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ADVANCE Discourse: Lab

"Missing Link"
April 7, 2014 1:36 PM by Michael Jones

Type 2 diabetes has been a growing concern in the United States for several years. While the established research has pointed to two specific hormones, glucagon and insulin, as the primary factors leading to the development of the disorder in patients, researchers have discovered a third key player in a recent news release from Johns Hopkins. The Johns Hopkins scientists discovered that Kisspeptin 1 (K1), a hormone typically associated with puberty and fertility, directly influences and interferes with the production of insulin in the pancreas.

“Glucagon and insulin alone never really made complete sense,” said Mehboob Hussain, MD, lead investigator, endocrinologist and metabolism expert at the Johns Hopkins Children’s Center. “There was always something missing and, we feel, kisspeptin 1 is a very good candidate to be that missing part. All of our findings point in this direction.”

According to the release, the general opinion prior to the discovered impact of K1 was that the slow build-up of blood sugar due to elevated levels of glucagon eventually tired out the pancreatic beta cells responsible for insulin secretion. Instead, it seems that, rather than the cells slowly wearing out, high glucagon triggers the production of K1, which targets the cells and suppresses the secretion of insulin, leading to the high blood sugar and low insulin levels associated with the disorder. In experiments with human blood and liver cells and eventually mice, once the Johns Hopkins researchers rendered their livers incapable of producing K1, the levels of insulin and blood sugar returned to normal.

“Our findings suggest that glucagon issues the command, but K1 carries out the orders,” explained Hussain. “And, in [doing so,] it appears to be the very cause of the declining insulin secretion seen in type 2 diabetes.

Additionally, Hussain and his colleagues speculated that the evolution of K1 arose from the need to prevent dramatic decreases in blood sugar during fight-or-flight situations. This research, while still in its preliminary stages, has offered a third key component in the assessment of type 2 diabetes and the possibility of a new method of treatment for the disorder. Rather than treating as needed with the injection of insulin, the disorder could potentially be cured by limiting and even eliminating the production of K1. 

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Stem Cells and Nerve Damage
March 25, 2014 4:27 PM by Michael Jones

Regenerative medicine is a field that seems like something right out of the pages of science fiction. In a recent study from the University of Pittsburgh Medical Center (UPMC), researchers studied the effect -- and subsequent success -- of stem cells derived from human muscle tissue in repairing nerve damage in mice. A UPMC press release detailed the study and speculated on the potential impacts to the healthcare industry given the results of the experiment.

“This study indicates that placing adult, human muscle-derived stem cells at the site of peripheral nerve injury can help heal the lesion,” said Johnny Huard, PHD, senior author and professor of orthopedic surgery, UPMC School of Medicine. “The stem cells were able to make non-neuronal support cells to promote regeneration of damaged nerve fiber.”

According to the release, the study involved creating a quarter-inch defect in the sciatic nerve of test mice and then treating with “cultured human muscle-derived stem/progenitor cells” injected into the damaged nerve. It noted that treatments for peripheral nerve damage have had limited success so far, so the introduction of a successful treatment utilizing regenerative medicine techniques is a promising start -- even if it was only in the preliminary stages of testing. Not only did the treated mice experience full regeneration in the nerve, but the study also found that the mice eventually experienced a restored gait.

“Even 12 weeks after the injury, the regenerated sciatic nerve looked and behaved like a normal nerve,” commented Mitra Lavasani, PHD, assistant professor of orthopedic surgery at the UPMC School of Medicine and author of the study. “This approach has great potential for not only acute nerve injury, but also conditions of chronic damage, such as diabetic neuropathy and multiple sclerosis.”

The ability to heal living organisms simply by using their own biological materials puts modern science in view of fictional pipedreams. The early success of tests incorporating regenerative medicine could potentially make room for uses in healthcare for humans. The press release specified injury repair and the developments of “delivery systems, such as gels,” and a prospective next step in healing larger areas. 

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Advances in Organ Transportation
February 19, 2014 10:18 AM by Michael Jones

For as developed and state-of-the-art as modern medicine has become, the standard practice for organ transportation has a lot of catching up to do. Typically moved from facility to facility in an ice-filled cooler via helicopter or some other form of emergency vehicle, the tissues in organs start to breakdown and the organ becomes unusable after a certain period of time. A recent article from NPR covered a potential breakthrough for the storage and transportation of lung (and possibly heart) transplants. 

“For the first time, the donor lungs can be maintained in a breathing, warm, nourished state during transport,” said Abbass Ardehali,MD , transplant surgeon at the UCLA School of Medicine in the NPR story.

According to the story, the “lung in a box” or Organ Care System “circulates blood through the lungs and pumps oxygen through the lobes.” Essentially, this allows the lungs to continue to function for an extended period of time before being utilized for a transplant.  The company behind the “lung in a box,” TransMedics, is also working on similar technology to keep hearts beating outside the body -- the NPR story even noted that it “keeps a heart warm, pumps blood through it and feeds it nutrients.”  Additionally, the portable nature of the machine allows it to be transported with the organ to ensure better preservation during longer journeys.

“On an annual basis, more than 30 or 40 hearts in Hawaii go unused,” continued Ardehali in the NPR piece. “Because of the distance, these hearts cannot be transported to the mainland.”

Although the technology for the “lung in a box” has not yet been approved by the FDA, the NPR story mentioned trials and studies either underway or in preparation to test the equipment’s effectiveness. Ardehali commented on Hawaii, noting the sometimes extended amounts of time it takes to transport vital donor organs – especially from more extreme distances. Due to these concerns, the benefits of the technology behind the Organ Care System could be substantial for those waiting on transplant lists across the country.  

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Crowdsourcing: Funding Vs. Information
February 13, 2014 2:22 PM by Michael Jones

In a recent post, I covered some unique opportunities presented by crowdfunding for technological advances in areas like molecular diagnostics. While the crowdsourcing mentality can work well in gathering funds for equipment producers, crowdsourcing medical information through sites like Wikipedia can carry more limitations and even dangers. A recent article from NPR opened up discussion on the subject.

“I think that’s the double-edged sword of Wikipedia,” said Amin Azzam, MD, MA, professor of psychiatry at the University of California, in the NPR piece. “Because anyone can edit, we don’t necessarily know the expertise of the people doing the editing. [On] the other hand, the reason it’s so popular is because everyone can contribute.”

The story noted that, according to a January IMS Health Institute study, Wikipedia is “the ‘single leading source’ of healthcare information for both patient and healthcare professionals.” Due to the website being open to the open to public editing, this is not always a benefit and can lead to the circulation of incorrect medical information. According to the article, Azzam teaches a course in which he works with fourth-year medical student to clean up the material available on Wikipedia, editing pages and improving the quality of information.

“It’s not just adding references and not just improving the gaps,” continued Azzam in the NPR piece, “but thinking about how to make it more readable and more digestible for the people that are reading Wikipedia.”

An intriguing side effect of having student edit the pages, as noted both by Azzam, is that they were forced to present the information in a way readers could comprehend. One commenter on the NPR page even took it a step further and wrote, “Med School students editing Wikipedia articles does something else which no one here has commented upon--it just might help the future doctors learn to talk to Patients in a way that the patients can understand,” suggesting that the practice could also potentially improve patient communication.

 

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Crowdfunding MDx
February 5, 2014 4:38 PM by Michael Jones

We’re all familiar with the popularity of crowdfunding websites like Kickstarter for both the largely successful and also the somewhat misguided attempts to gather funding for movies and music videos, but lately a much more serious group has turned to crowdfunding: clinical researchers. In an effort to gain additional funding for its handheld POC DNA test for malaria and drug resistance, tentatively called “Q-POC,” a biotech company based in Newcastle, UK, QuantuMDx Group, decided to turn to internet-based public funding on Indiegogo as of February 12, 2014. A recent video explains the technology as well as the concept of the project.

“Our Crowdfunding campaign is unique,” explained Elaine Warburton, OBE, CEO of QuantuMDx, in a press release. “Not only are we looking for contributors to support this phenomenally worthy cause to help save many hundreds if not thousands of children’s lives, but we’re also offering everyone the chance to leave a lasting legacy in the fight against malaria by contributing their winning ideas to the look and feel of our device and to take part in re-naming it from the current research name of Q-POC.”

According to the press release, the world loses one child per minute due to malaria. The impact of a handheld DNA testing assay without the need for clean water or a stable electricity source could make all the difference in developing nations and countries in need. The funds rasied via Indiegogo will go towards further development and the effort to expand clinical trials for the new technology.

“We have spent years developing our tech and we now have a prototype device that has completed a sample-to-result malaria DNA test in under 15 minutes,” said Jonathan O’Holleran, CSO of QuantuMDx and inventor of their signature handheld assay, in the press release. “Contributions will help take our life-saving device from the lab to the field and directly save lives. We have health workers around the world crying out for our technology and are now receiving the support of major MGOs, we just need help to finalize our development and drive the technology through clinical trials.”

I’ve discussed handheld options and extreme POCT before. In a domestic capacity, similar handheld devices to the “Q-POC,” could potentially change how we care for home-bound patients, while the foreign applications are virtually limitless -- especially in regards to developing nations. For modern clinical laboratories, the addition of a fully mobile, handheld molecular testing device could change the concept of laboratories and expand the reach of modern medicine.

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Sunshine Act on Cloudy Finances
January 29, 2014 3:37 PM by Michael Jones

The implementation of the Affordable Care Act, or ObamaCare, has already seen several new laws and regulatory measures introduced since its implementation, with many more soon to be on the horizon. One of these is the Sunshine Act, a law requiring public disclosure of any financial agreements between healthcare vendors and providers. Recent articles from both the New England Journal of Medicine (NEJM) and Dark Daily discussed the specifics of the new law and the potential impact to those affected in the healthcare industry.

In terms of the specifics, the Sunshine Act became effective on August 21, 2013 and the NEJM story identified all drug or device manufacturers in the US, as well as doctors of medicine, osteopathy, dentistry, podiatry, optometry, chiropractic medicine, physicians and teaching hospitals. In order for an amount to require disclosure, it must be a transaction of at least $10 or more than $100 annually. The law also requires that certain items also be reported, including “cash or a cash equivalent, in-kind items or services, stock, consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel (including the destination), education, research, charitable contributions, royalties or licenses, current or perspective ownership or investment interest, speaker compensation for CME events and grants.”

Additionally, the Dark Daily piece discussed some concerns about the financial disclosure, specifically regarding the strain placed on the relationship between patients and providers. While the impact of financial records being made available online could be substantial for “computer-savvy patients,” there is also concern that availability of this information could jeopardize the trust between patients and physicians, leading patient to ultimately question a doctor’s decisions. The information is set to be published as of September 2014.

“Whether transparency will lead to fewer relationships is really the million dollar question,” commented Daniel Carla, MD, director of the Pew Charitable Trusts Prescription Project, in the Dark Daily piece. “The kinds of relationships that may drop off may well be the most inappropriate relationships.”

The story went on to note that Carla also mentioned the possibly of pharmaceutical companies or medical equipment manufacturers finding new ways to maintain relationships with physicians and clinicians. The NEJM article, on the other hand, examined the purpose of the program: “to provide objective information on the type of financial relationships that exist between manufacturers or GPOs and physicians or hospitals.” Regardless of the predicted changes, the Sunshine Acts stands leave its mark across the healthcare industry.

Apart from its impact on industry vendors, providers and patients, the Dark Daily briefing also noted another area that stands to be affected: the laboratory. According to the Dark Daily article, the impact could be seen by pathologists and laboratory professionals, especially in the case of in vitro diagnostics, manufacturers of which fall under the vendor category of the new law. In the coming future, new policies -- not only federal, but within the companies themselves -- should be taken into account for laboratory professionals. 

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Geisinger Partners with Regeneron Pharmaceuticals
January 21, 2014 11:49 AM by Michael Jones

The influence of genetic sequencing has left its mark across the healthcare industry. In a recent partnership with Pennsylvania’s Geisinger Health System, Regeneron Pharmiceuticals, who recently came out with Eylea for age-related macular degeneration, is looking to take some of the the first substantial steps in making that vision a reality. A recent story from the New York Times detailed the extent of the project.

According to the article, the price of whole genome sequencing has already dropped significantly since it was first announced and continues to do so as more and more advancements are made in the field, it hasn’t quite reached the “$1000 genome” mark yet. As such, the collaboration between Regeneron Pharmiceuticals and Geisinger Health will mainly be focused on patient exomes rather than the entire genome at first. The study, which reflects smaller projects across the country and around the world, will be mutually beneficial to both parties.

 “Scientifically and medically, it’s pretty exciting,” said Leslie G. Biesecker, MD, chief of the genetic disease research branch at the National Human Genome Research Institute, in the New York Times piece. “As far as I’m aware, it’s the largest clinical sequencing undertaking in this country so far by a long shot.”

All patient information used by Regeneron will remain confidential and used for research, while Geisinger will be able to keep the patient data for their own records. The New York Times article continued, noting similar public studies in Britain, Saudi Arabia, and varying health systems across the United States. Additionally, the department of veterans affairs is also planning a large-scale DNA collection as the price of sequencing continues to drop.

Since it was announced over a decade ago, the industry has been expecting a surge of new drugs targeting our genome. The potential Impact of prescriptions that function and work directly with a patient’s DNA stands as a landmark in treatments. As genetic medicine is a field that has been poised to expand rapidly for years, the industry can finally expect to see more genetic-based treatments and medications along with increased testing for patients with the shrinking cost of sequencing options. 

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Multiple Genomes
January 3, 2014 5:34 PM by Michael Jones

The concept of genetic mosaics and chimeras in terms of our individual genomes has come up before, but continued research seems to be confirming the suspicion that there is no one individual genome lately. As I discussed in the last article, “chimera” is a term used to describe “a living thing with several populations of cells with different genetic makeup originating from conception,” while a “mosaic” is “‘the presence of two populations of cells with different genotypes in one individual who has developed from a single fertilized egg.’” According to an article from Dark Daily, the genetic phenomenon might be a little more common than originally thought.

The news briefing from Dark Daily noted recent research studies with results showing a larger volume of the population could possess more than one genome, specifically. In laymen’s terms, this essentially means that, while it was originally thought that DNA from a saliva sample would produce the same genetic results as DNA from cells in other areas of the body, the body is now thought to possibly be home to multiple genomes in those other cells.

“[T]hree years ago, suggesting that there was widespread genetic variation in a single body would have been met with skepticism,” said Alexander E. Urban, PhD, assistant professor of psychiatry, behavioral sciences and genetics at Stanford University School of Medicine, was quoted in the Dark Daily piece. He later continued, “rather than monoliths, our bodies may be mosaics composed of cells whose genomes differ.”

The Dark Daily piece also pointed out possible flaws in past genetic testing -- specifically in the area of forensic science, stating “They use DNA matching to identify criminals or murder victims. Multiple genomes in one person could prove misleading in the identification process.” It also discussed the idea of potentially skewed results for genetic counselors, as differing genomes from differing groups of cells could retain important mutations that might otherwise go overlooked.

As genetic science continues to advance in modern medicine and research, scientists are coming into a greater understanding of the many aspects of our DNA -- and, possibly, the many genomes within our bodies. According to the Dark Daily briefing, “this new knowledge further complicates how genetic testing is used for diagnostic and therapeutic purposes,” but the information obtained by the study of genetic mosaics and chimeras also stands to open whole new doors in research. 

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Emerging PCR trends
December 27, 2013 2:50 PM by Michael Jones

Digital technology is a factor that affects almost every field across the country. Specifically, the implementation of digital counterparts to traditional tests and assays in the clinical testing industry has already started to leave a mark on the field. While the introduction of new techniques is common in the evolving backdrop of the industry, a new digital approach to polymerase chain reaction (PCR) tests is proving to have several benefits over its traditional predecessor.

In a recent news release from Dark Daily, the benefits of digital PCR testing approaches are singled out as a step towards more precise results due to a number of factors. It discussed the high sensitivity delivered by a digital PCR test, noting the test’s ability to “target specific DNA sequences in just one molecule of DNA.” This precision allows the digitalized PCRs to find inconsistencies or variances in mutant alleles, in some cases leading to entirely new assays. An example of this would be the introduction of Microbiome SenseIT bsh test developed by Jorge Ganopolsky, PhD, and his research team for Canada-based Company, Micropharma Limited.

According to the briefing, the test analyzes the amount of the bile salt hydroiase (bsh) gene in samples from the patient’s gut. BSH “produces an enzyme active in the human GI tract that modified bile acid for the benefit of its host,” and low numbers can result in complicated and disorders such as inflammatory bowel disease, irritable bowel syndrome and even Type 2 diabetes. The Microbiome SenseIT bsh test utilizes a droplet-based platform from Bio-Rad, which provides 95% accuracy and a quick turnaround time.

Other, chip-based platforms work by incorporating a disposable chip and separating samples. The briefing continued, pointing out that, “The idea is similar to drop technology in that each DNA partition ideally has one molecule of DNA and detects specific sequences using fluorescence.” Regardless of the technique or platform, digital PCRs single out molecules and target sequences specifically to provide more precision than traditional PCRs without being repeated to amplify the DNA.

According to the briefing, the current limitation of digital PCRs in terms of their application in the industry comes down to making the tool a standard for testing. This could be due to cost and ROI, a lack of familiarity with the instrument or simply a lack of applicability to certain types of research. While there are limitations, the article also noted that “expectations that wide adoption of digital PCR is inevitable. 

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CMS Reconsiders Reimbursement Cap
December 19, 2013 4:49 PM by Michael Jones

Across the country, laboratories and laboratory professionals have been bracing themselves for substantial cuts to Medicare reimbursements planned to move forward in the coming year. According to a press release from ASCP, the proposed cuts would have limited reimbursements for some laboratory tests by up to 80 percent, reducing total revenue by an average of 25 percent for independent labs and 6 percent for pathologists by estimates from the Centers for Medicare and Medicaid Services (CMS). In a recent decision, CMS has decided against the Medicare reimbursement cuts. Despite applauding the choice not to pursue the proposed cuts, ASCP noted additional concerns regarding other pieces of regulation.

Among the concerns regarding the proposed regulatory cuts were going to have a substantial impact on independent laboratories by limiting their reimbursement to the same level of larger facilities like hospitals. In a recent interview with ADVANCE, Steven Kroft, MD, FASCP, professor of pathology at the Medical College of Wisconsin and president of ASCP, commented on the potential impact of capped rates. He pointed out the larger facilities have larger economies of scale and more complex business models to support smaller reimbursements, while smaller laboratories can’t rely on those additional services.

“This ruling would have probably forced a lot of labs out of business -- a lot of local, free-standing laboratories out of business, including some that did fairly niche or esoteric testing that might not be routinely performed in a hospital laboratory and ultimately possibly reduce access or even availability to some of this testing,” explained Kroft.

Additionally, ASCP voiced concerns over a proposal moving forward, which will “bundle reimbursements for specific outpatient pathology and laboratory services rather than paying them separately as is done now” according to the press release. Kroft pointed out that the consequences of this new regulatory measure remain to be seen as it is not yet clear how the policy will be implemented. Along with this, CMS will be moving forward with a large-scale re-evaluation of all clinical laboratory fee schedule codes -- a decision viewed with skepticism in the laboratory industry.

“CMS believes that technological advances will have brought down the unit cost of performing some of these services,” continued Kroft. “And, so, they want to go back and go through every one of these codes and see how much they actually cost currently as opposed to when they were originally created.”

A major cause for concern regarding the initial proposal for the code re-evaluation is the idea that testing had become less expensive over time with the introduction of more advanced technologies with no speculation that it could have also become more costly. According to Kroft, CMS has since acknowledged that the codes could be adjusted up instead of simply down with cuts. Along with reconsidering the possibilities of code re-evaluation, CMS has also allowed the process to be open to public nomination.

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Genetics and Litigation
December 11, 2013 1:16 PM by Michael Jones

In recent months, there has been a lot of litigation and government influence regarding companies offering genetic sequencing services. Following the memorable SCOTUS ruling against Myriad Genetics in June and the company’s subsequent law suit involving Ambry Genetics, the FDA joined in on further regulatory disputes with a cease-and-desist letter to 23andMe in November. A Dark Daily news briefing detailed the specifics of the FDA letter as well as backlash from costumers against 23andME.

According to the briefing, 23andMe received a letter from the FDA about a saliva test being marketed by the company, which claimed to work in a preventative capacity. The letter specified that the company should cease all marketing of the product and respond within 15 days, as the product would be used in a diagnostic capacity and would subsequently require FDA clearance. 23andMe complied and is currently in communication with the FDA.

On top of problems with the FDA, a class action law suit has also been filed against the company by Lisa Casey. According to the Dark Daily piece, Casey voiced concerns about the validity of the test, calling the results “meaningless.” Additionally, the story noted the company’s “hopes to pool the information from millions of customers to eventually create databases that can be mined for medical research.”

“It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database,” said Mark Ankcorn, a San Diego-based attorney who filed in the class action suit on behalf of Casey, in the Dark Daily release. He continued, “I anticipate they are going to fight it and use every available resource they have to deny the claims.”

The news briefing discussed the concept of putting together a genetic database and the impact it could have both on the company putting it together as well as the industry as a whole. With an accessible database, 23andMe could potentially see financial benefits from patenting based on information obtained from their records for example. The news briefing also pointed out that clinical laboratories and pathologists could also benefits from an overall database of genetic information. 

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Lab-On-a-Chip, Round 3
November 29, 2013 3:56 PM by Michael Jones

Now, I’ve already covered the benefits of smaller and smaller computer chips and their impact on the clinical laboratory a few times, but never quite to this degree. The idea of an implanted microchip, monitoring the chemicals in our blood stream and measuring our vitals, has been around for a long time and has even become a reality in the past few years through scientific research. A recent article from Dark Daily detailed the work of researchers at the Swiss Institute of Technology (EPFL), who developed an implantable device that can be linked to a smart phone or tablet to provide warning for potentially life-threatening risks before the patient displays symptoms.

The research team, led by Giovanni De Micheli, PhD, developed an “implantable blood laboratory,” which can be used in patients undergoing chemotherapy and other high risk patients 24/7. At just 14 millimeters, the tiny gadget features five sensors, a radio transmitter, a power delivery system and is covered with an enzyme that allows it to “capture a targeted substance.” According to the story, the EPFL researchers hope to produce a commercially available product in four years.

“It will allow direct and continuous monitoring based on a patient’s individual tolerance, and not on age and weight charts or weekly blood tests,” said De Micheli in the Dark Daily piece.

Despite the positive impact regarding the possible introduction of the new technology, there are both limitations within the system as well as concerns from the clinical laboratory field. One of the main limitations of the technology comes down to a limited window due to the enzymes only lasting roughly 45 days. On the top side, however, the small chip is extremely easy to remove and implant. For the industry as a whole, the article notes that the new technology could end up hindering clinical laboratories in the short term due to its convenient nature, but can also prove to lead to new opportunities in the long-term as clinical laboratories move towards a more virtual model.

The implications of this kind of technology are immeasurable in terms of the future of the clinical testing industry. All the same, healthcare professionals and laboratories are each going to be facing some drastic changes in the realm of technological advancements. The prospect of a clinically available model of this “lab-on-a-chip” stands to create new standards for testing and pathology. 

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A Blessing and a Curse
November 20, 2013 2:29 PM by Michael Jones

Every day, there are unprecedented advances in any number of fields in the healthcare industry. As personalized treatments become the norm, genetic sequencing options allow physicians to understand their patients at the genetic level -- and what could be more personal than that? On top of this, electronic health records (EHR) transfer specific patient information all throughout a facility, providing access for any treating clinician.

In a recent article from NPR, entitled Why a Patient’s Story Matters More Than a Computer Checklist, Regina Harrell, MD, wrote about her experience with her facility’s Meaningful Use program to a surprising effect. Her story detailed an elderly patient with dementia and an arthritic knee, his relationship with his wife, his history and the details surrounding his complications. Contrary to all the benefits of EHR implementation in healthcare organizations, Harrell pointed out some key details of her patient interactions that simply couldn’t be understood via an EHR system.

In her descriptions, Harrell managed to simultaneously sum up meaningful use as both a blessing and a curse. Early on in his dementia, the patient, who was referred to simply as “Mr. Edgars,” would wander off into the woods surrounding his house. Since his knee had started acting up, Mrs Edgars had limited his medication to prevent any more field trips into the forest. Mr. Edgars knew his wife, even experiencing anxiety when she left, and knew his house enough to feel comfortable in it. Apart from that, he didn’t particularly care about much else.

Much to the frustration of Harrell, the details of Mr. Edgars’ life didn’t fit into the EHR criteria. She pointed out that maintaining her electronic records after an appointment took up a substantial portion of her day that could otherwise be used to treat other patients confined to their homes, similar to her experience with students as a teaching physician, who had to be trained on the system when they should have been getting trained on possible patient complications and how to handle these situations.

I’ve spent a lot of time writing about the benefits of personalized medicine and the incorporation of EHRs -- of which there are plenty. In striving to achieve a more patient-specific, shared approach to treatment, however, it will always remain important to understand your patients as people rather than just a chart or record or data sequence. Harrell’s article serves as a reminder of the importance of developing a personal relationship with patients to avoid the impersonal side of personalized medicine. 

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Molecular Manipulation
November 14, 2013 2:37 PM by Michael Jones

Molecular engineering has been a favorite topic for socio-political science fiction writers all over the world. Similarly, the concept of manipulating viruses to fight other infections or disease -- in this case, cancers -- stretches even beyond the ideas of those authors into a whole new territory of treatment options. According to a recent article from Medical News Today, researchers from Purdue University have engineered the Sindbis virus (ESV1) to target cancer cells.

“We have now overcome a major challenge by not only inserting a targeting molecule of our choice, but also successfully stripping the virus of its native entry preferences,” said Richard Kuhn, PhD, Gerald and Edna Mann director of the department of biological sciences at Purdue University. “This was a big step in unlocking the potential of developing this virus into a platform for both targeted drug delivery, where it would sneak drugs inside cancers cells, and oncolytic virotherapy, where the virus itself destroys cancer cells.”

Kuhn and his research team were funded by the National Institutes of Health (NIH). Their experiments used rational design procedures to introduce different factors and agents into the molecular structure of the virus, which allowed them to change its functions as necessary in the fight against cancer cells. According to the story, the researchers added human epidermal growth factors (EGF) to the virus and secured by changing some of the virus’ amino acids. Since cancer cells are already extremely receptive of EGF, the virus is able to slip in as the factors bind to the cells.

“We’ve now reached the point where we can easily change the virus to carry a variety of cargos and to seek out specific types of cells,” continued Kuhn. “We know where and how to add the characteristics we want and eliminate those that we do not.”

ESV1 was the culmination of trial-and-error-style experimenting in which the most effective versions of the virus were then cloned. The story went on to not that, although the virus is effective, it does not replicate well, creating a need for multiple doses during their treatment with slight alterations made with each new dose. Although the new treatment option is still in its experimental testing phases, the potential of fighting cancers from within by utilizing molecular structures is promising for the future of the field. 

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Possible Biomarker for Parkinson's Disease
October 16, 2013 1:45 PM by Michael Jones

Despite the comparatively small amount of information we know about it, Parkinson’s disease is extremely common. A recent article from Medical News Today noted that the neurological disorder affects over a million people in the US and has developed a reputation as being difficult to diagnose. Up until recently, the disease was only caught by physicians following the appearance of more common and telling symptoms like tremors -- by which point, a substantial number of brain cells would have already been destroyed. Fortunately, researchers have started to have some luck after the discovery a protein in the nervous system that could act as a biomarker.

“A reliable biomarker could help doctors in more accurately diagnosing Parkinson’s disease at an earlier stage and thereby offer patients therapies before the disease has progressed,” said Roy Freeman, MBChB, a professor of neurology Harvard Medical School and the director of the Automatic and Peripheral Nerve Laboratory at Beth Israel Deaconess Medical Center (BIDMC), in the story.

In a study from BIDMC, scientists tracked levels of the protein, called alpha-synuclein, finding the increased levels of the protein in the skin of Parkinson’s Patients. Although little is currently known about the role of the protein, the BIDMC researchers “have found it is the main component of the abnormal clumps of protein or Lewy bodies, that form inside the brain cells of people with Parkinson’s disease” (sic.). According to the Medical New Today piece, the study consisted of 20 Parkinson’s patients and 14 “controls matched for age and gender” and demonstrated higher concentrations of alpha-synuclein “in the skin nerves supplying the sweat glands and the pilomotor muscles” of patients with Parkinson’s disease.

“Alpha-synuclein deposition within the skin has the potential to provide a safe, assessable and repeatable biomarker,” continued Freeman in the Medical News Today article.

The success of the BIDMC study could be the first step towards the development of preventative measures, eventually leaving clinical laboratories up to the task of performing the assays essential to diagnosis. Although the presence of increased levels of the protein was successfully linked to Parkinson’s and the severity of the disease, the next step is to establish if the protein could be used as a biomarker for those at risk. 

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