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.

Posted by Kerry N. Jardine at 04:18 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 01:16 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 11:15 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:14 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:12 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:11 AM | Permalink | Comments (0) | TrackBacks (0)

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.

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

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.

Posted by Kerry N. Jardine at 06:08 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:43 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:42 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 08:40 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:38 PM | Permalink | Comments (0) | TrackBacks (0)

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."

Posted by Kerry N. Jardine at 08:36 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:34 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:30 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:27 PM | Permalink | Comments (0) | TrackBacks (0)

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

Posted by Kerry N. Jardine at 08:24 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:20 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 06:44 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Seth A. Katz at 06:40 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Scott J. Eldredge at 06:38 PM | Permalink | Comments (0) | TrackBacks (0)

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).

Posted by Kerry N. Jardine at 06:36 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 08:19 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:34 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:29 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:27 PM | Permalink | Comments (0) | TrackBacks (0)

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

Posted by Kerry N. Jardine at 06:25 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:19 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:14 PM | Permalink | Comments (0) | TrackBacks (0)

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."

Posted by Kerry N. Jardine at 06:22 PM | Permalink | Comments (0) | TrackBacks (0)

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.

Posted by Kerry N. Jardine at 06:11 PM | Permalink | Comments (0) | TrackBacks (0)

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 Unive