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July 31, 2007

UNM may run no-consent trials of cooling to help with brain trauma

A study proposed by University of New Mexico Hospital could help prove or disprove a theoretical treatment for Traumatic Brain Injury. To do so means anyone injured in or around Albuquerque could become a test subject. When the paramedics come after injury, they can use you to test this medical theory. It involves putting ice packs under the arms and putting you in a bodysuit for 48 hours that induces mild hypothermia. The method has shown promise in reducing complications in traumatic brain injuries in preliminary studies. Elaine Stack, clinical nurse specialist in the UNM Department of Neurosurgery said patients in the study will be unconscious. Hospital staff will try to find a family member to approve or deny the procedure, but the immediacy of the injury means getting consent first is close to impossible.

Doctors have used cooling to help heart attack patients for the past 25 years, and the idea has been around for about 60 years, said Howard Yonas, chairman of neurological surgery and principal investigator for the study. "The brain has to be supplied with nutrients every second," Yonas said. "Just five minutes of no circulation, and the brain's eating itself and dying. But if you cool the body down, for every degree you drop it slows the need for brain nutrition by 10 percent. If you can protect the normal surviving tissue that way while the blood supply is compromised, it's easier to survive.” An earlier, more general study, used patients from a wide age range to test the theory. Overall, the cooling didn't change patient outcomes much, but in the age range of 16-45 the process seemed to help. "In those younger than 45, the severe disability rate went from 76 percent down to 52 percent," Stack continued. Younger children have more complex physiology, which makes it difficult to use them as test subjects. The method likely doesn't work as well in older people because the body has started to decline.


Car Camera Records Accidents as They Happen

Traffic accidents are a daily occurrence, but when they happen how is it determined who pays for the damages? Lately, technology in cars has been getting bad press because of the increasing number of traffic accidents caused by distracted drivers text messaging or talking on mobile phones while driving. Not technology is bad. Japanese drivers are taking extra precautions to ensure they're cleared of any accidents caused by others by mounting a small camera on their windshield called the Clarion DriveEye camera. The camera is constantly recording, but once it senses any forceful emergency braking, 15 seconds of footage is saved before the crash and five seconds after impact. The camera's housing is made of heavy duty magnesium alloy built to survive the deadliest crash. It would be nice if future cars adopt this technology.


GlaxoSmithKline Profits Despite Avandia Troubles

Shares in pharmaceutical company GlaxoSmithKline rose Wednesday, following a 0.9% increase in profits that was unexpected after heavy criticism of its diabetes drug Avandia. The increase is due in part by Glaxo announcing it will buy back up to $25 billion of its own stock in the coming years, up from roughly $10 billion in a previously announced plan. Despite a 22% drop in sales of the firm's diabetes pill, only two months after reports based on clinical trials claimed it increased the risk of heart attack by 43%, the overall picture is positive. Earnings per share rose 2.9% to and operating profits were up 0.9%.


GlaxoSmithKline is still vigorously defending Avandia, which brought in $2.9 billion in 2006, even though a U.S. Food and Drug Administration advisory committee hearing is scheduled on its possible dangers. "Whilst some uncertainty remains around Avandia, we stand firm in our belief that it is an effective and valuable treatment for patients with diabetes," said Chief Executive Jean-Pierre Garnier on Wednesday. However, last week another study attacked the treatment, led by Dr. Bernd Richter of Heinrich-Heine University, who claimed it could actually worsen complications arising from diabetes.


FDA pulled reviewer off Glaxo’s Avandia drug

A senior Food and Drug Administration scientist has told congressional investigators that the FDA removed them from their work on GlaxoSmithKline Plc's drug Avandia after voicing concerns about the safety of the diabetes pill. The unnamed FDA medical officer was the primary reviewer for Avandia. The scientist has believed since 2005 that there was enough evidence for a strong "black box" warning on Avandia about a risk of congestive heart failure. The FDA reviewer was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia. The scientist was interviewed by senate committee investigators. In a statement titled "Senators reveal effort by the FDA to suppress scientific dissent and downplay safety concerns" released with their letter, they said the reviewer was "sidelined after voicing safety concerns" about Avandia. The allegation is significant and raises the level of concern about FDA interference in safety decisions.



July 30, 2007

FDA to ask if Avandia should stay on market

The U.S. Food and Drug Administration will ask outside advisers if the diabetes drug Avandia should be taken off the market or remain on sale with new warnings or limits, a summary released on Thursday July 26th said. It also said the agency has "considerable concern" about data that shows a signal of possible heart attack risks with Avandia. The various data currently available has "somewhat inconsistent findings.” If the advisers decide Avandia should stay on the market, the FDA will ask about whether it would be prudent in adding a strong "black box" warning or limiting use to certain patients. The FDA released the summary among more than 400 pages of documents prepared for the advisory panel review of the drug's heart risks. The maker of Avandia said in documents that its data showed no higher heart attack risk with Avandia than other oral diabetes drugs. The FDA usually follows advisory panel recommendations.


Helmets and seat belts lower risk of damage to the brain

Every five minutes one person will die and another will become permanently disabled because of a traumatic brain injury. An estimated 1,165,000 children will require hospitalization following a traumatic brain injury, while one in 10 will live with moderate to severe impairments. Like the spinal cord, the brain does not repair itself. Any damage to the brain is likely to have lasting effects. Helmets, safety belts, air bags and car seats decrease the risk of brain injury and death. Simply wearing a bicycle helmet can reduce such injuries by 85%. Approximately 5.3 million Americans are disabled as a result of a brain injury. The average patient will pay upwards of $4 million to support ongoing medical care and related services during their lifetime. 61% percent of survivors will suffer from neurophysical disabilities such as seizures, loss of balance, speech impairments and headaches.

Injury to the brain is a serious problem with long-term consequences. Taking smart, simple precautions like wearing helmets and seat belts can help dramatically reduce the 30,000 permanent disabilities sustained by children each year. Many local EMS agencies have implemented programs to distribute bicycle helmets to those in need as well as assist with the proper installation of children's car seats. In light of this, strap on that bike helmet and click that seat belt.


Senate Approves Wounded Warrior Bill

The Senate unanimously passed legislation Thursday July 26th to improve the health care and treatment of wounded soldiers returning from Iraq and Afghanistan. It was followed by a separate report from a Presidential Commission concerning an integrated solution. White House press secretary Tony Snow said that President Bush will probably integrate the commission's recommendations with other efforts. If the Senate bill is included, the integrated solution will include a plan for preventing, treating, and diagnosing traumatic brain injury and post-traumatic stress disorder in soldiers.


TBI and Visual disorders

The Blinded Veterans Association is trying to influence legislation that would establish a military eye-injury registry and set up a joint traumatic brain injury optometry screening program between the Pentagon and the Department of Veterans. Two types of eye injuries have become more prevalent in soldiers returning from Iraq and Afghanistan, direct blast injury to the eye and traumatic brain injury, in which the eyes do not necessarily suffer cuts or contusions but severe brain concussion affects nerve pathways related to sight. Visual disorders associated with traumatic brain injury (TBI) include diplopia (double vision), convergence disorder (an eye-muscle disorder affecting near vision), photophobia (light sensitivity), ocular-motor dysfunction (also an eye-muscle disorder) and an inability to interpret print. Many patients could exhibit better eye health following a TBI if neuro-optometric exams are performed. About 20 blinded military personnel who fought in Afghanistan and Iraq will attend BVA’s 62nd national convention next month in Albuquerque, N.M. ABC correspondent Bob Woodruff, who sustained a severe head injury from a roadside bomb blast in Iraq, is invited as the keynote speaker. He lost 30 percent of the vision in his left eye as a result of the injury.


July 27, 2007

Notre Dame Coach Loses Medical Lawsuit

A jury ruled against Notre Dame football coach Charlie Weis on July 24th in his malpractice lawsuit against two doctors he claimed botched his care after he had gastric bypass surgery five years ago. The jury deliberated for less than half a day before finding Massachusetts General Hospital surgeons Charles Ferguson and Richard Hodin were not negligent. Weis accused the surgeons of negligence, saying they allowed him to bleed internally for 30 hours before performing a second surgery to correct the complication. Weis nearly died after the 2002 surgery. He testified that he still has numbness and pain in his feet and sometimes has to use a motorized cart.


Ferguson, director of Massachusetts General's surgical residency program, and Hodin, a surgeon and professor at Harvard Medical School, said internal bleeding was a well-known complication of the stomach stapling surgery. They said they believed the bleeding would stop on its own and were concerned about performing a second surgery because of the risk of a pulmonary embolism. Ferguson testified that Weis ignored his advice and pushed to have the operation done quickly rather than going through a recommended six-week preoperative program.



Victims not to Blame for Problems with Malpractice

Admittedly, costly medical malpractice insurance is a realistic problem. The solution most often voiced is putting limits on jury awards in malpractice trials. The debate over the rise in cost of premiums needs to stop demonizing trial lawyers if solutions are to be found. Trial lawyers are a tempting target for retribution, but it's the people they represent who would be the victims of dollar limits on damages for pain and suffering. With HMOs and insurers trying to keep down costs, doctors are taking casualities, some leaving the area or limiting their care. Others are altering their practices, such as ob/gyns deciding to stop delivering babies. The assertion that all this is being driven by greedy lawyers is unconvincing. The size of jury awards has gone up in recent years, but according to the Center for Justice and Democracy payouts from verdicts and settlements have raised no faster than the rate of inflation in medical costs.

New solutions need to be explored, such as a specialized medical court without juries, or a no-fault system for claims involving neurologically impaired infants. Perhaps, a crack-down targeting the licenses of chronically incompetent or negligent doctors would help. There must be other, more creative ideas. Unfortunately, they may never be explored if the debate remains fixated on attacking damages awarded to patients for their pain and suffering as the root of malpractice premiums rising or deserting doctors.


San Francisco Court Says Law Protects Medical Students

A medical student who injured a patient's foot during a routine eye exam is protected by the same law that limits malpractice suits against doctors, a state appeals court ruled in dismissing the patient's damage claim. The 1975 law applies to medical students who are legally allowed to treat patients, said the First District Court of Appeal in San Francisco. The court upheld a judge's dismissal of a lawsuit by Eve Chosak, who said she went for an eye exam in June 2003 and according to her lawsuit, her foot became jammed between a piece of equipment and the examination chair, which was being controlled by intern Lynn Valdez. Valdez was a University of California optometry student at the time. Valdez was unable to dislodge Chosak's foot and Chosak had to twist her foot out of her shoe and then fell to the floor. A doctor told the patient two weeks later that she had a sprained ankle, but the pain persisted and a later examination showed a bone spur that continues to cause discomfort, Chosak said.

In March 2005, Chosak sued Valdez, the university and others involved in her diagnosis and treatment. The lawsuit was dismissed. Chosak's appeal argued that medical students are not covered by the 1975 law, which applies only to those who are "licensed or certified'' to provide health care. The appeals court said the law, read literally, appeared to apply only to licensed professionals, but that it could also be plausibly interpreted to cover others, like medical professionals and graduate interns who are authorized to treat patients. The broader interpretation is consistent with the law's goal of reducing malpractice insurance costs by limiting lawsuits, said Justice Sandra Margulies in the 3-0 ruling. She said medical students "may be less adept than licensed doctors'' but are supervised by doctors and play a role in the health care system. Chosak's lawyer, Paul Seiner, said the ruling was "scholarly'' but raised questions about "whether one can rely on the plain meaning of any statute.'' He said he was unsure about a further appeal.


July 26, 2007

Stem Cell Therapeutics Corp. Announces Pre-clinical TBI Study

Stem Cell Therapeutics Corp. announced the beginning of a pre-clinical study designed to discover the neuro-regenerative effects of stem cell prolific agents plus erythropoietin (EPO) in an animal model of traumatic brain injury (TBI). SCT recently announced encouraging results from the interim analysis of its ongoing Phase IIa clinical study in stroke patients with a regimen of human chorionic gonadotropin (hCG) followed by EPO. The current study will explore a different but related therapeutic area, TBI. It is designed to describe the ability of prolactin or hCG followed by EPO to promote recovery of the brain following moderate to serious injury to the brain. The result of this study, to be conducted at Louisiana State University under Dr. Ludmila Beleyev and in collaboration with the Department of Neurology, is to compare prolific agents plus EPO in a rat animal model of TBI. A therapy with the ability to improve neurological and functional recovery after a brain injury and decreasing rehabilitation time and cost is an extremely important goal. This is similar in concept to the stroke therapy that SCT is currently testing in stroke victims in a Phase IIa clinical study.

SCT has developed a therapeutic regimen of two drugs. It targets the treatment of stroke by using two approved and clinically well-defined drugs. Human chorionic gonadotropin (hCG) is the first drug administered and aims to increase the number of neural stem cells (NSCs) located in the brain of a patient suffering from a recent stroke. Erythropoietin (EPO) is the second drug administered and aims to promote the differentiation of these newly formed NSCs into new neurons. New neurons thus formed are anticipated to provide benefit to the patient through the replacement of the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function in animals that received the regimen after a stroke. SCT is currently enrolling patients in a phase IIa clinical trial in the United States in order to investigate the safety and efficacy of it in humans.


Older Drivers Safer on Roads than Younger

Young drivers between 15 and 24 years old are three times as likely to cause car accidents as senior citizens, U.S. researchers at the Rand Institute for Civil Justice found, noting that the findings contradict policies that make it harder for older drivers to renew their licenses. People over the age of 65 make up 15% of drivers but were responsible for only 7% of the 330,000 fatal two-car crashes in the past 25 years. Drivers up to age 24 represented 13% of drivers, but caused 43% of the accidents across the United States. Senior drivers were only 16% more likely to cause an accident than drivers between the ages of 25 and 64.

"There is pretty widespread public concern about the safety of older drivers," said David Loughran, an economist at RAND who worked on the study. "Over the past 20 years, there has been a strong trend to adopt more stringent licensing policies," he added. "The fact that older drivers are not that much riskier, suggests that these policies are certainly questionable."


A Catastrophic Injury Brings Concern and a Call for Insurance

Stephen Murray, 27, was injured June 22 at the Dew Tour event in Baltimore. During the finals of the BMX dirt-jumping competition, he attempted a double back flip during the final set of jumps. He flew off his bike in midair, falling more than 10 feet and landing on his head. The impact broke three vertebrae in his neck, and he is paralyzed below the shoulders. His condition has caused other athletes to consider the life-altering consequences of what happens when things go wrong in action sports and have renewed calls to create an association to assist athletes in dealing with such catastrophic injuries. Since his crash, Murray has had two operations and spent nearly a month in the Maryland Shock Trauma Center in Baltimore. Last week, he was moved to Craig Hospital in Denver, which specializes in rehabilitating patients with spinal cord and traumatic brain injuries.

Since the X Games began in 1995 and brought these sports to the mainstream, no top professional action-sports athlete in BMX freestyle, skateboarding or freestyle motocross had ever sustained such a serious injury in competition. Other athletes expressed disgust with NBC, which owns the Dew Tour, for not providing insurance in case of serious injuries.


July 25, 2007

Largest Clinical Trial to Study New Drug in TBI

University of Pittsburgh Medical Center, which has conducted several studies on traumatic brain injuries, is preparing to begin the largest clinical trial in North America to study the drug citicoline, which shows promise in helping the brain recover. The trial will recruit about 1,300 patients nationwide. The demand for better treatment and care for soldiers with traumatic brain injury will result in better care for the estimated 9 million Americans who suffer from it, said Carey Balaban, a professor at Pitt who is working with researchers at the Naval Medical Center in San Diego to study the injuries. "When there's a need for the military, it has spin-off benefits, collaborative benefits for the entire population," he said. "There are longer-term benefits here."

Politicians and doctors in Pennsylvania are teaming up to tackle the "signature injury" of the Iraq war. "This is probably the most under-sung disease ... of our generation," said Dr. Ross Zafonte, director of the UPMC’s federally funded Traumatic Brain Injury Model System. Doctors are increasingly concerned with brain injuries from explosions in Iraq. Among veterans from Iraq and Afghanistan treated at Walter Reed Army Medical Center in Washington, about 65 percent have traumatic brain injuries, said U.S. Rep. Jason Altmire, D-McCandless. He introduced legislation to address traumatic brain injuries in soldiers. Between January 2003 and May, 2,414 veterans of service in Iraq and Afghanistan were treated for traumatic brain injuries at the federally funded Defense and Veterans Brain Injury Center's nine medical centers. Repeated mild brain injuries can cause cumulative damage, so proper screening could help prevent soldiers who have suffered one traumatic brain injury from being put in situations where they are at high risk for suffering another. Altmire said he became familiar with the issue and Zafonte's expertise in traumatic brain injuries while working for UPMC before he was elected to the House last year.


Pilot project works with brain injured veterans

To moderate Traumatic Brain Injury, Easter Seals is launching a pilot project to help veterans of Iraq and Afghanistan. At the onset of the project, three affiliates with funding provided by the Ludy Family Foundation, will provide cognitive rehabilitation through the use of Posit Science's Brain Fitness Program, a non-invasive computer-based training program that has demonstrated significant improvement in memory, communication and clarity of thinking in studies with older adults. This purpose of this project is to evaluate the program's efficacy for use in individuals with TBI. Veterans and their families are encouraged to call toll-free, (866) 423-4981, or e-mail veterans@easterseals.com to participate in this 14-week pilot project. The program is offered at no charge to participants.


Hot Dog Chili Sauce to Blame in Botulism Outbreak

The FDA warned consumers to throw away 10-ounce cans of Castleberry's, Austex and Kroger brands of hot dog chili sauce with "best by" dates from April 30, 2009, through May 22, 2009. Castleberry's, owned by Bumble Bee Seafoods LLC, has recalled the products flagged by the FDA, as well as seven others produced at the same time. On Thursday July 19th, the Food and Drug Administration, Agriculture Department and Centers for Disease Control and Prevention were investigating a Castleberry's Food Co. plant in Augusta, Ga., where the suspect product was canned. An equipment malfunction may be responsible for the contamination. The company experienced a production problem about two months ago, when cans were being overheated, which can cause them to expand enough to allow in contamination, before being cooled. Production was halted until the foods being canned at the time could be checked. One food safety expert said the new outbreak was disturbing. "It raises concerns that the existing food safety programs that have been functioning are losing ground because of gaps in FDA oversight," said Caroline Smith DeWaal, director of food safety for consumer group Center for Science in the Public Interest.

Four people have been hospitalized and are expected to survive. Botulism is a muscle-paralyzing disease caused by a toxin made by a bacterium, Clostridium botulinum. Symptoms of botulism include double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, dry mouth and muscle weakness that moves down the body. Eventually, paralysis can cause a person to stop breathing and die, unless supported by a ventilator. Botulism is fatal in about 8% of cases. Most victims eventually recover after weeks to months of care. Botulinum toxin is extremely potent. Even opening a contaminated can may expose consumers to the toxin if it is inhaled, swallowed or absorbed through the eye or breaks in the skin, health officials said


Legislation encouraged for Adults wearing bike helmets

In Canadian provinces that have adopted mandatory helmet legislation for children, bicycle-related head injuries have fallen 45%, compared with a 27% drop in provinces that have not mandated helmet use. More surprising is that among adults cycling-related head injuries continue to increase. In Ontario, which has helmet laws for children but not adults, say injuries have soared 20% over the past three years. A discrepancy that has led to renewed calls for all-ages legislation. To date most legislation has focused on children, for whom cycling is one of the leading causes of traumatic injury. (Only three provinces, British Columbia, Nova Scotia and New Brunswick have all-ages helmet laws.)

Alison Macpherson, an assistant professor in the department of kinesiology and health science at York University in Toronto says adults too can benefit greatly from wearing a helmet and legislation seems to be the most effective way of bringing about that change. According to her research 69,670 adults were treated for cycling-related injuries in Ontario emergency rooms between 2003 and 2006. Of that total, 16,172 were head injuries. Over the three years of the study, the number of injuries remained steady, but the number of head injuries increased 20%.

Charles Tator, a neurosurgeon who heads the Think First Foundation that promotes brain injury prevention, said the most devastating consequence of a cycling-related accident, is invariably brain injury. "The impact of a head with the pavement, the impact of a head on a car ... you sustain horrible injuries," he said. Aside from the personal pain and suffering, there is a tremendous cost to the health system, he added, noting that it can cost up to $8-million to treat a serious brain injury. Yet, Dr. Tator said, a helmet costing about $10 can prevent or mitigate most injuries. According to one study, helmets prevent 88 per cent of cycling-related head injuries. That is why he is a staunch advocate of all-ages helmet laws.


July 24, 2007

Another Ortho Evra Patch Victim shares her story

In November 2006 Gillian, 24 and healthy, was prescribed the Ortho Evra Patch and as advised, her doctor told her that there was a risk of blood clots, but with her family history she should be fine. On January 16th she started to have sharp stabbing pains in her chest. She called her doctor the next day and had an appointment with her that evening. During the appointment she asked if she might be having pulmonary embolism because of what she had read about the Patch online. Her response was ‘no’ that a pulmonary embolism would make Gillian short of breath. The chest pains continued intermittently and she began to experience a 'creaking' sensation in the bottom of her right lung.

The following week the sound was loud enough that her friends at work put their hands on her back and felt a vibration. She went back to doctor, got an x-ray and was prescribed steroids and antibiotics. The x-ray results showed a precipitate in her lung and it was consistent with pneumonia. She took a week off from work and while on the medication she noticed a pain in her right calf. Gillian’s aunt, a supervising nurse at a hospital, found out that Gillian was on the Patch she thought it might be a blood clot. The pain moved up her thigh. She asked the doctor a second time if it was a blood clot and was told it was probably a pinched nerve. The doctor’s reasoning being if she had deep vein thrombosis (DVT), the leg would be swollen and red. Those symptoms were not apparent. Gillian’s aunt told her to mark an 'X' on her leg where it hurt the most to see if the pain was traveling. By the end of the weekend it had moved up her leg two inches. The following Monday she went to the ER. She explained her chest pains, showed the ‘X’ on her leg and told them she was on the Patch. She had a three-foot long blood clot going from her calf to the top of her inner thigh. The resultant CT scan to check the lungs showed multiple pulmonary embolisms scattered throughout her lungs.

Gillian was in the hospital for five days and had to remain still the entire time. She was on an IV and a clot-busting drug would be injected into her stomach. She is now on blood thinners and has lost up to 10% of her lungs. The ‘creaking’ sound was dead space in the lungs. She is upset the Ortho Evra Patch is still prescribed and that is the reason she shares her story. She wants to make others aware of the dangers. She goes on facebook.com and corresponds with a group on myspace.com called Ortho Evra Awareness who are victims who have had issues with the Patch. Her new doctor has told her that a history of blood clots could cause future dangerous clotting complications if she gets pregnant.


Corneal Transplant Patient Files Lawsuit against Advanced Medical Optics

Debbie Wooten, a 44-year-old operations manager at a financial services company, alleges she has suffered permanent vision loss due to Acanthamoeba keratitis, an extremely painful infection of the cornea, from use of AMO's Complete MoisturePlus Multi Purpose contact lens solution. "The infestation in my left eye destroyed my cornea. I had to administer drops in my eye for a year," explained Wooten. "At first I had to administer the drops every hour around the clock. It took twenty minutes to administer the drops because I had to wait five minutes between each drop. The pain was unbearable. The microorganisms were chewing on my nerve endings."

Wooten was a regular purchaser of AMO contact lens solution, using the product as instructed. In late 2004, she began to suffer symptoms of light sensitivity, tearing, and redness. Wooten sought medical attention but her doctors were unable to accurately diagnose her condition. At the end of 2004, Wooten lost the vision in her left eye. In January 2005, Wooten was diagnosed with Acanthamoeba keratitis. "Once the treatment ended, I then had to wait nine months for the corneal replacement surgery in case the infestation was dormant," Wooten stated. "I am extremely fortunate that I did not lose my eye but my vision is still impaired. I may need additional surgery. This was a terrible experience. I hope my lawsuit causes AMO to ensure its contact lens solution products are safe to use."

On May 25, 2007, the FDA alerted health care professionals and their patients who wear soft contact lenses about a voluntary recall of AMO's Complete MoisturePlus Multi Purpose. The recall was undertaken because of reports of a link between a rare, but serious eye infection, Acanthamoeba keratitis, caused by a parasite and use of AMO's contact lens solution.


Former Notre Dame Coach Weis malpractice retrial under way

Notre Dame football coach Charlie Weis was back in court July 16th, pressing his medical malpractice case for a second time against two surgeons he alleges botched his care after he had gastric bypass surgery five years ago. The first trial ended in a mistrial in February after a juror collapsed and the Massachusetts General Hospital doctors being sued rushed to his aid. After that surprising end, some thought Weis, 51, the former offensive coordinator for the New England Patriots would agree to a settlement to avoid a second trial. That was not to be the case as Weis was sitting at the front of the Suffolk Superior courtroom.

Charles Ferguson, director of Mass. General’s surgical residency program, and Richard Hodin, a surgeon and professor at Harvard Medical School, insist they gave Weis excellent care after his surgery in June 2002. William Dailey Jr., a lawyer for Ferguson and Hodin, said internal bleeding was a well-known complication of gastric bypass surgery. Dailey said Ferguson, Hodin and several other doctors who cared for Weis believed the bleeding would stop on its own, as it does in most cases after such surgery. They also were concerned that Weis could develop a pulmonary embolism, a potentially fatal condition and did not want to perform another surgery with that possibility. In opening statements to the jury, Weis’s lawyer, Michael Mone, said the doctors acted negligently by allowing Weis to bleed internally for 30 hours after the surgery before performing a second operation to correct the complication. Weis went through a long and painful rehabilitation and still suffers pain in his feet, forcing him to sometimes use a motorized cart. The trial is expected to last one to two weeks. Weis was in a coma for two weeks and nearly died.


Recipients of a Liver Transplant or Victims of Liver Disease at Risk for NSF

According to the FDA, patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing the debilitating, and a potentially fatal disease, Nephrogenic Systemic Fibrosis (NSF). Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity. FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006.

Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine); and Prohance (gadoteridol).


Marine charged in Iraqi’s death may have brain injury

Repeated exposure to bomb blasts may have impaired the judgment of a Marine corporal charged with kidnapping and murdering an Iraqi civilian, an expert in war-related brain injuries told a military judge July 16th. Attorneys for Cpl. Trent D. Thomas, 25, of Madison, Ill., hope to show that a traumatic brain injury impeded his ability to say no when his squad leader ordered him to snatch the man from his home in Anbar province. Thomas, an infantryman on his third combat tour in Iraq, had been exposed to more than 25 bomb blasts, said Maria Mouratidis, head of the traumatic stress and brain injury program at the National Naval Medical Center in Bethesda, Md. "Cpl. Thomas would have difficulty with decision-making, problem-solving and especially with coming up with different solutions in a high-pressure atmosphere," Mouratidis said. "The evidence suggests that he would be very susceptible to influence and have difficulty seeing other options." Thomas is in the second week of a court-martial. He would get a mandatory life sentence if convicted of murder.


July 23, 2007

Banyan Biomarkers Inc. undergo clinical trials for a TBI Biomarker

Sports agent Leigh Steinberg describes traumatic brain injury as "an undiagnosed health epidemic" and "a ticking time bomb." NFL officials are listening. According to the Brain Injury Association of America, football is responsible for approximately 250,000 head injuries each year. The National Football Leagues estimates there are about 100 concussions per season. A player may suffer a concussion, a trauma to the brain that could manifest itself later in life in the form of depression, early-onset Alzheimer’s disease or dementia. Jason Demery, a University of Florida clinical assistant professor in clinical and health psychology says the majority of those who sustain a single Mild TBI go on to recover spontaneously, but there are still 10% to 15% who still have persistent, post-concussive symptoms a year after their injury. He goes on to say that the incidence of depression and emotional complications can be one of the aspects of a traumatic brain injury. "The research shows the incidence can be as high as 70% or 80% after a single concussive episode," he said.

Ron Hayes is the director of traumatic brain injury studies at the University of Florida and chief clinical program officer of Banyan Biomarkers Inc. Banyan is a Gainesville-based biomedical research company that is developing a biomarker that can tell if brain injury has occurred based on a simple blood test. According to Hayes the biomarker development is inevitable because already routine diagnoses are done on every other body organ to detect dysfunction using a blood draw. After that, the diagnosis can be made unequivocally. "We are on the cusp of having the same technology available for brain injury," Hayes said. "Here is a subjective test administered in a culture that doesn't want to tell the medical truth. Instead, you need an organically based, objective assessment, and it will become available quite soon."

Hayes said Banyan is two or three years removed from approval of its biomarkers for traumatic brain injury. Such a biomarker will identify proteins that are present in the blood as a result of damage to the brain after a suspected concussion. Clinical trials are under way in the United States and Europe. "The development of this blood test will benefit everyone including NFL players, children on the sports field, accident victims and American soldiers at war," he said.


NSF Sufferer Seeking FDA Approved Treatment

A rare and painful disease, known as Nephrogenic Systemic Fibrosis (NSF), has caused Jeanie Deason’s legs and right arm to become frozen in a bent position. She fears that the condition will take hold of her left arm, leaving her an invalid. "It's completely stopped my life. My mother comes over here to take care of me. She's 77 years old. I should be taking care of her." Deason's disease is newly recognized and not well understood by doctors. Deason was born with kidney disease and underwent a magnetic resonance imaging scan in October. Her symptoms began a few weeks later. "Up until this disease you wouldn't have even known I was sick," she said. Now, Deason uses a wheelchair, which she has trouble maneuvering because she has use of only her left hand.

Dr. John Zic, Deason's physician and an assistant professor of dermatology at Vanderbilt, said that for NSF and some other rare diseases, there are no clinical trials. Zic says a procedure called extracorporeal photopheresis offers Deason real hope for improvement. Photopheresis is FDA-approved to treat other diseases and there are few side effects. The treatment involves removing blood from a patient's body, exposing it to ultraviolet light and then reinfusing the blood back into the body. It's believed that the treated blood alters the body's immune system so it can better fight the disease. "This treatment has the potential to soften the skin to the point where patients have full range of motion," Zic said. "I treated one patient, who initially was unable to close her hand. After three months, the patient was able to use a pen to sign documents. Another patient began with significant joint stiffness and had difficulty walking. After six to eight months, the patient was walking with no significant limp." Zic has treated four with photopheresis. Three improved and one died because of issues with dialysis treatment, not because photopheresis was ineffective, he said. Without therapy, Deason's condition will probably continue to deteriorate. "As the skin becomes thicker and thicker, patients become more immobile and more prone to respiratory and skin infections," he said. "These conditions can lead to death." The therapy that Deason is seeking costs several thousand dollars per month. Deason would need to undergo two treatments a month for one to two years, according to Zic. It's something Deason could never afford with the $679 in Social Security she collects each month. The longer she goes without treatment, the worse her condition becomes.


House Approves FDA Overhaul Legislation that Would Improve Prescription Drug Safety

The House on July 18th voted 403-16 to approve a bill that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which expires on Sept. 30. The FDA proposed that pharmaceutical companies pay $393 million in user fees in 2008. The legislation calls for an additional $225 million in user fees from pharmaceutical companies over five years. In addition, the bill would reauthorize the Medical Device User Fee and Modernization Act, which also expires on Sept. 30. The FDA would receive about $287 million in user fees from medical device companies over five years. It would allow FDA to require pharmaceutical companies to conduct post market safety studies of new medications, limit distribution of certain treatments and order product label changes. FDA could fine pharmaceutical companies as much as $250,000 for a single violation of the requirements and as much as $1 million for several violations.

In the event that pharmaceutical companies do not address the violations after they receive notice from FDA, the agency could fine them as much as $10 million for a single violation and as much as $50 million for several violations. In addition, the bill would allow FDA to require new medications to enter post market risk-mitigation plans. FDA also could review and recommend changes to direct-to-consumer advertisements for new medications and could require disclosures in potentially false or misleading ads. The legislation also would establish prescription drug safety requirements for FDA. The legislation also would establish a "unique identifier number" for all medical devices that would allow FDA and health care providers to track the devices for potential problems. The bill also allows FDA to approve generic versions of medications regardless of whether manufacturers of the brand-name versions raise safety concerns or other issues.

The legislation moves to conference committee to reconcile differences with a similar bill (S 1082) approved by the Senate in May. According to the Times, the House version of the legislation "follows the same basic approach to safety as the Senate version" but "would give the FDA stronger regulatory powers in some areas." Both versions of the bill include a provision that would establish a computerized network to scan public and private health insurance and pharmacy records for indications of safety issues with new medications.


July 20, 2007

Man with TBI now author and artist after accident

Kevin Carey was almost killed six years ago when he was hit on the driver’s side door by a dump truck as he was leaving work. He feels he has been given a second chance at life and is now an author and award-winning artist. Carey, 29, hopes to inspire others to overcome struggles in their own lives. The former sixth-grade special education teacher at Pocono Mountain School District autographed copies of his book, “Transcending: An Artist’s Journey Back from Traumatic Brain Injury.” Following the March 7, 2001, accident he was air-flighted to the hospital and was in a coma for two months recovering from a traumatic brain injury on the left side of his brain, broken ribs, a collapsed lung, staples in the head and knee, and paralyzed vocal cords. Once he awoke, there were several months of physical therapy and an operation on his vocal cords. He learned to walk and talk again. In his book he talks about the struggles he overcame mentally and physically. Muscle spasms made his right hand useless so he worked 12 to 15 hours a day teaching himself to use his left hand to paint, draw, sketch, sculpt and write.

After the accident he used art as an outlet for his frustration. In November he learned one of his pieces was one of 10 selected from 500 entries in a national contest hosted by Carnegie Hall. His painting “Musical Inspiration” was on the front cover of the national theater monthly magazine Playbill in April. Weeks later, Carey earned his Masters of Art Therapy in May from Marywood University in Scranton. This fall he will be back in the classroom full-time as art therapy teacher at the Pocono Mountain School District. As an intern teacher during the spring he worked with students suffering from depression or other behavioral disorders. His book can be found on Amazon.com


Diabetes drug tied to increased cancer prevalence

Patients with diabetes, especially women, who take thiazolidinediones, which include the drugs Avandia and Actos, may have an increased risk of developing cancer, according to the newest issue of BMC Medicine. "There is more to these drugs than first meets the eye," Dr. Maria E. Ramos-Nino from the University of Vermont, Burlington, said. "The long-term consequences and benefits are not understood." Ramos-Nino and colleagues investigated the association of thiazolidinediones and cancer prevalence among nearly 9,000 diabetic patients participating in a large database. Random, selected samples of 1,003 of these participants were interviewed about personal and clinical characteristics, including any history of malignancy. After factoring in the potential effects of other risk factors, the investigators found that the use of any thiazolidinedione was associated with a 59-percent increased risk of cancer. The use of Avandia (rosiglitazone) increased the malignancy risk by 89 percent, whereas the increased risk associated with Actos (pioglitazone) was not statistically significant. Women taking thiazolidinediones were more than twice as likely to have cancer as women not taking thiazolidinediones, but the association was not statistically significant in men.

The authors acknowledge that the study has several limitations, including its cross-sectional design, lack of confirmation of cancer, and the absence of information on the temporal relation between thiazolidinedione use and cancer.


Baxter Healthcare Corp. Recalls Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps

The FDA and Baxter Healthcare Corp. have notified healthcare professionals and consumers of a Class 1 Recall of Baxter Upgraded COLEAGUE Triple Cannel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. The FDA defines a class 1 recall as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." The electronic pumps are used to deliver controlled amounts of medication or other fluids to patients through and intravenous or other direct line into the bloodstream.

The product was recalled because a software irregularity causes the newly upgraded pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels infusing fluids at the same time. Serious injuries have been reported because of this problem. Interruption of life-sustaining therapy could result in serious injury or death.

Pumps affected by the recall should be removed from service immediately according to the FDA's MedWatch Alert.


July 19, 2007

VA trains staff to determine difference between PTSD and TBI

Decades after returning home from the Vietnam War, Richard Marsh was diagnosed with post-traumatic stress disorder in 2002. Years of dealing with anger management and other emotional changes suddenly made sense. Marsh wonders now whether constant exposure to explosions during the war left him with another problem, a mild brain injury. The surgeon general of the Navy warned the Veterans Affairs and Defense departments this year to be careful about mistaking a mild brain injury for post-traumatic stress disorder. Similar to post-traumatic stress disorder, according to the CDC, a victim of a mild brain injury could have difficulty concentrating or making decisions. They could feel tired all the time, have no energy or motivation, or suffer from sudden mood and personality changes. Sleep problems are also common to both diagnoses. "There are probably a fair number of soldiers who have been diagnosed with (post-traumatic stress) who may have a brain injury," said Anne McDonnell, executive director of the Richmond-based Brain Injury Association of Virginia. "Women who are victims of domestic violence are frequently misdiagnosed with (post-traumatic stress) when they have a brain injury."

"In Vietnam, if you got shaken up a bit and got a headache, no one thought about a brain injury or went on sick call," said Marsh, now a service officer with the Newport News chapter of the Disabled American Veterans. "Soldiers need to think about that today."


New biosensor gives abused infants a fighting chance

Babies whose brains are injured from abuse can't speak, parents won't admit what happened and common symptoms such as fussiness and vomiting are typical baby behaviors. Toronto-based company, Axela Biosensors, has patented a technology that it claims could help doctors quickly identify infant brain injuries such as Shaken Baby Syndrome, the leading cause of mortality from traumatic brain injury in children under 2. The tool detects two proteins that are markers of brain injuries. With a simple blood test, doctors may know in less than an hour whether damage has occurred, the company says. Rocky Ganske, Axela's president and CEO, said the company's biosensor may have diagnostic implications for other conditions, such as heart disease, as well. He says he's excited about the possibilities when it comes to childhood brain injuries. Two teams of researchers in Pittsburgh and Salt Lake City will test the biosensor tool in a five-year trial set to begin this year, using a sample of 1,000 children. Detecting brain injuries in infants is vital, says lead researcher Rachel Berger, who specializes in head trauma from abuse and is based at the University Of Pittsburgh School Of Medicine. "If you miss them," Dr. Berger says, "they have a very high incidence of coming back dead." The biosensor, developed by researchers at the University of Toronto, detects small amounts of two proteins - neuron-specific enolase and myelin basic protein - that are released after a brain is injured. Dr. Berger has already run a preliminary trial and found promising results. "It works," she says. But the larger study is necessary if the tool is ever going to make it into emergency rooms. Ideally, Dr. Berger says, it will be a fast, easy tool to aid doctors when infants wind up there.


An International Registry to Record Catastrophic Injuries in Cowboys

A Canadian rodeo researcher is creating an international registry to record catastrophic injury to cowboys. The information could eventually lead to an international center for rodeo research excellence that would pull together education of cowboys, healthcare professionals and clinicians, according to University of Calgary sports epidemiologist Dale Butterwick. "As of today, anyone, anywhere in the world can access this database and report a catastrophic injury," Butterwick said in a statement. "By catastrophic we mean life-changing, losing a major organ, paralysis, even death. We need to know how these injuries occur and how often before we can meaningfully look for interventions." Once a catastrophic injury has occurred, Butterwick and a team of epidemiologists from the Cowboy's Professional Rodeo Association and the University of Calgary faculty of kinesiology will investigate the report to fully understand how the injury occurred and what might be done to prevent it in the future. Butterwick said he hopes this information will lead to increased safety for rodeo athletes and that the data will enhance support for research into rodeo injury prevention.


July 18, 2007

A Loma Linda University Med Center Abstract on NSF

The Loma Linda University Medical Center wrote an abstract on a study of 12 patients who had contracted NSF after an MRI/MRA event. It was published in American Journal of Roentgenology in November 2006. The department of Radiology, Surgery and Medicine at Loma Linda all contributed to the report.

OBJECTIVE: Nephrogenic systemic fibrosis (NSF) is a rare multisystemic fibrosing disorder that principally affects the skin but may affect other organs of patients with renal insufficiency. The purpose of the study was to identify any common risk factors and determine whether IV gadodiamide is associated with the development of NSF.

MATERIALS AND METHODS: A retrospective chart review was performed for 12 patients diagnosed with NSF at the Loma Linda institution between 2000 and 2006 to identify the clinical manifestations, timing, and dose of gadodiamide administration. Additionally, dialysis records, concurrent medications, surgeries, laboratory findings, imaging findings and clinical outcome. A review of the dialysis and MR records between 2000 and 2006 showed 559 MRI examinations on 168 dialysis patients including 301 contrast-enhanced examinations.

RESULTS: NSF was diagnosed by clinical findings and tissue diagnosis. All 12 patients had renal failure. Eight had dialysis-dependent chronic renal insufficiency and four with acute Hepatorenal Syndrome. All 12 patients developed skin fibrosis within 2-11 weeks after gadodiamide administration. The odds ratio for development of NSF after gadodiamide exposure was 22.3%. No other common event or exposure could be found. Four patients had abnormal bone scans with skin and muscle uptake of gadolidiamide. Lower-extremity MRI finding of edema in the muscles, intermuscular connective tissues and skin. Regardless of whether 10 of the patients underwent dialysis, within 2 days of gadodiamide administration did not prevent the development of NSF.

CONCLUSION. Development of NSF was strongly associated with gadodiamide administration in the setting of either acute hepatorenal syndrome or dialysis-dependent chronic renal insufficiency.


Army to Launch TBI and PTSD Education Program

Within 90 days, all soldiers will receive information to help them identify symptoms of post-traumatic stress disorder and mild traumatic brain injury, and they will be urged to seek treatment if necessary, Army officials told reporters at the Pentagon. Mental health care professionals will brief Army Secretary Pete Geren on the new program and by Oct. 18, the same educational supplement will have been presented to platoon-sized groups of active-duty, reserve and National Guard soldiers throughout the force. During two 30 minute multimedia presentations that make up the program, soldiers will learn to identify basic symptoms in themselves and other soldiers. Afterwards, health professionals will answer troops' questions. The Army also has produced a video to make soldiers' family members more sensitive to possible warning signs and treatment options.

"The mild traumatic brain injury and the post-traumatic stress disorders -- they're real," said Army Lt. Gen. James Campbell, director of the Army staff. "They impact soldiers and impact those soldiers' families and as a result of that, that impacts the readiness of our great Army." Campbell said the program's main objective is to reverse the tendency in military culture to attach a stigma to mental health care. "I'm not naive. There is a huge culture issue here, and it is this: that those leaders or soldiers who seek help could be perceived ... as being weak," he said. "The whole thrust behind this program is that if you are, in fact, someone who needs help, that desire to get that help is not perceived as a weakness but rather as a strength, as a personal courage to do it."


Kids with Traumatic Brain Injuries Often Misunderstood

A phone call on Valentine's Day changed Jennifer Erixton's life forever. Her son Joshua was hit by a train. He barely survived and when he did he was a much different boy. "It seems to be I'm the same person I was before the accident, because I don't remember how I was before," Joshua says. Every 23 seconds someone just like Joshua sustains a traumatic brain injury or TBI. Fifty-thousand don't survive. Those who do often find that recovery is only the first hurdle they face. The second can be friends and others who just don't understand.

Tracey East Porter says, "I'm a fairly educated person and I didn't know what brain injury was." In 2004 her son Justin was in a car accident and nearly died. "Three years later it's still a struggle," she says. Porter is the founder of Mothers Against Brain Injury. She travels to hospitals all over the state of Florida delivering tote bags filled with essentials to families facing the same experience she did. The support of others like her is critical. All these families know exactly what it means to have a new and different child after a brain injury. "These kids look perfectly fine, but all of them have long term deficits that can't be seen by anyone outside their immediate family," Porter says. Justin has trouble remembering things and his personality has gone from shy introvert to complete extrovert and he's lost some friends who just don't get it.

There is another side. While these kids want you to understand, they also want to be regular kids. It's a daily struggle for normalcy in a world that is no longer normal, but they are making it. They are happy to be alive to deal with it.


External Review Adds More Reasons to Avoid Avandia

According to a review of data by German researchers, little evidence supports using rosiglitazone (Avandia) to improve the quality or length of life among adults with diabetes. New data suggests that the drug might worsen complications of the disease such as weight gain, swelling, bone fractures and heart disease. The new review supports findings from an analysis of studies, published in May. The findings are considerably alarming because heart disease accounts for nearly 70 percent of deaths among people with diabetes. Type 2 diabetes affects about 18 million to 20 million Americans, according to the American Diabetes Association.

The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. The authors pooled data from 18 randomized controlled trials including more than 8,000 participants. About half of the patients took rosiglitazone and the others received either an alternative medication or a placebo. Most of the trials lasted about 6 months, although the longest one followed patients for four years. When the reviewers looked at "patient-oriented" results of the treatments such as side effects, diabetic complications or death, they found an extremely negative picture. The pooled data revealed that patients taking rosiglitazone gained up to 11 pounds in body weight and that the chance of developing edema (swelling) doubled. These changes indicate that the drug causes fluid retention, which can lead to shortness of breath and heart failure. The largest single trial included in the review involved more than 4,000 patients and showed evidence of raised cardiovascular risk, as well as increased numbers of broken bones in women.

"In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measures of glycemic control, the rationale for prescribing rosiglitazone at this time is unclear," say public health experts Bruce Psaty, M.D., and Curt Furberg, M.D., in a New England Journal of Medicine editorial published June 14. The journal published the initial analysis of Avandia. The Cochrane reviewers concur, saying, "Current drug approval for antidiabetic medications and possibly all new drugs needs to be changed." However, they also question "whether new studies with rosiglitazone will be ethical given the fact that less-dangerous therapeutic alternatives exist." "Rosiglitazone represents a major failure of the drug-use and drug-approval processes in the United States," Psaty and Furberg write, comparing the situation to the withdrawal of the painkiller rofecoxib (Vioxx) from worldwide markets in 2004.


July 17, 2007

Aurora Pit Bull Injures Woman and Granddaughter

A 60 year old woman and her 20 year old granddaughter were mauled by a pit bull last week when they visited an Aurora home near South Parker Road and East Quincy Avenue. Although the residents of the house weren't home, other visitors at the house tried to stop the attack by stabbing the dog with a large kitchen knife before calling police.

A neighbor was working in his yard when the visitors arrived and said that about five minutes later, he heard screams and saw a young woman running out of the house with a small child under one arm and a phone in her free hand. "She had blood on her hands and was pretty incoherent," said the neighbor, who helped tend the older woman who had been bitten to the bone and was slipping in and out of consciousness.

When police arrived, they shot the dog in the head through a glass door and dragged the dog outside. Despite having been shot and having a kitchen knife still sticking into its body, the dog wasn't going down without a further fight, so the officers shot it a second time.

The City of Aurora has banned pit bulls, but residents who owned dogs prior to January, 2006, were allowed to keep them if they were registered with the city and spayed or neutered. When kept at home, pit bulls must be kept in pens.

A next-door neighbor said the occupants of the house moved in about six months ago, and
Aurora Police Spokesperson Bob Friel noted that the dog wasn't registered to the address.


July 16, 2007

Defense witnesses testify in Centra Health neglect case

A malpractice trial against Centra Health had defense witnesses testifying Wednesday that an 84-year-old man did not die because he was neglected by Lynchburg General Hospital nursing staff during a 2004 stay. At the center of the trial is the late Leonard Mullins, who came to Lynchburg General Hospital in November 2004 after breaking his hip. Mullins’ family testified on Tuesday that hospital staff allowed a dirty catheter that was draining urine from his bladder to lead to a urinary tract infection that escalated into a fatal illness. The family also said Mullins was prematurely released from the hospital to Guggenheimer Nursing Home against the family’s wishes, only to be brought back to the hospital less than 24 hours later with a severely swollen belly. He died a little over a week later. Testimony from Mullins’ family also indicated he had not received adequate nutrition during his hospital stay. Guggenheimer and Lynchburg General Hospital are both owned by Centra Health.

On Wednesday, defense witnesses, including Lynchburg General nurses and an infectious disease doctor, testified Mullins received proper care for someone in his condition. They also said his transfer to Guggenheimer was appropriate because Mullins’ condition had been improving in the days leading up to his release. One nurse testified the amount of solid foods Mullins received was partly a result of trying to feed him only what he felt like eating. Paperwork cited by the defense on Wednesday also indicated Mullins’ family had approved of having him moved to Guggenheimer. The trial is expected to end with the defense attorney’s calling their final witnesses before the jury.


Side Effects Reports Triple for Diabetes Drug Avandia after Heart Risk Study

In the month after an analysis revealed possible heart risks from the diabetes drug Avandia, reports of side effects to federal regulators tripled. The sudden increase is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said. It also shows the flaws of the safety tracking system and suggests that a better one might have detected a potential problem before the drug had been on the market for eight years. In the 35 days after the publication May 21, the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped. The sharp rise in reports of heart problems appears in data obtained by The Associated Press through a Freedom of Information Act request to the federal Food and Drug Administration. Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet. There were a total of only 50 adverse events reported in January and 73 in February. From April 16 to May 21, 121 events were reported, including 11 deaths. In the 35 days after the study, 357 events were reported, including 38 deaths. The side effects reported range from as minor as a blister to as serious as sudden cardiac death. Most of the reports the AP reviewed seemed to involve serious side effects, and rosiglitazone was listed by the FDA as the "primary suspect" rather than other medicines the patient may have been taking.

Reporting a drug's side effects is voluntary, and only an indication rather than a scientific measure of how many problems patients are actually having. The FDA relies on this un-enforced system once a drug is on the market. Critics say it leads to irresponsible oversight in which problems can be missed because doctors don't make a connection between a drug and the symptoms they see in an individual patient. The FDA plans hearings on safety concerns about the drug on July 30. The issue has disturbed the medical community and ignited congressional questions into whether the FDA is properly investigating safety issues. The FDA issued a "safety alert" about the drug only after the May 21 study came out, even though Glaxo had informed the agency of its own analysis of heart risks nearly a year beforehand and possibly as early as 2005. Avandia's label warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.


LegalView.com Tracks Developing Stories of Returning Troops with TBI

LegalView.com is proud to be tracking stories of soldiers with TBIs on its brain injury blog, as well as its comprehensive portal on traumatic brain injury. The blog is part of LegalView's extensive brain injury news and information portal, meant to be the web's most complete set of resources on this important public health issue. With an entire generation of young adults and their loved ones affected by this alarming trend, LegalView.com is responding by offering free resources on TBI to the public through its brain injury portal. Visitors to LegalView.com's expansive traumatic brain injury portal can read original, informative articles about traumatic brain injury written for the layperson; frequently-updated feeds of news articles; a glossary that explains brain injury terms; the latest research and statistics from government agencies; a library of videos on TBI; and much more. And those who are looking for a brain injury lawyer to help evaluate a potential traumatic brain injury claim can take advantage of LegalView.com's confidential, nationwide attorney referral service. LegalView.com is a project from some of America's top law firms, including Burg Simpson


July 13, 2007

Leeches used in surgery to save fisherman's fingers

A New Zealand sailor who lost four fingers in an accident aboard a fishing boat has had three fingers reattached in a different order to save his hand function. The man, 24, lost his fingers on his right hand when a hatch fell on it aboard a fishing trawler on Sunday night. The fingers were kept on ice while the trawler made its way to shore and a rescue helicopter transferred the man to the hospital. The plastic surgeons spent more than nine hours of complicated surgery reattaching three of the fingers. The little finger was reportedly too badly "pulverized" to be reattached. So the strongest fingers were put on closest to the man's thumb, which was intact. The middle finger had been put where the man's index finger had previously been, his ring finger in the middle finger's position and his index finger where the ring finger had been. A leech had been put on the end of the ring finger to improve blood flow. "There's a good artery bringing blood in. The leech is helping to drain blood out,” one of the surgeons said. By Wednesday morning about 12 leeches had been used and more needed to be flown up. Although not often used, leeches were sometimes "excellent" for helping until the body was able to repair itself. The surgeon said the fingers had been crushed and torn in the accident, so that made reattaching them difficult. The man's fingers had the tendons that move the fingers torn out of his forearm and there was no way to reattach those tendons to the muscle. His ability to move his fingers would be limited and he might benefit from reconstructive surgery in the future said his doctor.


CO2 poisoning on Lake Powell houseboat

The night of July 10th sick children aboard a Lake Powell houseboat, including a vomiting baby who appeared to be having a seizure, were a family's first clue something was wrong. Before the night ended 21 people aboard the boat were treated for carbon monoxide poisoning in what one longtime Lake Powell physician's assistant called the largest case of carbon monoxide poisoning he had seen. None of the victims died or required transportation to a hospital. It was the third such poisoning in less than a week at Lake Powell. The victims in Tuesday's mass poisoning were among 40 people who were aboard the boat for a family reunion, said the National Park Service ranger at Bullfrog Marina. The children were sleeping in the rear of the boat next to an open window while a generator there was running to power the air conditioning. The family brought the sick children to the marina in a speedboat. Then rangers received word there were others on the boat also showing symptoms of carbon monoxide poisoning. Eventually, 36 people went to the marina's medical clinic for an examination, of those, 21 received treatment. The number of victims taxed the marina's medical clinic, which has three beds and typically does not have a doctor present. The family members were lined up outside the clinic waiting for oxygen treatment. "If the baby hadn't alerted everybody by having the first symptoms," the ranger said, "and [without] the mother waking everybody up we probably could have lost some of the children."

In recent years, rangers at Lake Powell have tried to warn the public of dangers posed by carbon monoxide emitted from boats. Houseboats, which have engines for propulsion and generators for electricity, have been the biggest source of carbon monoxide accidents. People who suffer poisonings from houseboats are usually swimming near or sitting on the rear of the boat, where the engine and generator spew exhaust. In many Lake Powell fatalities, the poisoning often caused the victim to lose consciousness and drown, but in some cases the poisoning was severe enough to kill the victim just by inhalation.


Reaction to Avandia Warnings Stronger Among Internists than Endocrinologists

Since the May 2007 release of a New England Journal of Medicine (NEJM) report that Avandia users are 43 percent more likely to suffer a heart attack and 67 percent more likely to die of cardiovascular causes than non-users of Avandia, it is no surprise that physicians intend to switch many type 2 diabetes patients from Avandia to therapies believed to pose less risk. Research from GfK Market Measures results on Avandia's increased CV risk, suggests a greater negative response by internists than endocrinologists. The GfK Market Measures study showed universal awareness of the NEJM report, though not all physicians recalled the exact percentages. The internists, however, demonstrated the strongest negative impact to the findings signaling they will "switch more than half their patients currently on Avandia to another therapy," according to Anna Marie Napolitano, Vice President and Leader of GfK Market Measures' Cardiology Practice. "This sharply contrasts with general/family practitioners and endocrinologists who expect to switch less than half of their patients." Forty percent of internists also indicated a high likelihood they will take all of their Avandia, Avandamet and Avandaryl patients off each respective drug, even though the FDA has not required it, in contrast to a smaller percentage of endocrinologists. Internists are also more likely than the endocrinologists to indicate a reluctance to prescribe any product containing Avandia.


July 12, 2007

Letter from Ortho Evra Patch Victim

Jennifer Gardner suffered two strokes at the age of 18, allegedly caused by the Ortho Evra Patch. She has since had to quit her job, but in spite of her disability (partial paralysis to her left side), she continues to seek employment. In a recent letter she updated her lawyer on her current employment position. “I just want to update you on everything. I was denied my job at the collection agency and a job at our local hardware store because of my inability to perform all job functions, which includes the use of my hand. So now I applied to the state for social security benefits and I will find out next month if I qualify. I never realized how hard everything is. I am now scared for college even more. Having a job always gave me security and confidence, now I feel like a lazy bum. But, I suppose I should take state help, it's all I can get. Paying for my vehicle, insurance, medications, food and rent is really difficult right now. So, I'm really hoping and pushing for this settlement against Ortho-McNeil (the makers of the Ortho Evra Patch). If I get enough money, I want to donate some to the Brain Trauma Unit that helped me get back to where I am today.”


American Market for Transdermal Patches Set to Climb Back Up by 2010

The transdermal patch sector has been undergoing significant market stress as one of the products sales have lost momentum. The contraceptive patch segment has seen its fortunes change dramatically. Ortho McNeil's Ortho Evra contraceptive patch sales have been adversely affected by reported health risks associated with blood clots among women using the patch. In spite of these market sector setbacks which resulted in total U.S. revenue of less than $2.2 billion in 2006, this sector should rebound to slightly more than $3 billion by the end of the decade. Growth will be driven in large part by transdermal patch therapies for new indications, primarily in the area of neurology.


CA Man wins malpractice suit with Harbor UCLA

Patrick Bell was in severe pain after an emergency appendectomy, but doctors ignored his complaints and sent him home. The pain became so intolerable that he returned to County Harbor-UCLA Medical Center later that night. This time, he would stay for months, facing one medical emergency after another. Bell had emergency laparoscopic surgery on Aug. 24, 2003. On the morning of Aug. 26, 2003, he said his pain was severe, and was given morphine. His family asked that he be allowed to stay another night, but he was released that afternoon, according to the appellate opinion issued Tuesday. He again returned to the emergency room that same night complaining of intense pain and bloating. At 3 a.m., he was diagnosed with a small bowel obstruction and readmitted. A few hours later, a CAT scan was performed, but the results were not reviewed for six hours. They showed an intestinal obstruction, distension of the bowel and free air in the upper abdomen. Bell was placed on observation, and then a second surgery was performed Aug. 29, nearly 55 hours after he returned to the hospital. Bell's abdomen was so swollen that the incision was left open and covered by sterile bandages. To keep him from scratching at the open wound, Bell was placed in restraints and put in a coma for six weeks during which he suffered from a severe infection, septic shock and respiratory failure. He had a tracheotomy, was put on a ventilator and had an arterial line inserted in his wrist, which cut off the circulation to two of his fingers, causing gangrene. The tips had to be amputated. Bell was released in Oct. 14, 2003, and sued the hospital for medical malpractice.

An appellate court agreed with a Compton Superior Court jury, which found that the hospital was negligent when it released Bell and that it waited too long to treat him when he came back with possibly life-threatening complications. The 2nd District Court of Appeal upheld the jury's $150,000 award for pain and suffering to Bell when he was a patient at Harbor-UCLA. California law caps medical malpractice awards for pain and suffering at $250,000. While he hoped the jury would award his client more, attorney Philip Kent Cohen said he was glad that the hospital was held accountable and that the appellate justices vindicated the claim. Cohen said the hospital offered about $10,000 to settle the case before trial. It's rare that such a case goes to trial.


Lawmakers Look to Improve Prescription Drug Safety through User Fee Reauthorization Legislation

The House later this month will be debating the reauthorization of the Prescription Drug User Fee Act. Since its passage in 1992 it has significantly sped up the FDA approval times for new prescription drugs. The Senate recently approved a bill (S 1082) that includes a five-year reauthorization of PDUFA. About 50% of new prescription drugs now first become available in the U.S., up from about 8% in the decade before PDUFA was passed. Moreover, the average FDA approval time for standard drugs fell to 14 months from 22 months between 1993 and 2003. PDUFA also has resulted in the number of FDA workers who review new drugs nearly doubling since 1992. However, many experts argue that PDUFA needs to be reformed by significantly increasing funding for the surveillance of drugs after they have reached the market. Part of the funding would do well to be spent on large databases maintained by CMS and private insurers that can be analyzed by computer programs to identify potential safety concerns with drugs on the market more quickly than the current method of risk identification, in which government regulators wait to receive reports about observed risks. Other experts argue that the FDA's reliance on funding from the pharmaceutical industry has the potential to compromise the agency's ability to monitor drug safety. In response the agency has requested $393 million in user fees for 2008, $87 million more than this year. The danger is the FDA's dependence on industry funding might corrupt the agency in subtle ways.


July 11, 2007

Bayer HealthCare Pharmaceuticals report on Magnevist use in NSF victims

As of May 31, 2007, Bayer HealthCare Pharmaceuticals and its parent company have received 78 reports where patients purportedly developed NSF following Magnevist administration, and all these reports have been filed with the Health Authorities. Onset of NSF signs and symptoms in the reports dates back up to several years, and the time span between the administration of MR contrast medium and the occurrence of signs and symptoms ranges between several days and several years. In terms of standardized causality assessments, 27 of the 78 reports have been assessed as "possibly" related to the administration of Magnevist; 46 have been assessed as "unclassifiable" since currently available information is not sufficient to verify the diagnosis of NSF by deep skin biopsy and histopathology and/or to link the cases exclusively to the administration of Magnevist; and 5 have been assessed as "unlikely" to be related to the administration of Magnevist.


The NSF Registry

The Centers for Disease Control and Prevention (CDC) co-investigated cases of NFD/NSF with doctors from the University of California in San Francisco when the disorder was first identified. Since then, the investigative effort has moved to Yale University. Dr. Shawn Cowper is currently in charge of confirming and investigating cases of NSF. The NSF Registry is a project that collects and organizes information about patients with NSF from all over the world. The goal of the project is to identify factors that may be related to or causative of NSF. In addition, information about treatment successes and failures will be collected in order to try to find effective therapies and design future medication/therapy trials. In order to ensure that the data collected in the registry are accurate, it is important to first confirm the diagnosis. Several conditions resemble NSF, and these must be excluded from the data collection effort.


The International Center for NFD/NSF Research (ICNFDR)

The ICNFDR is a new designation for a collaborating group of researchers based at Yale University who are involved with NSF research. The team consists of physicians and basic science researchers from several disciplines who have committed to working together in the search for the cause, treatment, and eventual eradication of NSF. The heart of the project is the NSF Registry, a direct offshoot of the original CDC investigation that began in California several years ago. Until recently, the Centers for Disease Control have not been involved in NSF investigation. Cases reported to the Food and Drug Administration are not necessarily fully reported to the ICNFDR, and vice versa. Ideally, all cases should be reported to both organizations.

The goals of the ICNFDR are as follows:

1) Identification and diagnosis of individual cases of NSF (contacts via physicians and patients)

2) Informing the public and physicians about NSF (website, publication, lectures)

3) Researching the pathophysiology of NSF (lab studies, clinical studies, collaboration)

4) Clinical trials of promising therapies


New Jersey Judge Rules Federal Law Does Not Bar Lawsuits Alleging Wyeth Did Not Warn About HRT Prempro's Risks

New Jersey Superior Court Judge Bryan Garruto on Wednesday ruled a federal law giving FDA the exclusive right to determine whether a drug's label or package insert has adequate health risk information does not bar state lawsuits alleging that drug companies did not adequately warn about the medication's risk. The ruling comes in response to a suit filed by Ellen Deutsch of Livingston, N.J., who took Wyeth's hormone replacement therapy Prempro from 1996 to 2002, as well as the company's earlier menopause treatment Premarin. Deutsch is alleging that the drugs caused her to develop breast cancer. Pharmaceutical companies since at least early 2006 have said that product liability suits are barred because of the federal Food, Drug and Cosmetic Act, but Garruto's ruling is at least the third by state and federal judges that says the law does not pre-empt such suits. Garruto's ruling will allow Deutsch's case to proceed and also likely will help other plaintiffs who have filed suits against drug makers. Deutsch's attorney, Esther Berezofsky, said, "The point is, a drug being approved by the FDA does not protect drug companies from being sued," adding, "The FDA regulations (on label warning) are a floor, not a ceiling."


July 10, 2007

Prognosis for some NSF patients

Nephrogenic Systemic Fibrosis is a rare and relatively recent diagnosis for people suffering from renal failure and who have been exposed to gadolinium-containing MRI contrast agents, the natural history of the disease is not well understood. Some patients report a gradual improvement in mobility and slight softening of the skin over time. Complete spontaneous healing in a patient with ongoing kidney disease has not yet been reported. Several patients with NSF have died as a result of complications of their kidney disease or transplant surgery. One patient, who elected to discontinue dialysis, had widespread fibrosis involving the diaphragm, psoas muscles, proximal esophagus and intimal areas of vessels of the kidney and lungs. Some patients with NSF (estimated at 5% or less) have an exceedingly rapid and fulminant disease course that may result in death. NSF, by itself, is not a cause of death, but may contribute to death by restricting effective ventilation, or by restricting mobility to the point of causing an accidental fall that may be further exacerbated by fractures and clotting complications.


Some specific conditions associated with NSF

NSF appears to affect males and females in approximately equal numbers. NSF has been confirmed in children and the elderly, but tends to affect the middle-aged most commonly. It has been identified in patients from a variety of ethnic backgrounds and from North America, Europe, and Asia. Besides kidney disease, conditions that may be associated with NSF include coagulation abnormalities and deep venous thrombosis, recent surgery (particularly vascular surgery), recent failure of a transplanted kidney and sudden onset kidney disease with severe swelling of the extremities. It is very common for the NSF patient to have undergone a vascular surgical procedure (such as angioplasty of a blood vessel) or to have experienced a thrombotic episode (thrombotic loss of a transplant or deep venous thrombosis) approximately two weeks before the onset of the skin changes. The associated conditions frequently confirm the use of gadolinium-enhanced MRI or MRA studies.


Treatment options for NSF sufferers

While there is no consistently successful treatment for NSF, improving renal function seems to slow or arrest NSF (and in many cases allows for gradual reversal of the process over time).

Treatments that have been tried and continue to be investigated include:

Oral steroids (prednisone): Has had some effectiveness. Patients with diabetes should be aware of the risks of hyperglycemia and gastrointestinal ulceration. Additionally, there is a possibility of osteoporosis being accelerated, sometimes creating a rapid calcium wasting state.

Topical Dovonex: Some patients report improvement in localized areas. The combination of occluded dovonex and clobetasol with vascular compression stockings has reportedly been of benefit.

Extracorporeal photopheresis (ECP): A recent article describes three patients in Europe who responded with softening of plaques after several courses of ECP. This treatment is currently under investigation, although no formal trials are yet offered.

Plasmapheresis: One study from Loma Linda University reported improvement in three patients with liver/kidney transplant. Some persons have reported slight improvement following plasmapheresis. Several others have been reported who noted no improvement.

Thalidomide: There are no formal reports on the success of this medication in NSF. However, some patients have reported subjective improvement. Long term tolerance of the drug may be an issue, however. There have been two reports among Registry patients of development of NSF in patients already taking thalidomide for other medical problems.

Ultraviolet therapy: No reports of success have surfaced. PUVA in combination with Soriatane and prednisone has been helpful in two patients.

Physical therapy (PT): Some patients have reported that physical therapy, in particular, swimming, may be helpful in slowing the progression of joint contractures. Deep massage has been reported to be of benefit.

Pentoxifylline (PXF): A recent report describes two NSF patients who received 1200 mg per day of oral pentoxifylline. Both patients stabilized, and the one with less severe disease improved somewhat. The use of PXF is theoretically justified as it has known antifibrotic activity. In addition, PXF is known to improve red blood cell flexibility, and therefore to improve circulation. As thrombosis seems to be an event for many NSF patients, it could also be partially responsible for the improvements noted clinically. Many more patients will need to be treated to further evaluate the efficacy of this drug.

High Dose Intravenous Ig Therapy: One patient showed objective improvements with one cycle of therapy with this medication. Further improvement with additional cycles was not observed.

Renal transplantation: Several patients have improved significantly with a return to normal kidney function (either as a result of transplantation or medical therapy). In other cases, kidney transplant has resulted in no obvious improvement of the lesions, even with a fully functioning, successfully transplanted organ.


Man overcomes TBI, loss of memory and now blogs to remember

Bob Westbrook on the way to visiting his grandmother, fell asleep at the wheel and turned his car end over end (not the usual rollover moving side to side) the traumatic brain injury (TBI) that occurred left him not knowing who he was, where he was from or what he did for a living. Remarkably, this was his fourth brain injury. His first TBI came when he was a boy in and drove a motorcycle into a parked car while going 45 mph, resulting in a broken neck and concussion. His head injury would go undiagnosed. Years later while trimming trees he fell from a ladder and broke his back and neck. Later, while working in a warehouse he fell 20 feet off a pallet which caused him to become belligerent and angry, one of the symptoms of TBI: personality change. His brain injuries weren’t diagnosed until the car accident in Oklahoma and until after he spent time living on the streets of St. Louis. Westbrook wandered aimlessly, trying to remember his life and ultimately landed in a hospital where his injury was finally officially determined.


Bob Westbrook keeps three blogs. The first thing noticeable about Westbrook’s blogs is that they do not read like other blogs. Detailed and with lengthy entries almost every day, Westbrook has an objective most other bloggers do not: he blogs so that he can remember. Bob has recovered from a lot of the memory loss he suffered six years ago, but still suffers from short-term memory loss and the resultant effects that have come with it. He also suffers from partial seizures. Making decisions is particularly hard, on a rough day it can be hard to decide where to set a spoon down. Going into a store is difficult because his brain tries to process the myriad of input around him. The crowds, the intercom, the many and then shelves full of products. He tries to continue moving through each day with as little confusion as possible. When it does get confusing, he writes his blogs. “This is a picture of what my daily life is and the problems I must overcome. It is all typical for people with traumatic brain injury,” he said. “My condition is the result of the decisions I have made, and a man reaps what he sows. I understand that I did this to myself so I accept it and do the best I can with what I have. No matter how you look at it, my life is a gift and every day that I wake up is a blessing.”


July 09, 2007

Brain injury survivor named to NM Brain Injury Advisory Council

While on the outside, Joe Zamora of Silver City NM may appear to be a man thriving at 47, he is actually plagued by invisible demons and one of 5.3 million Americans who suffer from a traumatic brain injury (TBI). Frequently Zamora strains to remember something as simple as where he was going and halfway through a sentence his thoughts disappear into thin air. He recently returned from a trek by foot of nearly 400 miles, from Deming to Chimayo bearing a wooden cross the entire way. The cross bore the names of brain injury survivors who, like Zamora, struggle to piece back together a life. Zamora's story began three years ago in Deming while attending a funeral for a family member. After the services, the family joined together at a relative's home and Zamora took the opportunity to go bareback riding. The details of exactly how Zamora was bucked from the horse are vague because he is the only witness and his memory of the event fleeting. His skull was crushed and doctors worked on him for hours piecing his skull together and relieving pressure from internal bleeding. He was in a coma for eight days.

Since his injury and his walk, Zamora has been named to the state's Brain Injury Advisory Council by Gov. Bill Richardson, he's been traveling and learning and spreading the word about TBI, the invisible disease, including being featured in the film "Every 21 seconds: Or why I scream at the refrigerator." 21 seconds being how often an American suffers a TBI. The film details the lives of eight TBI survivors. More recently, Zamora has been named a spokesman for the 10 in 10 Project, a new national, non-profit aimed at getting help for veterans, the fastest-growing number of TBI survivors.


Malpractice and the 3Rs: Recognize, Respond, and Resolve

During a surgical procedure in February, a malfunctioning medical device tore the lining in Carrie Maddox's abdomen. The mistake caused weeks of internal bleeding, required additional surgery and resulted in another $15,000 in medical expenses. Instead of suing her doctor to recover the costs, Maddox took part in a unique insurance program being used in Colorado by Copic Insurance Co., an entity that provides medical malpractice insurance to more than 80 percent of privately insured physicians in the state. "I didn't want to go after my doctor for millions of dollars," said Maddox, 40, an administrative assistant at a law firm. "All I wanted to do was solve the financial issues."

The insurance initiative, known as the "3Rs" program, encourages doctors to disclose medical errors to patients. It also allows the patients to receive financial compensation for the additional medical expenses without having to go to court. The Copic program is being looked at as a model by insurers in other states and received praise in the most recent issue of The New England Journal of Medicine. The 3Rs program, which stands for "Recognize, Respond and Resolve," is regarded as "the best-known private-sector disclosure program" in the nation, according to the article. The program, which started in 2000, provides patients with up to $30,000 in compensation for out-of-pocket health care costs and loss of time that results from medical errors. The program also provides training for physicians which encourages them to disclose errors to patients. Dr. Alan Lembitz, a vice president with Denver-based Copic, said that about half of the 6,000 physicians insured through Copic statewide are enrolled in the 3Rs program. He said it is unclear if the program has helped rein in malpractice premiums, which have remained unchanged during the past two years for Copic physicians. Nonetheless, he said, it is clear that the program has not resulted in additional costs or premium increases, as some critics had predicted. He said the program is a no-fault process, which means Copic does not investigate whether the physician was negligent. However, instances of obvious negligence are not eligible for the program. Patients using the Copic program would not waive their right to sue the physician, rather, it allows patients to recover financial losses without the added stress of a protracted legal battle.


Pennsylvania Patient Safety Authority Releases Wrong Site Surgery Data

Wrong-site surgery data received by the Patient Safety Authority shows that every other day in Pennsylvania healthcare facilities an actual adverse event or near miss of a wrong-site surgery occurs. According to Dr. Stan Smullens, chief medical officer of the Jefferson Health System and vice-president of the Patient Safety Authority Board of Directors, wrong-site surgeries are no more common in Pennsylvania than they are in other states. In short, Pennsylvania is not an exception. In a 30-month time period (June 2004 -December 2006) the Authority received 427 near misses and serious events of wrong-site surgeries. Of those, 253 were near misses or did not reach the patient. Of those events that reached the patient in the operating room, sixty-nine percent were wrong site surgeries, fourteen percent were wrong body part surgeries, nine percent were wrong procedure and eight percent were wrong patient.

"Patient safety is an integral part of every hospital's mission-patient safety starts with leadership and is carried through to every person in the organization. Patient safety must be owned, valued, tested and constantly improved," said Carolyn F. Scanlon, President and Chief Executive Officer of The Hospital & Healthsystem Association of Pennsylvania. "As partners with the Patient Safety Authority, committed to ongoing education and collaboration to reduce medical errors and create environments for learning and improving care, we support the Authority's work on the issue of wrong-site surgery. While a rare event in health care, wrong site surgery has far-reaching consequences for patients and caregivers. The Patient Safety Advisory points to multiple risk factors and system breakdowns that can occur in the complex world of medicine. And from this information, hospitals and health systems will continue to improve their protocols and practices to ensure such devastating mistakes do not occur."


July 08, 2007

Professor studying brain injuries from 1995 bombing to help soldiers

A Colorado State University professor's research on traumatic brain injuries among Oklahoma City bombing survivors could also have implications for injured soldiers. The Oklahoma State Department of Health asked Pat Sample, an occupational therapy professor at CSU, to study the effects of the 1995 bombing, which killed 168 people and injured more than 800 when a bomb rocked the Alfred P. Murrah Federal Building. Sample was the best choice for the study because of her experience in the TBI field. Sample specializes in studying the effects of traumatic brain injuries.

The health department got a grant from the Centers for Disease Control and Prevention to do the study, which aims to assess the effects of brain injuries among the survivors. The study was commissioned in 2005, the 10-year anniversary of the bombing, and started last summer. The purpose of the study is "to find out what kind of health and medical needs those people (have) after 10 years since the bombing," Sample said. She said hospital records showed that about 45 people suffered brain injuries in the bombing, but after 10 years only half of them could be found to interview. "Some of them had had many surgeries," Sample said. "One man has had at least 50 surgeries." Sample said the symptoms of brain injuries, such as memory problems, getting tired and having difficulty finding proper words when speaking, were common among the survivors.

"The goal of the study is that the medical community and community services know that brain injuries are so much more than just a few weeks," Sample said. Sample said brain injuries have become more common, with more American soldiers suffering from them in explosions in Iraq. She said her findings will help medical staff and people who are working or living with a brain-injured person gain a better understanding of what the long-term needs of those people are. "We hope to publish the information so that people would be able to learn about this terrorist attack and know about the traumatic brain injuries," Oklahoma's Archer said. "A lot of brain-injured survivors still have needs and there is definitely a lot to be done."


Do Pediatricians Face A Malpractice Crisis?

In the first systematic multi-year analysis of malpractice claims solely against pediatricians, researchers from the Indiana University School of Medicine report in the July issue of the journal Pediatrics that the answer is neither yes nor no. “We studied pediatricians and malpractice because while the medical malpractice issue is extremely stressful and gets a lot of press, and we all have heard numerous horror stories and anecdotes, there is little actual data reported, especially for pediatricians. So we took a retrospective, comprehensive look at malpractice claims against pediatricians. Surprisingly, we found that from 1985-2005 society hasn't become more litigious, at least not against pediatricians,” said Aaron E. Carroll, assistant professor of pediatrics at the IU School of Medicine and a Regenstrief Institute, Inc. affiliated scientist.


Dr. Carroll looked at the two decades of malpractice claims data and found that 68% of malpractice cases against pediatricians were withdrawn or dismissed. Only 5% of malpractice suits against pediatricians went to trial, and of these 4 out of 5 were found in favor of the pediatrician. Although children are responsible for a large percentage of healthcare consumption, he found that pediatricians accounted for only 2.97% of all malpractice claims. During the 20-year period, 214,226 closed malpractice claims were reported to a database maintained by the Physician Insurer Association of America, a trade association of medical malpractice insurance companies. Together, these companies insure approximately 60% of all private practicing physicians and surgeons in the United States. Pediatrics ranked 7th in terms of 28 specialties in settlements or awards made directly to plaintiffs as a result of claim-resolution process. Slightly more than a quarter of all claims against pediatricians were settled for the plaintiff before going to trial, often because settlement costs less than the median cost of going to trial at $40,000.

"Malpractice is a serious issue. Some will read the results of this analysis and draw comfort; others will view the same data with alarm and surprise. Regardless of how one interprets these findings, they are important in truly informing the debate with generalizable facts," the study concluded.


Worker Injured in Ladder Fall Recovering

54-year-old Joseph Martinez of Aurora, CO, is a cement finisher by trade and an ex-Marine who teaches karate. He was injured in a construction accident two months ago after falling 15-feet off a ladder onto concrete inside a Denver Water pump station under construction. He landed on his feet and broke his femur, heel and a bone in his spine. "The last few feet was like slow motion. When I hit, I heard it go crush." In the past few days he's been learning how to walk again. It took firefighters 45 minutes to rescue him. "They couldn't get to me. They had to climb up 30 feet, then down 30 feet, then walk over to get me," says Martinez. He said the firefighters helped comfort him during a very scary situation. "He kept hearing me go, 'hoowa' because it hurt. And he said, 'You're a Marine aren't you?' I said, 'Yes.' He said, 'Semper Fi,' which means always faithful." Martinez hopes to be out of the care center in two weeks.


July 07, 2007

New York awards grant to the Brain Injury Association Of New York State (BIANYS)

New York State Developmental Disabilities Planning Council (DDPC) announced an award of $150,000 to the Brain Injury Association Of New York State (BIANYS) to establish and sustain a web-based resource for families and school district personnel working with students with Acquired and Traumatic Brain Injury. BIANYS and the DDPC recognize that successful life transitions for students with TBI require very specific knowledge and awareness of brain injury. It was also well established that teachers and parents do not have enough resources to address the needs of students with TBI. This grant will develop a sustainable website called Project LEARNET that can be utilized by parents and teachers as a resource when looking for the best solution to a variety of problems involving students with brain injuries. School personnel that have used Project LEARNET’s problem solving assessments have noted that this approach benefits the students by engaging them and it helps the staff to be analytical and systematic, resulting in far more useful ideas.


Israeli developed drug could minimize brain damage after head trauma

A Weizmann Institute of Science researcher is developing a drug that, by removing toxic amounts of a chemical produced during the trauma, could drastically reduce damage to the brain. Professor Vivian Teichberg of the Weizmann Institute's Department of Neurobiology, who’s field is in neuropharmacology is a chemist by training and searches for drug-mediated solutions to brain diseases. His focus is a neurotransmitter called glutamate, a chemical that relays messages between brain cells. Glutamate plays a vital role in the functioning of the brain, but it also has a dark side: "When you suffer a head trauma or a stroke, the brain reacts in a negative way," Teichberg says. "One of the consequences is the release of glutamate: when a cell dies it releases a large amount of glutamate, which over-excites neighboring cells and kills them." This is a chain reaction which leads to the deaths of many more cells than just those directly affected by the head injury or blood clot. While the core brain cells can't be saved, those cells that would be killed by the excess glutamate can be if reached in time.

Many researchers world-wide have been working on this problem for several decades, trying to develop drugs that block the glutamate from activating receptors on the still healthy brain cells near the site of the injury which would lead to their death. Teichberg decided to take a different approach. Teichberg and his team, working together with Prof. Yoram Shapira and Dr Alexander Zlotnik of the Soroka Medical Center and Ben Gurion University of the Negev, decided to tackle the problem by pumping the excess glutamate out of the brain. Teichberg's idea was to move the excess glutamate from the brain into the blood, which would then carry it safely away and prevent its destructive effects. There is already glutamate in our blood and so the problem was how to encourage far greater amounts of the chemical to move from the brain into the blood rapidly after brain injury so as to prevent as much cell death as possible. There is an enzyme present in blood, known as GOT, which is able to break down glutamate in the presence of a chemical called oxaloacetate (O). Teichberg figured that by injecting large amounts of O into the bloodstream, this would drive more glutamate from the brain into the bloodstream. "After a head injury, you give one injection of O for a short, intense time of thirty minutes, and this drains excess glutamate from the brain into the blood and protects the brain."

The method has been very successful in rats and a start-up company, Braintact, has been established within the Meytav life science technology incubator in Kiryat Shmona in northern Israel in order to take the research to the next stage: clinical trials on humans. However, humans don't have high enough concentrations of GOT in our blood so it is the combination of O and the enzyme GOT that will be injected into the bloodstream in human trials to see if this drives glutamate out of the brain in a similar way and prevents brain damage after a stroke or head injury. because brain injuries and conditions are so widespread and there is no current treatment for the problem of toxic glutamate, the US Food and Drug Administration (FDA) is allowing the trials to be "fast-tracked" through the initial processes for the investigation of a potential new drug, says Teichberg, who acts as a consultant to Braintact. He hopes that the first phase of clinical trials will start in four months. If all goes well, and human trials demonstrate the efficacy of this drug, it could be on the market within a decade.


Child awarded large damages over medical care in California

A Superior Court civil jury has awarded an estimated $96 million in future damages in the case of a child who developed a rare but serious neurological disorder caused by untreated jaundice shortly after his birth four years ago. The jury's 9-3 verdict is calculated in two ways. The current value of the award is $15 million, but it is expected to reach $96 million over the course of medical care for the boy during his lifetime, said attorneys for Aidan Ming-Ho Leung. That would make it one of the largest jury awards in recent California court history. Aidan was born March 24, 2003, at Verdugo Hills Hospital under the care of Dr. Steven Wayne Nishibayashi, who also was listed as a defendant in the case. According to the lawsuit, Aidan exhibited several risk factors for kernicterus, a neurological disorder that can cause mental retardation, cerebral palsy and hearing loss, when he developed jaundice shortly after birth. The jaundice was a sign of the buildup of bilirubin, a yellow bile pigment, produced in greater quantities than a baby's liver can excrete. Aidan, now 4, requires constant medical attention, said Phan, whose firm employs Aidan's father. "He has normal intelligence, but he can't walk. He can't talk, can't feed himself. He can't control a single muscle and it was all preventable," Phan said.

The hospital presented a dramatically different version of events. Thomas said that Aidan was born healthy and that his mother requested a discharge from the hospital while he was still in excellent health. When she left with Aidan, the baby was then beyond the hospital's responsibility, Thomas said. "It's the hospital's position that they did nothing wrong and that all follow-up care was out of their hands," Thomas said.

Lawyers USA Online, which covers court decisions, legislation and litigation trends, said the largest California verdict last year was a $106-million award to the family of a murder victim seeking to prevent a defendant from profiting from book or movie deals. That award was reduced to $16 million and is on appeal. California has a $250,000 cap on medical malpractice awards. It was unclear how the limit would affect the jury’s award.


Gov Blagojevich of IL announces landmark TBI and PTSD program for Illinois Veterans

Governor Rod R. Blagojevich was joined by Tammy Duckworth, Director of the Illinois Department of Veterans’ Affairs (IDVA) on July 3rd to announce a first-of-its-kind program to screen every returning Illinois National Guard member for traumatic brain injury, offer TBI screening to Illinois Veterans and 24-hour toll-free psychological assistance for Veterans suffering from PTSD. The program increases health care benefits for Veterans and will later become part of the Governor’s Illinois Covered insurance plan. The program will work in two parts: The TBI portion will mandate screening for all Illinois National Guard members returning from deployment and offer free screening to all Illinois Veterans, especially those returning from Operation Enduring Freedom and Operation Iraqi Freedom. The PTSD portion will offer 24-hour, toll-free psychological assistance to give Veterans suffering from PTSD a place to turn, day or night, for help. The announcement makes Illinois the first state in the nation to establish a statewide TBI program offering screenings for all Veterans and mandatory screening for Illinois Army National Guard members.

The Illinois Department of Veterans’ Affairs (IDVA) and the Illinois Department of Healthcare and Family Services (HFS) will be working with the Rehabilitation Institute of Chicago (RIC) to implement the screening tool for TBI. The tool was created by Dr. Elliot Roth, Senior Vice President, Medical Director, and Felise Zollman, Medical Director of the Brain Injury Program at RIC. The screening will take approximately 20-30 minutes. The program will offer mandatory screenings for Illinois Army National Guard and the option for all returning Illinois Veterans, especially those returning from Operation Enduring Freedom and Operation Iraqi Freedom. TBI shares many of the same symptoms as PTSD so healthcare professionals often misdiagnose mild traumatic brain injuries for PTSD. This misdiagnosis becomes problematic because TBI and PTSD are treated differently. The screening will assist clinicians in diagnosing the service member and refer them for further TBI screening if needed.


Avandia May Get Bone Warning

GlaxoSmithKline diabetes drug Avandia (thiazolidinedione), already linked to heart ailments may get a warning label from U.S. regulators to reflect increased risks of bone fractures. Two tests linked the drug to broken bones in women. A trial in the June issue of Diabetes Care found that men on the product for an average of 16 months had lower bone mineral density in the spine and hips as well. Morgan Stanley's Andrew Baum said the new data will add to concerns about fractures. Researchers from the VA Medical Center and Louisiana State University in Shreveport, suggest that Avandia treatment is a risk and can contribute to a higher incidence of fractures. Baum said Avandia is “almost certain” to get a new warning about fracture risks in women on its label. An advisory panel of the U.S. Food and Drug Administration is scheduled to discuss Avandia at a meeting on July 30.

Glaxo said in an e-mailed statement that the study's conclusions were “limited” and the clinical relevance unknown. A study funded by Glaxo and published in the New England Journal last year, found an increased risk of fractures in the hands and feet of women, but not in men. “The study is a retrospective study of bone density involving very low patient numbers,” Glaxo said of the Diabetes Care study. “It does not correct for potential confounding factors, such as age, other medical conditions, duration of diabetes, and medications that could affect bone density.”


University of Cincinnati receives $1.7M to research molecular treatment of brain injury

The National Institutes of Health has awarded $1.7 million to a University of Cincinnati scientist for molecular research that could lead to better treatments for brain injury patients. Kenneth Strauss, PhD, will study two types of molecules known as eicosanoids (eye-KO’-sa-noids), which are created by injured brain cells, to confirm that they can actually protect healthy brain cells from further damage. If successful, Strauss’s research could lead to a new class of drugs designed to enhance the levels of these helpful molecules, and thereby improve outcomes in patients who have suffered traumatic brain injury. When the brain suffers traumatic injury, Strauss explains, it automatically takes self-protective action. The brain cells release arachidonic acid, which triggers a series of events that draw additional cells to the injured site. While some of the compounds resulting from the initial trauma appear to be protective and to inhibit harmful inflammation, Strauss says, others are harmful if they remain for too long. Their fight to save the injured brain can spill over into nearby areas, damaging neighboring structures. Strauss and other researchers previously found that the enzyme COX-2 is one of the contributors to harmful inflammation. COX-2 increases following injury and, to the brain’s detriment, remains elevated for many days. Thus far doctors have been unable to prevent or manipulate these progressive changes that follow traumatic brain injury.

Strauss had originally been studying the potential of the arthritis drug Vioxx, a COX-2 inhibitor, for reducing inflammation in the injured brain. His plan was shelved when Merck withdrew Vioxx in 2004 after clinical trials showed that long-term use increased the risk of heart attack and stroke. Strauss then shifted his focus from suppression of the harmful COX-2 enzyme to the potential for elevating two theoretically helpful eicosanoids, known as “HETEs” and “EETs. We believe eicosanoids reduce the number of inflammatory cells that fester around the injury site and cause chronic tissue degeneration,” Strauss says. “We think this plays a role in impairment not only after trauma, but also after other brain injuries, including strokes, seizures and the chronic neurodegenerative conditions like Alzheimer’s disease.” Strauss hypothesizes that manipulating the chemistry of the injured brain cells to favor the creation of the beneficial eicosanoids will aid recovery from traumatic brain injury. These compounds could set the stage for the development of drugs that would benefit traumatic brain injury patients.


July 06, 2007

Wading Pool Drain Injures Minnesota Girl

Six-year-old Abigail Taylor was playing in the wading pool at the Minneapolis Golf Club, when she sat on an open drain hole. The powerful suction from the drain tore a two-inch opening in her rectum, then pulled out part of her intestinal tract. Doctors at Children's Hospital had to remove what remained of her intestines. Abigail's family contends that the drain hole was improperly covered, but the golf club's general manager said he didn't think anything was wrong with the pool.

Since the 1980's, there have been at least 147 documented incidents of suction entrapment in swimming pools, including 36 deaths. Suction entrapment occurs when a swimmer, often a small child, is trapped by the suction created when water rushes out of the drain at the bottom of the pool. Sometimes the swimmer is trapped underwater until they drown, and others suffer serious injuries to various parts of their bodies.

The pool industry has included drains in swimming pool designs for a long time, believing that they're required to provide circulation throughout the pool, prevent stagnation, and remove contaminants. But if drains can cause debilitating injuries and death, are they really necessary? One expert says no.

Ray Cronise, Co-Founder of Trilogy Pools, says that the premise under which drains were included on most pools is faulty. He believes that death and injuries caused by suction entrapment can be completely eliminated, without any negative effects, simply by sealing the drains in existing pools and not building them into new pools. Working with an expert in computation fluid dynamics, Cronise built a simulation to track contaminants in various areas of the pool, and tracked the amount of time needed to remove them using the pool's circulation system, with and without a drain.

The simulations showed that, for the first 1,000 seconds, contaminant levels in pools without drains are actually lower than pools with drains. After the 1,000 second mark, the contaminant levels were the same, whether or not a drain was used. Cronise acknowledged that in the past, circulation of water in a pool was diffult to see and impossible to measure, then concluded, "But CFD simulation clearly shows that drains not only are not necessary, but they do not improve the circulation in a pool or enable its ability to clear contamination."

The Consumer Product Safety Commission (CPSC) recommends that pools be inspected to be sure appropriate drain covers are in place, and that missing or broken drain covers be replaced, as they are a major reason many entrapment incidents occur.

Also, the CPSC says that pool and spa owners can consider installing a Safety Vacuum Release System (SVRS), which detects when a drain is blocked and automatically shuts off the pool pump or interrupts the water circulation to prevent an entrapment.


Don't become a traumatic brain injury statistic

Let’s focus on ways to prevent or reduce the risk of damaging the brain. The statistics for traumatic brain injuries are staggering, 50,000 die, 90,000 are left with long-term disability. Traumatic brain injury can permanently and tragically change lives in an instant. What's the significance of the numbers for us? Statistics can wow us with percentages and tell us how many of what occur each second, minute, day, year, but honestly, what does it do for you? What kind of personal risk do you face and how can you not become a brain injury statistic? Understanding what the numbers really mean might be the first step in motivating you to make some easy lifestyle changes to avoid brain injury. First though, remember that brain injury is what most of us would group together with all head injuries. It's more specific than that. We can bump our heads without suffering brain injury. Because of the complexity of the brain, the loss of function covers a nearly endless arena. The changes that can result from brain injury can be divided into three main categories: Physical, cognitive and behavioral.

Physical changes may include problems with vision or speech, decreased coordination, muscle spasticity, paralysis, seizures, sleeping difficulties, difficulty swallowing, speaking and more. The cognitive (thinking) deficits might include long- and short-term memory problems, slow thinking, difficulty reading or writing, attention and concentration issues, difficulties with perception, communication, reasoning, judgment and problem solving. Behavioral changes often include mood swings, depression, anxiety, difficulty with self-esteem and motivation, sexual dysfunction, restlessness, impatience, irritability, agitation, inappropriate laughing or crying, anger control issues, violence, delusions and more.

How can you reduce the risk of traumatic brain injury for you or your loved ones? You can start by using a seatbelt and wearing the right helmet for a particular sport or activity and wearing it correctly. Ensure that rooms in your home have good lighting, get rid of throw rugs or use the non-slip fabric underneath or double-sided carpet tape; check carpeting on stairs for fraying or loose parts; be sure that all stairways have strong and sturdy hand rails. Keep the floor and grounds at home clear of tripping hazards, such as shoes by the stairs, toys and books. In the bathroom, install hand grip bars near the toilet and tub. At the playground, check the ground for adequate, intact padding. Keep firearms unloaded and locked. Many traumatic brain injuries are the result of accidental gunshot wounds. Check ride-on toys and sports equipment for safety before your children use them. The majority of traumatic brain injuries that occur annually are preventable; particularly those caused primarily by falls and motor vehicle accidents. Your actions or inactions will directly affect your risk.


People Tell Their Stories of Traumatic Brain Injury

Yvonne Hoffman used to be a lot of things: a suicide prevention and hot line counselor; an emergency room and hospice volunteer; a religious group president; a corporate employee; and most recently, an owner of an interior decorating business. However, that all changed when Hoffman walked her dog six months ago, misjudged her step, fell and suffered a traumatic brain injury. Months later, Hoffman sometimes finds herself in a controlled panic, unable to formulate words and suffering from migraines and other serious problems. "My treatment sessions have ended and I am so scared," she says, referring to the end of her insurance coverage of her TBI-related care. Hoffman was among several TBI patients who told their stories recently at Civilian Traumatic Brain Injury: The Other Story at the National Press Club, Washington, D.C., An event sponsored by the American Speech-Language Hearing Association. Like Hoffman, Carolyn McCormack, another TBI patient who spoke, knows what it is like and is also in danger of losing TBI care because of inadequate insurance coverage. McCormack, a former business owner from Montana, suffered a TBI in a car crash. As a result, she suffers from headaches, memory loss, and confusion, which ultimately forced her to give up her business and then sell her home to replace lost income. After her insurance company denied her coverage for related rehabilitation services, McCormack appealed the decision-and won.

ASHA President Noma B. Anderson says access to care can be difficult indeed. According to most polled speech- language pathologists who belong to ASHA and work on rehabilitation care teams, inadequate health insurance coverage hinders recovery. Many insurance companies either provide no coverage of cognitive rehabilitation services, or they offer very limited coverage of the services. Specific problems can include plans, which allow too few care visits. ASHA has been at the forefront of urging insurance companies to expand their coverage, collecting a significant amount of research evidence that clearly supports cognitive rehabilitation provided by speech-language pathologists. ASHA's president says insurance companies, the health care system, and the public all need to become far more informed and accepting about TBI so that it becomes much better known and understood, and treatment for optimal recovery becomes widely available. Anderson adds that ASHA urges the public to see a physician if they are experiencing any kind of problems following a TBI. Individuals need to follow up on a TBI diagnosis by asking their physician to refer them to an SLP if they are having cognitive or communication problems that limit their recovery. Insurance companies need to provide coverage of TBI related rehabilitation services that are conducive to optimal recovery. Individuals with TBI need to demand that their insurance coverage includes TBI rehabilitation services that are conducive to optimal recovery. The public to appeal if they are denied insurance coverage, noting the importance of good record-keeping and having someone who can help the injured by clearly explaining what has happened and assisting them with the appeal process. Family members and friends to become involved if they suspect a loved one is having difficulty recovering from a TBI. The public to take precautions such as making sure young children ride in car seats, and wearing seat belts and safety helmets to protect themselves against brain injuries at work and play. The federal government should invest more research dollars into finding out more about what works in treating TBI.


Victims of brain injuries write to soldiers suffering similar injuries

There are two members of a traumatic brain injury support group who wrote letters of encouragement to U.S. soldiers now coping with war-related brain injuries. The letters were written at a group therapy session sponsored by a Jewish Community Center. Mickey Basner, wrote from experience. He had a stroke two years ago and said he understands the tough road to recovery for soldiers serving in Iraq and Afghanistan who have suffered traumatic brain injuries. Jim Cockren, was in a coma for three weeks after a medical accident. Basner knows there's hope. After two years of limited vision, he can now read a newspaper, he said. Though he walks with a cane and can't climb stairs well, he recalls, "Doctors once thought I would never walk again." In his letter, he assures the unknown soldier there is light at the end of "this long dark tunnel." Cockren, a former optician, said that "writing to someone going through what I went through made me feel a little bit better." A middle aged woman, Nadine, suffered brain injury after contracting encephalitis which led to a coma. She is hopeful as she writes, "That your life, while certainly different now, will bring the appreciation of those things that we were once so busy and didn't notice. Please know that you are not alone and you're not unappreciated."

Officials at Walter Reed Army Medical Center in Washington, D.C., have seen an avalanche of letters from across the nation, and while they welcome support, they urge groups to channel their messages through Web sites such as americasupportsyou.com. Although it's unclear whether hospitalized soldiers have seen the letters by Basner, 70, or Cockren, 53, the act of consoling the soldiers is empowering and therapeutic for members, said Lisa Barnett, a social worker who conducts the sessions. "Our clients felt really good about offering hope to the soldiers," Barnett said. "Writing the letters to soldiers was therapeutic for our people. It was a beautiful exercise."


Catastrophic head injuries in football higher at high school level than college level

The incidence of catastrophic head injuries in football is dramatically higher at the high school level than at the college level, according to a study published in the July issue of The American Journal of Sports Medicine. Catastrophic head injuries, which include brain bleeding and swelling, are rare and can be devastating. Athletes with major brain injuries may be left with permanent brain damage. According to lead author, Barry P. Boden, M.D., from the Orthopedic Center in Rockville, Md., high school football players have more than three times the risk of a catastrophic head injury than their college peers. Boden and coauthors also found a high percentage of high school athletes playing with neurologic symptoms from a previous head injury at the time they sustained a catastrophic injury.

Football has more direct catastrophic injuries than any other sport tracked by the National Center for Catastrophic Sports Injury Research (NCCSIR). More than 1.2 million high school athletes played football during the 2001-2002 academic year. The researchers found that there is approximately one injury per every 150,000 athletes playing or 7 catastrophic injuries yearly. There were 0.67 injuries per 100,000 players at the high school level and 0.21 injuries per 100,000 for college level football players. Dr. Boden suggests that players should be discouraged from using their heads to tackle, since 81% of the injuries were caused by helmet-to-helmet collisions and helmet-to-body collisions. Of the difference in catastrophic head injuries between high school and college players, Boden theorizes: "High school students might take longer to recover from a concussion than college players. Another possible reason for these reported injuries may be that there aren't as many team physicians covering high school games as college games. Consequently, some high school athletes may not be properly evaluated or receive medical attention."


July 05, 2007

Construction Workers Injured in Greenwood Village High-Rise Collapse

Thirteen construction workers from Beck Construction and Concrete Express were injured today when a section of a wet concrete roof collapsed onto the top floor of a luxury high-rise being built in Greenwood Village. All thirteen workers were taken to area hospitals, and some have been released; but four workers are seriously injured.

The high-rise building in The Landmark development at 7677 E. Berry Ave. is part of a residential and retail complex being built near the light-rail station at East Belleview Avenue and I-25. The tower is scheduled to open next spring and will contain shops, restaurants, two residential towers and a high-end, six-screen Landmark Theatres outlet. Condos in the tower will be priced from $500,000 to $2.5 million. Beck Residential is the lead contractor on the job.

Rick Palese of Everest Development said that concrete for a flat roof was being poured by Concrete Express onto a metal sheet that sagged and became detached, pinning one person. Those who were working at lower levels apparently were not injured and were evacuated.

Leonardo Gonzalez, a foreman at the site, said he heard a loud noise and then part of the floor sank. He and eight other workers held on to a railing to avoid falling. Several others fell to the floor below but evidently suffered only scratches. Mr. Gonzales said about 300 workers were on the job at the large high-rise this morning. "Thank God, nothing more serious happened. It could have been a lot worse," he said.


New Jersey company Pharmos settles lawsuits over brain drug

Pharmos Corporation announced on June 8th that it has agreed to settle several class action lawsuits in the US brought because of statements allegedly made by Pharmos regarding the effectiveness of dexanabinol in treating traumatic brain injury. The settlement, which is covered in its entirety by Pharmos' insurance, has been reached with no admission of liability by any party. Pharmos entered into the settlement "to avoid costly and time consuming litigation by all parties," according to the company. The lawsuits commenced in January 2005 and are currently pending in the US District Court for the District of New Jersey. The settlement is subject to court approval.


Research fee for TBI and Spinal Cord Injures May be Unfair

Each year, according to the Centers for Disease Control, more than 1.5 million traumatic brain injuries and 11,000 spinal cord injuries occur. More than 5.3 million people are living with the effects of brain and spinal cord injuries. Some of the injuries have drastically changed lives, stealing mobility, intellect and emotional health. Those studying spinal cord injuries are currently focusing on ways to protect surviving nerve cells, replace and stimulate regrowth of damaged nerve cells and restoring body functions by retraining neural circuits. Research into how to restore brain functions are ongoing as well. Such studies are worthy but the research dollars are tight. Indiana is placing part the responsibility for funding research on the shoulders of Indiana motorcyclists. Beginning July 1, Indiana bikers must pay a $10 surcharge on their motorcycle license fees so the state can raise about $1.6 million for a spinal cord and brain injury fund. Proceeds from the fund will be channeled to state hospitals and universities. The top two causes of spinal cord and traumatic brain injuries are motor vehicles crashes and falls. Since 2000, statistics show that motor vehicle crashes cause 20 percent of the nation's traumatic brain injuries, while falls cause 28 percent of them. So if all motor vehicles are primarily responsible for these injuries, why aren't they charging all motor vehicle owners for the research? If lawmakers think this research worth funding, then they need to find a revenue source that is fair to all.


Holiday fun and risk of catastrophic injury increases

On the Fourth of July in 2003 an explosive ball of fire shot toward Brandon Kemp from an illegal firework, a Roman candle. It struck him just above the right eye and exploded, burning his face and detaching his retina. Covering his face with his hands, 21 year old Kemp tried to contain the blood as his friends scrambled to call 911. Kemp was rushed to the University of Michigan Health System, where doctors operated several times. Doctors there eventually told him he would lose 95 percent of his vision in his right eye.

Fireworks accounted for 9,200 injuries and 11 deaths nationwide last year, reports the U.S. Consumer Safety Commission. National fireworks consumption has risen since the 1970s. More than half of all U.S. fireworks injuries in 2006 were caused by firecrackers and rockets, the commission said. The more catastrophic injuries Dr Greg Walker sees usually come from poor judgment. He recalled one man several years ago who lit a cherry bomb in his mouth. The firecracker blew off nearly half of his face. The scars on Kemp's face are now healed. Plastic surgery has all but erased any physical evidence of his accident. But he said he has trouble finding work and adjusting to his loss of depth perception. Still, he will celebrate this year's Independence Day anyway. He just won't light any Roman candles. "Ever since then, I stay away from fireworks at all costs," he said. "Just be as careful as you can."


July 04, 2007

Clubhouse garden helps with healing for TBI victims

Twenty-five years ago, Nancy Knight had a heart attack that resulted in a loss of oxygen to her brain. Nancy was once a talented seamstress who crafted sails for sailboats on the East Coast, but her injury left her unable to do many of the everyday tasks she once had taken for granted. Sewing and gardening, two of her loves, suddenly were out of reach. This spring, for the first time in years, Nancy has been able to plant flowers and tend a garden plot, thanks to the Ballinger TBI Clubhouse garden in Akron Ohio. Although the clubhouse is the only one of its kind in the Akron area, 20 are in operation across the country. It is a nonprofit, faith-based organization offering long-term support in a non-medical setting to people with traumatic brain injuries (TBI) who want to keep their independence.

Three days a week, Nancy and a dozen other clubhouse members gather to cook meals, take field trips and work on life skills, with the help and support of clubhouse staffers and volunteers. In this family like setting, club members also share stories and jokes and enjoy the company of others who can appreciate what it's like to live with a traumatic brain injury. The Ballinger TBI Clubhouse was founded in 2003 by Betty Bacalu, whose son Lloyd suffered a brain injury in a car accident nearly 10 years ago. Betty, along with a small group of TBI survivors and their families, attended a TBI conference in 2002 and learned about the clubhouse model. Motivated by what they had learned, Betty and parents of other TBI survivors decided to bring the idea to life in Akron.

Gardening fits right into many of the goals of the clubhouse, such as developing self-esteem, community involvement and personal growth. Clubhouse members began their gardening efforts in April by starting tomato, squash and marigold seeds indoors. In just a few weeks of gardening, they already have noticed changes in clubhouse members. The physical activity gives members practice with eye-hand coordination and endurance. The gardening activity improves their disposition, and makes moods brighter. Gardening also gives the members the opportunity to make something out of nothing, taking on a project from start to finish. When they see what they created, out of what used to be just grass and weeds, they can't believe what they'd done.'


LegalView.com Continues to Track Brain Injury News and Resources

LegalView.com is continuing to track brain injury research and news. Visitors to LegalView.com’s traumatic brain injury information portal and its accompanying brain injury blog, can stay updated about brain injury news and research that may lend hope to survivors at no cost. Individuals interested in learning more about the types of traumatic brain injury are invited to visit LegalView.com’s brain injury blog and its accompanying brain injury attorney resource center, a collection of information and news about brain injury intended to be the most comprehensive brain injury portal online. The LegalView.com team has collected original articles, news feeds, government information, a glossary of brain-injury terms and much more for visitors concerned about preventing and treating a traumatic brain injury.

The Traumatic Brain Injury Blog and Traumatic Brain Injury Information Portal are part of LegalView.com’s ongoing efforts to be the Internet’s most complete online collection of resources about important legal issues. As always, those who are ready to find a skilled local attorney to help them evaluate their own cases may use LegalView.com’s free, nationwide attorney referral service. LegalView.com is a free public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of America’s best law firms: Anapol Schwartz; Brent Coon and Associates; Burg Simpson; Cohen, Placitella and Roth; James F. Humphhreys and Associates; Lopez McHugh; and Thornton and Naumes. For more information on LegalView.com’s distinguished law firm sponsors and their accomplishments, or to get in touch with LegalView.com’s attorneys, visit http://www.legalview.com/.


July 03, 2007

Senate panel OKs Group 8 use of VA system for TBI and PTSD

The Senate Armed Services and Veterans’ Affairs Committee approved legislation Wednesday 27Jun that would reopen the Department of Veterans Affairs health system to 1.7 million veterans in Priority Group 8, those who have adequate incomes and no service-connected ailments. The Group 8 provision is in the Traumatic Brain Injury and Other Health Programs Enhancement Act (S 1233). Other provisions would:

· Require the VA to develop individualized plans for rehabilitation and reintegration of veterans who suffer traumatic brain injury (TBI)

· Extend eligibility for VA health care for all combat veterans from two years up to five years after release or discharge. This would provide more time to identify and treat TBI and post-traumatic stress disorder (PTSD).

· Direct that VA enter into agreements with non-VA care facilities to provide TBI care and rehabilitation when VA care is not available at a reasonable distance from the veteran’s home.

· Direct that VA conduct a five-year pilot program to assess the effectiveness of providing assisted living services to veterans with TBI to enhance rehabilitation and quality of life.


Be Safe and Keep Fireworks Fun

http://www.burgsimpson.com/personal_injury.htmlFireworks-related injuries cause thousands of emergency room visits in the United States, about 40 percent of which involve children age 15 and younger. Of the hundreds of injuries which involve children ages 5 and under, about half come from using seemingly innocent sparklers. Fireworks can inflict burns, eye injuries and even the loss of fingers. The safest way to see fireworks is at a professional display.

Only a few types of fireworks are legal for residential use in Colorado, such as ground spinners and sparklers. Small fireworks may seem safe, but they can reach temperatures as high as 1,800 degrees.

Children and amateurs aren't the only ones affected. Earlier this year 47-year-old Rai Henniger, a senior vice president with the Colorado Springs Sky Sox, was severely injured during a fireworks explosion before a game. Henniger is licensed to handle fireworks, and was placing a commercial-grade shell into a cylinder. The team sets off fireworks after home runs, victories, and other special occasions. Mr. Henniger suffered multiple skull fractures, and lost his left eye. The cause of the explosion was unknown, but it's a grim reminder that, even when used by licensed professionals, fireworks can be extremely dangerous.


Man opposes the odds with his brain injury

Dwayne Jacobs of Chandler, AZ was expected to die or live in a vegetative state 30 years ago after a devastating car crash. Jacobs, now 44, surprised everyone, except his parents, by learning to walk again, talk again and live independently. He even learned how to drive. Dwayne Jacobs has short-term memory loss and no sense of smell. He'll never fully recover, but he's made great strides. Jacobs has handicapped license plates so he can find his car in a busy parking lot because he would often forget where he parked it.

Despite Jacobs' disability, he volunteers with the Chandler Special Olympics, coaching softball and basketball. He recently received a volunteer of the year award from the Chandler Special Olympics. Thirty years ago, no one would have thought he'd be receiving awards for helping others. He and his brothers and father were hit by a drunken driver who ran a stop sign. Dwayne was thrown from the car and landed on his head. Dwayne’s medulla oblongata, a part of the brain stem, was twisted, giving him a traumatic brain injury. Doctors said he wasn't going to survive and even if he did, he would be in a vegetative state.

His parents were the key force behind his recovery. They took him home and after a year and a half, he had learned how to walk again, spell again and read and write again. "We worked with him 24 hours a day," said Art Jacobs, 74, a retired Air Force major and retired faculty associate of Arizona State University's W.P. Carey School of Business. "Dwayne has made remarkable progress. He has moments of lapses, but it gets better every day. The Center for Transitional Neurorehabilitation at Barrow Neurological Institute in Phoenix was also instrumental in Jacobs' recovery. He still goes back a couple times a month. That's where he learned to use a datebook, which helps him live his life. Jacobs uses his massive datebook on a daily basis. He writes down his plans for the day, directions to where he has to go, important phone numbers and a journal of the day's activities. The datebook is his memory.


Clinic nephrologist contributes to publications on NSF

Dr. Ambreen Gul, nephrologist and Director of the Monroe Clinic Dialysis Center in Wisconsin, was recently published in leading health care publications. Gul wrote a chapter for third edition of Comprehensive Clinical Nephrology titled, "Assessment of Renal Function." Comprehensive Clinical Nephrology is a highly-respected source of the best and newest information on every clinical condition encountered in nephrology, the branch of medicine focused on kidney health. The chapter written was published in January 2007, and discussed the condition called nephrogenic systemic fibrosis, which is a relatively recent identified disorder seen only in patients with kidney failure. While these publications are designed to reach medical experts and helping them build on another's findings, Gul explained that patients will ultimately benefit from the literature. "We must take the initiative to introduce new findings into literature instead of keeping it to ourselves. Doing so not only allows us to make progress, but it also keeps us on our toes," Gul said. "It's a little bit of an intellectual stimulation. If you want to contribute, you have to stay up-to-date."


July 02, 2007

HBO Coma Documentary debuts July 3rd

According to the Brain Injury Association of America, traumatic brain injury affects more Americans each year than breast cancer, multiple sclerosis, HIV/AIDS and spinal cord injury combined. Academy Award nominated director Liz Garbus’ insightful documentary COMA explores the mysteries of the injured brain and its ability to heal when the exclusive HBO presentation debuts TUESDAY, JULY 3 (9:00-10:45 p.m. ET/PT). Giving voice to people whose quality of life and very existence have been threatened, the special goes inside a top U.S. medical facility for the treatment of head trauma and follows four coma survivors over the course of a year.

In the wake of the Terri Schiavo media spectacle and the "awakening” of Terry Wallis from a minimally conscious state after 19 years of silence, Garbus strives to find answers away from the glare of the media. With unprecedented access to the Center for Head Injuries at the JFK Medical Center in Edison, NJ, she chronicles the emotional stories of four families for one year, looking through the eyes of their renowned physicians and neuropsychologists, led by Dr. Joseph Giacino and Dr. Caroline McCagg. COMA debuts nationwide Tuesday, July 3rd at 9:00p.m.,on HBO.


Senate panel OKs Group 8 use of VA system for TBI and PTSD

The Senate Armed Services and Veterans’ Affairs Committee approved legislation Wednesday 27Jun that would reopen the Department of Veterans Affairs health system to 1.7 million veterans in Priority Group 8, those who have adequate incomes and no service-connected ailments. The Group 8 provision is in the Traumatic Brain Injury and Other Health Programs Enhancement Act (S 1233). Other provisions would:

· Require the VA to develop individualized plans for rehabilitation and reintegration of veterans who suffer traumatic brain injury (TBI)
· Extend eligibility for VA health care for all combat veterans from two years up to five years after release or discharge. This would provide more time to identify and treat TBI and post-traumatic stress disorder (PTSD).
· Direct that VA enter into agreements with non-VA care facilities to provide TBI care and rehabilitation when VA care is not available at a reasonable distance from the veteran’s home.
· Direct that VA conduct a five-year pilot program to assess the effectiveness of providing assisted living services to veterans with TBI to enhance rehabilitation and quality of life.


Stroke and the use of the Ortho Evra Patch

Davida Godett of Philadelphia, PA woke up one morning and found her entire left side numb and her vision blurred. She had experienced a mini-stroke. Interestingly, she was on the Ortho Evra patch at the time. She had a child in March of 2003 and went on the Ortho Evra Patch shortly thereafter and continued to use it until November 2005. That was when she had her mini-stroke. The doctor in the ER where she was taken asked her what meds she was taking and she told him the Ortho Evra Patch. At the time she was 30 years old, in good physical shape and didn’t smoke. She had no other conditions to indicate a stroke risk, nor did her family experience any medical issues that she could have inherited. A doctor in ER told her she could never use the Ortho Evra patch or any kind of birth control pill again. He explained that the amount of hormones fluctuating in her body could cause another stroke. The hospital also sent letters to her gynecologist saying she cannot have any extra hormones in her body due to heightened estrogen levels. She followed the doctor’s orders and never used the patch or the pill again.

The second stroke occurred on Valentine's Day, 2007. She can't remember much about it because it affected her memory. She was outside shoveling snow and her body suddenly didn't feel right and her left arm was aching. Nevertheless, she went to work the next day, but her arm felt worse. So she called her neurologist and explained the symptoms. He urged her to come in right away. On the way there, her speech began to slur and when she got to ER, they did some tests and concluded that she had suffered a full-blown stroke this time. She is a mother of a four year old and since this last stroke she has been on disability, yet hopes to return to work eventually. Now she has to take Plavix and Topamax for the rest of her life and fears having another stroke.


18 year old suffered two strokes using the Ortho Evra Patch

When she was just 18 years old, Jennifer Gardner suffered two strokes causing irreparable damage. When Jennifer's cardiologist found out she was on the Patch, he told her to cease using it immediately. Jennifer was only on the patch for five months, from March to July of 2005. Since then, she has had several setbacks.

She was prescribed the Ortho Evra Patch to regulate her menstrual cycle. Instead it gave her headaches, made her feel light headed all the time and caused her a lot of pain. Her mother took her to their doctor and he sent Jennifer to a cardiologist to have an EKG. He thought the blood loss had to do with her heart, but the tests came back normal. She still stayed on the Patch. She was going to high school and living in Georgia with her Dad, her mother had to drive her back from New York because she was too week to drive herself. On the way home she was bleeding a lot and as soon as she got home she couldn't walk and her left hand went numb. Her parents took her to University hospital in Atlanta and she was admitted for three days for observation. They came to the conclusion that she had a mild stroke. She saw a lot of different specialists. They asked many questions and when she told them she was on the Patch, they told her to get off it immediately. She was then informed that she had to have heart surgery because her blood had thickened and clotted so badly that it caused a tear in her mitro valve, one of the main heart valves. The doctors had also put her on an anti-psychotic medication because she had suffered brain damage from the stroke. After she was discharged she returned to New York. Once back in New York they could not do surgery because they were hesitant of the blood clotting. She then saw a hematologist for five months and was bed-ridden.

Surgery had occurred in June 2006, almost a full year from the first diagnosis. Just when she was beginning to recover she got a Staph infection. For three months she took a series of antibiotics to get over it. Again in September 2006 she had another stroke, this time much more severe. She lost all feeling in her left side for two months. She was admitted to rehab for two months to learn to walk again and use her left hand. Her muscles have deteriorated and have limited use. She will eventually have to get the mitro valve replaced. For the rest of her life she will have to take Plavix and aspirin and never again use hormones.


July 01, 2007

Integra LifeSciences Supports Newest Edition of Guidelines for the Management of Severe TBI

Integra LifeSciences Holdings Corporation announced its support for the third edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury. The Guidelines are nationally recognized and referenced by many of the leading trauma centers in treatment of patients with traumatic brain injury. The Guidelines were developed by the Brain Trauma Foundation (BTF) in association with the American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons (CNS), and the AANS/CNS Joint Section on Neurotrauma and Critical Care, and incorporate the latest published research findings relevant to the diagnosis and treatment of severe traumatic brain injury. Guidelines include specific recommendations with regard to monitoring intracranial pressure (ICP) and brain tissue oxygen (BtO2) management. Intracranial pressure may be monitored by the Integra Camino(R) Advanced Monitor. Brain tissue oxygen may be monitored by the Integra Licox(R) Brain Tissue Oxygen Monitor. By educating health care providers in the use of these guidelines, the BTF estimates that thousands of lives could be saved in the U.S. and many would be spared life-long disabilities. With over 1000 trauma centers nationwide, more than 600,000 pre-hospital care providers, and a variety of physicians and nurses treating patients with severe TBI, it is an enormous challenge to get information to all those who care for brain injury patients in the U.S.

The Brain Trauma Foundation (BTF) was founded in 1986 as a non-profit organization to improve outcomes for Traumatic Brain Injury (TBI) patients. The BTF is the only organization of its kind dedicated to improving TBI care during the acute phase after injury, in the ambulance and in the hospital. By educating medical professionals in this area, thousands of lives can be saved each year in the U.S. and thousands more will be spared life long permanent disabilities.


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