Posts Tagged ‘Medical Research’

Autism and Wandering – a constant struggle

Wednesday, August 3rd, 2011

I have written before in this space about special needs children, including children with autism. This week I want to turn my attention to one aspect of autism – wandering – and some of the ways parents and schools are trying to keep kids safe. Wandering is something I really had not heard of before, but I’ve since learned that it is a serious danger to children with autism or other cognitive deficits. It is also a major source of stress to parents who are constantly worried about their child wandering off.

All children have a tendency to wander away from their parents at times. When my daughter was two, I lost her at Sports Authority. I thought she was standing right next to me while I was looking at something, then I looked down and she was gone. After a few frantic minutes – and with the quick help of the store employees – we found her all the way on the opposite side of the store looking at balls. She was perfectly fine, but it was terrifying for me.

For reasons that are not well understood, children with Autism Spectrum Disorder (ASD) tend to wander more than non-autistic children. As reported by the Child Mind Institute and others, a recent study by the Interactive Autism Network has finally tried to quantify what has traditionally been more anecdotal evidence about wandering.

According to the responses from more than 800 parents, roughly 50 percent of children between the ages of 4 and 10 with an ASD wander at some point, four times more than their unaffected siblings. The behavior peaks at 4, almost four times higher than their unaffected siblings, but almost 30 percent of kids with an ASD between the ages of 7 and 10 are still eloping, eight times more than their unaffected brothers and sisters.

Autistic children seem to wander for two basic reasons. One is to find something they like, such as their favorite pond or playground; and one is to get away from something they don’t like such as a stressful school environment. It’s not really running away, at least as that term is usually used to describe a child who decides to leave home because of some real or perceived injustice at home. A majority of parents in the study described their child as happy and focused when they wandered off. It is usually a matter of the child being drawn to something that he or she likes. One child referenced in the Child Mind story had a fascination with exit signs. One day at school, the boy wandered off through the woods toward the highway to find his favorite exit sign. Thankfully, a good Samaritan picked-up the boy and returned him to where he belonged.

The danger for children is very real. While concrete statistics are difficult to come by, drowning seems to be the biggest danger (there are some who believe that autistic children are drawn to water). Children can also wander into traffic. Of course, when any small child wanders alone there is the risk of getting lost or being abducted. To further complicate matters, thirty-five percent of families in the study reported that their child is never or rarely able to communicate basic identifying information such as name, address and phone number. This obviously makes it harder for a wandering child to get back home. Even older or more high-functioning children may – due to their social anxiety – be reluctant to seek out help or cooperate with someone who is trying to intervene.

Wandering represents a challenge to schools because it can be very difficult to monitor a child all day long, especially during class changes and recess. The problem, however, also occurs at home. Wandering occurs not just during the day; night-time wandering is an especially big fear for parents of autistic children. Some children have been known to get up in the middle of the night, undo the deadbolt on the front door, and walk-off into the night. The terror of finding your child gone in the middle of the night is unimaginable. Some parents have installed deadbolts higher up on the doors, some have installed alarms that go off if the door is opened. Some parents have gone so far as to have their children wear tracking devices that send out a signal that can be pin-pointed. While all of these techniques can help, there are no sure-fire methods of preventing wandering. It is a constant worry for parents.

The autism community has taken action by getting the Center for Disease Control’s safety subcommittee to assign a specific medical code for wandering, which will be in conjunction with the diagnosis of ASD. By doing this, it is hoped that doctors will more readily recognize wandering as a legitimate diagnosis that they can address with the parents or other caregivers (the new code applies to adults with ASD as well). The American Academy of Pediatrics is also preparing a fact sheet to educate doctors on the topic so that they can better work with parents to try to reduce the incidence of wandering. The new code may also make it easier for parents to seek reimbursement from their insurance companies for alarms and tracking devices, and it may make it easier for parents to argue to their schools that a one-on-one monitor is needed as part of the child’s Individualized Education Plan (IEP). The new code takes effect in October 2011.

Lori McIlwain, Chairwoman of the National Autism Association, recently discussed how to deal with wandering:

The best overall strategy is a multi-tiered approach, which includes educating the child about safety and dangers using whatever means of communication works, including social stories, language and/or visual prompts. It’s also important that caregivers—and schools—work to understand what is causing, or contributing to, the wandering or bolting behaviors so that any triggers may be addressed or eliminated.

Have any of our readers had any experience with wandering? I’d like to hear your stories as to how you deal with it and how it affects your life.

Related Nash and Associates Links:

Dogs a Huge Help to Special Needs Kids

The Daily Struggle of Raising a Disabled Child

Many Parents Still Believe Vaccines Cause Autism

 

 

Photo courtesy of: Issueswithautism.com

Coming Soon? Restored Breathing for Spinal Cord Injury Patients

Wednesday, July 20th, 2011

image from msstrength.com

The online version of the journal Nature publishes an article today about a potential breakthrough in the treatment of spinal cord patients. While I do not have access to the full article, medicalnewstoday.com provides an overview of the research work. The highlight is that the researchers from Case Western Reserve University School of Medicine were able to restore breathing in rodents with spinal cord injuries.

This research provides optimism for similar success in humans (clinical trials with humans are hopefully forthcoming). In the recently released studies, the scientists combined “…an old technology a peripheral nerve graft, and a new technology an enzyme” to be able to restore 80-100% of breathing function in the rodents.

Using a graft from the sciatic nerve, surgeons have been able to restore function to damaged peripheral nerves in the arms or legs for 100 years. But, they’ve had little or no success in using a graft on the spinal cord. Nearly 20 years ago, [Jerry Silver, professor of neurosciences at Case Western Reserve and senior author,] found that after a spinal injury, a structural component of cartilage, called chondroitin sulfate proteoglycans, was present and involved in the scarring that prevents axons from regenerating and reconnecting. Silver knew that the bacteria Proteus vulgaris produced an enzyme called Chondroitinase ABC, which could break down such structures. In previous testing, he found that the enzyme clips the inhibitory sugary branches of proteoglycans, essentially opening routes for nerves to grow through.

In this study, the researchers used a section of peripheral nerve to bridge a spinal cord injury at the second cervical level, which had paralyzed one-half of the diaphragm. They then injected Chondroitinase ABC. The enzyme opens passageways through scar tissue formed at the insertion site and promotes neuron growth and plasticity. Within the graft, Schwann cells, which provide structural support and protection to peripheral nerves, guide and support the long-distance regeneration of the severed spinal nerves. Nearly 3,000 severed nerves entered the bridge and 400 to 500 nerves grew out the other side, near disconnected motor neurons that control the diaphragm. There, Chondroitinase ABC prevented scarring from blocking continued growth and reinnervation.

“All the nerves hook up with interneurons and somehow unwanted activities are filtered out but signals for breathing come through,” Silver said. “The spinal cord is smart.”

Three months after the procedure, tests recording nerve and muscle activity showed that 80 to more than 100 percent of breathing function was restored. Breathing function was maintained at the same levels six months after treatment”

From medicalnewstoday.com

This could be life-changing for those spinal cord injury patients who currently need ventilators to survive. If human studies prove the efficacy of such treatment, patients would have the hope of being able to breath on their own again. Not only would this dramatically improve these patients’ quality of life, but it would also provide a dramatically improved outcome for these patients. Currently, “[r]estoration of breathing is the top desire of people with upper spinal cord injuries. Respiratory infections, which attack through the ventilators they rely on, are their top killer.”

The BBC is reporting that “[r]esearchers hope to begin trials in humans. They are also investigating whether bladder function can be restored, which can be lost when the lower spine is damaged.”

The CDC’s most recent statistics, which are a few years old, suggest that there are currently about 200,000 people in the United States who are living with spinal cord injuries. This number increases by approximately 12,000-20,000 new patients annually. If some portion of these individuals could be provided hope for breathing on their own and or regaining bladder function, their lives could be dramatically improved.

Related Articles:

Spinal Cord Injury Updates: More Reasons for Optimism?

New Treatment Holds Promise for Patients With Spinal Cord Injuries

New Microchip Promises to Make Life Much Easier for Paraplegic Patients

Can religion make you fat?

Friday, April 1st, 2011

Last week this blog addressed the issue of obesity and the possibility that it could be reduced with breastfeeding. Continuing with the topic of obesity, there is a recent study put out by the American Heart Association (and reported by Medical News Today) that is sure to stir up some controversy. The authors of that study claim there is a link between religious activities during young adulthood and obesity later on in life.  While I am usually reluctant to belittle medical research, this study really has me scratching my head and asking, “Who cares?” Before anyone decides to skip church this weekend, let’s look at the details of the study.

The study was actually a long-term study with a high number of participants, which generally tends to give clearer answers than short-term studies with fewer participants:

The study, involving 32,433 individuals from the longitudinal CARDIA (Coronary Artery Risk Development in Young Adults), aged from 20 to 32 years initially, were monitored for 18 years.

However, even with a high number of participants, I am very leery of the results of this study and what it has to do with our health. In terms of what the study found, the authors claim that “those who attended at least one religious event per week had almost twice the risk of becoming obese between early adulthood and middle age compared to those who had no religious commitments.” As everyone knows, obesity is just one factor that can impact a person’s overall health and life expectancy. As the authors of the study recognize, there are a number of factors that can influence heart health – blood pressure, obesity, smoking status, diabetes, high cholesterol. Obesity was the only factor that appeared to be linked to religious activity. The other factors did not appear to have any link.

Why just obesity? It is impossible to answer. Personally, I have a difficult time understanding any possible link between religious activities and obesity, and the study does not actually answer the question of what it is about religious services that may lead to obesity. They theorize that perhaps church activities tend to be more sedentary (more so than watching television or playing computer games?) or that perhaps it is the church get-togethers that have an abundance of fatty foods. However, sedentary activities and poor food choices permeate our entire society and are not restricted to religious people. So why would religious activity be associated with obesity? The authors don’t say, which leaves a gaping hole on the question of what are we supposed to do with this information. Are the authors suggesting it would be healthier to skip that once-a-week church event?

Recognizing that the study’s claim could be construed that church is causing people to get fat, the authors point out that overall, religious people are quite healthy (is anyone surprised?). Furthermore, the authors don’t actually advocate skipping church to lose weight.

The investigators stress that their study does not prove in any way that going to church, attending mass or other religious services makes you fat.

If that’s the case, then I wonder what is the purpose of reporting the study. Usually a medical study into an aspect of health will carry some recommendation of a behavioral change, e.g., avoid saturated fats, get more Vitamin D, etc. With this religion study, there is no recommendation for a change in behavior and there is no explanation for why religious activity would be problematic in terms of health. So all we’re left with is a possible statistical association with no answers as to why and no call for a change in behavior. Which takes me back to my original thought — who cares? If a study has no answers and no recommendations, then perhaps the study didn’t need to see the light of day.

I would also point out that other studies have looked at the link between religion and health and found that regular religious activity actually improves health and leads to longer life expectancy. However, that study also could not explain the specific reasons for its conclusions. Such studies are notoriously difficult to conduct because they are observational only rather than studies where the researchers can control external factors. There are so many factors that go into one’s overall health that it is difficult to single out any one activity as being blame-worthy, especially one as nebulous as attending a church activity once per week.

One encouraging — if simplistic — aspect of the study is that it may cause some churches to include a message of nutrition and exercise for their congregation. But did we really need a long-term study with thousands of participants to tell us that? We should all eat better and exercise more, regardless of our religious affiliation or preferences.

I would be curious to hear from our readers whether they think this claim has any merit or not, and what the reason for the alleged link may be. And the choir said, Amen! What say you?

 

To breathe or not to breath: Lancet study show chest compressions may be as good as CPR.

Friday, October 15th, 2010

Physician’s First Watch published a summary of an online posting by The Lancet this morning regarding a meta-analysis of outcomes for chest-compression-only versus standard cardiopulmonary resuscitation. This analysis related solely to “out-of-hospital” cardiac arrests.

The author of Physician’s First Watch gives the following summary of the Lancet study:

Researchers combined data from three randomized trials of dispatcher-assisted CPR for adults with out-of-hospital cardiac arrest and found that survival was significantly higher with chest compressions alone than with compressions plus rescue breathing (14% vs. 12%). Analysis of data from seven observational studies, however, found no difference between the methods (these studies did not examine dispatcher-assisted CPR).

The authors conclude: “Emergency medical services dispatch should instruct bystanders to focus on chest-compression–only CPR in adults with out-of hospital cardiac arrest. However, whether chest-compression–only CPR should be recommended for unassisted lay bystander CPR is unclear.”

The readers of our blog, Eye Opener, may recall that we recently did two pieces on automated external defibrillators (AED’s) – one relating to 24,000 defective AED’s, which were the subject of an FDA MedWatch Safety Alert, and the other premised on a reader’s comment to the first posting. It would be most interesting if there was data regarding the effectiveness of these devices versus either chest-compression-only and CPR interventions.

I’m not sure what the intent of The Lancet piece is other than what is listed in its “interpretation” summary:

For adults with out-of-hospital cardiac arrest, instructions to bystanders from emergency medical services dispatch should focus on chest-compression-only CPR.

I just hope that, if I ever find myself in a position of having to attend to someone who has suffered an out-of-hospital cardiac arrest, there is an EMS or someone with ACLS certification standing in the crowd.

Study Revelas New Clues About Chronic Pelvic Pain

Friday, October 8th, 2010

Chronic Pelvic Pain is a non-specific medical condition describing pain in the pelvic region lasting six months or longer.  Many patients diagnosed with chronic pelvic pain don’t know what is causing their pain.  In some patients, this condition is usually indicative of a different disease process. Many other patients report pain, which appears to be unrelated to known disease processes in the pelvic region.

Symptoms of chronic pelvic pain include:  severe and steady pain, intermittent pain,  sharp acute pain, cramping, pressure or heaviness deep within the pelvis, pain with bowel movements, pain with urination, pain during intercourse,  and pain associated with prolonged sitting or standing.

A new study from University of Pennsylvania (Department of Obstetrics and Gynecology) could explain why patients with chronic pelvic pain report symptoms involving multiple organs.  For example, many patients diagnosed with this condition often report bladder pain and bowel pain. In many instances, while physicians may be able to diagnose a specific disease process in one of the organs, they cannot explain the pain associated with the other organ.

According to this new study, the nerves that surround (innervate) an organ don’t just communicate with the brain, they also communicate with the nerves that innervate adjacent organ structures. As such, when a disease process of a particular pelvic organ causes its nerves to send signals to the brain, the same communication is transmitted to the nerves of the adjacent organs, causing them to also react by sending signals to the brain.  This communication between the nerves of adjacent organs is referred to as cross-sensitization.  When this occurs, the brain is simply not able to distinguish which of the two organs is actually subject to a disease process.  Consequently, the brain sends pain signals to both organs, causing the patient to perceive pain with respect to both organs.

As a result, the patient may be experiencing pain associated with a perfectly healthy organ. If you have been diagnosed with chronic pelvic pain and are frustrated because your physician cannot provide you an explanation or diagnosis, you pain could be the result of the cross-sensitization process described above. However, this should never be a forgone conclusion. Make sure that you are properly assessed by a physician.

Bone-Strengthening Drugs and Esophageal Cancer – Potential Link Should Not Be Ignored

Monday, September 6th, 2010

In the last year, there has been considerable debate about the link between bone-strengthening drugs, also known as bisphosphonates, and esophageal cancer. It started last year when the FDA released information regarding nearly two dozen cases of esophageal cancer in patients that have been taking oral bisphosphonates such as Fosamax. According to Diane Wysowski, PhD, the FDA official who first claimed that there may be a link between bisphosphonates and esophageal cancer, the FDA has continued to receive reports of esophageal cancer in patients on bisphosphonates since 2009.

The FDA’s announcement was followed by the release of a research study of more than 80,000 people, which focused on the link between bisphosphonates and esophageal cancer. The study, which was recently published in the Journal of the American Medical Association, claims that the link between bisphosphonates and an increased risk for developing esophageal cancer is insignificant.

“[Researchers] compared the rates of esophageal and stomach cancer in 83,652 people, half of whom had received at least one prescription for oral bisphosphonates in the previous decade. Just over 80% of the participants were women, and the average age was 70. … Eighty-nine and 92 cases of esophageal cancer were reported in the bisphosphonate and control groups, respectively, as were 49 and 57 cases of stomach cancer—a negligible difference.”

The authors conceded, however, that the study was not perfect.  For example, the study lasted for only 4.5 years, an insufficient period of time to measure the risk of esophageal cancer among patients on bisphosphonates.  Researchers were also not able to insure that all of the study participants actually took bisphosphonates as prescribed. Additionally, they did not account for other comorbidities and risk factors that might increase the risk for esophageal cancer.

According to Chris Cardwell, PhD, the study’s lead author: “Our study is the largest to date, but on the basis of our results we cannot rule out small increases in esophageal cancer risk in individuals taking bisphosphonates.”

A more recent study on the same subject was published last week in the British Journal of Medicine.  This study concluded that that there is an increase in the incidence of esophageal cancer among patients who have been taking oral bisphosphonates for several years (ten or more prescriptions or prescriptions over the course of five years).

“Researchers tracked almost 3,000 people with cancer of the esophagus or throat for eight years and compared them with a group of 15,000 people who did not have the disease. All were over age 40. The scientists found that 90 of the cancer patients had been prescribed the bone-building drugs, while 345 people in the larger group were taking the medication.”

According to this latest research study, the normal incidence of esophageal cancer among patients 60-79 who are not on oral bisphosphonates is about one per 1000. In the same age group, researchers found that the incidence of esophageal cancer doubled among those patients that have been on oral bisphosphonates for several years. It is suspected that bisphosphonates cause inflammation of the esophagus that may predisposes the patient to esophageal cancer.

Both of these studies seem to indicate a positive correlation between oral bisphosphonates and esophageal cancer.  Whether or not the correlation is significant is a determination the patient should be making with his or her physician.  The risk for developing esophageal cancer should not be ignored considering the number of people who take oral bisphosphonates on a regular basis. It is estimated that about 10 million women are diagnosed with osteoporosis in the U.S.  In this population, about 4.7 million take oral bisphosphonates on a regular basis.

If you have been taking oral bisphosphonates for five years or longer, discuss the risk of developing esophageal cancer with your physician and explore available alternatives if you are at risk. More important perhaps, be on the lookout for signs and symptoms consistent with esophageal cancer. They include throat, chest and digestive discomfort as well as difficulty swallowing.  If you have these symptoms, consult a physician immediately.

Contributing author: Jon Stefanuca

Drug information found lacking

Thursday, August 19th, 2010

Millions of people take daily or weekly medications for a variety of health concerns.  As we all know, each prescription we get comes with a leaflet or other print-out from the pharmacy that explains what the drug is, how it is to be taken, what the side effects are, etc.  The National Institute of Health and Reuters Health are reporting a new study that raises serious questions as to how useful and effective these leaflets actually are.

Dr. Carole Kimberlin and her colleagues at the University of Florida, Gainesville, studied product leaflets on two common medications:  lisinopril (a blood-pressure medication sold as Prinivil and Zestril) and metformin (a diabetes drug sold as Glucophage and Fortamet).  The study found a “great deal of variance” among the various leaflets, including substantial differences in word count, content, and readability.  The reason for these variances?  Unlike prescription labels, which are subject to strict FDA regulation, the leaflets provided by pharmacies are not.  The FDA only provides recommendations for leaflets.  Private publishing companies actually provide the content for leaflets and the pharmacy then decides what information to put on its leaflet, as well as the format of the leaflet.

The differences found by Dr. Kimberlin were striking.  Word counts on leaflets for the same medication ranged from 30 words to 2,500, with a corresponding difference in the amount of drug content contained on each leaflet.  Only three percent of leaflets for the drug lisinopril met at least 80% of the FDA’s recommendations of usefulness criteria.  Only one leaflet for metformin met this same criteria.  The study also found lacking the amount of information related to drug interactions, i.e., how the medication may react to other drugs the patient is taking.

While the differences in content were significant, the study found that even greater differences existed in readability.  It is up to each pharmacy to format its leaflets so there can be large differences in the size of type, the spacing of the text, and general visual clutter – including store ads or coupons.  All of this can make deciphering these leaflets even more difficult.

In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets’ readability. On average, leaflets from all pharmacies met less than half of the criteria for “comprehensibility/legibility.”  For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.

The bottom line – carefully read the product leaflet that comes with your prescription.  And if you have any concern about the drug’s usage, side-effects, drug interactions, etc., be sure to talk to your pharmacist or doctor directly.  You may not be able to rely on the information contained in the product leaflet.


Cardiac Health: Implantable Cardiac Devices – number of procedures on the rise, but is the technology really there to handle this boom?

Wednesday, May 26th, 2010

It is reported that an estimated 650,000 people in the United States currently have implanted cardiac devices (ICD’s) designed for defibrillation (cardiac electro-shock therapy) or combination defibrillation and heart pacing.  For you  Baby Boomers rounding (or having passed) the 60’s bend, these numbers are expected to grow exponentially.  Cardiovascular Business posted an article on April 20 advising that hospital admissions for implantation of ICD’s increased ten-fold from 1990 to 2005.

This same article was quite alarming in its lack of scientific data on factors that determine the best results.  While it may be comforting to know that several large patient-studies have recently shown that centers performing the greatest numbers of procedures have the lowest rates of procedural complications, it is important to also note that authorities in this area of medicine warn that more data and study are needed on individual operator volume, specialty identification, training, performance and outcomes.

Cardiovascular Business News released a feature on April 20, 2010, citing an article published in 2009 by the Journal of the American Medical Association.  The data suggest that your odds of having procedural complications were greater if the device was implanted by a non-electrophysiologist. In short, does this mean you have better odds with an electrophysiology cardiologist? What about a general cardiologist? Or a thoracic surgeon? The study data apparently did not adjust for underlying health conditions or patients who are more ill. Why not? Are we to assume the latter groups of patients may have merely been more prone to complications? Or do the non-electrophysiologists just have less experience and training in implanting ICD devices? As of this time, Boomers, the medical profession has not published answers to these questions.

Perhaps we should be encouraged that Medicare is requiring implant and performance outcome data. As of June 2009, the agency had collected information on more then 380,000 implants.  Yet almost a year later, with many more procedures entered into that same database, the medical specialty communities are still unable to let us know which are the safest specialists and hospitals performing ICD implant procedures.  Physicians say longer term outcomes are needed.

In the meantime, are Medicare and other payors paying for all procedures regardless of the quality of practitioner or hospital performance?

More alarming, on May 17, 2010, Dr. Westby G. Fisher, a cardiologist at North Shore University Hospital Health System wrote in medcitynews.com that the medical system currently can no longer sustain the volume to maintain the implanted devices safely. He complains that physicians are unable to re-program ICD devices remotely.  Is this true? Due to the growing volume of implanted devices now occurring, technicians with no medical degree are programing patient devices from remote locations with sometimes no documentation or notification to the patient’s physician. Physicians are supposed to be overseeing the process according to Dr. Foster. However, he is of the opinion that due to the high maintenance these devices require, along with the growing number of patients, managing the technology will be of great concern to the boomer population and their physicians.  Once again, how are the pressing issues of quality, safety, and cost going to be timely addressed in this burgeoning aspect of our healthcare?

Finally, perhaps we can be comforted by the recent news release from the Heart Rhythm Society. Apparently, the medical profession had never previously determined parameters on how and when to stop these devices at the end of one’s life.  The study cited a dying patient whose defibrillator went-off  greater than 12 times, causing the patient needless suffering. Several groups of medical societies have now have published a consensus statement outlining ethical and legal issues, a decision-making algorithm for withdrawing/deactivating the device(s), and rights/responsibilities for those physicians who have ethical conflicts. The Heart Rhythm Society is encouraging and educating physicians and patients on what needs to happen in this algorithm for ending ICD-sustained life.

One can only hope that a physician is not placed into a remote call-waiting voicetree for dying boomers when the time comes to deactivate. It’s bad enough that we don’t yet know how to choose the best physician and/or hospital to have these devices implanted. Now there is growing concern that simple but critical issues of maintenance, remote re-programming and the like will get out-of-hand due to the ever increasing volume of these devices being implanted.

Contributor: Sharon M. Stabile

Cerebral Palsy: Cord Blood Stem Cell Research and Treatment in Clinical Trials – Update

Thursday, April 29th, 2010

For those of  you who follow our blogs, you know well that this is a topic of interest for us.  It bears repeating – our job as lawyers is to properly investigate potential claims of malpractice in areas such as cerebral palsy and seek redress for our clients when the evidence demonstrates a connection between birth injuries and medical care, but the much more important topic for our clients and victims of cerebral palsy is in the field of medical research. It is through research efforts – including clinical trials – that this dreaded condition will be ameliorated and hopefully eradicated. Trust me, after practicing law for over 35 years, I’m not worried about job security – the frailties of the human condition will more than suffice to fill our file cabinets with people to help due to the negligence of others.

We have reported previously on various topics involving cord blood and stem cell research as they relate to a number of conditions, including cerebral palsy.  It seems that months have passed since there has been any significant news about two programs underway: one at the Medical College of Georgia and the other at Duke.  Earlier this month, an update came across the social media network via a post by Singularity Hub – Cord Blood Stem Cell Treatment for Cerebral Palsy in Clinical Trial | Singularity Hub.

Here’s our encapsulated version regarding the studies and Singularity Hub’s report.

Photo provided by MSNBC

Duke University

According to the website ClincalTrials.gov, Duke began a clinical therapeutic trial – identifier: NCT00593242 - in January 2008 (estimated completion date of January 2011) whose primary purpose is listed as treatment of newborns with hypoxic ischemic encephalopathy (HIE) – inadequate oxygenation in the perinatal period for purposes of this study – through the controlled “collection, preparation and infusion of a baby’s own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.” For information concerning the inclusion and exclusion criteria for participation in this clinical trial, see the online posting. Essentially, the babies are then to be “followed for neurodevelopmental outcome at 4 – 6 and 9 – 12 months at Duke’s Special Infant Care Clinic. MRI’s will be obtained between postnatal weeks 1 and 4, and, for study purposes at 4 – 6 postnatal months.”

While other aspects of processing and administration are no doubt part of the key components of this project, it is readily apparent that the end-point goal is discovery of an effective treatment of cerebral palsy for the identified neonates in the study and then development of a second stage clinical trial to take such treatment modality to a greater number of potential beneficiaries.

Medical College of Georgia

For detailed information on this study, which began in February of this year, similar information is available through ClinicalTrials.gov under identifier NCT01072370.  This clinical trial investigation has a patient population consisting of children from ages of 2 to 12, “whose parents have saved their infant’s cord blood, who have non-progressive motor disability, and whose parents intend to have a cord blood infusion.”  Again – for full details regarding inclusion and exclusion criteria, see the full online posting.

For those parents who may be interested in determining if their child would qualify to participate, the study is still recruiting participants.  The contact information is also available at this link: Contact: James E Carroll, M.D.     706-721-3371     jcarroll@mcg.edu

Today’s report from Singularity Hub provides some encouraging – albeit anecdotal – news of potential progress.

The anecdotal evidence in support of treating cerebral palsy with cord blood stem cells is astounding. Much of it has actually been been performed at Duke University by one of the investigators in the pilot study: Joanne Kurtzberg. Among those that have been successfully treated at Duke include Ryan Schneider, Maia Friedlander, Chloe Levine, and Dallas Hextell. All had CP or CP-like symptoms and all made remarkable recoveries after cord blood stem cell treatments. Dallas Hextell, who showed improvements just 5 days after his therapy was featured on the Today show (the original report contains video compliments of MSNBC).

In addition to the early good news coming out of these projects, one other lesson is learned – for the time being, the storage of cord blood is an important component for those hoping to participate in such studies – particularly that being conducted at the Medical College of Georgia.  We have earlier reported on this topic as well.  You may want to refer to our early posting for some basic information if you are interested.

Obviously, the implications – if these projects prove to be successful – are far-reaching. The enthusiasm of the participants in these research projects is not limited to them alone. The words of the author, Aaron Saenz, from Singularity Hub somewhat tells it all:

So we have some exciting news for cerebral palsy, and some exciting news for those thinking about cord blood. What about the rest of us? Well the MCG and Duke work has some far reaching implications. Neurological damage, whether it’s caused by oxygen deprivation or some other injury, is one of the most difficult things to heal in the body. Work in animals (like that done by Carroll on rats) show that stem cells can not only help damaged brain cells recover, but they can also replace cells that have died. We may find that stem cells therapies have a wide range of applications for many different forms of brain damage. Kurtzberg is researching many different ways cord blood could be used (autologous or through donors) to treat a variety of conditions. In other words, today stem cells conquer cerebral palsy…tomorrow, the world.

Let’s all hope that Mr. Saenz is a prophet.

Computer May Be Better Than Your Doctor in Providing Information for Obtaining Your Informed Consent

Tuesday, April 13th, 2010

When most people think about medical malpractice, they think about a doctor making a mistake during surgery, or failing to order a necessary test, or making the wrong diagnosis. In other words, a mistake in the actual rendering of medical care. However, a doctor can also be negligent in his or her communications with a patient even before the doctor undertakes the treatment at issue.

Under the law, a doctor is required to explain to the patient the risks, benefits and alternatives of treatment so that the patient can make an informed decision about whether to proceed with treatment. This is called “informed consent” and is a critical step in the process of getting competent medical care.  

While some doctors and hospitals have generic consent forms that you sign before surgery, the actual informed consent process is typically handled by the doctor, usually in the doctor’s office. At this time, the doctor is required to explain the treatment, what it entails, the risks involved (i.e., death, infection, etc.), and whether there are any less  invasive alternatives or other available options for care. If the doctor fails to thoroughly explain these issues, then he or she can be held liable if the patient did not understand the full ramifications of the procedure and suffered injury as a result.

One of the difficulties of informed consent is that it is usually done verbally, and we all know the difficulty of trying to remember all the details when someone is explaining something to us, whether it’s directions to a local store, or how to program a new cell phone. It can be especially difficult in the context of a doctor’s office when the patient is already under stress and is being bombarded with complicated medical terminology. It is not surprising that many patients have little or no recall of the actual risks of treatment that doctors routinely say they explain to their patients.

One method that is currently being explored to improve this process is the use of computer programs to help educate patients. In a new study, researchers at the University of Melbourne and Austin Hospital in Australia tested a computer program in forty patients scheduled to undergo surgery to remove the prostate gland.

The computer program included slides with animations detailing the procedure, its potential complications and the post-surgery recovery. Each slide contained questions for the patient to answer, and he could move on to the next slide only after he gave the correct responses.

Patients were randomly assigned to one of two groups. One group received standard informed consent verbally from their doctor. The second group got to use the computer. The study found that the patients in the computer group scored much higher on test questions about the procedure – 78% correct answers versus 57% in the standard group. Why the difference?

Having patients answer questions helps turn the process into an “education and knowledge tool,” according to Dr. Nathan Lawrentschuk, one of the researchers on the study, which appears in the urology journal BJU International.  It may also allow doctors and nurses to “hone in on areas not understood, rather than assuming our patients understand what we say,” Lawrentschuk told Reuters Health in an email.

We look forward to further advances in this technology so that patients can make informed decisions about their medical treatment. Let us know if you have ever given ‘informed consent’ after being advised of the risks and alternatives by a computer.  We would appreciate you sharing with us how, if at all, that process improved your understanding of the surgery you were about to undergo.