Fort Worth, Texas resident Debbie Wooten filed a personal injury lawsuit against Advanced Medical Optics, Inc. (AMO) for her suffering after the use of their Complete MoisturePlus Multi Purpose contact lens solution. The 44 year old says she suffered permanent vision loss due to Acanthamoeba keratitis, an extremely painful infection of the cornea, from use of the solution. 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. She had to wait nine months for a corneal replacement surgery to make sure that after treatment of the infestation, the microorganism was dormant.

The Complaint charges that AMO's contact lens solution was not effective in disinfecting contacts lenses, and vastly inferior to other multipurpose solutions available on the market. The Complaint alleges that AMO's own data demonstrated the product's lack of effectiveness in preventing the growth of protozoa microorganisms, including acanthameoba. The protozoa acanthameoba are directly associated with a disproportionate risk and increased incidence of Acanthamoeba keratitis in users of contact lens solution products. Wooten's lawsuit brings claims of negligence, strict liability, breach of warranty, fraud, unjust enrichment, and violations of California statutory law. Wooten seeks compensatory and punitive damages against AMO for the injuries she has suffered.

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 the 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 07:01 PM | Permalink | Comments (0) | TrackBacks (0)

A group of doctors in Tennessee has decided to stop prescribing the Ortho Evra patch to patients over concerns that it could increase risk of blood clots or other problems. In a letter to their patients, the doctors cited a study which showed that women who use the Ortho Evra patch are at an increased risk of deep vein thrombosis. Concerns about the potential side effects of Ortho Evra have risen steadily in the five years since the patch came on the market. As result, the Food and Drug Administration forced Ortho-McNeil, the manufacturer of the birth control patch, to strengthen consumer warnings about the risk of Ortho Evra side effects. A "black-box" warning was added to the labeling in order to alert consumers and their doctors about the risks posed by the Ortho Evra birth control patch. Despite these warnings, at least 23 women died as a result of side effects they suffered while using the Patch, and at least 17 of these deaths were the result of blood clots. Hundreds more women have suffered blood clots, heart attacks, pulmonary embolisms or strokes after using the patch.

Studies indicate that health officials received at least 9,000 reports of side effects among Ortho Evra users during the first year and a half that the patch was on the market. Over a six year period, officials received only about 1,300 adverse reports from users of birth control pills. Based on these statistics, the rate of Ortho Evra side effects was more than 27 times greater than that experienced by users of the pill. Despite evidence linking the Ortho Evra patch to cases of blood clots, heart attack, pulmonary embolism, stroke and even death, neither the FDA nor its manufacturer, Ortho-McNeil, have called for an Ortho Evra recall.

Posted by Seth A. Katz at 02:39 PM | Permalink | Comments (0) | TrackBacks (0)

Fourteen-year-old Scotty Raymond of New Jersey was released from the hospital August 25th after being seriously injured August 2nd when he was struck by a car. He was walking his bike with a friend at around 10:30 pm at the time of the accident. Scotty, who was not wearing a helmet, suffered a traumatic brain injury when his head hit the concrete. He also had a large open wound on his leg that would require plastic surgery and another on his arm. His head and ear had large lacerations, and his whole body was bruised. Scotty was released from Children's Specialized Hospital at Mountainside after a miraculous recovery helped by family support and a message board created by his aunt of which more than 500 comments of support were posted. He was transferred to Children's on August 17th from Hackensack Unive rsity Medical Center, where he had been in the intensive-care and acute-care units. At Children’s, he underwent six hours of speech, occupational and physical therapy daily. Nevertheless, he was still suffering from "confusion, short-term memory deficit, mood swings and poor attention span," according to Dr. Krishan Yalamanchi, a neurodevelopmental pediatrician who treated him at Children's. On August 18th, everything changed. He started looking at some pictures of his German shepherd on his father's computer and remembered. "I started remembering things after I saw the picture, and then everything just snapped into place," the teen said. His father couldn't believe his son's instant recovery. His pediatrician says his recovery has been remarkable.

Posted by Kerry N. Jardine at 02:15 PM | Permalink | Comments (0) | TrackBacks (0)

An article in Popular Science mentions Doctor Bennet Omalu who is finding that football players are at increased risk of dementia brought on by head injuries on the field. A condition he calls football-induced chronic traumatic encephalopathy, or CTE. Other researchers are getting involved but the NFL still isn't convinced, but New Hampshire-based Simbex is offering something that can help lessen the problem. Their Head Impact Telemetry System, or HIT System, is a football helmet packed with sensors that can detect sudden impacts and wirelessly relay information to a remote station. So if a player takes a particularly hard hit, the coach can see it right away and take steps, even if the player looks fine. The side benefit is that the HIT System might help determine whether CTE is a genuine condition or not. Since its introduction, it's been used to collect data on over 250,000 impacts, the kind of real-world data set that researchers look for.

Posted by Kerry N. Jardine at 10:38 AM | Permalink | Comments (0) | TrackBacks (0)

Dear Mayor Newberry and the Lexington Community:

One year has passed since so many lives were forever changed by the accident involving Comair Flight 5191. The many family members and friends of the passengers who lost their lives that day have been left to carry on without them. The entire city of Lexington continues to bear the burden of such a tragedy occurring in your tight-knit community. And finally, Comair employees also mourn the lost members of our family.

This accident will forever be part of all of us, and as we approach the anniversary, our hearts remain heavy. I am a man of faith and believe that those left behind will meet again with those we have lost. Until then, we remember them through our many memories and honor them in our daily actions.

The upcoming memorial events are a milestone in the ongoing journey to heal. The enormous effort put forth for these events is a testament to the caring people of Lexington. Throughout the past year, you have helped lift the families' burdens by making their sorrow your own and reassuring them that they are not alone in their time of grief. I cannot think of a better example of what it means to be a truly supportive community.

On behalf of everyone at Comair, please accept our sincere appreciation for the year-long support we have received. We are grateful for all your efforts to honor the Flight 5191 passengers and your kindness to the Comair team. I personally am honored to call Kentucky my home.

Now, even one year later, it's difficult for me to find the words to express my sorrow. We continue to keep the passengers, crew and their loved ones in our thoughts and wish them peace and loving remembrance always.

Respectfully,
Don Bornhorst
Comair President
(Representing Comair's 6,600 employees and their families)

Posted by Kerry N. Jardine at 06:57 PM | Permalink | Comments (0) | TrackBacks (0)

Since 1997, the medical community has been trying to determine the cause of Nephrogenic Systemic Fibrosis (NSF). NSF is also known as Nephrogenic Fibrosing Dermopathy. It is a rare and little understood disease that affects people with kidney problems. Since the first cases were documented, research into NSF has provided few clues into its cause, and even fewer as to its treatment. Most patients eventually diagnosed with NSF are first found to have high blood pressure, which is followed by burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and can eventually lead to death. The progression of the disease can be slow and can take several years for all of the symptoms to appear. However, some patients have a form that progresses so quickly that they often die of complications brought on by the disease.

There are no consistently successful treatments for NSF, but symptoms can be improved with several methods. Physical therapy, oral steroids and some other drug therapies have shown promise in treating NSF. Unfortunately, NSF is such a recent phenomenon that few studies on treatments have been completed. According to the International Center for Nephrogenic Fibrosing Dermopathy Research, NSF patients show the most improvement when improved kidney function can ease symptoms, and in some patients this seems to reverse the disease overtime. Some NSF patients who have received kidney transplants have improved dramatically, but there is no guarantee that all patients will see such results.

It is important that people with kidney problems be aware that the disease is associated with Gadolinium based contrast agents used in MRIs. These agents are injected into patients prior to an MRI in order to enhance images. Anyone with a kidney problem who is to undergo an MRI should make sure that agents with Gadolinium will not be used. Also, patients scheduled for an MRI using such contrast agents should always be screened for kidney efficacy.

Posted by Kerry N. Jardine at 02:39 PM | Permalink | Comments (0) | TrackBacks (0)

Soldiers deploying next month with the 1st Armored Division headquarters staff are taking part in the U.S. Army’s first large-scale test for traumatic brain injury. A traumatic brain injury, or TBI, disrupts normal brain function. The test on 1st AD soldiers in Wiesbaden, Germany could be especially useful in assessing mild brain injuries. “It’s the mild TBI guys” who are the focus, said Lt. Col. Jerome L. Buller, the division surgeon-general. “They are the diagnostic dilemma.” That’s because any damage done is generally hard to diagnose, since the injury is internal and thus more difficult to detect.

The computer based test, which takes 15 to 20 minutes, is part of the pre-deployment regimen that about 1,200 soldiers are going through at Wiesbaden Army Airfield. Buller indicated that the test likely would become part of the Army’s pre-deployment and post-deployment process. More than 400 soldiers at Fort Campbell, Ky., participated in a pilot program in June and July. It’s designed to capture baseline data on a soldier’s reaction time, processing speed, spatial memory, short-term memory and working memory, which is the skill to temporarily retain facts or thoughts while handling a task or solving a problem. All of the data won’t come into play unless a soldier is injured or experiences TBI symptoms following a blast. The expectation is that the baseline data on each soldier will help in the identification and treatment of mild brain injuries.

Posted by Kerry N. Jardine at 10:34 AM | Permalink | Comments (0) | TrackBacks (0)

Most everyone assumes if a doctor prescribes a drug or it's available through a pharmacy, then it's been approved by the Food and Drug Administration. That statement however, is not true. Hormone replacement therapy is a common treatment for women going through menopause. In the past couple of years studies have found the drugs can have dangerous side effects. One study released found women taking the drugs had twice the risk of breast cancer. Even though it's been prescribed to thousands of women, the drug Estratest has never been approved by the FDA. Estratest is a widely prescribed combination of synthetic estrogen and testosterone to treat the symptoms of menopause. One woman experienced an increase in facial acne and hair growth. It was the testosterone that seemingly caused it. Estratest has never been approved by the FDA and by law all drugs are required to get FDA approval before they are sold. Since Estratest has been on the market since 1964, most people assume it's been approved. The maker of Estratest applied for approval in 1979, but the FDA turned them down. The company tried again in 1981. Twenty-six years later and there is still no approval. The company doesn't hide the fact. Its literature clearly states, "This product has not obtained FDA pre-market approval." A federal appeals court in Atlanta said it was baffled and wrote, "It is incomprehensible that Estratest has been allowed on the market without approval for 35 years." They added, "There can be no good excuse for allowing a company to violate the law for 35 years."

Estratest isn't the only unapproved drug on the market. The FDA admits there are several hundreds. In June 2006, the FDA announced it was cracking down, but unapproved drugs like Estratest are still being sold. There are some safety concerns due to new studies on drugs used to treat the symptoms of menopause. The largest study had to be stopped because of safety concerns and the New England Journal of Medicine released another study that showed an increased risk of breast cancer among women who took the hormone replacement drugs. These studies are not going unnoticed. Consumer group Public Citizen put Estratest on its list of worst pills because of its link to breast cancer. In August of last year, the National Women's Health Network filed a petition asking the FDA to force the manufacturer to stop selling it. Two public interests groups have filed a class action lawsuit in California against the maker of Estratest.

Posted by Kerry N. Jardine at 06:32 AM | Permalink | Comments (0) | TrackBacks (0)

A new study, led by Timothy Hla at the University of Connecticut, may explain how COX-2 drugs such as Vioxx, Bextra, and Celebrex trigger life-threatening cardiovascular side effects such as heart attacks and strokes. The study was published online yesterday in The Journal of Experimental Medicine.

Drugs such as Vioxx target the COX-2 enzyme, which is produced in response to infection or injury and releases pain- and fever-inducing byproducts. Thus, blocking COX-2 reduces pain. But when scientists in the study blocked COX-2 in mice, it also stimulated the production of a protein called tissue factor, or TF, which initiates clotting. As heart attacks and strokes are often triggered by blood clots, it's possible that the production of TF is partly responsible for the drug's adverse effects on people. Scientists were able to counter the levels of TF in the blood by administering TF-lowering drugs.

Posted by Kerry N. Jardine at 06:40 PM | Permalink | Comments (0) | TrackBacks (0)

It seems our diabetic population has had to face a double wammy in recent months. First it was the effects of gadodiamide contrasting agent used in MRIs and MRAs causing a rare and possibly fatal skin disease called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Systemic Dermopathy (NSD). Then it was an article written for the New England Journal of Medicine concerning the diabetic drug Avandia that helps the body use insulin more efficiently, causing a higher risk of cardiovascular death (64% increase) and heart attacks (43% increase). As well as possibly causing macular edema, it is fluid retention in the eye that can cause vision impairment. Now the FDA is under attack by the government for not taking more extensive steps in preventing these types of drugs reaching the market without proper drug trials. It is in these times that we need to keep asking questions of our doctors. If you or loved one is experiencing kidney disease or any degree of renal failure, you may want to talk to your doctor about getting an MRI or an MRA and discuss the current gadodiamide issues. You may also want to discuss the possible risks in taking Avandia and Actos (another diabetic drug). In today’s times of insufficient and expensive health care we need to take control of our own medical issues and know the current events concerning drugs and treatments. Stay aware and stay involved.

Posted by Kerry N. Jardine at 02:53 PM | Permalink | Comments (0) | TrackBacks (0)

Saving human memory is one of the highest level of care sought by modern medicine. The concept is integral in the treatment and care of individuals suffering from a traumatic brain injury or Alzheimer’s. New research suggests the discovery of a protein that controls the odds of memory formation may lead to an entirely new approach for preserving memory. The finding, by scientists from UCLA/University of Toronto is important because until now, scientists knew little about how the brain assigns cells to participate in encoding and storing memories. As reported in the April 20 edition of Science, a new approach for preserving memory in people suffering from Alzheimer’s or other brain injury may be forthcoming. Alcino Silva, principal investigator and a professor of neurobiology and psychiatry at the David Geffen School of Medicine at UCLA explains, “Learning triggers a cascade of chemicals in the brain that influence which memories are kept and which are lost. Earlier studies have linked the CREB protein to keeping memories stable. We suspected it also played a key role in channeling memories to brain cells that are ready to store them.”

http://www.burgsimpson.com/brain.htmlSilva and his colleagues used a mouse model to evaluate their hypothesis. They implanted CREB into a virus, which they introduced into some of the cells in the animal’s amygdala, a brain region critical to emotional memory. Next they tested the mouse’s ability to recall a specific cage it had visited before. To visualize which brain cells stored the mouse’s memories about the cage, the scientists tracked a genetic marker that reveals recent neuron activity. When the team examined the animals’ amygdalas after the experiment, they found substantial amounts of CREB and the marker in neurons. “We discovered that the amount of CREB influences whether or not the brain stores a memory,” said Silva. “If a cell is low in CREB, it is less likely to keep a memory. If the cell is high in CREB, it is more likely to store the memory.” Human implications of the new research could be profound. “By artificially manipulating CREB levels among groups of cells, we can determine where the brain stores its memories,” he explained. “This approach could potentially be used to preserve memory in people suffering from Alzheimer’s or other brain injury. We may be able to guide memories into healthy cells and away from sick cells in dying regions of the brain.”

Posted by Kerry N. Jardine at 10:02 AM | Permalink | Comments (0) | TrackBacks (0)

A 22-month study of Fort Carson soldiers returning from the Middle East found that nearly 18 percent suffered from at least a mild form of traumatic brain injury. Of 13,440 soldiers examined since June 2005, 2,392 exhibited some of the symptoms associated with mild TBI which include headaches, memory loss, irritability, difficulty sleeping and balance problems. Like post-traumatic stress disorder, there is no "identifying marker" that would make brain injuries easy to diagnose. Bullets and shrapnel that penetrate the skull are the obvious causes of TBI, but explosions that have rattled the head of Fort Carson soldiers are overwhelmingly to blame. Blast waves and the resulting sudden change in air pressure from explosions are the leading cause of the closed-head injuries.

In many instances in soldiers examined, symptoms did not occur until months after a soldier's return, and in others, symptoms resolved themselves even before a soldier got home. The post relies on a second screening 90-120 days after homecoming and on input from family members and the chain of command. "Symptoms can present themselves at different points in time. And you might ask why. I can only surmise that when a soldier returns to the United States and is subjected to the activities of daily living -- traffic, making formation ... perhaps the stressors then bring some of these symptoms to light," Col. John Cho, who commands the Evans Army Community Hospital at Fort Carson, said. "The good news in all of this is we have the mechanism to catch this."

Capt. Matthew Staton, 30, noticed he was having symptoms after returning home from a 2003-04 deployment after surviving several improvised explosive device and bomb explosions. "It's like getting your bell rung," he said of the blasts. He relies on a digital voice recorder and palm computer to remember things. He also is quick to anger. "It's depressing, frustrating. I'm a 30-year-old man," he said.

Posted by Kerry N. Jardine at 06:18 AM | Permalink | Comments (0) | TrackBacks (0)

A rare and painful disease, known as Nephrogenic Systemic Fibrosis, has caused Jeanie Deason legs and right arm to become frozen in a bent position. She fears that the condition will soon leave her an invalid. A Vanderbilt University Medical Center doctor says there is a therapy that may improve Deason's condition. However, TennCare, the state's insurance plan for the poor and disabled, will not pay for it because it's considered to be experimental.

Getting treatment for rare diseases is a widespread problem, said Mary Dunkle, spokeswoman for the National Organization for Rare Disorders. The organization estimates that there are 6,000 to 7,000 rare diseases affecting more than 25 million Americans. Marilyn Wilson, TennCare's spokeswoman, said TennCare had never covered experimental treatments. Patients with rare diseases often are left in a predicament: Insurance companies typically won't cover a treatment unless the FDA has approved it for that disease, but for the majority of rare diseases there are no FDA approved treatments. The National Organization for Rare Disorders says it’s a matter of economics and researchers have difficulty securing funding because the diseases affect such a small number of people. Additionally, drug companies will not put money toward research for rare diseases because it is not lucrative proposition for them.

For Jeanie Deason, she is appealing Tenn-Care's decision. An administrative law judge ruled in her favor in April, but that decision was overturned by a state finance representative. Her case will be reviewed for the last time by a judge in Davidson County Chancery Court. Kevin Fowler, Deason’s attorney is arguing that her illness is so rare that all treatments for it are by definition experimental. "This treatment has been shown to work," Fowler said, "When only 250 people in the world have a disease, how could you statistically prove what treatment is most effective?"

Posted by Kerry N. Jardine at 06:10 PM | Permalink | Comments (0) | TrackBacks (0)

A retired 71-year-old suburban Cleveland restaurant supplier, filed a lawsuit in U.S. District Court on March 14 against Tyco International and two healthcare subsidiaries, Tyco Healthcare Group and Mallinckrodt, Inc., claiming that their drug Optimark caused him a debilitating skin and joint disease known as Nephrogenic Systemic Fibrosis (NSF). It may be the first against Tyco stemming from the effects of Optimark, a contrast agent containing the metal gadolinium. Optimark is injected into patients prior to magnetic resonance imaging (MRI) to help diagnosticians distinguish blood vessels from nearby tissues. The suit notes that in 2006 the FDA issued Public Health Advisory alerts about the development of serious, sometimes fatal, NSF/NFD following patient exposure to gadolinium-based contrast agents, including Optimark. The suit claims that Tyco was aware, or should have been aware of the risks of Optimark. There have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Optimark according to the suit. Further, the suit alledges that the Defendants have not revised their package inserts, material safety data sheets, and other product-related literature, nor conducted appropriate post-marketing communications in order to convey adequate warnings.

Within days of his Optimark injection last year, this retiree experienced excruciating pain and suffered serious, progressive, and incurable injuries," says Peter J. Brodhead, a partner in the Cleveland litigation law firm of Spangenberg, Shibley & Liber, who filed the suit. Spangenberg, Shibley & Liber in association with Burg Simpson Eldredge Hersh & Jardine are seeking to represent NSF victims nationwide. "This man-made disease caused his skin to harden and his joints to lock up and to swell," says Brodhead "He was sent to a nursing home and confined to bed and a wheel chair. Today he is at home, but he continues to require regular physical therapy in order to walk." The lawsuit asserts that the plaintiff was admitted to University Hospitals in Cleveland in January 2006 for dialysis and other treatment. Before his MRI, he was injected with Optimark. Shortly afterward, he developed NSF with its incapacitating consequences, according to the complaint. "Neither he, nor his prescribing physician, nor the performing radiologists or technicians were warned or cautioned by the defendants about the serious health risks presented by the administration of Optimark," states the suit.

Much has been made public recently about the relationship between gadolinium-based contrast agents and NSF. In its Public Health Advisory last December, the FDA said it was notifying health care providers that patients with moderate to end-stage kidney disease that receive an MRI with a gadolinium-based contrast agent may get NSF. The FDA called NSF "debilitating" and added "it may cause death." The Clinical Journal of the American Society of Nephrology reported on NSF in its February issue. "NSF is a fibrosing disorder that involves predominantly the skin but also affects systemic organs, such as the liver, heart, lungs, diaphragm, and skeletal muscles," said the publication. The U.S. Centers for Disease Control (CDC) also has been investigating illnesses related to metallic dyes containing gadolinium used in MRI scans. "When possible, use of gadolinium-containing contrast agents should be avoided in patients with advanced renal failure, particularly in patients who are undergoing peritoneal dialysis," the CDC concluded in its late February Morbidity and Mortality Weekly Report. The American College of Radiology, in a Guidance Document for Safe Practices, recently recommended that gadolinium-based contrast agents not be administered to patients with advanced kidney disease unless the benefits clearly outweigh the risks. Even more strongly, the European Agency for the Evaluation of Medicinal Products issued a recent advisory against the use of Optimark and one other gadolinium-based contrast agent for patients with severe renal disease.

Posted by Kerry N. Jardine at 04:56 PM | Permalink | Comments (0) | TrackBacks (0)

Evaluating a patient's kidney function can help determine their ability to safely receive IV contrast including gadolinium prior to CT and MR imaging procedures. This is an important precaution especially for patients with risk factors such as diabetes, known kidney impairment, and advanced age especially in the wake of nephrogenic systemic fibrosis. Currently, such blood tests must be sent to a lab before the patient can undergo a CT or MRI procedure, a time-consuming step that can cause delays in busy radiology departments. E-Z-EM, Inc. a leading manufacturer of contrast agents for gastrointestinal radiology announced the release of the company's new EZ CHEMTM blood analyzer. The blood analyzer is a convenient device used in detecting blood creatinine levels in patients prior to CT and MRI. The FDA cleared the technology in May 2007. EZ CHEMTM performs a simple test for assessing kidney function in the imaging room and produces results in as little as 30 seconds. The device analyzes a finger prick sample of blood for levels of creatinine which is an important indicator of a patient's renal function. Such blood values are often required to determine a patient's kidney function before IV contrast agents are administered. This new technology may not help current victims of nephrogenic systemic fibrosis, but for radiologists the release is welcome news

Commenting on the announcement, Brad S. Schreck, the Company's Senior Vice President-Global Sales, Marketing and Engineering, said, "EZ CHEM provides the ability to quickly and accurately assess kidney function where it is needed most, at the point-of-care. Screening for patients with renal insufficiency has been in focus recently, as certain contrast agents, particularly those used in MRI, have been associated with Nephrogenic Systemic Fibrosis (NSF)-a debilitating and potentially severe condition that currently has no clear and widely successful treatment. We believe EZ CHEM will help reduce the risks associated with the use of IV contrasts for certain patients while improving productivity in the imaging suites, all through a simple, reimbursable test. We have been pleased to work with Nova Biomedical during the development phase and are excited to begin offering EZ CHEM to the radiology and gastroenterology marketplace."

Posted by Kerry N. Jardine at 02:23 PM | Permalink | Comments (0) | TrackBacks (0)

A study published by the Journal of the American Society of Nephrology written by researches at Copenhagen University Hospital in Denmark reports on its findings back in 2006. They found that Nephrogenic Systemic Fibrosis was a new, rare disease that affects patients with renal failure. Single cases led to the suspicion of the role of gadodiamide being used for magnetic resonance imaging. A study reviewed all of the confirmed cases of Nephrogenic Systemic Fibrosis with respect to clinical characteristics, gadodiamide exposure, and subsequent clinical course. It was found that all had been exposed to gadodiamide before the development of nephrogenic systemic fibrosis. The ratio for acquiring the disease when exposed to gadodiamide was seven (54%) patients became severely disabled, and one died 21 months after exposure. No other exposure or event related to gadodiamide was common in the patients that could be identified. These findings indicate that gadodiamide played a role in Nephrogenic Systemic Fibrosis.

Posted by Kerry N. Jardine at 06:13 AM | Permalink | Comments (0) | TrackBacks (0)

The FDA has announced that labeling for MRI and MRA imaging contrast agents that contain gadolinium will have stronger new warnings. The contrast agents are often used to improve the visibility of internal structures when patients undergo MRI/MRA procedures. Five of the contrasting agents have been approved in the US: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The new boxed warning describes risks and necessary screening procedures for a serious condition related to gadolinium exposure called nephrogenic systemic fibrosis (NSF). NSF is characterized by fibrosis of the skin, muscle and internal organs. It is debilitating and potentially fatal. The warning will state that certain patients have a higher risk of developing NSF if they are given any of these gadolinium-based agents. Specifically those affected with severe acute or chronic renal failure and those with acute renal failure of any severity who have hepato-renal syndrome or are currently preparing for or are healing from a liver transplant. Hepato-renal syndrome is a term used for a group of diseases involving both the liver and kidney. Clinicians should avoid using these products with high-risk patients unless the diagnostic information is essential and cannot be obtained any other way.

The new labeling will contain several other recommendations. Before using these agents, all patients should be evaluated for renal failure either by obtaining a medical history or conducting laboratory tests. When administering these products, do not exceed the dose recommended in the product labeling. And do not re-administer these agents until enough time has elapsed to ensure that the prior dose has been eliminated from the body. After administering a gadolinium-based contrast agent, consider prompt dialysis for patients already receiving hemodialysis. It is unknown whether dialysis prevents NSF, but data indicate that it does speed up the elimination of the agent from the body.

Posted by Kerry N. Jardine at 02:29 PM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/defective_drugs.htmlThe FDA announced that the Nonprescription Drugs Advisory Committee will meet in October to discuss the safety and effectiveness of cough and cold drug product use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age. In preparation for the meeting, FDA is reviewing safety and efficacy data for the ingredients of these products.

Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents must carefully follow the directions for use of the product in the “Drug Facts” box on the package label.

What should parents know about using cough and cold products in children?

* Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.

* Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).

* Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.

*If other medicines (over-the-counter or prescription) are being given to a child, the child’s healthcare provider should review and approve their combined use.

* Read all of the information in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.

* Follow the directions in the “Drug Facts” box. Do not give a child medicine more often or in greater amounts than is stated on the package.

* Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.

* For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.

* If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” box on the package label, or is recommended by the child’s health care provider.

* If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your healthcare provider if you have questions or are confused.

* Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.

* If a child’s condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.

Posted by Kerry N. Jardine at 10:53 AM | Permalink | Comments (0) | TrackBacks (0)

At present, there is no known effective treatment for NSF. Physical therapy or treatment with topical and systemic steroids has had a variable benefit. Immunosuppressive therapy is ineffective. Plasmapheresis, a process in which blood taken from a patients is treated to extract the cells and corpuscles which are then added to another fluid and returned to the body, has led to an improvement in some. The drug Thalidomide led to an improvement in a few patients as well. Others have improved after restoration of normal renal function either spontaneously or as a result of a renal transplant. There is a proposal that a dose reduction in erythropoietin, a hormone produced in the kidneys that increases development of red blood cells in bone marrow, might improve NSF. Two patients were given Pentoxifylline, a substance with activity against tumor necrosis factor. Skin changes in the first patient who had late-stage disease seemed to slow or arrest it and the second patient stabilized and had a slight reversal of disease.

Posted by Kerry N. Jardine at 10:16 AM | Permalink | Comments (0) | TrackBacks (0)

Gadolinium contrast agents have long been used in Magnetic Resonance Imagining (MRI) to enhance the quality of images, but in some patients, it can have a toxic affect, causing a condition known of Nephrogenic Systemic Fibrosis (NSF). It is injected into the bloodstream right before an individual undergoes an MRI. The agent helps the MRI computer differentiate between normal and abnormal tissue. In 2006, researchers discovered that the use of Gadolinium based contrast agents had a direct correlation to the development of NSF in patients with pre-existing kidney problems. The FDA then warned that the agents were tied to a number of NSF cases. At that time the FDA warned physicians to screen patients for kidney problems prior to using a Gadolinium based contrast agent during MRIs. In May 2007, the FDA requested that the manufactures of the five Gadolinium contrast agents (including Ominiscan, Magnevist and OptiMark) used in MRIs include a boxed warning on their labels highlighting the risk they pose to patients with kidney problems.

NSF is a disorder that can cause high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. Further it can progress to the point of causing severe stiffness in joints, and could possibly be terminal. Currently, there is no proven treatment or cure for NSF. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF, the only way to improve their kidney function is with a transplant.

Gadolinium based contrast agents could potentially injure millions of people. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. The foundation also estimates that 20 million more are at increased risk for developing chronic kidney problems. It is vital that patients who are about to undergo an MRI speak with their healthcare providers about the risks associated with Gadolinium based contrast agents.

Posted by Kerry N. Jardine at 06:24 AM | Permalink | Comments (0) | TrackBacks (0)

A man employed by a subcontractor as part of a two-man rubber removal team on a runway at Denver International Airport was killed earlier this month when he was struck by a giant runway sweeper operated by a DIA employee.

A Denver Police Department spokesman said the dead man was about 46 years of age, had apparently bent over to retrieve an item, and could not be seen by the operator of the sweeper. He was struck and killed by the machine, which is a very large vehicle used to pick up debris on the runway. The sweeper has a broom about 22-to-24 feet long.

OSHA has been notified and will conduct an investigation into the events that led to the death. It's still unknown what occurred in the moments before the accident.

The runway was closed for a brief period of time, but reopened by 8:45 a.m. Since the airport's other runways were able to handle all incoming and outgoing flights, the accident did not cause a disruption to airport operations.

Posted by Kerry N. Jardine at 02:55 PM | Permalink | Comments (0) | TrackBacks (0)

Up to 23,750 people die in Canada each year as a result of medical mistakes. For the first time, organizations that represent medical institutions are developing policies to bring an end to medical secrecy in Canada, eventually making disclosing medical errors a routine part of medical care. Ontario leads the way, with changes to legislation moving through the Legislature that will make the records of all health professionals available to the public. Patients will be able find out if a physician is under investigation, has been accused of medical malpractice or professional negligence, and whether disciplinary action has been taken against a care provider or limits placed on a physician's license. Health professionals found guilty of an offense will be obliged to report findings against them, their respective health regulatory colleges will then make any subsequent findings of misconduct public on their websites. A single committee will be formed to address patient concerns rather than the current system in which complaints are channeled to a variety of committees. Starting July 1 2008, hospitals will be required to report medical errors to patients.

Posted by Scott J. Eldredge at 10:48 AM | Permalink | Comments (0) | TrackBacks (0)

Adeline Papke of Aberdeen South Dakota legs were amputated because of complications following knee-replacement surgery. The South Dakota Supreme court ruled she must get a new trial in her malpractice lawsuit against two doctors. The high court said Adeline Papke is entitled to a new trial because the jury in her first trial was given an improper instruction that probably influenced its decision to rule against her. Papke, who was 70 at the time, fell when her left knee gave out while she was watering flowers in her yard in September 2002. After she was taken to a hospital emergency room, she was evaluated by one of the defendants. Both defendants performed surgery to replace both of Papke's knees in October 2002, but her knees dislocated while she was recovering. The doctors put casts on both of her legs and she developed sores on her feet. Another doctor diagnosed Papke with circulation problems. Her condition worsened and both legs were eventually amputated above the knee. She then sued alleging that her medical treatment fell below the appropriate standard of care.

The original instructions to the jury said a doctor is not necessarily negligent because the doctor errs in judgment nor because the doctor's efforts prove unsuccessful. That instruction also said a doctor is negligent if the error in judgment or lack of successful treatment is due to a failure to perform duties defined in other instructions. The Supreme Court said language on "error in judgment" should not be used in jury instructions for ordinary medical malpractice cases in South Dakota because it does not explain the applicable standard of care at issue in those lawsuits. Papke's right to a fair trial also was violated when she was not given sufficient notice about testimony given by an expert witness for the doctors, the high court said. The ruling gives Papke another trial.

Posted by Scott J. Eldredge at 10:46 AM | Permalink | Comments (0) | TrackBacks (0)

http://www.burgsimpson.com/defective_drugs.htmlThe FDA and Confidence, Inc., has recalled one lot of Metabolism Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because it contains an undeclared drug ingredient, sibutramine. Although sibutramine is an FDA-approved drug used for appetite suppression, Metabolism Apple Cider Vinegar Brand Dietary Supplement has not been approved as a drug, so the safety and effectiveness of the product is unknown.

The use of sibutramine may pose a threat to consumers because it is known to substantially increase blood pressure and/or pulse rate in some people, and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers should return any unused product to the manufacturer.

Posted by Kerry N. Jardine at 10:31 AM | Permalink | Comments (0) | TrackBacks (0)

Doctors are human and make mistakes. Most experience significant distress when they do, according to a new study of more than 3,100 doctors in the United States and Canada. Doctors say they need additional training on how to disclose errors and counseling to deal with the aftermath of serious errors, but many fear that such counseling might not be kept confidential or that their malpractice insurance costs would rise. Here are some stats on what doctors in the survey reported:

* Involved with a near-miss or a minor or serious error: 92%
* Increased anxiety about future errors: 61%
* A loss of confidence following errors: 44%
* Difficulty sleeping following errors: 42%
* Reduced job satisfaction following errors: 42%
* Harm to their reputation after making an error: 13%
* Received education or training in disclosure of errors: 18%
* Interested in receiving education or training in disclosure of errors: 86%
* Feel their healthcare organizations adequately supported them in coping with error-related stress: 10%

Posted by Scott J. Eldredge at 06:44 AM | Permalink | Comments (0) | TrackBacks (0)

A New Jersey state appeals court has refused to reduce a $70.8 million medical malpractice award to the family of a brain-damaged infant, ruling it was not excessive in light of the injuries. The three-judge panel chose to confine its ruling to the facts, finding that courts should not interfere with a jury award unless it was shocking. "A civil plaintiff has a constitutional right to have a jury decide the merits and worth of her case," the Court said. "Determining just compensation for an accident victim, particularly when the damages are not susceptible to scientific precision, as in the case of pain and suffering damages, necessarily requires a high degree of discretion. That is so because there is no neat formula for translating pain and suffering into monetary compensation. "

The plaintiff, Casey Pellicer, underwent successful spina bifida surgery at St. Barnabas Hospital in Livingston, N.J., in 1998 when he was 4 months old. During recovery, an endotracial tube aiding his breathing moved, depriving his brain of oxygen for five to 15 minutes. Casey was rendered a quadriplegic, is blind and cognitively delayed, and will require around-the-clock care for the rest of his life. His attorney says Casey will live for six or seven decades.

Posted by Scott J. Eldredge at 06:43 PM | Permalink | Comments (0) | TrackBacks (0)

The manual is the first of its kind. It guides medical staff through how to inform patients and their families of medical mistakes and apologize for them. The manual, called "When Things Go Wrong: Responding to Adverse Events," was compiled by 16 facilities affiliated with Harvard Medical School and published in March last year. The writers of the guide urge doctors and hospitals to be honest about mistakes. The manual states: Even if it is not clear whether medical malpractice has occurred, explain everything that is known and take responsibility. Express regret over the incident. If malpractice is discovered, apologize. Identify measures to avoid a recurrence of the error.

By adopting the manual, the University of Michigan Health System has succeeded in cutting claims and lawsuits filed against it by 56 percent over four years. Court expenses, which had cost upward of 3 million dollars annually, have been slashed by two-thirds. When a lawsuit is filed, the law in some states does not consider an apology a liability for the doctor being sued.

Posted by Scott J. Eldredge at 02:40 PM | Permalink | Comments (0) | TrackBacks (0)

Every year in the United States, 7 million people go to hospital emergency rooms complaining of chest pain or other symptoms suggesting they might be having a heart attack. A missed heart attack diagnosis has the highest malpractice payout among all medical malpractice cases. When patients enter a hospital or an emergency room, doctors have a professional obligation to perform all the routine tests that will either diagnose heart disease or rule it out. When profit is put ahead of patient care, doctors may not take the required time to do their jobs thoroughly and effectively. Patients are often discharged from the hospital when they should be admitted for further testing and treatment. Patients not admitted to the hospital are twice as likely to die as patients properly diagnosed, admitted and treated.

If physicians and ER staff used certain technology within the first hour of a suspected heart attack, patients would have a much greater chance for survival. ACI (acute cardiac ischemia) predictive software can reduce the number of heart attacks missed by physicians. When thrombolytic therapy (blood clot dissolving therapy), is done in the first hour after a heart attack, it increases the chance of survival. A cardiac sestamibi scan allows doctors to evaluate the heart's pumping ability and monitor the amount of blood flow to the heart muscle.

Heart disease is the number one killer in the nation, and failure to diagnose a heart attack is the number one medical malpractice mistake in our country. Being aware of the warning signs and what diagnostic options should be made available to you in the hospital may just help save your life.

Posted by Scott J. Eldredge at 10:38 AM | Permalink | Comments (0) | TrackBacks (0)

Utah soldier Doyle Peterson joined fellow service members and volunteered to help the people of Afghanistan develop new agriculture skills. A roadside bomb destroyed Peterson's vehicle in rural Afghanistan two years ago. Physically he is recovering, but like many roadside bomb survivors Peterson sustained permanent damage to his brain. Utah has more National Guard soldiers and reservists than any state in the nation, and an increasing number of returning soldiers with brain injuries. Those not killed usually suffer traumatic brain injuries from the shock wave of the blast. The new type of bombs used by insurgents focus the blast into the vehicle that sends a tremendous shock wave with it. The resulting concussion causes an injury similar to shaken baby syndrome. The damage to Doyle Peterson’s brain forever changed his life and personality, but he says he does not regret his decision to volunteer. Military doctors say many of the returning soldiers don't immediately know they have a brain injury and neither do medical care providers. Doyle Peterson and his wife spoke with community health workers at Camp Williams, Utah to help them better identify and treat soldiers with brain injuries.

Posted by Kerry N. Jardine at 06:35 AM | Permalink | Comments (0) | TrackBacks (0)

Cruising down the street in a padded bicycle helmet might not be the look you want, but helmet hair is the least of your problems as compared to what would happen if you were in an accident without head protection. Each year, more than 500,000 people are treated in emergency departments across the United States for bike-related injuries. The most serious and fatal injuries often involve the head, commonly experienced as a traumatic brain injury which has life long implications. Helmets are too often ignored. During the summer months, with the start of school and fall semester at universities and colleges, there are more bikes in use than any other time of the year. Often, bike riders share local roads with vehicles, which can present safety issues. Bikers should always remember to use caution and follow traffic signs and signals. Parents should also remain vigilant in ensuring that their children understand and adhere to basic bike safety rules.

These rules include:
- Wearing a properly fitting helmet that meets standards set by the Consumer Product Safety Commission; these helmets come with a CPSC sticker on them;
- Never riding against the flow of traffic;
- Using proper hand signals;
- Avoiding road obstacles that can be associated with falls, such as wet leaves, large puddles, rough surfaces, curbs, gravel or rocks and, most important, other bikers or pedestrians.

Posted by Kerry N. Jardine at 06:20 PM | Permalink | Comments (0) | TrackBacks (0)

Canadian military scientists are trying to develop technology to detect possible brain injuries in soldiers exposed to powerful blasts that can leave them with dangerously hidden wounds. The current problem is that there is no way to know whether troops who are exposed to blasts, but bear no visible injuries, have suffered a mild form of brain trauma even if they are a distance from the explosion. Dr. Bob Cheung, a scientist with Defense Research and Development, is looking at several real-time technologies, including ones that measure brain wave activity and cerebral blood flow. He is exchanging information with colleagues in the U.S. and is hoping the portable device they hope to develop will be applied to the civilian population. American researchers recently developed a small device that resembles an oversized iPod and has an electrode strip that can indicate whether a patient's brain functions deviate from normal.

The U.S. recently dedicated $450 million for research into treatment of brain injuries in the wake of studies that show roughly 40 per cent of combat soldiers in Iraq have suffered some form of head injury. While physicians know what to do with soldiers who have a penetrating wound from an IED or are knocked unconscious, they have no way of knowing what kind of impact the over-pressure from a blast has on the brain. Dr. Homer Tien, a trauma surgeon at Sunnybrook Hospital in Toronto, said soldiers that are as far as one mile from a blast may suffer damage, even if they're not knocked out or visibly wounded. A bomb's acceleration force can stretch the brain's nerve fibers, but that stretching may not manifest itself until days or weeks later in the form of confusion, anxiety, behavioral changes and hearing loss. "Our current ability to screen for these people will show nothing," he said, referring to CAT scans and other conventional methods that won't detect subtle injuries. The issue for physicians and military leaders is knowing who needs to be scanned for possible injury. If someone was one mile from a blast site, for example, could they have suffered damage? "Who do we define as those who are at risk? Some may not have been knocked down and are still subject to this over-pressure of air from the explosion," Tien said. "At what point do you send them for further screening? No one really knows."

Posted by Kerry N. Jardine at 02:29 PM | Permalink | Comments (0) | TrackBacks (0)

A joint Humana Insurance and University of Miami research effort will study the effects of drugs already on the market. One of its first focuses will be on diabetic patients and how they have been affected by the drug Avandia. It will take time before the study is finished because of the more than 40,000 diabetic patients in Humana's 11 million person database. A preliminary paper, led by UM professor Hermes Florez, questions the work on the drug done by Steven Nissen at the Cleveland Clinic. The Florez paper said the pooled results of the Nissen meta-analysis of 14,000 Avandia patients found that 86 had suffered heart attacks, compared to 72 of 11,634 diabetics who weren't taking the drug, which the Cleveland researchers said meant a 43 percent higher risk for Avandia group. The Florez paper, from the Southern Medical Journal, noted the ''widespread panic and confusion'' caused by the Nissen findings. “The use of odds ratios to compare a small number of events occurring in a large pool of patients and using summary trial-data would seem disingenuous, especially considering the experience of the authors.”

Posted by Kerry N. Jardine at 10:11 AM | Permalink | Comments (0) | TrackBacks (0)

'Hearing voices' is not a symptom restricted to patients with psychosis, physicians in Switzerland report. They describe a case illustrating how auditory hallucinations can occur when neurological conditions affect the parts of the brain used to process and monitor speech. According to Dr. Daniela Hubl at the University Hospital of Psychiatry, the patient was a 63-year-old, previously healthy woman, who suffered a traumatic brain injury caused by a bicycle accident.

She regained consciousness seven days after the injury. 2 months later, she worsened suddenly, and EEG indicated epilepsy. After treatment she still spoke with single words and short sentences. 2 months after that she began having auditory hallucinations. She described them as "her own thought aloud, echoes of earlier conversations (and) voices of the hospital staff commenting on things that had just happened." She said that the voices sounded just like other voices, "except that they said only very simple and short sentences." Once the patient's medications were switched to sodium valproate and levetiracetam, the hallucinations stopped, and there have been no recurrences by the time of her last visit in June, 2007. The patient's experience with speech deficits that were the same as her own supports the hypothesis that auditory hallucinations "derive from inner speech that has been misidentified as coming from outside the self, because of defective monitoring."

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

A concussion is like a bruise of the brain with results ranging from mild trauma to permanent damage. Heads accelerate forcefully when sports players collide, and the brain keeps moving within the skull, possibly injuring nerves and blood vessels. It can also happen if a kid is hit by a ball, falls out of a tree or is just playing around the house. The more vigorous the activity, the more impact involved, the more likely it is that someone will receive a concussion. Many kids experience mild concussions without anyone realizing it, but the injuries should not be shrugged off. Amnesia and loss of consciousness are red flags. Other symptoms may include disorientation, lack of coordination and delayed response to questions. Injured players may need to go to the hospital or at least sit out the game, depending on the symptoms. Parents should wake them during the first night to check their responsiveness and continue to watch them for headaches, nausea, visual disturbances and difficulty concentrating. The damage from repeated concussions can be cumulative so returning to action too soon or without evaluating recovery a risk that's not worth taking. In what's known as second-impact syndrome, for example, someone who appears to have recovered from a recent concussion suffers another injury. It may seem to be just a minor bump first, but the brain can react with massive swelling very quickly. It can be fatal within an hour. It's the thing that scares team physicians more than anything.

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

With the FDA determination that the diabetes pill Avandia should remain on the market with stricter warnings, many doctors are now faced with determining whether they should still prescribe the medication for their patients. Doctors on Sermo (an online physician community), however, have been debating the risks versus benefits of Avandia since the drug's safety was first called into question in May. They have been exchanging insights on when it should or should not be used. With more than 20,000 physicians nationwide, Sermo has become the "go-to" medical community for doctors to ask and answer questions of each other, build consensus around the latest medical trends, and exchange view points about drugs, devices and treatment options. This real-time collaboration has led to the forecast of health and medical trends before they hit the market and the consumer mainstream.

Sermo (http://www.sermo.com) is the fastest growing online community created by physicians, for physicians. It has recently partnered with the American Medical Association (AMA) to improve medical practice, physician advocacy and patient care. On Sermo, physicians exchange knowledge with each other the minute it is learned and gain potentially life saving insights from colleagues as they happen instead of waiting to read about them in conventional media sources. Sermo harnesses the power of collective wisdom and enables physicians to discuss new clinical findings, report unusual events and work together to improve patient care in a way not possible before.

Posted by Kerry N. Jardine at 10:48 AM | Permalink | Comments (0) | TrackBacks (0)

In Virginia, Kathleen Fletcher never thought she might have to divorce her husband, Eric, to get him the health care he needs. She also didn't expect the emotional and financial struggles she's endured the past two years since her husband sustained brain damage from a motorcycle crash. Though he made a surprising physical recovery, learning to walk and talk again, Eric Fletcher's cognitive skills, including reasoning and short-term memory, remain fragile. He has attempted suicide three times this year and is often physically aggressive. As long as she's married, Kathleen Fletcher remains fiscally responsible for her husband. She has already depleted the family's savings and says she doesn't have the thousands of dollars needed monthly for a private neurological or nursing facility. On his own, Eric, 46, would probably enter a mental hospital. From there, he might find permanent placement in a Medicaid-approved, out-of-state neurological center or nursing home. Brain injury advocates say the Fletchers' story is not unlike the experiences of others who face financial challenges caring for loved ones who have severe traumatic head injuries. Eric Fletcher receives $1,500 a month in Social Security money but, his family has spent more than $100,000 on in-home assistance and 11 medications.

Finding placement where patients can be properly assessed and treated is extremely challenging. Many families are left considering nursing homes or assisted-living facilities which are costly and because of the perceived safety risks, often reluctant to accept patients who have disruptive behaviors. As a result some will wind up in prison, often languishing among other inmates with mental illnesses who are awaiting a bed in a psychiatric hospital or other nursing facility.

Posted by Kerry N. Jardine at 06:45 AM | Permalink | Comments (0) | TrackBacks (0)

A wrongful death lawsuit has been filed in federal court against the manufacturer of Avandia. The suit was filed on behalf of Peggie Stanford and Ryan Alan Stanford, wife and son of Larry Alan Stanford, 60, who died of a heart attack. The court document alleges negligence on the part of GlaxoSmithKline. It markets the prescription drug, Rosiglitazone, under the brand names Avandia, Avandamet and Avandaryl.

The "factual background" portion of the lawsuit notes that in January 1997, the FDA approved the drug to treat Type II diabetes. It was promoted to the diabetic patient population as able to assist the body in using insulin more effectively. In May 1999, Glaxo obtained FDA approval for its own brand-name products containing the drug and consequent sales were phenomenal. The lawsuit accuses the company of withholding from physicians, patients and the public information it had on adverse side effects. At least by September 2005, Glaxo was in possession of evidence that could reasonably be expected to diminish the sales of its second largest selling drug, the lawsuit adds. The information was not made public. During the following year of concealment, Glaxo pressed its sales of Avandia to a distribution of approximately 13 million prescriptions in the Unites States, the document notes. With a month's supply of Rosiglitazone costing between $90 and $200, Glaxo was able to rack up sales of $2.2 billion in 2006. Knowing by way of 42 different studies of patients using the drug that its product was unreasonably dangerous, Glaxo continued to expand sales. The lawsuit charges Glaxo with failing to inform the public and physicians of the risks associated with its products, with marketing a defective product due to inadequate warnings, instructions and/or labeling, and of inadequate testing. The suit also alleges Glaxo is guilty of selling a product defective in design because the company was aware of the foreseeable risks of serious harm posed by this drug and that they were sufficiently great in relation to its alleged benefits. Had Stanford and the general public known of these risks, they would not have ingested the drug, the lawsuit adds

Posted by Kerry N. Jardine at 06:43 AM | Permalink | Comments (0) | TrackBacks (0)

Former NFL player Andre Waters, 44, shot himself in the head after struggling with depression. Terry Long drank a bottle of antifreeze at 45. Justin Strzelczyk, 36, heard voices and died in a crash while fleeing police. All dead before their 46th birthday and according to autopsies performed by physician Bennet Omalu, all with signs of brain damage. Omalu, a former neuropathologist at the University of Pittsburgh School of Medicine, believes he's the first to pinpoint forensic evidence of a condition he has dubbed football-induced chronic traumatic encephalopathy (CTE), a variation of "boxer's dementia." Symptoms include confusion, mood disorders, slurred speech and memory loss. Now chief medical examiner for San Joaquin County in California, Omalu discovered abnormal proteins in each player's brain similar to those found in 90-year-old dementia patients. He believes that scores of players have analogous damage, but proving it requires postmortem brain sectioning. "These are not the first football players to develop dementia, become destitute, and suffer from depression," he says. "The novelty is that for the first time, we have direct, indisputable tissue evidence."

Meanwhile, the company Simbex is developing technology that could help prevent CTE altogether. It makes sensor-embedded telemetry helmets that can gauge in real time a concussive-level impact and notify personnel on the sidelines. In addition to helping staff decide when to bench a player, the technology is enabling researchers to better understand the biomechanical causes of head trauma, which in turn could lead to better headgear. Seven universities and five high schools now require players to wear the helmets. The NFL is considering the technology but has no firm plans to adopt it.

Posted by Kerry N. Jardine at 06:40 PM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration announced Tuesday August 14th that Avandia will now have a strong "black box" warning on its label, advising an increased risk of heart failure for users. The “black box” warning is the FDA’s strongest label warning. After reviewing post-marketing reports, the FDA decided that an updated label was needed for the entire class of anti-diabetic drugs. These include Avandia, Actos, Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). The new warning tells doctors to watch patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain; shortness of breath, and edema (swelling) after starting drug therapy. The warning also says that these drugs should not be used by people with serious or severe heart failure with "limits on their activity and who are comfortable only at rest or who are confined to bed or a chair," the agency added.

"This new boxed warning addresses FDA's concerns that, despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

Posted by Kerry N. Jardine at 02:38 PM | Permalink | Comments (0) | TrackBacks (0)

The Centers for Disease Control and Prevention (CDC) has designated the Mount Sinai School of Medicine in New York City as its newest Injury Control Research Center (ICRC) for people with traumatic brain injuries. The new center will conduct research in order to better understand the consequences of their injury and to help enhance the quality of their lives. “Connecting research to communities is a primary focus for CDC and we are pleased that Mount Sinai’s ICRC is now part of this critical research network,” said Dr. Ileana Arias, Director of CDC’s Injury Center. “Their work in TBI will fill a critical gap and can help shape a better understanding of how to improve the lives of those affected.” They will focus on discovering how to prevent and control injuries more effectively. As well as, work to identify critical knowledge gaps in injury risk and protection and also conduct research to address these gaps. Furthermore, this newest ICRC will provide technical assistance to injury prevention and control programs within their region. At the Mount Sinai the focus will be only TBI, including concussion. Mount Sinai’s new Center will evaluate promising treatments that address many of the consequences of brain injury, such as impaired cognitive functioning, mood disturbances, and emotional difficulties. The Center will help better identify people with brain injury, and their needs and problems. Lastly, it will look at improving community integration and functioning, and will help educate those most affected by TBI.

Posted by Kerry N. Jardine at 10:37 AM | Permalink | Comments (0) | TrackBacks (0)

Columbia University Medical Center researchers have demonstrated using functional magnetic resonance imaging (fMRI), that brain activity was increased in stroke and traumatic brain injury survivors who underwent Vision Restoration Therapy (VRT), a rehabilitative treatment that helps these patients recover lost vision. Researchers examined the fMRIs of six patients aged 35-77 with vision loss on the same side of both eyes (called homonymous hemianopia) caused by stroke or traumatic brain injury. The therapy is based on visual stimulation, which the patient performs daily at home on a dedicated computer. The fMRI data showed increased activity in visual processing areas of the brain as patients learned to detect stimuli in between the seeing and non-seeing fields. This improved activity was identified one month after beginning treatment and suggests that the brain is responding accordingly.

NovaVision VRT is approved by the U. S. Food and Drug Administration to treat vision problems in people who have been left partially blind due to stroke or brain trauma. Customized treatment is created from a comprehensive diagnostics that map the seeing and non-seeing areas of vision. Patients perform the therapy daily at home for six to seven months, gradually improving their vision through the repeated detection of light stimuli directed at the border between the seeing and blind areas of the visual field. Through further enhancements of this therapy, the hope is to help the approximately 1 to 2 million stroke and brain injury survivors in the United States who suffer from major visual field deficits, a number that increases by more than 90,000 each year.

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

Under growing scrutiny the Food and Drug Administration in recent months has rejected a number of experimental drugs or delayed their approval and required more data. Besides keeping drugs some patients might desperately need off the market the rejections have negatively affected drug company stock prices. Denials and delays have hit everyone from pharmaceutical giants such as GlaxoSmithKline PLC, Merck & Co., Novartis AG, Sanofi-Aventis and Wyeth down to struggling startups trying to get their first drug on the market. The FDA also has recently stiffened warnings on several drugs; most prominently diabetes drugs Avandia and Actos, and five months ago made Novartis withdraw its constipation drug, Zelnorm. It has been said the FDA has systematically implemented more controls for scrutinizing drugs, particularly for heart and liver side effects. The FDA now is requiring experimental drugs similar to ones already on sale to be more effective and safer than their predecessors. Some experts say they already see a trend toward increased rejections, although drugs for life-threatening diseases or conditions with no good current treatment are generally being approved.

The agency has approved 61 percent of drug applications through mid-August, down from 73 percent in the same period last year, according to a biotech and pharmaceutical research service. A report has been published recently showing FDA approvals of drugs made from new chemical compounds rather then just reinvented existing drugs shows so far this year only seven were approved through the end of July, versus an average of 12 over the first seven months of each year since 1998. The FDA has cited safety or effectiveness questions in rejecting or delaying approval for experimental drugs including Novartis' diabetes drug Galvus, Sanofi-Aventis' weight-loss drug Zimulti, and even a higher dose of GlaxoSmithKline's Advair Diskus for bronchitis and emphysema symptoms. Wyeth's experimental schizophrenia drug bifeprunox and Wyeth's Pristiq have also been denied, which would have been the first nonhormonal drug for menopause symptoms. Likewise, small pharmaceutical companies have been hurt. Pozen Inc., this month got its second FDA request for more information about a migraine treatment called Trexima it is jointly developing with GlaxoSmithKline. That news sent Pozen shares down 46 percent.

Posted by Seth A. Katz at 02:04 PM | Permalink | Comments (0) | TrackBacks (0)

Douglas Arbesfeld, termed the pharmaceutical industry's mole inside the FDA, attempted to malign the reputation of cardiologist Dr Steve Nissen by sending a malicious email to reporters after Dr Nissen published a study that found the diabetes drug Avandia increased the risk of heart attack and death. Dr Nissen's name appears on Time Magazine's list of the top 100 most influential people. When a drug or medical device is dangerous he says so. He is also responsible for warning the world about the serious health risks associated with Merck's Vioxx. Mr Arbesfeld's attempt to harm Dr Nissen’s reputation led to a Congressional investigation. The investigation is focused on Mr Arbesfeld's ties to the pharmaceutical industry. The lawmakers have linked Mr Arbesfeld to drug giant Johnson&Johnson, and further investigation revealed that he has been employed by almost all pharmaceutical companies at one time or another, including Avandia maker GlaxoSmithKline in 2002. Prior, Mr Arbesfeld was promoting medication patches that have since been found to be lethal on behalf of Johnson&Johnson's Ortho-McNeil division which is currently facing a large number of lawsuits alleging the company and the FDA hid studies that showed the Ortho-Evra birth control patch caused blood clots.

On October 10, 2004 the New York Post reported that a "popular and profitable contraceptive patch promoted by sexy TV ads caused 11 times as many fatal or life-threatening blood clots as a leading birth-control pill, a new lawsuit charges." Since its release in 2002, the patch has been responsible for 17 deaths in women age 17 to 30. The Freedom of Information Act facilitated the ability to obtain records from the FDA which revealed 21 other life-threatening conditions such as blood clots, strokes and heart attacks. In the Post article, Mr Arbesfeld maintained that the "adverse event reports for Ortho Evra are consistent with the health risks of other hormonal contraceptives." On October 25, 2004, he told the Associated Press that four million women in the US had used the patch since it came on the market in 2002 and about 800,000 women were currently using it.

Johnson&Johnson has consistently denied knowledge of any problems with the patch. However, according to a story by CBS News, documents surfaced in a lawsuit that showed the company's own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004. Litigation documents showed the company had been analyzing the FDA's death and injury reports on women using the patch and had charts that showed a higher rate of blood clots and death in women on the patch when compared to women who took birth-control pills. Within 16,000 adverse reaction reports there were 23 deaths. Doctors who reviewed the 23 deaths said about 17 appeared to be clot-related. Further, about a dozen women, those in their late teens and early 20s, died from clots in 2004, and dozens more experienced strokes and other clot-related problems. In addition, according to the Associated Press on November 11, 2005, an internal company memo shows that in 2003, the company refused to fund a study comparing the Ortho patch to the company's Ortho-Cyclen pill because there was "too high a chance that study may not produce a positive result for Evra" and a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen." According to J&J's Annual Report, as of December 31, 2006, there were approximately 1,500 claimants who have filed lawsuits or made claims regarding injuries to due to the Ortho Evra patch. Because J&J knows that blood clots rarely develop in young women of childbearing age, legal experts say not to expect to see public jury trials in cases involving the birth control patch. In fact, many lawsuits have quietly ended in confidential out-of-court settlements with little fanfare in the mainstream press. This all begs the question, where do Douglas Arbesfeld loyalties lie? With the drugs or with the safety of the people who take them?

Posted by Seth A. Katz at 10:01 AM | Permalink | Comments (0) | TrackBacks (0)

A new analysis of data on the effects of the diabetes drug rosiglitazone (Avandia) found that the risk for heart attack and death from cardiovascular disease is “uncertain”. The analysis states that it neither increases nor decreases risk. Authors say an earlier study, which found the drug associated with increased risk for myocardial infarction and cardiovascular death, had several flaws. The authors re-analyzed the data from the earlier trial. Authors say that the risk controversy will only be solved with “prospective clinical trials designed for the specific purpose of establishing the cardiovascular benefit or risk of rosiglitazone.”

Posted by Kerry N. Jardine at 06:30 AM | Permalink | Comments (0) | TrackBacks (0)

On Aug 1st the FDA announced that many consumers may still not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involves the use of the solution after the recall was announced. Individuals who wear soft contact lenses should stop using the product immediately and discard all remaining solution including partially used or unopened bottles.

The complete list of products to discard is listed below for confirmation.

1. 90104 (MoisturePLUS, 12 oz)
2. 90105 (MoisturePLUS, 2 X 12 oz)
3. 90106 (Complete MoisturePLUS Lens Comfort Pack)
4. 90168 (Complete MoisturePLUS 2 oz Starter Kit + Lens Case)
5. 90169TR (Complete MoisturePLUS, 2 X 16 oz, TRAY)
6. 90170 (Complete MoisturePLUS, 4 oz + Lens Case)
7. 93184 (Active Pack, Complete MoisturePLUS 2 oz & B-N-C 5m1 + Lens Case)
8. 93185 (Complete MoisturePLUS, 12 oz, BEAUTIFUL EYES PROMO)
9. 93186 (Complete MoisturePLUS, 2 X 12 oz, BEAUTIFUL EYE PROMO)
10. 93187 (Complete MoisturePLUS, 2 X 16 oz, BEAUTIFUL EYES PROMO)
11. 93220 (Rejuvenate Kit -contains Complete MoisturePLUS 90174)
12. 93221 (Complete MoisturePLUS, 12 oz + Blink Sample)
13. 93280 (Complete Starter Kit -2 oz Complete MoisturePLUS + Lens Case)
14. 93341 (Complete MoisturePLUS, 4 oz)

Reason for Recall:

There is a recent increase of a rare but serious infection in people who wear soft contact lenses. The infection is Acanthamoeba keratitis, caused by a parasite that is commonly found in nature. Acanthamoeba keratitis can cause permanent damage to the cornea and loss of vision. Some patients may require a corneal transplant, a surgical procedure that replaces the clear outer covering of the eye, in order to maintain vision in the affected eye. Early diagnosis and treatment of Acanthamoeba keratitis is important to prevent permanent damage of the cornea. On May 25, 2007, Advanced Medical Optics (AMO) issued a press release announcing the voluntary recall of its Complete® MoisturePLUS™ Multi-purpose Contact Lens Solution from the market. AMO sent information on this recall to corporate accounts and eye care professionals. The following are recommendations for users of the product family: Remove your lenses and stop using the solution immediately. Contact AMO at 1-888-899-9183 for instructions on what to do with unused solution. Replace your contact lenses and storage case. Ask your eye care professional about choosing another appropriate alternative cleaning/disinfecting product.

Posted by Seth A. Katz at 06:57 PM | Permalink | Comments (0) | TrackBacks (0)

Katie was only on the Ortho Evra Patch for 10 months when she developed superficial deep vein thrombosis. Her doctor prescribed the Patch in October, 2005 as a method of birth control. After 10 months she began to have severe leg pain. She was shocked to be diagnosed with superficial deep vein thrombosis. Her doctor told her to take off the patch immediately. For the next two months she took heparin and other blood thinners. She had to stay home and rest for a week and wore a medical leg brace that keeps the blood circulating. After discovering what happened to many other young women who wore the Patch, she admitted she was very fortunate. She was surprised to find her local clinic still advertising the Ortho Evra Patch in their waiting room. So Katie ask’s “Why is the Ortho Evra Patch still on the market? Why didn't you do more testing? And what are the profits worth if you lose in people and lawsuits?"

Posted by Seth A. Katz at 02:55 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration said on Wednesday August 1st it was concerned that consumers were still using the contact lens solution Complete MoisturePlus Multipurpose solution made by Advanced Medical Optics that was recalled in May. Regulators said several new cases of the potentially deadly infection known as acanthamoeba keratitis, a parasite linked to the product, had been reported to the U.S. Centers for Disease Control and Prevention. The CDC earlier this year identified more than 20 cases of the infection in people who used the solution. The FDA reiterated its warning that people who wear soft contact lenses should stop using the solution and throw away any partially used bottles.

Posted by Seth A. Katz at 10:53 AM | Permalink | Comments (0) | TrackBacks (0)

After reviewing postmarketing adverse event reports, the FDA has determined that "black box warnings" (the FDA's strongest warning) should be provided on the labels of the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in combination with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes.

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

A possible harbinger of things to come in the medical malpractice community, a video of sealed evidence from several of 122 medical malpractice cases against Dr. John A. King, appeared on the popular share site YouTube. A civil jury found Putnam General Hospital negligent for hiring Dr. John A. King which could potentially expose the hospital to further lawsuits alleging King harmed or even killed patients through unnecessary surgery and other malpractice during his six months there. The video allegedly shows videotaped pretrial deposition testimony from six of the plaintiffs. For five of those plaintiffs, it also shows apparent surveillance video or photos in an apparent effort to contradict their claims. The three-minute video appeared online June 26, more than three weeks after Putnam County Circuit Judge O.C. Spaulding barred both sides from releasing any information from the cases.

Posted by Scott J. Eldredge at 06:52 PM | Permalink | Comments (0) | TrackBacks (0)

Former Missouri Insurance Commissor Jay Angoff analyzed financial statements of 15 of the largest medical malpractice insurance companies in the U.S. His report found there was no basis for high insurance rates. The 15 largest insurers paid out an average of 31.4 cents in claims for every dollar they collected in 2006. Meaning that for every $1 that a hospital or health care provider paid in insurance premiums, insurance companies were able to keep 68.6 cents. The surplus was then used to fund executive salaries, marketing and advertising and lawyers and lobbyists. What was left they continued to hold in reserve. Further, the report notes that over the last three years, the economic losses of the 15 largest insurers fell by 50%. Yet publicly they claim their losses were increasing. This new information comes at a time when physicians and health care providers are complaining about the high cost of malpractice insurance and health care costs in the U.S. continue to rise exponentially. Insurance companies and tort reformers want to use high malpractice premiums as an excuse to enact restrictive reform measures that do not allow the doctors to be held responsible for any harm they cause. This report further illustrates that the reason for high premiums is the greed of the insurance industry. Doctors should fight back at their insurancing companies and demand rate cuts.

Posted by Scott J. Eldredge at 06:50 PM | Permalink | Comments (0) | TrackBacks (0)

A veteran obstetrician claims that the Detroit Medical Center stripped him of his hospital privileges in retaliation for testifying against the center's hospitals and its doctors in malpractice cases. The hospital system denies the allegations of Dr. Michael Berke, but admits that his testimony in those cases was among the complaints lodged against Berke before a panel of DMC doctors in March which revoked permission for him to practice medicine in DMC hospitals. The Detroit case is one of several around the country in which hospital "peer reviews" of doctors have come under fire. Among the issues is whether a 1986 law to protect patients, the federal Health Care Quality Improvement Act, instead helps hospitals get rid of doctors who criticize patient care. The act generally grants immunity to hospitals and doctors involved in peer review discipline. Berke, 62, though still able to run an office practice, is unable to deliver babies or perform other operations without his hospital privileges. "This case has negatively affected my professional and personal life in many ways, but the greatest impact right now is on my availability to my patients," he said.

Sallyanne Payton, a professor at the University of Michigan who teaches medical law, said doctors rely on hospital facilities for the tools of their trade and whether Berke was treated comparably to other similarly situated doctors will be one of the issues in the case. Payton said there have been cases around the country in which hospitals and medical staffs were found to have retaliated against physicians whose actions threatened their interests and relatively few physicians with good credentials are willing to testify on behalf of plaintiffs in malpractice cases.

Posted by Scott J. Eldredge at 02:48 PM | Permalink | Comments (0) | TrackBacks (0)

Health Courts, which would replace juries with health care professionals in medical malpractice cases, would leave malpractice victims dangerously unprotected, Attorney Jeffrey Hensley said. The American Medical Association (AMA) adopted principles in early July that favor Health Courts, which would do away with juries and replace them with judges trained in medical standards. The idea of health courts dangerously tips the standard of justice in malpractice cases against victims who may be entitled to sizeable judgments when they are seriously harmed by poor medical care. Having medical people passing judgment in medical malpractice cases reminds us of the “fox guarding the henhouse” notion. How can people who have suffered very serious injuries or a relative’s death have any confidence in a system that is run by the very profession that caused their injuries? Medical malpractice victims should have full access to a court system in which their peers consider evidence from both sides and then determine possible damages that are based fairly on the extent of their injuries or loss. Health courts seem hardly the answer. A better way to limit malpractice judgments would be to limit substandard medical treatment. "If the AMA wants to limit the claims that get awarded in medical malpractice suits, a good place to start would be in its own backyard," Hensley said. "People have a right to expect good, professional health care and, when they don't receive it, they should have a right to reasonable financial claims." Hensley said it is important to remember that the duty of a medical professional is not to cure, or even to guarantee a good outcome from treatment. Rather, the duty is to provide good medical care according to accepted standards. "Medicine is not an exact science, and doctors are not required to be right every time they make a diagnosis," Hensley said. "A misdiagnosis becomes malpractice, however, if the doctor fails to get a medical history, order the appropriate tests, or recognize observable symptoms of the illness."

Posted by Scott J. Eldredge at 10:47 AM | Permalink | Comments (0) | TrackBacks (0)

If you get a credit card, buy a car or sign up for a cell phone plan and you’re unhappy with the transaction chances are a judge will not hear the story. Many consumer contracts include mandatory arbitration clauses that force individuals to go through arbitration, instead of civil court, if a dispute arises. Some of these clauses also ban customers from joining class-action lawsuits. For years, consumer advocates have claimed these clauses are unfair. Now Congress is considering a blanket denial of pre-dispute mandatory arbitration agreements. The Arbitration Fairness Act of 2007, recently introduced in the Senate and House of Representatives, proposes making the clauses unenforceable. "This is, by far, the most comprehensive bill that has been introduced. There have been bills that ban arbitration in the employment section or the banking section," said Paul Bland, a staff attorney with Public Justice, a national nonprofit public-interest law firm in Washington, D.C. Mandatory arbitration clauses tend to give companies, not the public, protection and companies tend to win arbitrations

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

If you're going to be killed accidentally during surgery, it might be better for your relatives if it happens outside of Texas. "This is also a bad place to be maimed by a doctor," said Paula Sweeney, a Dallas medical malpractice lawyer who has seen her business evaporate since 2003 state legislation that limited personal-injury lawsuits, especially those against doctors and hospitals. Sweeney said many people who believe they were injured by medical negligence no longer can have their day in court because of the legislation. Some lawyers, injured folks and political activists are alarmed. "When you take accountability out of the system, what you do is encourage unqualified doctors to come to a place where they can practice without worry," Houston medical malpractice lawyer Jim Perdue Jr. said. As an example state records show that a doctor who lost her license in Virginia and New Mexico was granted a restricted license in Texas!

Supporters of the changes say reducing lawsuits was exactly the point. Since the 2003 law added requirements that made medical malpractice cases harder and more expensive to prove and less lucrative if won, the numbers of such suits filed in county courts has been cut in half. Insurance premiums for doctors and hospitals have dropped 21.3% statewide, and a flood of physicians into the state has created a licensing backlog. Even though the Texas Medical Board's budget has grown, it doesn't have the resources to provide significantly expanded enforcement in the face of increases both in complaints against doctors and in license applications, the board's spokeswoman said.

Dion Ramos, a Houston lawyer whose business defending doctors has declined, said the law went too far. "I believe the threat of litigation keeps people working harder. You need that check on the system," Ramos said. Patients seem to fall in two camps. Some are publicly thankful for the good work of new Texas doctors. Others speak publicly about losing loved ones or being disabled but are unable to get lawyers to take their cases. Time will tell whether the 2003 change is fair or unfair. Many will likely change their view if the negligence of doctors or hospitals injures their own loved ones. Then they'll know right away whether the law seems fair.

Posted by Scott J. Eldredge at 06:34 PM | Permalink | Comments (0) | TrackBacks (0)

The medical malpractice suit contends that the VA is to blame for the death of Lance Corporal Jeffrey Lucey, a 23-year-old Marine who hanged himself in June 2004 after he was denied mental health care while exhibiting signs of posttraumatic stress disorder that arose from a tour of duty in Iraq. The legal challenge to the VA and the federal government was cited by veterans' advocates as a new and unprecedented attempt to hold the government accountable for what is widely seen as a systematic failure to provide adequate and timely healthcare for veterans returning from Iraq and Afghanistan. The Lawyer, Cristobal Bonifaz, who filed the case on behalf of the family, said that the VA's failure to recognize Jeffrey Lucey's suicidal tendency amounted to medical malpractice and negligence by a system that was overstressed and understaffed. The lawsuit filed in federal court seeks unspecified damages and names the US government and specifically Nicholson, who oversees the sprawling VA system of medical centers and benefits programs for wounded veterans.

Lucey's parents have become staunch advocates for veterans and have spoken out at conferences and testified before Congress about their son's suicide and what they perceive as a system that is too strained to handle the large influx of Iraq and Afghanistan war veterans who are coming home with severe mental health problems. Jeffrey Lucey served in Iraq in 2003 and 2004 and, according to his family, returned home a changed person. He had nightmares, insomnia, and deep depression and began drinking heavily. His family said he became suicidal and told his sister, Debbie, that he had picked out the rope and the tree from which he planned to hang himself. They persuaded him to seek care at the VA, where he admitted himself on May 28, 2004. He was placed in a locked psychiatric ward, but was released three days later. Two days after he was out, he totaled the family car in what his family believed was a suicide attempt. They persuaded Jeffrey to return to the VA on June 5 and this time, his family says, he was denied treatment and they were told no psychiatrist was available to meet with him. On June 22, he hanged himself in the basement of the family home.

The government does not keep track of how many veterans have committed suicide once they leave the service, but groups like Veterans of America have estimated, based on website and media reports, that 117 Iraq war veterans have killed themselves.

Posted by Scott J. Eldredge at 02:32 PM | Permalink | Comments (0) | TrackBacks (0)

Three years after medical malpractice lawsuit reforms, Texas has gone from a doctor shortage to a doctor surplus. According to the state medical board, more than 4,000 doctors applied to practice in Texas last year, an increase of more than 30 percent from 2005. However, some people now argue that malpractice reform laws are preventing patients who are hurt during healthcare from seeking justice.

Ellie Plunkett is among them. Two years ago, Plunkett voluntarily underwent a laparoscopic lap band operation to help her lose weight. Lap band is considered minimally invasive when compared with gastric bypass surgery. Medical records show that during the procedure, Plunkett's doctor punctured her esophagus. "He was in there for hours trying to patch the holes," Plunkett said. "I was in ICU for five days on a ventilator... near death." A punctured esophagus is not on the list of potential risks associated with this surgery, according to documents Plunkett signed at the doctor's office. So, she pursued a medical malpractice lawsuit. Time after time, she says lawyers told her, "They would not be interested in it, because it would cost more to sue them than what they would make on it." Jury awards for pain and suffering in the state of Texas are capped at $250,000 because of medical malpractice reform laws passed in 2003. The laws were designed to cut down on medical lawsuits.

Now, patients and lawyers agree that there is a disturbing aftereffect. "It's destroyed a lot of patients’ ability to seek any kind of justice if they are injured by a doctor's negligence," said Dallas attorney Mike Sawicki. Neither Dallas nor Tarrant counties keep track of medical malpractice filings. But Houston reports a 41 percent drop in the number of cases filed last year alone. Since the medical malpractice reform law went into place, other laws have gone into effect that may also stop patients from seeking damages. Among them, a law requiring that insurance companies be repaid for medical costs before the patient gets a dime. When you factor in all the expenses associated with trying a case, Sawicki said the maximum $250,000 jury award for pain and suffering isn't worth it for lawyer or client. "In the end, I have to pay my light bills, they have to pay their medical bills, so it ultimately is about money," Sawicki said.

Posted by Scott J. Eldredge at 10:30 AM | Permalink | Comments (0) | TrackBacks (0)

A savant is an individual that possesses an extraordinary ability to perform mental tasks that seem superhuman. Savants are typically autistic people that are limited in intellectual capacity, but perform like a genius in others. The most widely known example of a savant is the real person that inspired the movie, “Rainman.” Darold A. Treffert, a leading medical expert on autism, states that savants tend to have exceptional abilities in one of five areas: music, art, lightning calculations, calendar calculating and mechanical or spatial skills. They may be able to play a complete symphony after hearing it, or put together a 500-piece jigsaw puzzle in minutes… face down. What’s even more astounding is that there is another type of savant, those known as acquired savants. These individuals developed astonishing skills after a traumatic brain injury. Often they are left with a mental impairment, but are able to do calculations and exhibit near perfect recall of certain types of memory.

A most unusual case involved Orlando Serrell. Orlando was a normal 10-year old boy until he was hit in the head with a baseball. Within a few months of that injury Orlando began recalling such things as every license plate of the cars that had passed. Or, if you mention a date since his accident, he can effortlessly recall the weather and his whereabouts for that day. Unlike many autistic savants, however, Orlando still retains normal brain function. According to Allan Snyder, a researcher in mental cognition, each of us actually has a perfect recording of every thought and observation that has ever occurred during our lives. In other words, it really is all in there somewhere. The challenge is how to access all of that incredible data.

Posted by Kerry N. Jardine at 06:32 AM | Permalink | Comments (0) | TrackBacks (0)

It has been concluded in Pennsylvania that there is not evidence of sufficient market capacity at the current time to mandate an increase in primary medical malpractice insurance limits in Pennsylvania. Deputy Insurance Commissioner Randy Rohrbaugh has ruled. He was responding to a proposal in state law to raise limits from $500,000 to $750,000 the primary coverage health care providers must obtain from private commercial insurance carriers. "In making this decision, our priority was to protect the consumers who are accessing health care in the state," Rohrbaugh said. "We did not want to prematurely raise the limits before there is adequate capacity in the medical malpractice insurance marketplace, as this could have an adverse effect on the availability of health care."

He said that an actuarial study by Pricewaterhouse Coopers shows that since the passage in 2002 of Act 13 and other reforms, there continue to be improvements in the medical malpractice marketplace on many fronts. He cited concerns that the current marketplace would not be in a position to absorb greater risk, "so it would be irresponsible to allow an increase in limits to $750,000 at the primary insurance layer."

Posted by Scott J. Eldredge at 06:29 PM | Permalink | Comments (0) | TrackBacks (0)

In response to the 14% increase in medical malpractice insurance for New York doctors, John B. Bonina Jr., one of the city’s leading med mal practitioners was asked for a response and he did not hesitate to reply. “The cause of medical malpractice payments is medical malpractice,” Bonina aptly noted. “In New York, 68 percent of medical malpractice payments are made on behalf of 7 percent of physicians. Thus the problem is not their patients, or their lawyers, the problem is the few physicians who are responsible for the lion’s share of the negligent acts in this state.” The solution he argues “is to find a way to re-educate the repeat offenders and take away the licenses of those who cannot be re-educated. Blaming victims of medical negligence, or their attorneys, for issues surrounding medical malpractice is preposterous,” says Bonina. “In fact, if any entity is to blame for the current situation, it may very well be the state of New York, which dissolved the Medical Malpractice Insurance Association (MMIA) several years ago.”

Explaining his theory, he says that MMIA was created in 1975 to cover shortfalls in the medical malpractice insurance market at the time. Over the next 25 years, MMIA played a valuable role in the insurance market. Why? “MMIA,” says Bonina, “run by the state, served as an insurer of last resort, insuring some of the highest-risk doctors and repeat offenders, and also provided excess insurance to numerous additional doctors and hospitals.” Under that system, he maintains, “the private medical malpractice insurance market flourished, several new insurers entered the market, which does not happen in a ‘crisis industry’, and rates did not rise at a rate higher than inflation.”

MMIA Was Working. Bonina, believes that the state erred in diminishing, then eliminating, MMIA, which in turn helped create the current problems. “Not only did the private market flourish during MMIA’s existence, MMIA itself was able to turn a tidy profit despite being the ‘insurer of last resort,’ essentially insuring the high-risk pool of physicians. By 1999,” he explains. “MMIA had more than $600 million in reserves. However, under the Pataki administration, the state was beginning to run significant budget deficits, which prompted the Comptroller to suggest ‘raiding’ the fund to fill budget gaps. The fund was shut down, the money ‘raided’ to fill budget gaps. As a result, the responsibility of insuring the highest risks and repeat offenders fell back onto the private insurers and thus the current problem.” Why not bring back MMIA? “The state was able to operate MMIA at a profit, despite insuring the highest risks,” asserts Bonina. “Why the private sector is incapable of doing that is an interesting question. The Spitzer-Dinallo rate hike, and their flimsy explanation for it, ‘it’s the lawyers, again!’ is anything but funny.”

Posted by Scott J. Eldredge at 02:27 PM | Permalink | Comments (0) | TrackBacks (0)

A 25 year old New Jersey man is paralyzed from the waist down after receiving contaminated chemotherapy treatment for leukemia was awarded $18.5 million by a Superior court jury in New Brunswick, New Jersey. The jury found the pharmacist who prepared the contaminated medication, responsible for the paralysis.

Anton Weck was permanently paralyzed from the waist down as a consequence of a mistake in the preparation of a drug administered at Saint Peter's University Hospital in New Brunswick. He had been undergoing chemotherapy for 3 years for Leukemia and was receiving his final dose of the chemotherapy treatment that day. Experts testified that the dose which was given to Weck was contaminated when the wrong drugs were mixed for treatment and then injected into his spinal cord, paralyzing him from the waist down. After a three week trial and two days of deliberations, the jury returned its verdict in the amount of approximately $18,500,000.00, including $17.5 million for pain and suffering and $500,000 for lost wages.

Posted by Scott J. Eldredge at 10:25 AM | Permalink | Comments (0) | TrackBacks (0)

Recently, an Associated Press article, “Electrodes aid man with brain injury,” appeared in the news. The article talks about one man aroused from a minimally conscious state due to implantation of electrodes in the brain. This treatment has been available in Japan and Russia for many years and is just now receiving attention in the United States. It has been used successfully in other countries, along with intensive neuro-rehabilitation.

Recently, more than 50 experts from around the world gathered in Mohonk, N.Y., to discuss the growing problem of severe traumatic brain injury (TBI), and especially those who remain in the vegetative state, the minimally conscious state and in the “locked in” state. The group prepared a report to Congress describing in detail the issues. For example, 44 out of all diagnoses of vegetative state are incorrect. There are a growing number of young people living in these states of consciousness and most wind up living out their lives in nursing homes. “The Mohonk Report on Disorders of Consciousness” was presented to Congress, along with a major recommendation for the development of a comprehensive, innovative treatment and research center to provide the latest technology and science to assist in recovery. Laurel Highlands Neuro-Rehabilitation Center, along with partners from Cornell University Hospital in New York, John F. Kennedy Hospital in New Jersey and the Department of Rehabilitation Sciences & Technology of the University of Pittsburgh are collaborating on the creation of a state-of-the-art treatment and research center to serve the young men and women who have come home from Iraq and Afghanistan with severe brain injuries. This program would be the most advanced center in the world. All that is needed is word from Washington to proceed.

Posted by Kerry N. Jardine at 06:30 AM | Permalink | Comments (0) | TrackBacks (0)

Horseback riding causes the highest proportion of traumatic brain injuries among sports-related recreational, activities, according to the CDC. Ice skating is next. Young people account for almost two of every three sports-related traumatic brain injuries treated in every year, said the CDC in the July 27 issue of Morbidity and Mortality Weekly Report. Further the CDC elaborates about 135,000 of the approximately 208,000 sports-related brain injuries treated annually occurred in people ages five to 18, or about 65%. About 8% of those traumatic brain injuries required in-patient care.

Such injuries, defined as concussion or internal organ injury, “are very serious and should never be ignored," CDC director Julie Gerberding, M.D., said in a statement. For all ages, basketball and bicycling accounted for the greatest number of emergency visits for all causes, but the proportion of brain injuries was highest for horseback riding (11.7%), ice skating (10.4%), all-terrain vehicles (8.4%), tobogganing or sledding (8.3%), and bicycling (7.7%). To discern the numbers related to sports and recreation, the agency turned to the National Electronic Injury Surveillance System-All Injury Program (NEISS-AIP) for the period 2001 though 2005.

Posted by Kerry N. Jardine at 06:23 PM | Permalink | Comments (0) | TrackBacks (0)

The Army launched its Post Traumatic Stress Disorder and mild Traumatic Brain Injury chain-teaching program at the Pentagon last week by training flag officers and Army senior executive service civilians how to recognize and help distressed Soldiers who may or may not recognize their unseen injuries. Announced by the Army July 18, the PTSD and mild TBI program is mandatory for all active-duty and reserve-component Soldiers, from the highest to lowest levels in the chain of command. More than one million Soldiers are expected to receive the same training as the senior leaders within 90 days.

Dr. (Col.) Elspeth Cameron Ritchie, psychiatry consultant to the Army Surgeon General Health Policy and Services Directorate and the chief developer of the chain teaching project, started the session by telling the leaders that PTSD and mild TBI were not the same, but Soldiers could experience the effects of both simultaneously. Treatment and recovery for mild TBI are usually a simple process that involves simply rest and relation for a few days, but it's important for Soldiers to not neglect seeking treatment and for their fellow comrades-in-arms to let their chain of command know when they suspect a battle buddy is suffering from concussion. The key to recovery from concussion is time, knowledge and education, Dr. Ritchie added. She cautioned that should a Soldier suffering from a concussion return to duty too early and become involved in another blast or accident, that Soldier could suffer irreversible brain damage. Soldiers diagnosed with mild TBI should ensure their medical records are updated for future reference, she said.

The Army provides many sources to help Soldiers suffering from PTSD and mild TBI or other behavioral-health problems. These include chaplains, deployable stress-control teams, medical and behavioral-health clinics, and the Military One-Source hotline at 1-800-342-9647.

Posted by Kerry N. Jardine at 06:20 PM | Permalink | Comments (0) | TrackBacks (0)

With the FDA advisory committees vote to keep GlaxoSmithKline's Avandia on the market, the debate over its safety may finally be drawing to a close. The episode has called into question the FDA's handling of the situation and damaged GSK's sales of the drug. As a result, many diabetes specialists and General Practitioners have stopped prescribing Avandia to their new patients and started switching their existing Avandia patients to other drugs, leading to a significant drop in GSK's Avandia sales. Looking at the bigger picture, there are a few questions that have been posed to the medical community. Can the FDA or any other authority make a decision on safety of a drug based on a meta-analysis (a group of unrelated studies) vs. hard data? Observing the speed with which the meta-analysis was published by the NEJM, without informing FDA and GSK, was there really a mix of science and politics?

In these circumstances, the panel's decision was correct. Given the current lack of hard data it would be unjustifiable to make a decision on whether Avandia's risks outweigh its benefits based on the meta-analysis alone. The committee acknowledged the fact that although there may be cardiovascular risks associated with Avandia, it is for trusted physicians to make the final call. However, the commercial damage to Avandia has already been done and despite GSK's confidence that its ongoing trial will bring clarification and hard data evidence to confirm the safety of the drug, it is not expected to recover well. Instead, it is expected that Avandia will slowly fade out of the market over the next five years, in which period it will be significantly affected by key patent expiries within the TZD class, and by the introduction of new anti-diabetic agents.

Posted by Kerry N. Jardine at 02:18 PM | Permalink | Comments (0) | TrackBacks (0)

Auckland New Zealand based Neuren Pharmaceuticals has bought a US drug company to target a multibillion-dollar market for treating post stroke, Alzheimer’s, Parkinson’s and traumatic brain injury caused depression. The purchase of Washington DC-based Hamilton Pharmaceuticals will get Neuren the license to a compound called Motiva. Motiva is being developed for psychological and cognitive disorders caused by stroke, traumatic brain injury, Alzheimer's and Parkinson's diseases.

Neuren chief executive David Clarke said Motiva had proven effectiveness in phase II trials for a broad range of cognitive deficits but Neuren planned to run another trial to prove definitively the drug could be targeted at post-stroke depression. The post-stroke depression market was worth more than US$2 billion globally, he said. The drug could take six to seven years to reach the market. Hamilton approached Neuren when it was looking to sell the drug to a company in which it had confidence to run trials. The opportunity was too good to pass up, Clarke said.

Posted by Kerry N. Jardine at 10:16 AM | Permalink | Comments (0) | TrackBacks (0)

The Brain Injury Association of Michigan (BIAMI) and Ernie Irvan's non-profit organization Race 2 Safety will hold the third annual LAPS Walk, presented by AAA and endorsed by NASCAR, on August 16 at Michigan International Speedway (MIS). Irvan, fellow NASCAR celebrities, members of the American military, NASCAR fans and Traumatic Brain Injury (TBI) survivors will come together on the track for opening ceremonies and a Tribute Lap to conquer TBI in America. This year's walk will honor "Helmets and Heroes," with a portion of the funds raised to help treat and care for returning veterans with traumatic brain injuries. Many veterans will participate in the event. The Michigan Army National Guard will have activities including an obstacle course and rock-climbing wall, display of military hardware and a fly-in by Blackhawk and Chinook helicopters. NASCAR celebrities are scheduled to appear such as the NASCAR legend Bobby Allison. A Tribute Lap will include AAA-branded Miller Industry tow trucks driving beside the LAPS Walk pace car and military vehicles to honor those who have sustained TBIs. An additional element, includes a live performance by country singer and TBI activist Christi Bauerlee,

Race 2 Safety was formed in 2004 to make a positive difference in the lives of men, women and children across America by informing and educating them about the latest transportation-related head protection equipment and technologies and actively promoting the everyday use of such equipment. Race 2 Safety works closely with safety equipment manufacturers, head injury prevention and treatment associations, as well as state and federal transportation safety organizations to help dramatically reduce the number of transportation-related traumatic brain injuries that occur every year.

Posted by Kerry N. Jardine at 06:59 AM | Permalink | Comments (0) | TrackBacks (0)

Shenzhen Beike Biotechnology Co., Ltd. announced the successful treatment with umbilical cord stem cells of a three-and-a-half-year- old toddler, Lukas Nguyen. At the age of one, Lukas suffered a severe traumatic brain injury (TBI) leading to cerebral palsy. Prior to his China stem cell treatment, doctors had previously examined Lukas at Lucile Packard Children's Hospital in Stanford, California. After his first trip to China, the same doctors stated Lukas's improvement between visits was "remarkable." The doctors made the statement in a Neurosurgery Outpatient Letter dated March 8, 2007, which was written following an additional evaluation period by physicians, therapists, and family members. In the report, Lukas' doctors further stated, "We are very pleased with his dramatic improvement and his progress. We recommended the parents to continue their therapies as indicated." The doctors were not aware that Lukas had gone for stem cell treatment in China between the two examinations in which the "dramatic improvement" had been made. Starting from October 11, 2006, Beike Biotech provided umbilical cord stem cells for Lukas' treatment. After only two rounds of stem cell injections and therapy, in October of 2006 and April of 2007 respectively, family members noted that Lukas achieved milestones at a much earlier point than expected after such a serious accident. Lukas continues progressive recovery of his motor and cognitive skills.

Lukas had just turned one when he fell down the stairs on January 7, 2005. Lukas was with a nanny when he fell down half a flight of carpeted stairs. Initially Lukas appeared to be okay, but soon after he fell unconscious. He was rushed to the nearest trauma center. He immediately fell unconscious and sustained severe brain injuries that technically included an interhemispheric subdural hematoma causing generalized cerebral edema (swelling of the brain). To manage his edema, doctors induced a coma and performed a bi-frontal craniotomy to decompress the swelling. Doctors told his family to prepare for the worst. They said he would likely be in a vegetative state.If not, he would require medication, surgery, equipment and constant medical care for the rest of his life. After seven days of being in an induced coma, the doctors awoke Lukas. Lukas's family knew they would now need to care for a child with many serious motor and cognitive challenges. The accident caused Lukas to lose more than 35% of his brain mass and reduced Lukas' motor and cognitive skills to the level of a newborn. Over the next year and a half, Lukas made very slow progress as his brain mass continued to decrease. From here, the family's heartfelt journey of endurance, patience and persistence began. After his first and second stem cell treatment, Lukas's family and doctors have seen significant improvements. The family plans to take Lukas for a third round of treatment in early 2008. Ms. Nguyen said, "Since the stem cell treatments, Lukas's brain mass is increasing, he's talking and understands language much more. His gross motor skills and muscle tone have also improved. He can even stand balancing and unsupported for a few minutes. We are very hopeful for similar gains on our future visits."

Posted by Kerry N. Jardine at 06:57 AM | Permalink | Comments (0) | TrackBacks (0)

Ever get a packet in the mail saying that you are part of a class action lawsuit? You haven’t done anything to participate in the lawsuit and otherwise weren’t planning to sue anyone, but the information says that you might be able to recover money. So the question remains, what is a class action? In short, a class action is a lawsuit filed by one or more people on behalf of themselves and a larger group of people who are facing the same issues. It is the procedural device used in litigation for determining the rights and remedies for large numbers of people whose cases involve common questions of fact and law.

There are benefits to class actions. A class action ensures that a company which causes widespread harm, but does so minimally against each individual, must still compensate those individuals for their injuries. In addition, if used properly, class actions can increase the efficiency of the legal process and lower the cost of litigation (i.e.: one lawsuit instead of hundreds). If you're included as a plaintiff in a class action lawsuit, you fit the description of the “class” as determined by the court. First, you should read the notice carefully and verify that you are indeed part of the “class.” Next, you are left to decide whether you want to participate in the lawsuit. Under federal law, you will automatically be included as a class member in the lawsuit and generally do not need to take any affirmative steps to remain part of the lawsuit. By participating in the class action, you give up your ability to assert your own lawsuit on the same issues. However, people who have no intention of filing a lawsuit on their own often participate because they feel like they have very little to lose. They may recover something if the class action is successful, or lose nothing if the lawsuit fails because they had no intention of filing an individual lawsuit in the beginning.

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

The Government Accountability Office will study whether the Department of Defense and Veterans Affairs are providing proper mental health care for veterans returning from Iraq and Afghanistan. In letters to Senators Wayne Allard and Ken Salazar of Colorado, the GAO said it would assess the VA's treatment of veterans with mild traumatic brain injury, the Department of Defense's pre- and post-deployment screenings for mental health conditions and mild traumatic brain injury and whether policies pertaining to personality disorder discharges have been followed. The studies are to be completed by the end of the year. Allard and Salazar sent their own letter, which broadened the scope and asked the GAO to provide recommendations for legislation to improve mental health care and to capitalize on "best practices" in the military. "We owe our armed forces exceptional health care, and the increased focus on their mental health care by Congress is much needed," Allard said.

Army leaders say soldiers are reluctant to seek help because they believe their careers will be ruined if they do. Earlier this month, the Army launched a "chain teaching" program aimed at educating 1 million soldiers about PTSD and mild traumatic brain injury. During the next 90 days, senior leaders will teach their immediate subordinate units, who in turn will teach their subordinate units, and so on down the line. Across the Army, an effort to hire an additional 260 to 270 mental health care providers also is underway. Fort Carson has been training leaders about PTSD since January and February and expanded the program in the spring to all ranks.

Posted by Kerry N. Jardine at 02:31 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration and Health Canada have released data that seem to show that Nexium and Prilosec, the two most-used treatments for heartburn, were more likely than surgery to cause heart attacks and cardiac deaths in studies lasting many years. Both the FDA and the Canadian regulator disagree with the new data and say the risk is probably a false alarm. Regulators may be learning from the disaster surrounding the announcement of risks that emerged for Avandia. However, the regulators had received a similar analysis, from the drug maker more than a year prior. In Europe, information about this analysis was placed into the approved product labeling for Avandia. That didn't affect sales or create an international furor. The New England Journal analysis, from cardiologist Steven Nissen, was front-page news. By releasing this new data on Nexium and Prilosec early, even before a full analysis is done, the FDA and Health Canada have done the right thing.

The irony of the Avandia controversy is the FDA had not only missed the opportunity to make a statement about a potential link between Avandia and heart attacks, even if only to dismiss it. It had also been scooped. It was working on its own, incredibly thorough analysis on the existing data that both Nissen and GlaxoSmithKline had used in their analyses. It had planned to release them on a Wednesday, but Nissen's study came out on Monday. The FDA may be learning not to sit on data too long, for fear of losing control of the public debate about the safety and efficacy of particular drugs. Thanks to legislation expected by the end of the year and the discussion of drug safety that has occurred since Merck's Vioxx, the FDA is going to get better at tracking the long-term safety of the pills millions of people take every day. That means more and more potential side effects are going to crop up, years after drugs make it to market. Disclosure is a first step to dealing with these risks.

Posted by Kerry N. Jardine at 10:38 AM | Permalink | Comments (0) | TrackBacks (0)

Ill fitting seatbelts raise the risk of serious injury to children involved in car accidents. Seat belt injuries should alert physicians to look for signs of more serious consequences which are not always immediately apparent. In the event of a car accident, injuries such as bruising and tenderness should prompt a search for further injuries to the spinal-cord, vertebral fractures and intra-abdominal injuries. “If spinal-cord injury is missed or not diagnosed early, the consequences can be devastating,” said Harsh Grewal, M.D., in a report published in August issue of the Journal of Spinal Cord Medicine. Grewal, a pediatric surgeon at Temple University School of Medicine and Hospital, and his colleagues reviewed 10 years’ worth of data on motor vehicle accidents involving children. They found that children involved in car accidents who were inappropriately belted were at higher risk for “seat-belt syndrome,” a group of injuries to the spine and abdomen. When healthcare professionals see bruising or seat belt marks in children who are car accident victims, they should highly suspect the possibility of more serious injury. Car accidents are the most common cause of injury and death in children, as well as the most common cause of spinal cord injury in children and adolescents. Boys are more affected than girls, and the incidence increases with age. Children who are 4 to 8 years old are most likely to be using ill-fitting seatbelts or restraints. In general, seat belts and safety restraints should be adjusted according to age and weight.

Posted by Kerry N. Jardine at 06:53 AM | Permalink | Comments (0) | TrackBacks (0)

Senators Patty Murray, D-Wash., and Larry Craig, R-Idaho, are co-sponsoring legislation to establish six epilepsy research and treatment centers across the U.S. They made a joint announcement August 6th of a plan to set aside $6 million a year for centers of research, treatment and education programs related to the incidence of epilepsy in current and future veterans. There has been no research yet to show that brain injuries in Iraq and Afghanistan veterans are resulting in epilepsy, but about half of Vietnam veterans who had penetrating brain injuries suffered from post-traumatic epilepsy. VA research, conducted in collaboration with the Pentagon, found that 53 percent of Vietnam veterans with penetrating head wounds developed epilepsy within 15 years and that about half had a seizure within the first year of receiving their head wound. Other research has shown that in cases of concussion from roadside bombs used in Iraq against U.S. troops and convoys, the onset of seizures can be delayed for two years or more.

Dr. John Booss, VA national director of neurology and a Yale University professor emeritus of neurology, told the Senate committee in May that post-traumatic epilepsy will be “a significant long-term consequence” of the brain injuries suffered by U.S. combat troops in Iraq and Afghanistan. Booss, an Air Force veteran testifying on behalf of the American Academy of Neurology, endorsed the idea of creating specialized VA research and treatment centers.

Posted by Kerry N. Jardine at 06:42 PM | Permalink | Comments (0) | TrackBacks (0)

Nevada resident Michael Smith was retrieving files on a warehouse dock on Feb. 6, 1990, when a worker attacked him. A cerebral hemorrhage from the beating left him with brain damage that changed his life. Trauma during the attack caused injuries in other parts of the brain, an ordeal that put him in and out of rehabilitation for more than three years. "My injury cost my parents over $250,000 in the first two years alone," he said. "In my case, I became a burden. After years of my mother trying to help me, she sent me to California. Right now, I'm getting paid by my mom not to be home." Smith's parents were divorced and he spent a year in California with his father, before he was deserted in a California campground.

He said his experience is common. Testimonials at a Web site sponsored by the Brain Injury Association of America speak of the isolation and a change in priorities. In Smith’s case he suffers from depression and has considered suicide like most of those with brain damage. People with brain damage think differently after they've been hurt, Smith said. "I remember being at a football game with 50,000 people," he said. "Everyone was tuned into the same thing, but you don't connect with that flow. You aren't inside that envelope. It's the same thing with time. Someone with brain damage can be so disconnected that they have no grasp. They always have to fight to be aware of it I can be sitting there and looking at you but not be conscious. I can easily lose two to three hours." Early symptoms can vary, including anything from headaches and difficulty concentrating, to a loss of smell or ringing in the ears, according to information from the Association. The symptoms can be subtle and may not appear until a day or weeks after the trauma. The Centers for Disease Control and Prevention estimates that at least 5.3 million Americans have long-term or lifelong need for help to perform daily activities.

Smith gets a boost out of helping others. He does a little of everything, from collecting food for a local food bank, to cleaning houses, to collecting cans for the Humane Society. His latest cause is raising the consciousness of brain injuries and what these people must endure, in addition to advocating for any preventive measures. Employers often won't consider hiring these people due to their frequent seizures, he said. Smith likens living with brain damage to throwing a pebble in the water. "At first the water is choppy," he said. "But sooner or later the circles smooth out. People with brain damage do become more competent." There aren't a lot of rehabilitation facilities in Nevada, but the Brain Injury Association is helping build supportive chapters here, Smith said.

Posted by Kerry N. Jardine at 02:49 PM | Permalink | Comments (0) | TrackBacks (0)

A brain injury rehabilitation program for active-duty military personnel has proved to be a successful treatment model as it turns one year old this summer. Scripps Memorial Hospital Encinitas and Marine Corps Base Camp Pendleton have teamed to develop an outpatient day treatment program that meets the recovery needs of military patients with traumatic brain injuries. The program is geared toward helping troops rehabilitate so they can achieve their individual goals, whether it's returning to full-time, active-duty status, or assimilating to the private sector. Of the 31 patients who have completed the program to date, 22 have returned to full-time duty. Other patients who have completed the program are pursuing an education or career outside of the military. The partnership is believed to be the nation's only "full-service" outsourced program between the military and a private health care provider that treats closed-brain injuries of active-duty military patients on an outpatient basis. Patients in the Scripps program have access to specialists not readily available at other programs, including physical therapists, speech therapists, occupational therapists, recreational therapists, neurologists, psychiatrists and others.

Posted by Kerry N. Jardine at 02:40 PM | Permalink | Comments (0) | TrackBacks (0)

15 years ago David Krempels left for his honeymoon with his new wife Ettamae. They were hit by a tractor-trailer near Portland Oregon in 1992. Ettamae was killed and David was severely brain injured. After struggling for years both financially and emotionally, Krempels was two years later awarded a large settlement by the court. The money David received became the catalyst for the Krempels Brain Injury Foundation, which today helps hundreds of people affected by brain injury, through two main programs, Family Support and SteppingStones. Stepping Stones is the only program of its kind in the state and helps victims of brain injury integrate themselves back into society in a successful and meaningful way.

Greg Major, a Navy veteran and one of the participants of SteppingStones, has recently decided to interview veterans and write their stories. Major comes to SteppingStones three times a week where he receives support and guidance from the volunteers and other brain injury survivors. Greg Major plans to interview other veterans of all ages on what it is like to transition back into civilian life. Joe Barrett, who suffered a brain injury from a bicycle accident, has used SteppingStones while simultaneously completing his degree in therapeutic recreation at the University of New Hampshire. "Your life is not over after an injury," said Barrett. "It is radically and drastically changed but it is not over."

Posted by Kerry N. Jardine at 10:38 AM | Permalink | Comments (0) | TrackBacks (0)

When you have been injured by an individual or a group then you should seek the advice of a personal injury attorney. Typically the personal injury attorney will specialize in the specific area of injury. When involved in a personal injury, do not reach a settlement with an insurance company without first consulting a personal injury attorney. Personal injury attorneys can help by obtaining payments for such areas as: lost wages, medical bills, pain and suffering, rental car fees (if applicable) and distress payments. The attorney is bound to fight and get the highest possible settlement. In most cases a personal injury attorney will provide a free consultation.

What is personal injury? There are several different types of injuries that one can file a personal injury claim against. The most popular personal injury experienced is in automobile collisions. Next would be medical malpractice. Medical malpractice is when a physician provides inadequate treatment that resulted in injury or death to you or a loved one. Another type is caused by defective products or drugs. Recently nursing home abuse has fallen under the personal injury chapter. It is a way the family can seek advice from an attorney when they feel that their loved one is being abused or neglected. All the above are cases that a personal injury attorney is trained to deal with.

Posted by Kerry N. Jardine at 10:33 AM | Permalink | Comments (0) | TrackBacks (0)

The American Association of Clinical Endocrinologists (AACE), along with the rest of the medical community, has watched with concern the debate regarding usage of Avandia in diabetes and the question of whether it increases cardiovascular risk. AACE welcomes the recommendation of the FDA endocrine advisory panel, which voted almost unanimously that Avandia remain in the US market. At the same time, AACE recognizes the strong statement of the panel that the drug may increase risk of cardiovascular disease (CVD). Concerns are shared by many from the panel that the method used in suggesting an association between Avandia and CVD was far from optimal. Three well-designed long-term randomized controlled studies will greatly enhance the understanding of whether or not this agent helps to decrease diabetes complications. Physicians can continue to treat diabetics who are well controlled with Avandia, knowing that it has been shown useful and effective in controlling glucose, a crucial step to preventing diabetic complications. AACE continues to support the development of ways to manage the issues of weight gain, fluid retention and reduced bone mass in diabetic patients receiving both Avandia and Takeda's pioglitazone (Actos)

Posted by Kerry N. Jardine at 06:48 AM | Permalink | Comments (0) | TrackBacks (0)

On Aug. 2, 2006, Ryan Hoffman, a Summit County resident, was involved in a construction accident that left him paralyzed below the waist. Since then Ryan looks to the future rather than focusing on the past. While still in recovery in the hospital, Ryan was already researching possible options for a full recovery. When he announced that he was going to China to undergo five umbilical cord blood transfusions, his friends and family realized that the need for finances above and beyond what insurance and workman's comp would provide, would be needed. Summit County rallied to Ryan's side. Restaurants, local businesses and hundreds of individuals came out for a fundraiser held on Nov. 16, 2006 for a party, silent auction and raffle at the Snake River Saloon. More than $11,000 was raised to help send Ryan to China. Some of the big contributors included were: Mathison Custom Builders, The Snake River Saloon, Breckenridge Building Center, Mountain Rose Community Acupuncture, Main Street Wellness, Vail Resorts, Arapahoe Basin, Arkansas Valley Adventures and Wilderness Sports. Ryan leaves for China and the non-FDA approved stem cell transplant therapy Aug. 12.

Posted by Kerry N. Jardine at 06:32 AM | Permalink | Comments (0) | TrackBacks (0)

The next edition of the journal Nature includes what doctors call a "remarkable" case of a brain-injured man helped by deep brain stimulation. The 38-year-old man had been in a "minimally conscious state" for six years after suffering a severe traumatic brain injury in an assault. A minimally conscious state is different from a coma or a persistent vegetative state. Patients in a minimally conscious state occasionally show signs of arousal and organized behavior, but they have a "profound deficit in consciousness," states an editorial published in Nature. After getting deep brain stimulation, he is now able to talk and eat on his own.

Before the implants were surgically in place and despite rehabilitation therapy, the man was nonverbal and couldn't swallow or communicate reliably. The man's brain scans showed that while he had severe brain damage, some of the networks within his brain were still intact. Based on those brain scans, Nicholas Schiff, MD, of New York's Weill Cornell Medical College and his team asked the man's family to let them try deep brain stimulation. The doctors surgically implanted electrodes in the man's brain, targeting the thalamus. Two days after surgery, the doctors turned the electrodes on as an initial test of deep brain stimulation. When they did, the man was able to keep his eyes open longer than before the surgery as well as able to turn his head when someone spoke. Over the next six months, the doctors gradually gave the man deep brain stimulation. He gained the ability to chew and swallow food and to talk more, even occasionally saying sentences up to six words long.

In a Weill Cornell Medical College news release, the patient's mother states, "My son, as well as the entire family, had little hope of further recovery. If it were not for the deep brain stimulation surgery and rehabilitation, we would be no further along than we were in 1999. Now my son can eat, express himself, and let us know if he is in pain. He enjoys a quality of life we never thought possible." The result raises hope, but "not all patients with disorders of consciousness will benefit from thalamic stimulation," states the editorial in Nature.

Posted by Kerry N. Jardine at 06:46 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA has issued an early communication about the ongoing review of new safety data for proton pump inhibitors Prilosec and Nexium. The new safety data was from two small long-term clinical studies in patients with severe gastroesophageal reflux disease (GERD). In both studies, patients either took one of the drugs (Prilosec/omeprazole or Nexium/esomeprazole), or were treated by surgery.

The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs, compared to patients who had surgery. After reviewing these and other data submitted by the drugs' maker, AstraZeneca, FDA's preliminary conclusion is that the data do not suggest an increased risk of heart problems. The FDA stated that healthcare providers need not change their prescribing practices, and patients on Prilosec or Nexium should not change their use of these products at this time.

Both drugs are used for the treatment of GERD, esophageal erosions, and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec is also sold over the counter for frequent heartburn.

Posted by Kerry N. Jardine at 06:35 PM | Permalink | Comments (0) | TrackBacks (0)

Congress this week will likely not finalize a bill that would reauthorize the Prescription Drug User Fee Act and expand FDA oversight of prescription drug safety, despite a requirement that the agency distribute layoff notices if the lawmakers do not complete the legislation before the August recess, CongressDaily reports. It was confirmed that a conference committee to resolve differences between the House and Senate versions of the bill will not occur this week. Senate Health, Education, Labor and Pensions Committee ranking member Mike Enzi (R-Wyo.) also believes that Congress will not finalize the legislation this week. In a letter to Senate leaders last week, Enzi raised concerns that the layoff notices would prompt FDA employees to seek other jobs.

House Chief Deputy Minority Whip Eric Cantor (R-Va.) has raised similar concerns and said FDA will distribute the layoff notices as early as this month. However, Rep. Debbie Wasserman Schultz (D-Fla.) said, "We think the gentleman's characterization of the timing of that is a bit of a stretch." Democrats have indicated they are not very concerned about the layoff notices because they believe FDA employees will ignore them with the legislation so close to finalization.

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

Ernie Irvan, former NASCAR driver, walked through the John Heinz Institute of Rehabilitation and it brought back memories of his long road to recovery. He met and spoke with patients who suffered a traumatic brain injury, just like he did. Mr. Irvan, 48, no longer races for NASCAR, but uses his fame and influence to warn others about the injury many call the ‘silent epidemic’. “Lance Armstrong was one of my heroes. He conquered cancer. If he could do that, I figured I could do something,” Mr. Irvan said. Mr. Irvan became a NASCAR superstar in the early 1990s. His career and life were forever changed by a wreck in August 1994 at Michigan International Speedway. A blown tire caused his car to crash head-on into the wall at 170 mph. He suffered critical brain injuries and was given a 10% chance to live. He later had a comeback to NASCAR, running successfully for a three-year stint, but was forced to retire after suffering another head injury during a wreck at Michigan. Mr. Irvan started the Race2Safety group, www.race2safety.com, to raise awareness about brain injuries. James Brogna, a vice president at John Heinz Allied Services, said Mr. Irvan’s visit showed patients there is hope. “You have a celebrity people remember from his racing days. Some of the people here are at the beginning steps of their recovery. They see him walking around and functioning. It’s something they could aspire to as a goal,” he said.

Posted by Kerry N. Jardine at 02:28 PM | Permalink | Comments (0) | TrackBacks (0)

As a Food and Drug Administration expert advisory panel prepares to review the safety of the diabetes drug Avandia next week, two U.S. senators have questioned whether the agency suppressed internal critics of the medication. In a letter to the FDA, Senators Max Baucus (D-Mont.) and Charles Grassley (R-Iowa) said a senior FDA scientist told Senate investigators of being removed from work on the drug after voicing concerns about its safety regarding the risk of congestive heart failure. The unnamed FDA medical officer at one time was the primary reviewer looking at the potential heart risks of Avandia. The senators said this medical officer is the second senior FDA official known to have been removed from the research of the drug after voicing safety concerns about Avandia. The FDA revealed last month it is now seeking what the two ousted officials wanted, a "black box" warning about the potential of congestive heart failure for some patients who use Avandia. The FDA also has requested the same warning for rival diabetes drug Actos.

Posted by Kerry N. Jardine at 10:44 AM | Permalink | Comments (0) | TrackBacks (0)

When a study published this spring showed that Avandia also increased risk of heart complications, Dr. Mary M. Newman, an internist, was in a quandary about what to advise her patients taking the medication. "It was easy for patients to feel the drug was proven to be dangerous and everyone was concerned," Newman said. "But the thing is there were benefits." In the end, she said, the decision on whether to continue the medication varied with each patient.

Last week, assessing Avandia became even more complicated for Newman and her patients when an FDA advisory committee voted 20-3 in finding that Avandia does indeed increase the risk of heart disease in Type 2 diabetes, but at the same time the panel voted 22-1 to leave it on the market! At a time when more information than ever is broadly available about illnesses and the effects - positive and negative - of the drugs used to treat them, doctors and patients are facing a growing challenge as they attempt to sort out the benefits and risks of medications and therapies. Every week, professional journals and other sources report the results of new medical studies, a rising amount of information that sometimes seems contradictory. Increasingly, some physicians say, patients come to them with fixed opinions based on what they have heard or read about in the latest medical studies. "They actually tend to believe more what's in the newspaper and what's on the Internet than they believe me," said Dr. Joanna Saba, an Owings Mills internist. Consumers also may reach incorrect conclusions about studies they read or hear about. Some studies make medications sound attractive to people who don't need them. Others scare away patients from potentially beneficial therapies. Published research, especially in widely read, peer-reviewed journals, should provide sufficient information to help make informed decisions about courses of treatment.

Posted by Kerry N. Jardine at 10:26 AM | Permalink | Comments (0) | TrackBacks (0)

The National Office of Veterans Affairs (NOVA) created 17 regionally-based polytrauma facilities providing specialized care for the increasing number of veterans returning from the wars with Traumatic Brain Injury (TBI). One of which is located in Denver at the Denver VA Medical Center. Traumatic Brain Injury (TBI) is becoming more common among troops and this facility is only one of 17 in the nation. Historically, approximately 20% of battle casualties were diagnosed with TBI, or in World War II the term was referred to as "Shell Shock." NOVA also created four major Polytrauma Rehabilitation Centers located in Minneapolis; Tampa, Fla.; Richmond, Va. and Palo Alto, Calif. Each has interdisciplinary teams of specialists who work together on the complex medical needs of each patient.

Posted by Kerry N. Jardine at 06:24 AM | Permalink | Comments (0) | TrackBacks (0)

The Canadian Press reports a class-action lawsuit has been filed against an Alberta hospital. St. Joseph’s General Hopital is at the centre of a sterilization scandal when they were negligent in failing to ensure that instruments used on patients were properly cleaned. The lawsuit, which names the hospital and the East Central Health Region as co-defendants says "The plaintiff, while a patient of the hospital, was examined and underwent wound care and suturing with respect to prior hip and knee surgery, during which procedure equipment and instruments were used which had not been properly sterilized." The claim further alleges the hospital "failed to satisfy the standard of care and breached its duty of care to the patients" by not properly maintaining and sterilizing the equipment. It also claims the hospital didn't properly sterilize water, sufficiently train staff or warn patients quickly enough (or not at all) about the risks they may have been exposed to between April 1, 2003 and last March 12.

Patients potentially exposed to blood-borne illnesses from the unsterilized instruments have gone through repeated testing since the hospital's problems became public last spring. The 12 members of the St. Joseph's board were already forced to resign by the provincial government after a Health Quality Council report. The 25-bed hospital had to be closed in March for several weeks to all but emergency patients after reports surfaced that instruments were being recirculated with flecks of blood and dead tissue on them. There was also concern over an antibiotic-resistant superbug. A government official confirmed that 60% of 3,000 former patients have been tested for HIV, hepatitis and other diseases. The class action has to be certified by a judge before it can begin making its way through the courts.

Posted by Scott J. Eldredge at 06:35 PM | Permalink | Comments (0) | TrackBacks (0)

Members of the Texas state dental board may no longer act as expert witnesses for other dentists facing malpractice lawsuits unless they have received permission from others on the dental board. The new law that takes effect Sept. 1 will limit the controversial practice and will require the full board or the board's executive committee to grant permission. Earlier in the year, several former board members said they saw no ethical problems with being paid as experts for dentists facing lawsuits, although at least one acknowledged that his testimony probably received more weight in court because of his position on the board, which licenses and disciplines dentists.

A similar provision covers the Texas Medical Board, which licenses doctors, physician assistants and others. Members of that board also have worked as experts for doctors facing lawsuits. "We had dentists and doctors calling us" to do something after they learned of the practice, said state Rep. Fred Brown, R-Bryan, who sponsored the legislation. Gary McDonald, the dental board's presiding officer, said he supports the legislation, adding that for nearly a year the board has had an internal agreement to avoid doing expert witness work.

Posted by Scott J. Eldredge at 02:33 PM | Permalink | Comments (0) | TrackBacks (0)

A panel of experts on Monday told US drug regulators to keep diabetes drug Avandia on the market despite an increased risk of heart problems. By a 20-3 vote, the Food and Drug Administration Advisory Committee agreed that current clinical trials showed Avandia, produced by GlaxoSmithKline, increased the risk of heart attack in people suffering from type 2 diabetes. "Data does suggest there is an increased risk," said committee president Clifford Rosen. However, the experts also voted 22-1 that the therapeutic benefits of Avandia outweighed its risks and justified keeping it on the market. The panel's decision is non-binding, although the FDA usually follows its recommendations. Several committee members suggested the FDA demand stronger warning labels on Avandia packages, but a doctor on the panel said the proposal was dropped because it lacked consensus. After the FDA panel's recommendation to keep Avandia on the market, shares of GSK gained six percent closing at 52.45 dollars at the close of the New York Stock Market.

Posted by Kerry N. Jardine at 10:31 AM | Permalink | Comments (0) | TrackBacks (0)

The Canadian Press reports Tony Merchant of The Merchant Law Group is attempting to launch class action lawsuits in two provinces against the makers of Avandia. The group filed statements of claim in Saskatchewan and Ontario, alleging GlaxoSmithKline should have done more to warn consumers of the drug's risks. Merchant says statements of claim will be filed in other provinces later this week. "(The plaintiffs) have suffered heart attacks or suffered loss of their vision, and in some cases they have died," Tony Merchant alleged. "Every drug does some good or bad," he continued. "The question is whether people were sufficiently warned.

Merchant's lawsuit filed in Saskatchewan alleges that one victim began to have chest pain, shortness of breath and heart failure within two months of beginning to take Avandia and within a year, suffered at heart attack and died at age 75. The Attorney General of Canada is also named as a defendant in the statements. More than one million prescriptions for Avandia were filled in Canada last year, according to IMS Health Canada. Earlier this year, Bonnie Latimer launched her own lawsuit in Manitoba against the makers of Avandia, alleging the drug caused permanent injury to her eyes after she began taking it in 2003. Merchant says Latimer and others who are launching their own lawsuits would do better if they joined one of his class-action lawsuits. "It will be very difficult for an individual to face the financial burdens of trying to win against a company of this size," Merchant said.

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

Dena Brehm Gennerman, 39, suffered a traumatic brain injury two years ago. As she cries during a physical therapy session in her parents’, Bob and Eva Brehm, home she could be in pain, but it's hard for them to know. Except for a couple of simple hand signs, fist up or down for "yes" or "no", what Dena thinks or feels is hard to determine. Pained by his daughter's sobs as she endures her morning physical therapy with certified nursing assistant Chris Mrdutt, Bob Brehm sometimes has to leave the room. While it is difficult for the Brehms to watch Dena struggle with even the simplest of tasks, they believe they are seeing tiny improvements since her recent visit to Shenyang, China, and the 463rd Hospital of the Chinese People's Liberation Army. There, doctors placed six injections of adult stem cells, gathered from umbilical cords, into the spine of Dena. Adult stem cells, which can be taken from bone marrow, umbilical cord blood and tissues throughout the body, have some ability to transform, possibly replacing damaged cells, studies suggest. Some researchers believe the cells also play a support role, excreting chemicals near injuries and assisting in repair. Except for bone marrow transplants, the federal Food and Drug Administration has not approved them for widespread therapeutic use.

Dena was a passenger on an Egyptian bus traveling back from Mount Sinai in 2005 when the bus rolled and her head was slammed against a rock. After an operation, she was comatose and on ventilators and then airlifted from Egypt to University Hospital in Salt Lake City. Paralyzed on her right side, Dena needs help bathing, dressing, eating and walking. Dena's husband and 3-year-old son visit several times a week. Her parents began looking for a treatment that might help restore at least some of Dena's motor and thinking skills. A conversation with a Salt Lake City doctor who treats brain injury patients with hyperbaric oxygen therapy further fueled the Brehms' interest in stem cell therapy. They decided to give the experimental therapy a try. Dena's U.S. doctors had mixed reactions; one expressed concern about the cleanliness of the clinic and the purity of the stem cells. “For the most part, they were encouraging," Bob Brehm said. One neurosurgeon said "we definitely need people like you to try these things," Eva Brehm added. "It's the future."

The Brehms traveled to Shenyang in May and stayed for nearly two months, while Dena received a bone marrow transplant and daily sessions of acupuncture and physical therapy along with the injections of stem cells. Provided by Beike, a Chinese biotechnology company formed in 2005, the stem cells came in batches of 10 million, packaged in tiny plastic vials, Bob Brehm said. Dena received the injections in her spinal cord. Each therapy lasted about 20 minutes and required that Dena lie still for hours afterwards to avoid getting a headache, a common side effect reported by patients. Following the injections, Dena was given growth hormones to stimulate the cells. While they were told it typically takes four to six months to see any results, they've already noticed some small improvements. At times, Dena is more mentally alert and able to follow movements with her eyes. She can draw lines and circles and is better able to tolerate the time she spends in her stander.

Posted by Kerry N. Jardine at 06:28 PM | Permalink | Comments (0) | TrackBacks (0)

Chris Nowinski's professional wrestling career ended with a kick to his chin. He was a WWE wrestler when he suffered a concussion, but didn't realize how badly he was hurt. Nowinski didn't know he had suffered a concussion. He didn't know that he shouldn't have been wrestling immediately afterward and he didn't know that this was probably the sixth concussion of his athletic career. Hard hits were nothing new to Nowinski, 28, who had played sports since childhood. Blows to the head were a normal risk in the games and matches of his career. Sometimes he blacked out. "The sky would change colors, or I would see stars, and get really dizzy, and I would just collect myself on the field or in the ring, and continue going, because that's what I thought I was supposed to do. I didn't realize that it was a serious brain injury." Nowinski continued to wrestle, which aggravated the injury. He developed post-concussion syndrome, a condition characterized by prolonged concussion symptoms. After his last concussion he experienced four years of headaches, memory problems, depression and sleep walking. He said he still endures migraines and memory loss. "My head just feels differently all the time," he said.

Nowinski decided to change what he considers the sports world's biggest liability. He's now on a mission to eliminate the damage from head injuries in athletics. His task is to educate coaches, parents and athletes about identifying and treating concussions and to help facilitate research to discover the injury's long-term effects. He wrote "Head Games: Football's Concussion Crisis from the NFL to Youth Leagues," published in 2006. He's been speaking before youth leagues, sports conferences and other public events for more than three years.

Nowinski and a group of top neurologists recently formed The Sports Legacy Institute. Part of the organization's purpose will be to study the effects of multiple head injuries. Investigating cases of a condition called chronic traumatic encephalopathy, or CTE, Nowinski said. CTE is a dementia-like condition caused by repetitive blows to the head over an extended period of time, according to the National Institute of Health. Wanting to communicate to the sports establishments that multiple concussions have permanent consequences, Nowinski began to work with a University of Pittsburgh neuropathologist, Dr. Bennet Omalu, who found the condition CTE in the brains of two deceased former National Football League players, Terry Long and Mike Webster. With Nowinski's help in obtaining the brain tissue, Omalu diagnosed the condition in two other former players who died, Andre Waters and Justin Strzelczyk. Both Long and Waters committed suicide. In the case of Waters, Omalu said, "Major depression was the cause of his suicide ... And the underlying causation here was trauma."

Posted by Kerry N. Jardine at 02:25 PM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit has been filed in the United States District Court, Middle District of Tennessee, Nashville Division (Case No. 3:07-0774), on behalf of clients Jerry and Lynne Hensley against Tyco International, Ltd., because of serious injuries caused by an injectable dye used in magnetic resonance imaging (MRI) scans. In 2004, Jerry Hensley, a kidney failure patient, underwent an enhanced MRI, which included injecting the drug OptiMARK, a gadolinium-based dye. One week after the MRI, Hensley started showing signs of Nephrogenic Systemic Fibrosis (NSF). Hensley's symptoms included thickened skin around both elbows and knees, additionally, pain in legs, knees and elbows as well as difficulty in walking.

The FDA has recalled gadolinium dyes stating, "Patients with moderate to end-stage kidney disease who receive an MRI with a gadolinium-based contrast agent may get NSF, which is debilitating and may cause death." The suit charges the defendants as knowing that the dye could cause NSF in kidney patients, but continued to distribute it. They also failed to warn physicians of the risks of kidney patients potentially developing NSF. Hensley's attorney, Lee Coleman, stated that, "Mr. Hensley had the right to be warned that because of his kidney disease, it was very risky for him to receive the injection of the dye (gadolinium) before he had his MRI. We believe we can prove that the defendants have known for years that kidney disease patients who receive the injection of gadolinium-based dye were at very high risks for developing NSF, which is a horrible medical condition. Unfortunately, the defendants chose to conceal the risk of the procedure, so Mr. Hensley's doctors could not warn him."

Posted by Kerry N. Jardine at 10:22 AM | Permalink | Comments (0) | TrackBacks (0)

Stores nationwide are continuing to sell recalled canned chili, stew, hash and other foods potentially contaminated with poisonous bacteria even after repeated warnings the products could kill. Thousands of cans are being removed from store shelves as quickly as investigators find them, more than a week after Castleberry's Food Co. began recalling more than 90 potentially contaminated products over fears of botulism contamination. The recall now covers two years' production at the company's Augusta, Ga., plant which includes tens of millions of cans. Spot checks by the Food and Drug Administration and state officials continue to turn up recalled products for sale in convenience stores, gas stations and family run groceries, from Florida to Alaska. The FDA alone has found them in roughly 250 of the more than 3,700 stores visited in nationwide checks, including Kentucky, Montana, New York and Indiana.

Four people have been sickened and hospitalized because of the contaminated food, according to the Centers for Disease Control and Prevention. Officials fear the numbers will grow. FDA investigators believe Castleberry's failed to properly cook some or all the products, allowing the Clostridium botulinum bacteria to survive the canning process. In the oxygen-free and moist environment of the sealed cans, the bacteria thrive and produce a toxin that causes botulism, a muscle-paralyzing disease. The longer the bacteria stay in the can, the worse it gets. The bacteria also produce gases that can cause contaminated cans to swell and burst. Already, cans being held in a company warehouse have begun to burst.

Health officials say the extremely potent toxin can infect people if it is inhaled, swallowed or absorbed through the eye or breaks in the skin. Health experts consider botulism a severe health threat but worry that word of the recall has not reached all consumers or retailers, especially mom-and-pop operations. "It has been a problem getting the message out. We're having a problem reaching the smaller stores," said Lynae Granzow, an epidemiologist with the Indiana Department of Health. Castleberry's has hired a company to collect the recalled products from stores. People who have any of the recalled products at home should double-bag and throw them away, the FDA recommends. Castleberry has posted a complete list of the recalled products, including some dog foods, on its Web site at http://www.castleberrys.com. Castleberry's is owned by Bumble Bee Seafoods LLC, based in San Diego.

Posted by Kerry N. Jardine at 06:17 AM | Permalink | Comments (0) | TrackBacks (0)

Kathleen Osberger‘s face was engulfed by flames while sedated on an operating room table during what was supposed to be a simple procedure to remove two moles from her face. Osberger, who lives in Chicago, settled a malpractice lawsuit in 2003 against Weiss Memorial Hospital for $6 million. She‘s had to wear special masks since, has had stents inserted into her nasal passages and still has trouble breathing or smiling. Osberger believes one of the ways to decrease surgery fires is to require mandatory reporting of them. She says doctors have never told her what they think went wrong and the hospital denied negligence.

Surgery fires are rare but serious enough that the American Society of Anesthesiologists plans to issue its first guidelines aimed at preventing them. Health officials aren‘t required to report surgery fires, but the medical group believes they have increased over the past two decades with the use of lasers and tools that use electric current. ECRI Institute, a nonprofit health research agency, estimates that there are 50 to 100 fires out of the more than 50 million surgeries performed in the United States each year. Such fires kill one to two people annually and 20 percent of patients suffer serious, disfiguring injuries. ECRI‘s Mark Bruley said too many anesthesiologists are using 100 percent oxygen instead of only what the patient needs. Patients can be kept stable with an oxygen level of 30 or 40 percent during the use of electrosurgery tools.

Posted by Scott J. Eldredge at 04:30 PM | Permalink | Comments (0) | TrackBacks (0)

As of February 2007, evidence to support an association between gadodiamide known as Omniscan and development of NSF has increased. Of the marketed gadolinium-based contrast agents, most cases of NSF have been associated with Omniscan, followed by OptiMARK (gadoversetamide, which is not licensed in Europe but is available in the USA) and a small number of cases have been reported with Magnevist (gadopentetate dimeglumine). The latest figures suggest that 90 cases of NSF associated with Omniscan, OptiMARK, or Magnevist have been reported to the US FDA. Elsewhere, more than 150 patients have developed NSF after exposure to a gadolinium-based contrast medium, more than 90% of which were exposed to Omniscan. The reports, collated by the European Society of Urogenital Radiology (ESUR), showed that patients who developed NSF had received Omniscan a few weeks before. Four patients may have received OptiMARK and Magnevist. The remaining cases the agent is not known because several agents were given or because there is inadequate information available.

The Medicines and Healthcare products Regulatory Agency (MHRA) is aware of 21 cases of NSF associated with gadodiamide, five of which were fatalities. Magnevist has informed the UK of 13 cases of NSF associated with Magnevist. The role of Magnevist for some cases is unclear because several agents were given or because there is inadequate information. However, for at least one case, in which the patient received high doses of Magnevist in a fairly short period of time, development of NSF seems related to Magnevist.

To date, there have been no reports of NSF in patients with normal kidney function. Since the 1980s, more than 200 million patients have been exposed to gadolinium-based contrast agents. Therefore, NSF does not appear to occur in patients without renal impairment. The people at risk are those with severely impaired renal function. Several researchers have suggested that liver transplant patients are prone to NSF. Gadodiamide is almost exclusively excreted by the kidneys.

Posted by Kerry N. Jardine at 02:27 PM | Permalink | Comments (0) | TrackBacks (0)

At present, there is no known effective treatment for NSF. Physical therapy or treatment with topical and systemic steroids has had a variable benefit. Immunosuppressive therapy is ineffective. Plasmapheresis, a process in which blood taken from a patients is treated to extract the cells and corpuscles which are then added to another fluid and returned to the body, has led to an improvement in some. The drug Thalidomide led to an improvement in some patients as well. Others have improved after restoration of normal renal function either spontaneously or as a result of a renal transplant. There is a proposal that a dose reduction in erythropoietin, a hormone produced in the kidneys that increases development of red blood cells in bone marrow, might improve NSF. Two patients were given Pentoxifylline, a substance with activity against tumor necrosis factor. Skin changes in the first patient who had late-stage disease seemed to slow or arrest it and the second patient stabilized and had a slight reversal of disease.

Posted by Kerry N. Jardine at 10:26 AM | Permalink | Comments (0) | TrackBacks (0)

NSF develops over a period of days to several weeks. Rapid, new-onset hypertension has been reported before development of skin lesions. The skin changes start as reddened or darkened patches, papules, or plaques. Over time, the skin feels “woody”, and the surface may have an appearance and texture of orange peel. Diagnosis is confirmed by the presence of specific features found on a skin biopsy, i.e. thickened collagen bundles. Skin lesions are usually symmetrical, with zones between the ankles and thighs. Later, lesions develop between the wrist and upper arms. Patients may have burning, itching, or severe sharp pains in areas of involvement, and may have swelling of the hand and foot with blister-like lesions. Some patients have reported yellow papules or plaques on or near the eyes.

For many patients, the skin thickening causes the inhibited ability to flex or extend joints, resulting in contractures or the contracting of joints. Those severely affected may be unable to walk or extend fully the arm, hand, leg and feet joints. Muscle weakness is common and deep bone pain has been mentioned in hips and ribs. About 5% of patients rapidly progress through the disease. NSF might contribute to death by scarring of body organs (which impairs normal function), restriction of effective ventilation, or restriction of movement leading to an accidental fall that might be further exacerbated by fractures and clotting complications. Other patients have died as a result of renal disease or transplant surgery. NSF occurs only in patients with renal impairment and the onset of this syndrome is associated with hypercoagulability, thrombotic events, recent vascular surgery or recent renal transplant failure.

Posted by Kerry N. Jardine at 06:23 AM | Permalink | Comments (0) | TrackBacks (0)