USA Today had an article on the annual meeting of the Society for Neuroscience and reported on encouraging findings scientists have discovered using two types of brain scanning techniques to detect mild traumatic brain injury. Researchers at the University of California in San Diego combined MEG (magnetoencephalography) and DTI (diffusion tensor imaging) to detect brain injury that the traditional MRI (magnetic resonance imaging) and CT had missed. Researchers at the University of Miami used MRSI (magnetic resonance spectroscopic imaging) which is a whole-brain method and is an advanced type of MRI t hat creates images from hundreds of voxels which are three-dimensional units of brain tissue. The MRSI detected widespread damage that sometimes fails to present itself in conventional brain scans. These latest technologies bode well for future victims of mild traumatic brain injury and TBI while the findings are encouraging.

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For families and patients who undergo hospitalization or medical treatment it is often difficult for them to receive their medical records once requested of the institution. In many cases the failure of the medical institution to produce the requested records delays the ability of the family to file any negligence lawsuit because of an imposed statute of limitations. It can be difficult to obtain medical records from hospitals and other treatment facilities after something goes wrong. Under federal law, every patient or a designated representative has the right to see and copy the patient's medical records. However, missing or disputed records are the most common source of complaints on USA TODAY's Patient Safety website (patient safety.usatoday.com), which was created in 2006 to give readers a venue to express concerns about inadequate medical care. Sidney Wolfe, a physician who leads the health research group at the non-profit consumer advocacy group, Public Citizen says, “there is essentially a double standard” when it comes to accessing medical records. When doctors or hospitals request medical records of their patients they usually get them however, “If it's just the patient who wants the records or the patient's family if the patient died, it's a whole different story,” Wolfe said. Harry Rhodes, a spokesman for the American Health Information Management Association, says most cases of missing records are honest omissions. The federal law that gives patients and family members access to medical records is the privacy section of the Health Information Portability and Accountability Act. HIPAA allows health care providers to withhold records in some circumstances, as long as they explain why they are doing so. Examples of records that may be withheld are psychiatric documents and documents generated in preparation for a legal action.

Posted by Kerry N. Jardine at 12:51 PM | Permalink | Comments (0) | TrackBacks (0)

For parents with an attention deficit hyperactivity disorder (ADHD) affected child or an adult diagnosed with ADHD a link has been found between traumatic brain injury and the incidence of ADHD. Although, researchers stress that an early head injury does not cause ADHD, but instead is associated with a subsequent diagnosis of ADHD. Researchers believe the risky behaviors undertaken by those with ADHD put them in a category of increased risk of traumatic brain injury. Professor Heather T Keenan of the Department of Pediatrics, University of Utah and colleagues reported their findings and published them on bmj.com. Her team studied children who had suffered a head injury prior to two years of age. What they found was those who had suffered a head injury nearly doubled the likelihood of receiving an ADHD diagnosis later in life. In an accompanying editorial, consultant child and adolescent psychiatrist Morris Zwi suggests that this research “strengthens the hypothesis that the ADHD core symptoms of excessive inattention, hyperactivity, and impulsivity might be key factors associated with an increased rate of injury. Primary care clinicians should assess children with injuries for symptoms of ADHD and continue to monitor them over time,” concluded Zwi.

Posted by Kerry N. Jardine at 09:49 PM | Permalink | Comments (0) | TrackBacks (0)

A family has filed a lawsuit against a swimming pool for inadequate lifeguard cover when their 7-year-old son nearly drowned leaving him with a “catastrophic brain injury.” Chad Mole was found lifeless with blue lips on October 18, 2005. He was revived but suffered a severe hypopoxic brain injury that has left him severely disabled. An inquiry was made under a Health and Safety Act that subsequently brought a charge to the owners and operators of the swimming pool. Attorney for the family claim the pool’s owners failed to ensure that Chad was kept safe by the lack of oversight and lifeguard coverage. In an opening statement the attorney told the jury, “The case you are about to hear concerns a very near drowning at Trecco Bay. It was caused, the Crown say, in simple terms by this company not having a proper system of work, not having sufficient lifeguards on duty, not having lifeguards clearly observing these people and not having a system where people would react properly when they saw a young boy in a dangerous part of the pool. As a result of that failure, we say that young Chad Mole, seven years of age, very, very nearly drowned. His life was saved but he will forever have a catastrophic brain injury which has severely disabled him.”

Posted by Kerry N. Jardine at 08:39 AM | Permalink | Comments (0) | TrackBacks (0)

The ETHEX Corporation is further expanding its drug recall initiated in late October. At that time ETHEX had voluntarily recalled 3 lots of their Dextroamphetamine Sufate 5 mg tablets due to oversized tablets made in the manufacturing process. They are now expanding the recall to include 5 further lots of generic products including:

Propafenone HCl Tablets - 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets – 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets - 15 mg
Morphine Sulfate Immediate Release Tablets - 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets - 10 mg

Overdoses of the above listed drugs can have serious or life-threatening consequences. Propafenone can cause an irregular heart beat and low blood pressure. Isosorbide Mononitrate can cause fainting and low blood pressure. Morphine Sulfate includes a difficulty or the inability to breathe and low blood pressure. Dextroamphetamine Sulfate can cause rapid heart rate and high blood pressure. The lots involved in the recall were all shipped prior to May 22, 2008. ETHEX has asked wholesalers and retailers who have received the recalled inventory to contact its customers who were given the drugs informing them of the dangers and recall. The U.S. Food and Drug Administration is encouraging consumers who experience any adverse reactions should contact their physician and/or healthcare provider immediately.

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The U.S. Food and Drug Administration has issued a warning letter to Sun Pharma’s U.S. based subsidiary Caraco in Detriot, Michigan for certain manufacturing deficiencies. The letter was issued as a follow up to the last FDA inspection of the company's manufacturing facility in Detroit initiated in May 2008. This latest suspension is on the heals of a ban imposed on 30 drugs manufactured by another pharmaceutical company, Ranbaxy in India. The FDA is directing Caraco to report what measures it will take to resolve the deficiencies. Until such a time, the FDA has suspended the approval of any drug applications until the issue is resolved. There are 96 abbreviated new drug applications (ANDAs) filed by Sun Pharma awaiting approval, of which 19 have been filed by Caraco. “The FDA has not banned the sale of Sun Pharma drugs in the US, and there was no recall of medicines by the company in the US market,” a company official stated. Sun Pharma and Caraco collaboratively market about 60 products in US. In response, company officials believe, “Any adverse happening in India and China always gets magnified adverse publicity.” Well, when hundreds of thousands of people are put at risk from lack of quality control measures, it tends to worry them. In addition to Ranbaxy, pharmaceutical companies Wockhardt and Granules India received similar warning letters from the US FDA in the past for defects at their facilities.

Posted by Peter W. Burg at 09:35 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration has been informed of a recall of on lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles offered by Tyco Healthcare Group LP (Covidien) due to possible mislabeling. It is believed that if patients use the needles they could receive as much as 2.5 times the intended dose which could lead to hypoglycemia, serious health consequences and even death. The recall applies to Lot Number 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin. The syringes are distributed by Can-Am Care Corp and sold only by Walmart and Sam’s Club stores under the Reli-on name. The mistake was made during the packaging process. The recall includes 4,710 boxes which has a total of 471,000 bad syringes. The manufacturer has received one adverse report related to a syri nge from this product lot.

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A dangerous trend seems to be emerging as legislators and consumer groups pressure the U.S Food and Drug Administration to rethink their decisions on drugs and products. In the case of Wyeth vs. Levine, drug preemption is being considered by the Supreme Court that if found in favor of the drug company, will immunize pharmaceutical companies from lawsuits and give consumers no legal recourse when harmed by an FDA approved drug or product. Most recently a panel of toxicology experts said the FDA did not properly assess the potential health risks posed by the chemical bisphenol A (BPA) found in plastic bottles which some studies have linked to cancer, diabetes, heart disease and developmental delays in children. They further accuse the FDA as relying too heavily on studies funded by the chemical industry in making its decision that BPA posed no health risks. Another example is the detritus left from the Avandia mess. Congress got involved, the press had a heyday and most importantly Glaxo, the manufacturer of Avandia, had not conducted studies that could definitively disprove the allegation that is caused heart attacks. What is the link between these issues? An already overburdened and pressured agency will ultimately have sole responsibility and accountability if a drug or product is found to harm consumers. The immediate threat to the drug industry isn't lawsuits, which big pharma has shown it can beat with their large reserve of funds for such casualties. It's the fact that safety controversies, such as BPA, have demoralized the FDA, made it defensive and made it impossible to get new drugs approved. Bottom line, if preemption increases pressure on the FDA, drug companies would suffer. If drug preemption is approved it could make the FDA more vulnerable to political pressure because the politicians gave the agency the absolute word on drug safety thus the next “miracle” drug may never be approved because of the FDA’s fear. As an afterthought Canada has moved to ban plastic baby bottles containing BPA and several U.S. states are considering restricting its use.

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Paul Martin, 38, takes a drug called Sinemet to help with his Parkinson’s disease. After he picked up his prescription at a supermarket pharmacy he began to suffer symptoms. Within days of receiving his medication he began to have difficulty walking and had involuntary muscles contractions. When his condition significantly deteriorated he checked his prescription and found he was given the wrong tablets with an incorrect dose. He was understandably upset and said, "I could have ended up in hospital and was absolutely fuming when I found out they had given me the wrong tablets. They were in the correct box so I didn't realize until I'd been taking them for four days. This should not have happened and I am considering legal action." Pharmacy errors happen more often than many realize and although the pharmacies have strict processes in place and constant monitoring, mistakes still happen.

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Even as Johnson & Johnson has paid out at least $68.7 million in out-of-court settlements over side effects of the birth control patch Ortho Evra, they still maintain it is a safe alternative for birth control. Over twenty women have died and in excess of 4,000 have filed complaints in state and federal courts claiming Ortho Evra was responsible for and caused deep-vein thrombosis-blood clots in the legs and pulmonary embolisms-blood clots in the lungs. As of mid-October Johnson & Johnson has not released financial records of the settlements to its investors. Gloria Vanderham, a spokesman for Ortho-McNeil Pharmaceutical, Inc., that manufactures the drug for Johnson & Johnson, told Bloomberg.com, “Ortho Evra provides a needed birth-control option for women and physicians. When used according to the FDA- approved label, Ortho Evra is a safe and effective method of hormonal birth control.” However, in 2005, after investigations by the US Food & Drug Administration, the company was told to update its product label to say that Ortho Evra exposes women to 60 percent more estrogen than the typical birth-control pill and that higher estrogen increases side effects. In 2006, a federal drug safety report “indicate that in 2004 when 800,000 women were on the patch the risk of dying or suffering a survivable blood clot while using the device was about three times higher than while using birth control pills.” It is still touted as a safe alternative by the drug company.

Posted by Seth A. Katz at 09:17 AM | Permalink | Comments (0) | TrackBacks (0)

Our northern neighbors in Toronto has published a study reporting that more than half of the homeless population have suffered a traumatic brain injury and approximately 70% of the injuries occurred before they became homeless. The study was published in the Canadian Medical Association Journal (CMAJ) and is currently the largest such study of its kind globally. The researchers interviewed approximately 900 homeless men and women who frequent Toronto homeless shelters. The study results show a 58% incidence rate of brain injury in homeless men, and 48% in homeless women. This rate is 5 times higher than the U.S. average. According to coauthor Dr. Stephen Hwang of the Centre for Research on Inner City Health at St. Michael’s Hospital in Toronto, the fact that a majority of the interviewees sustained traumatic brain injury before they became homeless suggests a causational link.

Posted by Kerry N. Jardine at 08:12 AM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration has posted new information on its site about medications with troubling safety profiles. This was a part of Congress’s mandate to the FDA last year in an attempt to limit medication related adverse events. The list is not to alarm patients, but to empower them with knowledge they can go to their doctor with and seek advice. It is in no way intended to prevent patients from taking the medication their doctor has prescribed. The medications were identified between January and March 2008. Some of the medications listed include: Cymbalta, Heparin and Nitroglycerin. The drugs listed have varying degrees of risk. Cymbalta can cause urinary retention, Heparin can cause allergic reactions, and Nitroglycerin has potential overdosing issues due to labeling confusion. Oxycontin and Dilantin are two on the list of particular interest for headache sufferers. The FDA’s list will be updated quarterly and currently includes 20 different medications. Many of the medications on the list have been a concern for quite a while.

Posted by Kerry N. Jardine at 12:09 PM | Permalink | Comments (0) | TrackBacks (0)

In the most recent issue of Science, Science Daily reports on a study that has found a way to regenerate neurons in brain and spinal cord injuries. There is currently no treatment for spinal cord or brain injury that allows for injured neurons to regenerate. However, a study from Children’s Hospital in Boston researchers temporarily silenced genes that prevent mature neurons from regenerating. The removal of inhibitory molecules from mice allowed for neuronic re-growth. Although this study used genetic techniques, key researcher Zhigang He, PhD, Associate Professor of Neurology at Children's and senior author on the paper, notes that it may be possible to accomplish the same re-growth through pharmacologic means. “This is the first time it has been possible to see such significant regeneration by manipulating single molecules,” says He. “We believe that these findings have opened up the possibility for making small-molecule drugs or developing other approaches to promote axon regeneration.” Kevin Park, PhD, Kai Liu, PhD, Yang Hu, PhD, and Patrice Smith, PhD, all of Children's, share significant authorship of the paper.

Posted by Kerry N. Jardine at 09:06 PM | Permalink | Comments (0) | TrackBacks (0)

After returning from a trip to Spain seven years ago Heather Payne, 62, started complaining about pain in her leg which was cold and discolored. She was diagnosed with deep vein thrombosis. In surgery, doctors inserted a filter in her neck which caused an internal bleed in her neck which blocked her airway causing heart and lung failure. It took 20 minutes to rive her at which time her brain was deprived of oxygen causing an irreversible catastrophic brain injury. Seven years later, Heather is confined to a wheelchair and suffers from memory problems and epilepsy. Her husband Ron had to take early retirement to care for his wife full time. “I’m just being a husband. Forty-one years ago we said our wedding vows in church and promised to love and care for each other in sickness and in health. That’s just what I'm doing, and I know Heather would do the same for me,” said Ron.

Posted by Kerry N. Jardine at 08:02 AM | Permalink | Comments (0) | TrackBacks (0)

The Oklahoma Supreme Court has dismissed a piece of a 2003 lawsuit reform calling in unconstitutional. The original measure required plaintiffs to give the defendants notice within 180 days of the alleged medical malpractice or have their case dismissed. In other types of lawsuits plaintiffs who fail to notify the defendant within 180 days still can have their case heard before it is dismissed. Whereas, this particular measure singled out medical negligence plaintiffs. In the ruling filed the Supreme Court states the law “denies such plaintiffs prior notice of dismissal proceedings while the ordinary plaintiff receives notice and an opportunity to be heard prior to any dismissal.” The court said the requirement violated the Oklahoma Constitution's ban on special laws because it puts medical negligence cases in a separate class from all other negligence claims.

Posted by Scott J. Eldredge at 12:57 PM | Permalink | Comments (0) | TrackBacks (0)

Diffusion tensor imaging, an advanced form of MRI, is being used by researchers at Weill Cornell Medical College and University of California at San Francisco in studying brains that have undergone a mild traumatic brain injury such as concussion. Often when a patient comes into a hospital after suffering a concussion they undergo a CT or MRI scan and then a basic neurological exam to determine damage. Most are sent home and many patients continue to report symptoms weeks and months later such as loss of concentration or memory loss. What sets the DTI apart is it allows experts to view the microscopic motion of water molecules within the brain’s tissue that connects and allows communication between different brain centers, known as white matter. The research group found that brain injury was visible using DTI in patients’ memory and attention centers of the brain. Further they identified two white matter areas, one associated with attention and the other memory. The research team believes these finding might be the first step toward clinical trials that will determine whether DTI will be effective in early and accurate diagnosis in patients afflicted with a TBI.

Posted by Kerry N. Jardine at 08:44 AM | Permalink | Comments (0) | TrackBacks (0)

For the life of one little boy and his mother things may be looking up. During delivery James Monroe, born in 1995, head was lacerated by a scalpel. Medical professionals attempted to staunch the bleeding for over an hour; he was transferred to another Hospital and was left with a brain injury. More than four years later his mother decided to file a medical malpractice lawsuit. The lower court dismissed the mother’s birth injury suit because of a statute of limitations. However, the statute also allows for malpractice lawsuits involving “brain damage or birth defect, the period of limitations is extended until the child attains 10 years of age.” The Nevada Supreme Court overruled the lower court’s dismissal of the case, indicating that the injury does qualify as brain damage or a birth defect under Nevada law and the case will be allowed to continue.

Posted by Scott J. Eldredge at 04:55 PM | Permalink | Comments (0) | TrackBacks (0)

The same drug that has been misused as a performance enhancer illegally is now at the center of the world’s largest traumatic brain injury study. Erythropoietin or EPO has been used in endurance athletes including some cyclists in the Tour de France, long-distance runners, speed skaters, and cross-country skiers. EPO has been banned by the Tour de France, the Olympics, and other sports organizations. However, a study in Australia hopes to use its red blood cell promotion in accident and assault victims with severe brain damage. Recent discoveries have found the hormone EPO can protect brain cells. Starting next year almost 600 severe traumatic brain injured patients in 42 Australian hospital ERs will be involved in the study usin g a synthetic version of the hormone. Professor Rinaldo Bellomo hopes EPO will work wonders for brain injuries, “If the drug proves to be effective, it could mean the difference between a young man sitting in a nursing home with a tube down their nose and being totally dependent on others . . . or the same young man being perhaps slightly weak down one side or having an uneven gait but being able to catch a train to work and lead an independent near normal life,” he said.

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At 9 months old Terry McGowan was dropped from a two-story apartment and suffered a traumatic brain injury. His TBI was further complicated by an adverse reaction to the smallpox vaccine at 18 months. This young man was dealt a bad hand of cards early in life, but has created an environment that he can operate fairly normal in. McGowan has difficulty paying attention, suffers from depression and impaired short-term memory. At home he uses two large whiteboards to remind him of appointments, phone calls, etc. “Sometimes I have to retrace my steps to make sure there is nothing burning, hanging, or blinking,” he jokes. He has also contracted temporal epilepsy that causes him to suffer seizures ranging from grand-mal e vents to relatively painless ones that happen while he is in mid-conversation. Even with the adjustments he has made in his life while living with a TBI, he still has difficulty with day-to-day activities. “When you have brain injury, you tend to be isolated, depressed and you don’t eat enough,” McGowan said. “It’s hard for people to understand.”

Posted by Kerry N. Jardine at 06:37 PM | Permalink | Comments (0) | TrackBacks (0)

A Utah woman underwent a C-section during birth of her second child and became infected with a flesh eating illness. In an effort to save her life, Lisa Speckmen underwent surgery and lost both legs, her right arm, one of her fingers, several organs, including a hysterectomy, her ovaries and nearly all of her large intestine and gall bladder. She and her husband filed a medical malpractice lawsuit for $16 million against those they felt were responsible. The lawsuit also claimed that Speckmen’s injuries were catastrophic and left her in permanent pain, produced emotional trauma, caused financial distress and “devastatingly” influenced her relationship with her husband and children. The suit further states that the medical staff failed to diagnose and treat obvious indications of infection prior to her delivery. The parties denied any wrongdoing and settled for an undisclosed sum of money bound by a confidentiality agreement.

Posted by Scott J. Eldredge at 12:52 PM | Permalink | Comments (0) | TrackBacks (0)

In 2004 Nevada under pressure from physicians, surgeons, hospitals and insurance company’s passed an amendment advertised as “Keep Our Doctors in Nevada.” This may have confused voters making them feel if they did not pass the amendment that doctors and surgeons would leave the state and place an already burdened medical system under more stress. The malpractice caps and time limitations imposed by the amendment has in fact bound voters in their right to seek legal recourse. One such person is 59-year-old Richard Krikalo who is almost blind because of a botched retina reattachment operation by an eye surgeon. Medical malpractice attorneys informed him that the cost of litigating a medical malpractice suit exceeds the amount limited by the malpractice caps. Even though Mr. Krikalo does not agree with frivolous lawsuits he concedes that compensation should be made for the medical negligence. Krikalo further states what personal injury, medical malpractice and wrongful death litigators across America already know, “There’s hardly any protection for the consumer any more. Now everything is in favor of doctors.”

Posted by Scott J. Eldredge at 08:50 PM | Permalink | Comments (0) | TrackBacks (0)

A ground-breaking computer system has been created for victims of traumatic brain injuries who are unable to speak or move. The system devised by computer researcher Dr. Paul Gnanayutham at the University of Portsmouth uses the power of thought and a laptop with sophisticated algorithms. The system uses patients’ brain waves and eye and muscular movements (called bio-potentials) to more a cursor on a computer. In an interview he said, “This technology has been around but very few people have used it for anything worthwhile, I worked with traumatic brain injured participants who were paraplegics, non-verbal and tube fed to give them a voice and the ability to say ‘yes’ or ‘no’ on a computer screen by using their bio-potentials. Learning how to navigate using their facial muscles or brainwaves isn’t easy and can take months. I worked for eight months with one young man who hadn’t communicated after his brain stem was broken in an accident. His mother knew he was ‘there’ and wasn’t giving up on her son but there had been no sign, no movement, nothing until he started using the brain wave system. The system works by attached probes worn around the head that pick up signals from the patient’s body. The signals are then sent to an amplifier that cuts out external noise and then to a serial port so the computer just sees the brain-body interface. The potential for such a system is enormous, but it will be limited to few TBI patients until Dr. Gnanayutham receives more funding. “I want people to be able to use it without doctors and without me. I want to give them their voice back. Only then will it be a real success,” he concluded.

Posted by Kerry N. Jardine at 08:29 AM | Permalink | Comments (0) | TrackBacks (0)

Ersel Allen was diagnosed in 2001 with pancreatic cancer at the University of Mississippi. Doctors there sent her to Hospice Ministries. A month later she died. Now this case doesn’t seem to be much different from other terminal cancer cases that have been handed over to hospice care to help them die comfortably. In Ersel’s case, however, the autopsy showed she never had pancreatic cancer. Instead, she died of a lethal dose of painkillers. Her family predictably sued Hospice Ministries and Dr. William Causey who was the medical director of the hospice at the time of Ersel’s admission and was responsible for patient care. The hospice settled for the maximum $1 million in insurance coverage it carried. In an appeal the Mississippi Supreme Court upheld the $4 million award to Ersel Allen’s family. However, the court threw out the $500,000 award for punitive damages.

Posted by Scott J. Eldredge at 12:05 PM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/brain.htmlBret DeFrancesco suffered multiple injuries in the Iraq war caused by a roadside bomb, including Post Traumatic Stress Disorder but the one he is currently rehabilitating for is his brain injury. DeFrancesco suffered a traumatic brain injury which disrupted his sense of balance. When he jogged he suffered motion sickness and going up and down stairs became a nightmare. As part of his rehabilitation the Fort Lewis soldier attended physical therapy once or twice a week at MultiCare Health System’s Vestibular Balance Clinic in Tacoma, Washington. “These appointments don’t solve everything,” he said during his final visit to the clinic, “but they’re helping a lot.” Karen Perz was his physical therapist. “They say my vertical line – what I consider my vertical line – is canted,” he said “It’s never going to get fixed. You need to retrain your mind.” Perz says treatment requires training the brain to recalibrate its sense of balance. “The brain is hardwired to work as though everything is normal,” she explained. “When something becomes not normal, part of what we do is train the brain to work around so the outcome is normal even though the brain circuitry isn’t normal anymore.” After Perz’s physical therapy some TBI sufferers can completely recover their balance. However, for those who don’t she teaches them drills to practice the rest of their life. “The longer someone works at it,” she said, “the more efficient the brain will become using the information correctly.” DiFrancesco drills included wearing safety goggles with a piece of white paper taped to the front with small eyeholes punched out. Perz would hold up a sign and tell the soldier to focus on a letter, close his eyes, turn his head, open his eyes and see if he could focus on the same letter. Perz called it “relearning where his head is relative to his body.” One exercise, in which he walks forward while moving his head while focusing on a point, is the drill Perz said he “gets to do the rest of his life.” He has come a long way since he first started going to the clinic. He knows that the TBI will affect him the rest of his life, but he is please by the progress he has made. His nausea has decreased considerably since the rehabilitation and he looks forward to getting back to work. He wants to stay in the Army and maybe eventually transfer to an aviation unit. “I know I’ve got work ahead of me,” he said. “I’ve got to keep working at this stuff. I still have PTSD and TBI. But I still feel like I’ve got more I can give.”

Posted by Kerry N. Jardine at 08:00 AM | Permalink | Comments (0) | TrackBacks (0)

a story about doctor becoming patient, neuroradiologist Wade Justice was a victim of a traumatic brain injury caused by a drunk driver. Dr. Wade Justice and his wife were on a scenic Big Island drive 3 ½ years ago when they were hit by a drunk driver. He shared his story at the recent Neurotrauma Conference sponsored by the Brain Injury Association of Hawaii. Dr. Geoffey Manley, chief of neurosurgery at San Francisco General Hospital, told the conference members that the traumatic brain injury classification of mild, moderate and severe is outdated and must be changed. It is like saying people have "OK cancer, bad cancer or they're at death's door," he said. Neurotrauma ranges from a concussion to a severe brain injury, "and we still don't understand concussion." At the time of Justice’s accident he was taken to a local hospital with an epidural hematoma. His wife Jill said the doctors did not believe he would last the night and to bring their children from their Washington home to say goodbye. “Wade absolutely would have been dead if we hadn't had a strange coincidence,” she said. “We were able to fly him directly out of Waimea Airport that night.” Normally, he would have been transported to Hilo or Kona, and he would not have survived another 40 minutes, she said. At about midnight a neurosurgeon was able to provide lifesaving surgery, but he remained comatose for another month and nearly died three more times. After being transported from hospital to hospital, Justice was finally flown to Craig Hospital in Denver for an assessment and rehabilitation plan. At one point after the accident when he could not walk or talk, he said he felt suicidal but decided "I can't just check out on the people I love. I've got to keep trying." Justice underwent extensive occupational, physical and speech therapy and treatment from a neuropsychologist. The traumatic brain injury expectedly has changed their lives forever. Their story is like millions of others. Traumatic brain injury cuts across all classes, races and income levels. It holds no prejudice. They were lucky, but thousands of others are not so fortunate.

Posted by Kerry N. Jardine at 07:58 PM | Permalink | Comments (0) | TrackBacks (0)

One of the little known side effects of Traumatic Brain Injury is spreading depression. Those of us without a brain injury think of this as a change in mood and behavior, but what TBI victims are facing is depression in the brain. When the brain is injured traumatically by a blunt force trauma or shearing “spreading depression” refers to the shutting down of electrical activity in the brain. According to Dr. Jed Hartings, a neuroscientist and U.S. Army veteran, the “spreading depression” occurs in almost every brain injury and, “seems to impact gene expression, blood flow, metabolism, all of which can be very harmful to the tissue.” Hartings and a group of researchers recently received a $2 million grant from the pentagon to conduct a trial for treatment of “spreading depression” in TBI. As part of the trial, doctors will place tiny electrodes on the surface of the brain to record brain activity post surgery. “Our hypothesis is that spreading depression causes expansion or enlargement of the brain injury, so our ultimate hope is that we can improve patient outcomes, improve the recovery from brain injury, by preventing spreading depression.” The researchers believe that anti-seizure medications could prove useful in stopping this side effect of TBI. Results of the trial are not expected for at least a couple of years.

Posted by Kerry N. Jardine at 09:57 AM | Permalink | Comments (0) | TrackBacks (0)

The non-profit consumer group Public Citizen has petitioned the U.S. Food and Drug Administration to pull the Type 2 diabetes drug Avandia off the market. Over the last two years concerns have arisen about the life-threatening risks associated with the drug including heart and liver damage. Starting in the spring of 2007 the drug had been denounced by a number of medical groups. Last week, the American Diabetes Association and a European counterpart jointly released updated treatment guidelines for doctors that clearly recommended against the use of Avandia. In a medical journal two years ago an article noted a 43 percent higher risk of heart attacks among patients taking Avandia in comparison of those taking other diabetes drugs. “The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities,” Public Citizen said in its petition. “Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.” In response the FDA said it will “carefully review” the petition and will continue to monitor Avandia’s safety record. Although scientists are still debating the link between Avandia and an increase risk of a heart attack, concerns about the medical evidence led to stronger warnings. As a result of the stronger warnings, Avandia use dropped sharply. Public Citizen produced its own evidence finding 14 cases of liver failure of which 12 led to death. Makers of Avandia, GlaxoSmithKline, in a statement, said it does not believe the drug causes liver failure. The company said its own data shows the drug has a good safety record when it comes to liver problems, but said the data on heart attacks is inconclusive and that Avandia is safe and effective.

Posted by Kerry N. Jardine at 06:54 PM | Permalink | Comments (0) | TrackBacks (0)

An alarming 1.5 million harmful medication errors occur annually. The Pharmaceutical Care Management Association (PCMA) released data from a new analysis of federal data by the Institute for Safe Medications that a record number of serious adverse drug reactions and more than 4,800 deaths have been reported to the Food and Drug Administration this year. The Institute of Medicine feels that if physicians use e-prescribing technology a number of the medication errors will decrease. “This new analysis reinforces the Institute of Medicine's (IoM) recommendation that all physicians begin prescribing electronically by 2010 to help prevent the 1.5 million harmful medication errors that occur annually. Securing full physician adoption of e-prescribing as soon as possible is critical to improve safety and quality in our health care system.” PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for more than 210 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D.

Posted by David P. Hersh at 07:51 AM | Permalink | Comments (0) | TrackBacks (0)

A former resident of Colorado was a recipient of a certificate of recognition award from vice presidential candidate and Alaska Governor Sarah Palin for his efforts in raising public awareness of Traumatic Brain Injury. When living in Colorado he suffered a traumatic brain injury as a result of a motorcycle accident shortly after graduating high school. Richard Warrington now lives in Kenai, Alaska. Now at 48 he attributes much of his rehabilitative success to the therapists at Craig Hospital in Denver and to his mother. In 1986 Richard moved to Alaska and learned the state had no support network for survivors of a traumatic brain injury similar to the type of network he depended on in Colorado. As a result he helped start a Kenai Peninsula brain injury support group. “I started giving presentations (on traumatic brain injury) through the Alaska Mental Health Trust campaign in 1996,” said Richard, and at the same time, he and his wife Mary began making the presentations to students in middle schools and high schools around the state. The couple advocates the wearing of helmets when cycling, riding all-terrain vehicles, snow-mobiling and other outdoor recreational activities. Their latest recognition certificate, signed by Governor Sarah Palin, is special. “We were up at the Alaska Brain Injury Network Board meeting (in Anchorage), and they started reading the certificate,” said Richard and unbeknownst to them the presenter announced Richard Warrington. Richard and Mary have also received the educator award from the Alaska Chapter of the American Red Cross in 2004, and were appointed ambassadors by the Brain Injury Association of America in 1996.

Posted by Kerry N. Jardine at 02:48 PM | Permalink | Comments (0) | TrackBacks (0)

An unusual story will be featured on the Discovery Health Channel in the show “Mystery ER” featuring a woman who suffered a traumatic brain injury and developed a foreign accent after a failed chiropractic adjustment. The show features real life medical mysteries using subject interviews and re-enactments of true events. The show will feature CindyLou Romberg who suffered a traumatic brain injury after falling out of the back of a Toyota in 1981 and splitting her head open from front to back. What makes Romberg’s recovery unusual is after a more recent failed chiropractic adjustment she developed a foreign accent described as sounding German, French or Russian and yet she has never studied the languages nor visited the countries. Foreign Accent Syndrome is a rare disorder brought on by neurological damage that affects a person's ability to speak and creates the impression of a foreign accent. Without warning Romberg’s accent changes. Sometimes she can’t remember the name of an object and has to gesture at it. At other times incoherent babbling is spoken. Only 50 or 60 Foreign Accent Syndrome cases have been verified worldwide. Typically, neurological damage generally in the brain's left hemisphere is followed by the inability to use words properly or at all, then a gradual return of speech, albeit altered. Most cases develop within one or two years of the original injury. Jack Ryalls, an expert on neurologically based speech disorders at the University of Central Florida believes the FAS could be a recovery stage, the brain’s way of compensating for lost function by rewiring.

Posted by Kerry N. Jardine at 07:43 AM | Permalink | Comments (0) | TrackBacks (0)

In a frightening trend among defective drug and medical devices, pharmaceutical companies are trying to argue in court cases that if the U.S. Food and Drug Administration approve a drug or medical device then the approval preempts any efforts to seek retribution for victims of companies’ products. In a recent Wall Street Journal article the case of Wyeth v. Levine was cited. Diana Levine lost an arm to gangrene because a nausea drug was improperly administered to her arm. She was a musician by trade and she lost her ability to ply her trade. In her case she argued that the drug maker should have put stronger warnings on the label. A Vermont jury agreed and awarded her $6.7 million in damages. The drug manufacturer appealed saying that the drug’s labeling was approved by the FDA thus overruling state law on issues of product safety. “This case is worth tens of billions to the pharmaceutical industry,” said Richard Rubin, Ms. Levine's lawyer. In January, the Supreme Court ruled in favor of pre-emption in a medical-device case involving Medtronic Inc. of Minneapolis. If pre-emption is upheld than drug makers will be given a firmer footing in many lawsuits. Johnson & Johnson has so far paid $68 million to settle cases involving its Ortho Evra contraceptive patch. Settlements over the anti-psychotic drug Zyprexa have cost Eli Lilly & Co. more than $1 billion. Merck & Co.'s Vioxx has cost them $4 billion so far, and Wyeth's fen-phen-related diet pills have reached $20 billion. Consumer advocacy groups argue otherwise. They say patients’ right to sue is the only deterrent to corporate irresponsibility and deceit and argue that the FDA makes mistakes and companies hide information. This is a dangerous trend and if preemption is upheld legal recourse would be almost non-existant.

Posted by Kerry N. Jardine at 06:38 PM | Permalink | Comments (0) | TrackBacks (0)

In an effort to protect young women from HPV (human papalloma virus) the vaccine Gardisil was created to guard against the virus linked to cervical cancer in women. However, the National Vaccine Information Center is concerned of the side effects experienced by the young women who elect to be vaccinated against HPV. In 2006, the NVIC questioned the efficacy of Merck’s pre-license Gardisil vaccine safety data for girls under age 16. In 2007 they made three reports analyzing serious adverse events experienced and reported to the federal Vaccine Adverse Event Reporting System (VAERS). In 2008 about 20 percent of all vaccine adverse event reports to VAERS were related to Gardisil. Such adverse events include some experiencing paralysis and 27 deaths that have been reported as a result of the vaccine. However, the Centers for Disease Control and the U.S. Food and Drug Administration are alleging that the 9,000 HPV vaccine adverse events are not related to the Gardisil vaccine based on an internal analysis. Now the VAERS are calling on the CDC and the FDA to publicly release the argumentative data showing Gardisil is safe with no serious side effects. “Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime - some of them paralyzed or dead within hours or days of getting Gardasil vaccine - deserve better answers than a whitewashing of this vaccine's very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.” NVIC was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination. http://www.nvic.org

Posted by Kerry N. Jardine at 09:35 AM | Permalink | Comments (0) | TrackBacks (0)