking high quantities of alcohol is detrimental to health. But a number of studies in recent years has shown that, when compared to heavy or no alcohol consumption, drinking in moderation can reduce the risk for heart disease, type 2 diabetes, and decline in cognitive function. Moderate drinkers also stand a lesser chance of dying in general, compared to heavy drinkers and those that simply don’t touch the stuff.

Researchers at the Harvard School of Public health wanted to extend these studies by taking a look at how moderate drinking affects overall health among aging populations. Because chronic conditions develop over time, the researchers argue, it is important to identify factors earlier in life that contribute to health later on.

The Nurses’ Health Studies are a series of long term studies in which the health of white registered nurses in the US is monitored with periodic completions of detailed health-related questionnaires. The first study began in 1976 to investigate the effects of long term oral contraceptive use. The study sought to draw links between health and diet, and so questionnaires included questions about food frequency, including wine consumption. Important factors such as whether or not they smoked, and whether or not they had a family history of heart disease or diabetes was also gotten from the questionnaires. The Harvard researchers were able to mine the Nurses’ Health Studies data for the alcohol consumption assessment of about 14,000 female registered nurses who made it to age 70.

Why moderate amounts of alcohol are beneficial to health remains a mystery.

In the US, one “drink” contains about 15 g of alcohol – a can of beer or a small glass of wine. For women, moderate consumption is one drink per day; for men it’s two. And heavy drinkers are those who average more. The researchers formed two groups: those who drank moderately in their late 50s and those who rarely or never drank. They then assessed the groups’ chances for “successful aging” to age 70. They define this enviable-sounding term as having avoided major diseases such as cancer, diabetes, and cardiovascular disease, as well as avoiding major physical or cognitive decline.

Compared with nondrinking teetotalers, women who averaged one-third to one drink per day in their late 50s had about a 20 percent higher chance of successful aging.

Their criteria sounds like something we would all hope to attain. What they called “successful aging” is reaching age 70 and “being free of 11 major chronic diseases and having no major cognitive impairment, physical impairment, or mental health limitations.” Just less than 11 percent of the study group attained successful aging. What’s more, regardless of total alcohol consumption, women who drank regularly fared better than women who drank occasionally. Those who drank 5 to 7 days a week had a 50 percent better chance of successful aging to age 70 than those who drank one or two days a week. This makes sense. It’s probably healthier to average 7 drinks per week if you’re drinking Monday thru Sunday, rather than reaching the average on Saturday and Sunday alone. As you are probably already aware, binge drinking – 4 or more drinks on occasion for women, 5 or more for men – is not so healthy, increasing the risk of certain types of cancer, contributing to depression, and often behind fatal traffic accidents.

A fair question to ask is whether or not moderate amounts of alcohol are really good for you, or is the better health due to, say, a more relaxed lifestyle, a more affluent lifestyle, better education, or drinking Bordeaux instead of Boone’s Farm. The authors of the study used statistical tools to control for a great number of would-be confounding variables. Age, smoking status, weight, amount of physical activity, diet, marital status, education – even husband’s education – and family history of several diseases are some of the variables they took into account (One would have to assume that the relative benefits of Bordeaux and Boone’s Farm were beyond the scope of the study).

Exactly what it is in a regular and small glass of wine that is beneficial to our health, no one can say. The much touted benefits of reservatrol remain controversial. But experimental data continues to establish that moderate alcohol intake is beneficial to multiple injurious processes such as insulin resistance and inflammation.

Despite the good news for those who like a drop of vino seven times a week on average, the authors don’t intend to send the message: If you want to be healthy, start drinking. “If you are physically active, if you have a healthy body weight at midlife, you can have much better odds of achieving successful aging,” Qi Sun, lead author of the study told Health Magazine. “You don’t have to use moderate alcohol consumption as a way to help achieve healthy aging.”

[image credit: For Ladies By Ladies and ABC of Wine]
image 1: Cheers
image 2: Healthy