NeuroHealing Pharmaceuticals is a company that develops products for individuals with traumatic brain injuries. The Food and Drug Administration recently awarded the company a three-year grant of $1,044,000 for the clinical development of NH001 from its Office of Orphan Products Development. The OOPD of the FDA is dedicated to promoting the development of products that demonstrate promise for the treatment of rare diseases or conditions. The NH001 product is currently in a phase IIa clinical trial attempting to improve the functional outcome of patients in a vegetative or minimally conscious state following a severe TBI. In the previous phase trials, the product has shown promising results and has received authorization from the FDA to begin an additional double blind Phase IIb clinical trial. Dr. Elkan Gamzu, acting Head of Clinical Trials at NeuroHealing, said, “This grant will provide the initial funding to begin the clinical program at the Spaulding Rehabilitation Hospital, a Harvard Medical School affiliated hospital and one of the leading rehabilitation facilities in the U.S., and will enable the continued development of this treatment which may offer patients, their families and physicians a new therapeutic option to help brain injured patients in an altered consciousness state.”

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Even with the increasing awareness of the worldwide epidemic of Traumatic Brain Injury, investors still are not interested in investing in companies that are developing therapies for TBI. According to Harry Tracy, who runs Cardiff, Calif.-based NI Research, a consulting and research firm focused on the neurological and psychiatric therapeutics industry, the amount of mid to large size firms developing drugs for brain injuries range from “zero to maybe 5 or 10 percent.” He further proclaims that “there are some promising programs that have really suffered” for lack of funding and investment. Most are small biotech or specialty pharma companies. While the current wartime as raised awareness of TBI, the condition has been “very much underappreciated from a drug development perspective,” according to Larry Glass, U.S. CEO of Neuren Pharmaceuticals Ltd. More than 1.5 million cases of TBI are reported annually in the U.S according to the Centers for Disease Control and Prevention and yet, “there have been virtually no big pharma efforts to develop drugs,” said Glass. While clinical development for TBI is complicated, uncertain and expensive, “the potential returns are phenomenal,” he concluded.

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A Draper, Utah teen was prescribed oxycodone hydrochloride to help him sleep and to relieve the pain he was experiencing from strep throat. The prescription bottle told him to take one teaspoon every four hours which he did. Jessie Scott, 18, now lays in a coma since April 30 because the Walmart pharmacy where he had it filled allegedly failed to dilute the liquid medication prior to handing it to his parents. Scott’s dosage ended up being 20 times more potent than what the doctor prescribed. Scott’s organs started to fail soon after he fell into the coma so he was put on a ventilator. He spent 16 days in the intensive care unit, then four days in intermediate care, but now resides in a rehabilitation center. Therapists are trying to stimulate his senses. Doctors are unsure how much damage has been done to Scott’s brain. “His brain is still very plastic, still very elastic and we’re hoping and praying that it can find ways around those areas to connect back up,” said Scott’s father, Wayne. “That’s our hope.” The Wal-mart pharmacies response so far is, “This is a very sad situation. Our thoughts are with this young man and his family.”

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Traumatic brain injuries due to falls are responsible for nearly 8,000 deaths and 56,000 hospitalizations in 2005 among Americans 65 and older, according to a new report from the Centers for Disease Control and Prevention. A study analyzed data from two agencies and provided a sampling of deaths and injuries in relationship to Traumatic Brain Injuries and the elderly. Death rates for fall-related TBIs were higher among men that women citing the numbers 26.9 per 100,000 for men and 17.8 per 100,000 for women. Traumatic brain injuries resulting in hospitalizations for both men and women were similar at 146.3 for men and 158.3 for women per 100,000. The rates of fall-related TBI deaths and hospitalizations increased with age. The median charge for TBI hospitalizations were $19,191 for men and $16,006 for women. With more baby boomers reaching retirement age, these types of injuries will increase and the demands on the health care system will be felt. In an effort to prevent as many as possible, the CDC developed tips and suggestions for older adults, their caregivers, health care providers and communities in a hope to communicate the dangers.

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One of the largest malpractice settlements has been awarded for the negligent Lasik surgery of a New Jersey man. James Dell’Ermo underwent Lasik surgery which rendered him legally blind (vision worse than 20/400 without corrective lenses). The $2.1 million settlement reached is part of a group of 16 malpractice lawsuits filed against the Lasik surgeon. The claims against the surgeon relates to his failure to recognize that Mr. Dell’Ermo was not a candidate for Lasik and that he had steep corneas. By performing Lasik the surgeon caused a condition known as ectasia which is a progressive condition which will ultimately require Dell’Ermo to undergo corneal transplants in both eyes. Dell’Ermo’s case and its companion lawsuits are evidence of the questionable safety of Lasik procedures. In fact, in April 2008, the FDA conducted hearings and questioned the safety and effectiveness of the surgery.

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In an effort to eliminate adverse medical reactions caused by prescription errors, U.S. Rep. Allyson Schwartz-D recently sponsored a bill that has been approved by Congress. The bill will require physicians to file prescriptions for Medicare patients electronically. The measure requiring e-prescriptions “will reduce the number of errors, dramatically save lives and save money,” Schwartz said in a phone interview. The E-MEDS bill, which had bipartisan support, requires physicians to electronically file prescriptions for Medicare patients, rather than by paper script, by Jan. 1, 2011. A recent study found only 4 percent of doctors in the United States has a “fully functional” electronic medical records system. In addition, the United States has the third highest rate of deaths from medical errors among the world's 30 most developed countries, including more than 1.5 million preventable adverse drug reactions annually, resulting in 7,000 deaths per year. Submitting prescriptions electronically would preclude misreading a script and pharmacies would have a list of other medications the patient is taking, Schwartz said.

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Even though hospitals are increasingly relying on robotics to reduce medication errors, in the case of the Corpus Christi death of twin infants, the systems available would not have prevented the pharmacy error. That's because many of the systems are confined to dispensing pills and cannot dispense liquids such as the blood thinner heparin, according to industry authorities. How effective can technology be in preventing the same tragedy from happening? Studies of rates of human error in hospital pharmacies vary anywhere from 3 errors in a thousand to 55 per thousand. Machine rates have about one in 10,000. About 51 percent of insured Americans are taking prescription drugs to treat at least one chronic condition according to a study by Medco Health Solutions. In crunching the numbers that amounts to hundreds of millions of prescriptions filled each year so the chances of a pharmacy error are inevitable. Some say that while technology may reduce prescription errors, the systems remain susceptible to human error, such as inputting the wrong patient information into a computer. Human diligence, quality control and responsibility need to be increased to limit future injuries ascribed to pharmacy errors, technology can’t be the only answer.

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A Corpus Christi hospital admitted recently that a mixing error in its pharmacy led to the overdosing of 17 individuals and may have caused the death of a twin brother and sister. The error involved the blood thinner heparin, but was unrelated to product labeling or packaging according the chief medical officer of Christus Spohn Health System, Dr. Richard Davis. The mixing error is believed to have occurred July 3, and that heparin batch was first administered in the neonatal intensive care unit July 4. Nurses noticed the overdoses during routine blood work and stopped using the heparin immediately giving patients medications to counter the effects. Twelve other patients received the overdoses and three infants may have just before they were released from the hospital. The hospital reported no ill effects in those three babies. The twins who died, Keith and Kaylynn Garcia, were born one month premature July 1 at Christus Spohn Hospital in Alice and transferred for higher-level care to Christus Spohn Hospital South in Corpus Christi, the Corpus Christi Caller-Times reported. The babies' parents received a judge's order preventing the hospital from destroying any records related to the babies' hospital stay or the heparin overdose. The Texas Department of State Health Services is conducting a review.

Posted by David P. Hersh at 08:08 AM | Permalink | Comments (0) | TrackBacks (0)

The myth that medical malpractice lawsuits are responsible for increasing malpractice premiums and health care costs needs to be addressed. Claims of a nationwide crisis are exaggerated. Malpractice insurance premiums represent less that 2 percent of health care costs. Putting malpractice caps on awards threatens patient’s rights to seek compensation when injury occurred from a preventable medical error. Further, punishment of the negligent doctor or institution is a way of preventing future errors. Tort Reform caps puts patients in danger because legal recourse is severely limited. A suggested solution to the rising costs was presented that consists of more emphasis on evidence-based medicine, independent screening, immediate disclosure of errors, and a no-fault system of compensation.

Posted by Scott J. Eldredge at 08:06 PM | Permalink | Comments (0) | TrackBacks (0)

A New York jury, that included two nurses, awarded $9 million in a malpractice suit for the family of a woman whose doctor failed to diagnose her breast cancer. Suzanne E. Crane died in 2004 after her breast cancer spread. The 33-year-old mother of two began seeing the doctor in 2002 and after three visits the doctor failed to diagnose her cancer. Even after a lump was found in Crane’s breast the doctor never performed a biopsy. It took a different doctor in 2003 to recognize the cancer. Sadly, Crane was seven months pregnant with her youngest son when the diagnosis was made, and she could not immediately receive treatment. The verdict of $9 million includes more than $6 million based on future monetary losses.

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In an environment of Medical Malpractice Tort Reform saber rattling, abominable patient care and medical negligence is still occurring. Take for instance the recent suspension of a doctor’s license by Washington state health officials for allegedly failing to properly treat four patients. Now the question is how badly can a doctor really behave before being disciplined? In Dr. George Mathew’s case he is accused of negligence, incompetence and malpractice. His immediate suspension is remarkable because health officials reserve it for cases in which they believe a doctor’s conduct puts patients in imminent danger. According to the charges Mathew allegedly failed to treat a 69-year-old man who was suffering a heart attack. The man spent about seven hours in the ER while Mathew was asleep in the doctor's lounge. Allegedly he failed to stitch up the severely lacerated leg of a 27-year-old woman planning to discharge her. Another doctor was called in to treat her. With the third patient he allegedly ignored the severely lacerated lip of a 49-year-old woman. Another doctor had to intervene and sent her to a plastic surgeon at another hospital. The fourth patient was a 60-year-old man who had arrived at the hospital complaining of blood in his vomit and stool, Mathew allegedly ignored him for six hours until another doctor came on shift. Understandably, after being informed of the suspension the hospital quickly suspended Mathew’s privileges to work there. Furthermore, in 2005 under a different name Mathew’s was sanctioned for providing prescriptions over the Internet to patients he never saw as well as failing to keep medical records on three men he prescribed narcotics to. If the allegations against him prove true Mathew could face the revocation of his medical license. These are the type of doctors medical malpractice litigation try to protect the public from.

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Regarding the Hepatitis C outbreak at the Endoscopy Center of Southern Nevada a judge has ruled that patients can claim damages for emotional distress in the class action lawsuit. Attorney for the clinic David MacDonald said, “In this case I don’t believe a physical injury was suffered.” District Judge Allan Earl disagreed and denied the clinic’s motion to dismiss saying the mental anguish of potential exposure could lead to physical symptoms. Lawyer Robert Cottle, representative for the patients, also suggested that the majority owner of the Endoscopy Center, Dr. Dipak Desai, might have used his influence as a former Nevada Mutual Insurance board member to avoid oversight by the insurance company putting the patients in danger. Judge Earl ruled otherwise after the insurance company’s lawyer said they had no duty to the clinic’s patients or to tell its doctors what to do. Judge Earl dismissed the insurance company from the lawsuit saying they had a responsibility to its shareholders not its patients.

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Dr. Donald Stein and his colleagues authored a paper regarding the neuroprotective effects of progesterone administered to those who have suffered a Traumatic Brain Injury. Stein, director of Emory’s University School of Medicine Department of Emergency Medicine Brain Research Laboratory first discovered the neuroprotective properties of progesterone in the laboratory. Members of his research team have been studying its properties for nearly 20 years as well. They found that giving progesterone to patients soon after brain injury may reduce the risk of death and decrease the degree of potential disability. Laboratory studies found that progesterone is critical for the normal development of neurons in the brain and offers protective effects on damaged brain tissue. Progesterone is naturally present in the brains of both men and women. In the study published in the Annals of Emergency Medicine, Stein and his colleagues reported that only 13 percent of severe TBI patients who received progesterone died compared to 30 percent of those given a placebo. Furthermore, after 30 days 56 percent of patients’ functions had improved after a moderate TBI, including improved motor response and abilities to communicate. Few clinically effective therapies currently exist for TBI so the progesterone findings are welcome.

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Until the day medical malpractice and other such information is widely available to consumers of healthcare, it is best to do everything possible to do research on a potential healthcare professional. It is important to find out when the doctor started practicing, where they went to school and how many surgeries they have performed (if that is the treatment sought). Ask for referrals from friends and call a local Medical Board. Ask the hospital or medical center where the doctor practices if any complaints or medical malpractice has been previously committed. In today’s atmosphere of distrust and potential tort reform it is imperative to cover all bases before undergoing the care of a medical professional because the healthcare consumer’s choices are being limited

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Seven weeks into the Salmonella Outbreak investigation and federal health officials are still finding it difficult to pinpoint the method of delivery. Cilantro and jalapenos are now under the same suspicious umbrella as tomatoes. Many find it is easy to fault the Food and Drug Administration and the Centers for Disease Control for their inability to zero in on the source and food type of contamination.

“This has gone on longer and has been more complicated than anything I've worked on at FDA,” expressed Dr. David Acheson the FDA’s food safety chief told AP Television. Many are comparing the spinach E.coli outbreak from 2006, but officials say this is different. The spinach affected was packaged with a barcode, the cilantro, tomatoes and jalapenos are sold as fresh produce with no barcode. “We really, really got spoiled, if you will, with the spinach outbreak,” Dr. Robert Tauxe, food safety chief at the Centers for Disease Control and Prevention, told The Associated Press. In the spinach outbreak victims could remember what they ate, but in this episode the stricken have difficulty remembering as well as differing food items. They say, "'Well, I'm not sure, I may have had guacamole, or a garnish," Tauxe said.

This latest salmonella outbreak has lasted an unusually long time, with a record of 1,065 confirmed cases, the latest found on June 26. The toll of this outbreak far surpasses recent outbreaks of any foodborne disease: salmonella in peanut butter in 2005, hepatitis A from green onions in 2003 and the spinach outbreak of 2005. The tainting has yet to break the cyclospora-spoiled raspberries from the mid-1990s. The current FDA search is looking to connections between jalapenos and tomatoes. The CDC just finished comparing 144 people who got sick in June with 287 people who live near them but didn't fall ill. Perhaps there are farms that grew tomatoes earlier in the spring and then switched to pepper harvesting, or distribution centers that handled both types of produce and contaminated incoming produce, Acheson said.

The government's asking the public to continue avoiding certain raw tomatoes, red round, plum and Roma unless they were grown in areas cleared of suspicion. The CDC is advising that people at highest risk of severe illness from salmonella should not eat raw jalapeno and serrano peppers with the most vulnerable being the elderly, those with weak immune systems and infants. Serranos are on the list because they're hard to distinguish from jalapenos.

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Over the past 20 years science has been able to get a handle on the visual effects of traumatic brain injury through refined and improved neuroimaging techniques. Even though many believe “information is power”, the gap between knowledge and treatment is increasing. Tens of thousands of Americans lie in nursing homes in comas and other diminished states resulting from traumatic brain injury. Thousands more will join them each year. Unfortunately the majority are at the mercy of a medical establishment ill equipped to assess their needs and provide treatment, according to several recent studies. Although there are many potential treatments in trials and studies globally, a paltry few are used as an established treatment measure. In the last decade scientists have learned that the brain doesn’t stop growing and can repair itself in a process that is still barely understood. This is why, with good therapy, people can learn to speak, eat and walk again. “The brain isn't a black box anymore - we know a lot about what's going on now with head injuries in patients who are comatose for days or weeks,” said Dalton Dietrich, a neurologist and scientific director at The Miami Project to Cure Paralysis. “We're way past the dark ages of brain and spinal cord injury [of] 20 years ago.” Doctors hold on to the promise that every brain is as unique as its injury. Scientists at the University of Miami and elsewhere are looking for new breakthrough treatments such as: stem cell treatment, deep brain stimulators used in Parkinson’s, artificial blood and hypothermia to retard trauma. Funding remains a problem, but it is an epidemic whose numbers have exceeded those of HIV/AIDS and breast cancer.

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Drug makers are starting to feel the pinch from the removal of their defective drugs from the market. It is cutting into their profits and delaying their chances of making money on new blockbuster treatments. Big Pharma is blaming the fact that it is taking longer for the Food and Drug Administration to approve their new drugs. For example Merck & Co executives, the recalled http://www.burgsimpson.com/vioxx.html manufactures, say they are facing a tough new regulatory climate that is delaying drug development. Over the last 16 months, Schering-Plough Corp. has pulled the plug on two drug development projects, one for obesity and the other for cholesterol, and considering pulling a third project. Chief Executive Fred Hassan believes the reason lies in the intensified focus on safety and the diminished tolerance for side effects. With the diabetes drug Avandia causing an increase of heart failure in some patients and the Ortho Evra birth-control patch causing blood clots and in some cases death, is it a wonder the FDA is taking longer? Drug companies are required to clear their new drugs with the FDA. If they want their products to come to market faster they need to focus their attention on screening their own products so that there is assurance that good and safe drugs are being released to the industry rather than making money.

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In a recent Psychiatric Times article, Dr. Ricardo E, Jorge professor of psychiatry at the University of Iowa, illuminated the impact of reintegrating Traumatic Brain Injury patients back into society. Consideration needs to be taken concerning their cognition and behavioral changes which constitutes the majority of TBI disabilities. In a control group of 939 TBI patients and 2,817 doctors a comparison was made between the effects of mental illnesses in those with moderate to severe and mild TBI. It was found that the prevalence of psychiatric illness in the first year following a moderate to severe TBI was 49 percent and those with a mild TBI experienced mental illness 34 percent of the time. What this means is that patients with moderate to severe TBI are 4 times more likely than the general population to develop a psychiatric illness in the six months following their injury. A discouraging 61 percent of those evaluated eight years after sustaining a TBI suffered from major depression and anxiety disorders, a significant amount more than those in the control group. Along with the increased number of mood disorders in TBI patients, researchers also found structural and/or functional alternations in the prefrontal cortex of the brain, indicating that structural brain damage plays a large part in psychiatric illness. Furthermore, not only does the TBI-caused damage to the prefrontal regions and limbic structures initiate mood disorders, but the disturbed neural circuits often continue to wreak havoc in the brain causing the illness to progress and evolve over time. As discouraging as this information is it helps create an increased awareness of the severity of this nationwide epidemic and will perhaps save a number of potential victims who instead chose to wear something as simple as a helmet.

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

http://www.burgsimpson.com/digitek.htmlIn what may be the first Digitek product liability lawsuit has been filed in the Michigan Supreme Court. The class action drug product liability suit is seeking damages in excess of $75,000 from Digitek manufacturers the Activis Group. Digitek is the brand name for the heart drug digitalis. During the manufacturing process the tablets were created double strength. There was an Food and Drug Administration recall shortly thereafter. An overdose of digitalis can result in death from ventricular arrhythmia, or heart block. Non-fatal complications include nausea, vomiting, severe weight loss, diarrhea, mental confusion, vision changes and elevated blood pressure, which can lead to cerebral strokes.

Posted by Kerry N. Jardine at 07:25 PM | Permalink | Comments (0) | TrackBacks (0)

Earlier in the year Utah legislators approved House Bill 174 establishing a Traumatic Brain Injury Trust Fund. The trust fund begins with a one-time allocation of $50,000 intended to train medical personnel in treatment and recognition of traumatic brain injuries. The program will also help uninsured patients cover medical expenses not covered by Medicaid. “This fund could really open up the door for people who have been shut out of services in the past,” said Ron Roskos, director of the Brain Injury Association of Utah. “We hope this will be another avenue that individuals can use to access services.” More than 2,500 traumatic brain injuries occur a year and the number is increasing due to our returning war veterans. Only a handful of states have similar funds set aside for traumatic brain injuries. Once the distribution process has been finalized Rep. James Gowans – D, sponsor of the bill, will return to the legislature in the next session requesting long-term funding.

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Orange County California will be at the center of a new clinical trial using a hypertonic saline solution by emergency workers and medical doctors in the treatment and resuscitation method for victims of severe traumatic brain injury. The group labeled The Orange County Resuscitation Outcomes Consortium includes hospitals, healthcare agencies and fire departments. The ROC group’s effort will attempt to substantiate previous studies that have shown that hypertonic saline safely and effectively decreases inflammation in brain traumas. A similar approach was used with considerable success with the Buffalo Bill’s Tight End Kevin Everett after he suffered a spinal cord injury during a football game. The Orange County ROC trial will differ from other clinical trials because many of its participants will not be able to give consent or have family nearby to do so. Consent is required for all clinical studies, although federal law allows for exceptions if the safety of the product to be used has been proven in previous trials and if study leaders conduct community outreach discussions and opt-out measures for those who do not want to participate.

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Massachusetts tri-athlete Kenneth L. McDonnell, 58, was struck by a woman straying into the breakdown lane by her car while bicycling last fall, leaving him seriously injured. The woman was sentenced to one year probation, $350 in court fees and 100 hours of community service in a hospital or nursing home after her negligence caused a traumatic brain injury in the bicyclist. What makes this case interesting is that she must also complete the Brains at Risk program which is an “awareness and prevention court referral program that links dangerous driving behaviors to the devastating effects of traumatic brain injury,” according to the Brain Injury Association of Massachusetts’ website. McDonnell who is biking again was initially given a 1-in 4 chance of survival. He said doctors credit the fact that he was in good physical condition at the time of the accident which probably saved his life. McDonnell said he was wearing a helmet at the time, but it was smashed when he flew off his bike and onto the car. He said the brain injury has left him with short-term memory problems and personality changes. The court ruling is disappointing because he has little financial support while seeking a full-time position that allows for the uniqueness of his injury.

Posted by Kerry N. Jardine at 09:14 AM | Permalink | Comments (0) | TrackBacks (0)

U.S. health officials are still struggling to find the source of the salmonella outbreak in certain types of tomatoes that as of July 4th has sickened 922 people in 40 states since mid-April. The FDA and the CDC are turning their sights to produce imported from Mexico according to a CNN report last week. The Food and Drug Administration (FDA) alerted growers and brokers handling their products that, starting on Monday July 7, inspectors will stop shipments from Mexico of ingredients common to Mexican cuisine, CNN reported. Tomatoes continue to be the primary focus of the investigation but officials have expanded it to include produce commonly eaten with tomatoes. Cilantro, jalapeno peppers, serrano peppers, scallions and bulb onions are among the products to be further scrutinized. The U.S. Centers for Disease Control and Prevention says Salmonella Saintpaul, the strain involved in the outbreak, is rare. Typically, the CDC sees only about 400 cases of Saintpaul infections in humans each year. Salmonella can cause fever, diarrhea, nausea, vomiting and abdominal pain, according to the FDA.

Posted by Kerry N. Jardine at 07:12 PM | Permalink | Comments (0) | TrackBacks (0)

Evidence found by clinician-scientists with the New York-Presbyterian Hospital/Weill Cornell Medical Center suggest that following a Traumatic Brain Injury patients should be given nutritional supplementation through a gastric feeding tube as soon as possible. They found it can improve the chances of survival by 4 times. “The evidence shows that the body heals better when it is given proper nutrition, not just the bare minimum that keeps someone alive,” says lead author Dr. Roger Hartl, a neurological surgeon at NY-P/Weill Cornell, and the Leonard and Fleur Harlan Clinical Scholar and assistant professor of neurological surgery at Weill Cornell Medical College. “Before now, patients were required to have nutritional supplementation within the first week following their injury, but our findings suggest that this is simply not soon enough.” The study's findings are published in this month's issue of the Journal of Neurosurgery. This is the largest study to ever look at the issue of nutrition and survival following TBI. The research team followed the survival outcome and nutritional care in 797 patients from 2000 - 2006. The study found that the best outcomes for patients with TBI were observed when theys received a minimum of 25kcal/kg each day. The study also found that as many as 62 percent of patients with TBI never experienced this level of caloric intake. Dr. Härtl said, “These new recommendations will be added to a widely used TBI handbook, 'Guidelines for Management of Severe Traumatic Brain Injury,'” published by the Brain Trauma Foundation.

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Before the 1974 Employee Retirement Income Security Act, otherwise known as ERISA, was enacted, patients had recourse in the medical malpractice arena. ERISA doesn’t sound as if it should have anything to do with medical care, but it does. This law is best known for governing pension plans, but it also covers most health plans offered as an employee benefit. ERISA was meant to protect us from corporate abuse, but includes a special provision that health organizations have used to protect themselves from lawsuits. The employee-benefit plans are exempt from state law. Which means that under state law, lawsuits can seek damages such as lost income, suffering and medical expenses, but under federal law a lawsuit can only be filed for the cost of the medical benefit denied. As an example, if you or a loved one dies of leukemia because the HMO wouldn't authorize an early blood test, you can recover no more than the cost of the test. Before managed care obvious negligence could result in a medical malpractice suit that could compensate at least a portion of what went wrong during a procedure. Post ERISA, most Americans don’t realize this exemption in federal law that makes it much more difficult to win a malpractice suit against an HMO. So if there is no financial penalty when the doctors HMOs hire are negligent, where is the check a balance to keep the profit-driven healthcare from withholding adequate medical care? Another case of Law of Unintended Consequences.

Posted by Scott J. Eldredge at 06:53 PM | Permalink | Comments (0) | TrackBacks (0)

A New York state Supreme Court jury in Queens awarded $19.6 million to a couple after their baby was brain-damaged and the mother was severely injured during delivery of their child with forceps. In October 1998 at St. Vincent’s Medical Center in Manhattan, during delivery a hospital resident yanked at the baby’s head with forceps for 23 minutes. The baby was born lifeless and severely oxygen-deprived requiring emergency resuscitation. The anesthesiologist then negligently inserted a breathing tube into the baby's esophagus, which carries food or liquid to the stomach, rather than into his windpipe and pumped oxygen into his stomach instead of his lungs. The boy, now 9, suffers from cerebral palsy. Furthermore, during the delivery the mother suffered a tear all the way to her rectum requiring two physicians to repair, of which one of the physicians left the room. Unassisted, the botched repair left the woman with a severe birth canal laceration. Five surgeries later to try and repair the area have left the woman with scar tissue and excruciating pain. “It was a violent, traumatic delivery that should never have happened,” said the couple’s lawyer. The jury of three men and three women found St. Vincent's and its physicians responsible for the injuries and awarded $12 million to the mother and $7.6 million to the child.

Posted by Scott J. Eldredge at 08:48 AM | Permalink | Comments (0) | TrackBacks (0)

Dale Otto died of cancer in 2003 after two physicians failed to diagnose his condition. In a 4 to 3 decision the Wisconsin Supreme Court ordered the physician insurance company to pay damages. Physicians Insurance Co. of Wisconsin will pay $1 million in medical malpractice damages to the estate of Dale Otto. They provided insurance to the doctors at the clinic that employed them. The clinic denied the medical malpractice claims in court, but in an oversight the Physician’s Insurance never responded to the suit.

Posted by Scott J. Eldredge at 01:46 PM | Permalink | Comments (0) | TrackBacks (0)

A warning was issued recently by the U.S. Food and Drug Administration to doctors informing them not to use Medtronic’s Infuse bone graft product in surgery on neck bones, which is considered an off-label practice the agency never approved. The Infuse powder is FDA approved for use in fusion surgeries such as in the lower back, some serious leg fractures and some oral and dental uses. The product is a genetically engineered protein that causes the body to grow its own bone. The warning issued this week also covers OP-1 brand bone graft products from Kalamazoo, Mich.-based Stryker Corp. The FDA’s warning is stating that for unknown reasons using these products in the neck can cause dangerous complications. The FDA has received at least 38 reports of complications in the past four years related to use of Infuse and OB-1 in neck fusion surgeries. The neck and throat tissue of some patients swelled, the agency said. Some patients had difficulty swallowing, breathing or speaking. Some required a second surgery to resolve the issue, and in some cases, health-care workers inserted tubes to keep them breathing, the FDA said.

Posted by David P. Hersh at 08:43 AM | Permalink | Comments (0) | TrackBacks (0)

The Breckenridge Outdoor Education Center in Colorado is credited with encouraging and motivating many with disabilities including Traumatic Brain Injuries. Richard Abbott of Summit County, CO is one of them. Almost two years ago he was hit by a car while biking to work in Dillon in 2006. He was taken by a Flight-for-Life helicopter to St. Anthony’s Central Hospital in Denver, where doctors found he had sustained major brain injuries, numerous facial fractures and was launched into a coma they thought he would never emerge from. After several surgeries, he was transferred to Craig Hospital, a rehabilitation center outside of Denver which specializes in patients with spinal cord and brain injuries. He had to learn how to talk, walk and swallow all over again. He spent almost a year at Craig. Since 1976, the BOEC has been providing outdoor experiences for people with disabilities in the Rocky Mountains and beyond. “One of the biggest populations we work with is people with traumatic brain injuries, and in early June, we hold a brain-injury camp in conjunction with the Brain Injury Association of Colorado” said development director Marci Sloan. Abbott decided to take advantage of a seven-day brain-injury camp and arrived at the Scott Griffith Lodge in Breckenridge for a week of biking, rafting, fishing and rock-wall climbing. Although he still suffers from frequent bouts of dizziness that slow him down, he recently participated in the Third Annual Adaptive Cycle Fest at Keystone Resort, joining eight other riders on a scenic tour of Summit County’s bike paths.

Posted by Kerry N. Jardine at 06:39 PM | Permalink | Comments (0) | TrackBacks (0)

Poly-ethylene glycol (PEG) is being hailed as a possible new treatment used to minimize traumatic brain injury. The research is still in its initial phases. In the Journal of Biological Engineering a paper describes an experiment infusing rats suffering from a TBI with the self-described “spackle-like” substance within 2 to 6 hours of the injury. The PEG helped neurons by “sealing up” leaky membranes. The scientists found that the rats that were given intravenous PEG within 4 hours after brain injury had a better recovery than the rats who received a placebo. If further studies prove successful PEG could soon be carried in ambulances for immediate use in head trauma victims.

Posted by Kerry N. Jardine at 12:35 PM | Permalink | Comments (0) | TrackBacks (0)

In recent months bisphosphonates such as Fosamax and Boniva have been linked to an unusual bone fracture called femoral stress fracture. A recent small study found that those who take Fosamax may be actually slowing the healing of stress fractures. The study followed 70 people of which 76 percent of them suffered a femoral stress fracture compared to 2 percent who did not take the drug. “While bisphosphonates like Fosamax have been proven to successfully treat osteoporosis and other metabolic bone diseases, we believe long-term use of these drugs may suppress the ability of bones to heal in some patients,” said the study's lead author, Dean Lorich, of New York-Presbyterian Hospital/Weill Cornell Medical Center. The findings are reported in the latest issue of the journal Orthopaedic Trauma. The researchers feel that the use of bisphosophonates can strengthen bones enough to prevent devastating hip fractures, but they also suggest that patients may benefit from taking brief respites between dosages, thus giving their system a “holiday” from the medicine.

Posted by Kerry N. Jardine at 06:33 PM | Permalink | Comments (0) | TrackBacks (0)

In response to pressure from the consumer group Public Citizen the U.S. Food and Drug Administration has added a “black box” warning to the family of antibacterial drugs called flouroquinolone. The use of Cipro, made by Bayer and Levaquin made by Ortho-McNeil may lead to tendon ruptures, a serious injury that can incapacitate patients and increase the possibility of extensive surgery. Some of the ruptures reported to the FDA occurred without warning when the patient felt a snap or pop soon after starting treatment suggesting that flouroquinolone antibiotics may be toxic to some people, the FDA said. Typically, patients felt some kind of pain or inflammation for a week or two before they suffered a tendon rupture. The link between the treatment of the antibiotics and the tendon ruptures is highly unusual and scientists still don't fully understand why it happens. The FDA further added that the risk of tendon ruptures decrease if patients stop taking the drug at the first sign of pain or swelling. Public Citizen petitioned the FDA nearly two years ago to add more effective warnings and feel the regulators took too long to act citing many injuries, “would have been prevented if patients and doctors had known a pain in the tendon is an early sign that leads to rupture,” said Sidney Wolfe, head of the consumer group. In defense, the FDA pointed out that the prescribing literature already carried clear warnings regarding the risk of tendon ruptures, but decided to emphasize the warnings because of continued reports of injuries indicated the public may not have been paying enough attention. FDA officials said they had received several hundred reports of tendon ruptures. Wolfe, of Public Citizen, said the number was 407 at the end of 2007, with another 341 reports of tendinitis. He continued to criticize the agency, saying it should also require drug makers to send individual letters to doctors about the risks. FDA officials said manufacturers could choose to send such letters on their own. The FDA’s analysis revealed that patients who are over 60, those on steroids, or patients with kidney, heart and lung transplants are at the highest risk of tendon rupture.

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

A lawsuit has been filed on behalf of a Minnesota woman who developed the debilitating and sometimes deadly disease, Nephrogenic Systemic Fibrosis. The woman contracted the disease following an injection of Magnevist Gadolinium contrasting dye manufactured by Bayer-Schering and its subsidiary Berlex Laboratories prior to an MRI (Magnetic Resonance Imaging). Nephrogenic Systemic Fibrosis is the consequence of gadolinium contrasting dye use in those with an impaired renal system such as kidney disease. Those with kidney dysfunction cannot eliminate the toxic dye as quickly and efficiently as those without, causing abhorrent side effects including the thickening and hardening of the skin, joint problems, deep pain in the ribs and hips leaving many wheelchair bound experiencing extreme pain. Death has also been known to occur once the disease reaches the internal organs. The woman received a gadolinium injection in March 2001 and in February 2007 was finally diagnosed with NSF by doctors at the Mayo Foundation. She continues to experience a progressive fibrotic debilitation causing severe impairment. Her lawsuit was filed with the Multidistrict Legislation, Northern District of Ohio alleging that Magnevist is defective and that the creators failed to adequately test and ultimately warn patients about its potential to cause NSF. In September 2007, the Food & Drug Administration (FDA) asked all manufacturers of gadolinium contrast dyes to add a “black box” warning to the product labels about its association with NSF in addition to warning patients with kidney disease who should avoid gadolinium contrast agents. Numerous cases have been filed in many federal districts against gadolinium contrast dye manufacturers. On February 29, 2008 the U.S. Judicial Panel on Multidistrict Litigation designated the U.S. District Court for the Northern District of Ohio as the venue for all the lawsuits that have been filed, and that will be filed in federal district court, against the makers of gadolinium contrast dyes.

Posted by Peter W. Burg at 12:28 PM | Permalink | Comments (0) | TrackBacks (0)

A new technology may be released soon that goes further to protect patients with renal failure while undergoing an MRI. Luna nanoWorks and the Washington University School of Medicine co-authored a paper that was published in the Journal of Medicinal Chemistry. The paper introduces a new avenue of gadolinium delivery that could protect patients with insufficient kidney elimination from the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis after undergoing and MRI. The paper describes the new contrast agent as encapsulating the gadolinium metal within an extremely stable carbon nanosphere, thus allowing for extended existence in the body. Patients with kidney insufficiency eliminate toxins slower than those with normal renal function. Luna's HYDROCHALARONE™ molecules have initially proven to be more effective at enhancing images and are potentially safer than current gadolinium-containing contrast agents, which have been associated with Nephrogenic Systemic Fibrosis. Currently gadolinium contrast agents are formulated in a chelate to prevent toxicity, but the chelate agent is designed to be in the body for a short period of time. In those with renal failure their slow elimination process allows the gadolinium to separate from the chelate, thus exposing the patient to the toxic metal. The new delivery process of gadolinium may be a boon to those who need to undergo and MRI, but suffer from kidney failure. The U.S. Food and Drug Administration continues to review reports of patients who have developed NSF after receiving the chelate-based gadolinium agent. In response to reports of patient exposure, the FDA issued a black-box warning, the highest available, to warn the medical community of the possible consequences of using the chela