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« February 2007 | Main | April 2007 »

 

March 31, 2007

Malpractice suit trial opens in Waco man's death

The adult children of a 75-year-old Waco, TX man who died five years ago after knee-replacement surgery are seeking up to $12 million in damages in the trial of a medical malpractice lawsuit that began March 26th. Kathy and David May and Suzanne Collier, claim that negligence on the part of four doctors who treated their father, Thomas L. May Sr., at Hillcrest Baptist Medical Center led to his death May 29, 2002. Drs. Nick Manitzas, Mark Mazzare, David Tuel and Todd Tyson have denied the allegations and say May received proper care and was preparing to go home when he got an infection that led to his death.

Dallas attorney Bill Zook, who is representing the May family with Ron McCallum, told jurors in opening statements that, despite his age and three prior surgeries to replace his left hip and left knee and to repair back problems, May was in relatively good health and enjoyed hunting, golfing and other outdoor activities. Zook told jurors that May’s knee-replacement surgery May 14, 2002, went well and that he and his family had expected him to be released from the hospital in about four or five days. Zook claims the doctors prescribed two types of pain medications, including one stronger than the recommended dose, and a blood thinner that formed a lethal cocktail when combined with blood-pressure medication that May already was taking. “We think it was an injustice the way these doctors cavalierly prescribed these medications, did not consider the interaction of them, and Mr. May died as a result,” Zook said. The doctors ignored a “black-box warning,” the most severe warning a drug manufacturer has to give a physician, that some of those drugs should not be combined, he said. May developed a condition known as sepsis, caused by inflammation, problems with blood clotting and low blood pressure. The sepsis led to respiratory problems, organ failure, pneumonia and an eventual heart attack, Zook said. He died from what is known as adult respiratory distress syndrome, Zook said.

Dallas attorney David C. McCue, who is representing Manitzas and Tuel, told jurors that, while May’s death was tragic, he was “not a glowing specimen of health” when he entered the hospital. He suffered from symptoms of asbestos exposure, had been a longtime, heavy smoker and had developed pneumonia after one of his previous surgeries, McCue said. He said the doctors had used all the drugs that they prescribed for May for years with no complications. May’s health took a turn for the worse when he ate a candy bar and aspirated it and some of his stomach contents got into his lungs, McCue said. An autopsy found E. coli in his system, which had to come from “bugs” from his intestines, McCue said. That led to the infection and pneumonia, not the combination of medications, he said. “It was bugs, not the drugs,” McCue repeated frequently during his opening, referring to bacteria from May’s intestines.


Florida women who ate tainted peanut butter file suits

Two Palm Beach County women who became ill after eating salmonella-contaminated peanut butter are suing its manufacturer, ConAgra Foods Inc. Brian Smith, a West Palm Beach attorney with Smith & Vanture, filed separate lawsuits Thursday in Palm Beach County Circuit Court on behalf of Ruby Reilly of Palm Beach Gardens and Gloria Deleo of West Palm Beach. There are close to 400 confirmed cases of illness that have been linked to the product in 42 states, FDA officials said. ConAgra is being sued for product defects, failure to warn consumers of the product's danger, and negligence. Each woman is seeking damages in excess of $15,000.

Seattle-based attorney Bill Marler, who in February filed a national class-action suit over the tainted peanut butter, said he represents 4,500 people who were sickened by the peanut butter. "Of that 4,500, there are close to 500 who had more than an emergency room visit. They had overnight hospital stays or days. We are looking at 10 possible deaths," Marler said.

ConAgra spokeswoman Stephanie Childs said Thursday it is working with the FDA to determine how the contamination occurred. "It concerns us greatly that any consumer may have been harmed by a product of ours," Childs said. The company has received 15 million calls from consumers about the recall, she said. "We are working with the FDA to finalize both the cause and the next steps," Childs said.


TBI Jail population presents new challenges

A jail is a reflection of societal problems. “It’s a little city, a complex society,” Hubbard County Chief Deputy Frank Homer said of a jail. “Everything that’s on the inside, is on the outside.” What’s being seen “on the inside” has evolved over the decades. Jail administrator Sherri Klasen joined the staff in 1986, when “alcohol was the main contributing factor” to those who were incarcerated. “Now it’s drugs,” she said. “And a huge part of it is methamphetamines.” In addition to the increase of inmates incarcerated for drugs and alcohol the Hubbard County Jail is seeing an increase in those with symptoms of mental health problems, as well. “We were warned of this in the late ’90s,” Homer said. State funding was “falling short.” State hospitals would be closing. The patients were to be given medication and sent “home.” Law enforcement was cautioned the impending problems could fall in their lap. As secure facilities disappear, the jail is dealing with more inmates with mental health issues for longer periods of time, Klasen said. Nationally, correctional facilities are seeing more mental health problems, UMMHC executive director Manfred Tatzmann said.

A recent survey by the federal Justice Department statistics bureau estimated a large percentage of prisoners nationwide reported treatment for or symptoms of major depression, mania or psychotic disorders such as hallucinations or delusions in 2006. Conditions faced by inmates may include fetal alcohol syndrome (FAS) or those who’ve suffered traumatic brain injury (TBI). TBI affects impulse control and memory. “They may forget to take their medications,” Tatzmann said. Offenders with TBI may suffer from depression, anxiety, cognition problems, violent thoughts, suicide attempts and discipline violations. The conditions may cause impulsive behavior and difficulties with the law, Tatzmann said. It’s been called the silent epidemic because there are no visible signs. “No two are alike,” Tatzmann said of patient symptoms resulting from TBI. People with brain injuries tend to self-medicate and domestic violence increases. The number of people with TBI has grown dramatically in the past 10 years because of medical advancements. Fifty percent of the people sustaining a TBI faced mortality previously, Tatzmann said.


March 30, 2007

Parkinson's Drug Causes Heart Damage, is Pulled from Market

At the request of the FDA, the Parkinson's drug Permax (generic: pergolide) has been voluntarily removed from the market by its maker, Valeant Pharmaceuticals, because of its link to heart valve damage.

"The reason for the withdrawal is because of the high rate of damage to the heart valves in users of pergolide," said Dr. Robert Temple, director of the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research (CDER). "The damage causes the heart valve to become leaky. The drug is called a dopamine agonist and is used as stating therapy for Parkinson's patients."

Pergolide has been available since 1988, but heart valve damage wasn't reported until 2002. The drug's label was changed in 2003 to reflect the risk of heart valve damage, but the FDA upgraded the warnings to a "black box warning," the strongest warning it can mandate, in 2006. In January, the New England Journal of Medicine published two studies that showed a fivefold increased risk of heart valve damage from taking pergolide. One of the studies reported that 23 percent of patients on the drug develop heart valve prpoblems, and that's what led to the FDA's request for withdrawal.

The voluntary withdrawal will not take place immediately, because patients taking pergolide need time to consult with their doctors and make appropriate treatment decisions. "We are telling these patients not to stop the drug abruptly," Dr. Temple noted. "If the patients, with their physicians, conclude they need a dopamine agonist, there are ways to switch."


Illinois state proposal could revive medical malpractice debate

">An Illinois House committee hearing could bring back the medical malpractice debate that for several years dominated Metro East politics. Supporters and critics who have strong opinions on a bill that would establish a pretrial hearing on the merits of any expert witness in a civil trial. Supporters, in particular, say they plan to go before the House judiciary committee on civil law when it hears the bill. Though the bill, numbered HB1896, would apply to all civil litigation, the debate is likely to cast a spotlight on ">medical malpractice trials, which routinely involve the use of outside expert witnesses such as doctors evaluating the case of a plaintiff. In addition to allowing for a hearing on any expert witness, the bill would also allow the hearing to be appealed before a trial proceeded. Lawyers who are backed by tort reform groups criticize such measures, as a way for defendants to boost expenses for plaintiffs and stall a verdict.

Doctors blame lawyers for filing what they see as frivolous lawsuits. Lawyers fault insurers, saying the companies raise rates and then blame the civil justice system. Many doctors still have qualms about the issue and particularly criticize the credibility of expert witness testimony, according to the results of a study released by Illinois Lawsuit Abuse Watch, a watchdog group that supports the bill. In a mail survey of 176 Illinois physicians, 97 percent said they believe at least some problem exists with the system. And 65 percent said they had personally seen or heard inaccurate or questionable statements by a medical expert witness.

East St. Louis plaintiffs’ attorney, Rex Carr, said that the additional appeal process could delay a case for years. He said any defense attorney can already file a motion that appropriately bars questionable testimony. "This is just another way to add cost to the bringing of lawsuits. It wouldn't prevent any lawsuits," said Carr. "We get experts that are competent because we want to win our cases." The medical malpractice issue has cooled in recent years, as the Legislature in 2005 passed a compromise bill, signed by the governor, limited damages a plaintiff could receive and also made changes to the malpractice insurance industry. That measure now faces a constitutional challenge in court.


Health care bill raises consumer concerns

Attorney General Paul Morrison of Topeka Kansas, victims of medical malpractice and plaintiff’s lawyers criticized legislation that would exempt health care professionals from the law that allows consumers to sue over deceptive practices. “This bill would prevent my office from investigating the most deceptive and unconscionable acts committed by anyone in the health care industry,” Morrison said. House Bill 2530 would exempt professional services by a physician or health care provider from the Kansas Consumer Protection Act. Opposing sides of the legislation squared off before the Senate Judiciary Committee who which took no action on the bill but the measure was approved by the House, 109-14.

Rep. Mike O’Neal, R-Hutchinson, and health care professionals defended the measure, saying it would limit lawsuits while there were other legal remedies that could be used for patients who allege they were wronged in their health care. “This is not about exempting doctors from claims against them,” O’Neal said. He argued that patients could still sue for medical malpractice if their health care or treatment were botched by a health care professional.

Jerry Slaughter, executive director of the Kansas Medical Society, said the bill was needed because the Kansas Supreme Court in a recent decision expanded the scope of the Kansas Consumer Protection Act to include deceptive acts by health care professionals. “Our intent is not to immunize or protect physicians, but to return to where the law was,” he said. However, Morrison, plaintiff’s attorneys and advocates for the elderly and patients disagreed. They said medical malpractice laws allow patients to sue for poor treatment or care, while the Kansas Consumer Protection Act allows for lawsuits against doctors who make false claims in advertising or in their claims about certain treatments. The recent court ruling simply stated the parameters of the act and didn’t expand its reach.


Charges may be filed in CME van wreck

The Colorado State Patrol is seriously considering recommending felony charges be filed against the driver of a Colorado Mountain Express van that crashed into a parked snowplow Sunday morning, sending the driver and all eight passengers to the hospital, Capt. Ron Prater said Monday afternoon. Prater said two passengers remained in critical condition on Monday and at least one other person needed surgery for injuries sustained in the crash.

The ski shuttle was on the way from Vail to Denver International Airport around 8 a.m. the morning of March 25th when the driver collided with a Colorado Department of Transportation snowplow parked on a portion of the interstate that had been closed so crews could clean up a prior accident. The snowplow involved in the crash was parked across two eastbound lanes of traffic to provide a barrier for workers mopping up a fuel spill caused when a semi-truck jackknifed about four hours earlier, said Colorado Department of Transportation spokesperson Mindy Crane. "It was a safety precaution to protect the workers from traffic," Crane said. CDOT warned drivers of the upcoming accident and asked them to slow down via messages on numerous electronic boards starting on the approach to the Eisenhower Tunnel on the Summit County side, Crane said.


Soldiers with brain injuries could develop epilepsy

Epilepsy experts worry that veterans arriving home with traumatic brain injuries are at risk for seizures and these electrical storms could be subtle and develop months to several years following their initial injury. "Epilepsy is very common following head injury," said Dr. Marc Dichter, professor of neurology and pharmacology at the University of Pennsylvania. "We are concerned that we will have a growing number of young people with head injuries who may develop epilepsy." Right now, there are no treatments to prevent epilepsy. Trauma and brain infection increase the risk for seizures. "As the brain tries to repair itself, it may take time to ripen into seizures," said Dr. Dennis Spencer, an endowed professor of neurosurgery at Yale School of Medicine in Connecticut.

Experts say it is hard to know exactly how many injured troops could later develop epilepsy. U.S. Army and other officials have said better medical care in Iraq has meant that more severely injured soldiers have been saved, only to return home with serious injuries, Dichter said. Severe brain trauma can trigger epilepsy in as many as 30 percent to 50 percent of the brain-injured soldiers, he added. Early warning signs for epilepsy can include subtle changes in behavior, lapses in memory, strange sensory auras, attention problems and depression.

Dichter is conducting a pilot study on head injuries, focusing on people who arrive at emergency rooms with gunshot wounds or wounds from accidents. These people are at greater risk of developing epilepsy over the next year or two. Funded by the Department of Defense, scientists also will test the effectiveness of short-term use of anti-seizure medicines to ward off seizures.


March 29, 2007

Injured patients want new rules for chiropractors

When Brittmarie Harwe woke up with a sore neck and shoulder in 1993, she sought help from a chiropractor recommended by a friend. At her second visit, something went terribly wrong. "When he did the first (adjustment), I felt it, like a rushing noise in my head, dizzy," recalled Harwe. "He looked me in the eye and realized I was in distress. I was having a stroke, right then and there." Harwe, 26 at the time, was rushed to the hospital, where she learned that her left vertebral artery had been crushed. In the days and years that followed she suffered from paralysis, vision loss, weakness and coordination problems, a paralyzed vocal cord and an inability to swallow. Today, she still uses a feeding tube.

Harwe plans to tell state lawmakers Monday that she had no idea stroke was one of the risks of cervical manipulation by a chiropractor. The legislature's Public Health Committee is considering legislation that would require chiropractors to inform patients, both in writing and verbally, of the risks and possible side effects of their treatments. State chiropractors say the legislation is unnecessary and unfairly punitive. They argue that a state law requiring a patient to give informed consent before a procedure is excessive given the statistically remote risk of injury and death. The bill was proposed by Sen. Leonard Fasano, R-North Haven, who has a constituent who suffered a stroke after a chiropractic visit. While he agrees many people benefit from visits to chiropractors, Fasano said consumers should have as much information as possible. "What is so bad about saying here are the potential risks?" Fasano said.

Janet Levy of Woodbridge, Fasano's constituent, formed the group Victims of Chiropractic Abuse last June. Five years ago, she woke up with a stiff shoulder ache and went to a chiropractor recommended by a friend. She immediately got a headache, but the chiropractor said it was only a reaction to the treatment. Days later, she went to the hospital and learned she had had a mini-stroke caused by a torn artery and needed emergency brain surgery. At the time, she was 48 and ran five miles a day. After the surgery, she was told she wouldn't walk again. But Levy persevered and went through two years of physical and occupational therapy, seven hours a day. Today she can walk, but still has balance problems and other neurological defects. Levy said she could have saved herself from those two years of suffering if she had known about the risks she faced.


Advocates Hope Lawmakers Will Take Initiative to Help TBI Victims

The Neurotechnology Industry Organization (NIO) met with lawmakers in Washington this week to discuss the many obstacles faced by companies and organizations working to help traumatic brain injury (TBI) victims. NIO members proposed federal research and developmental initiative programs to accelerate discoveries in the brain injury field.

"The economic burden our nation faces due to brain and nervous system disorders is $500 billion and climbing," said NIO Executive Director Zack Lynch. "Despite the large and growing unmet markets, massive economic cost, and untold human suffering, there are few effective treatments that delay, prevent and cure chronic neurological and psychiatric diseases. The NNTI provides the means for the United States to secure leadership in neurotechnology and improve countless lives."

NIP is a non-profit organization that represents companies involved in neurotechnology, neuroscience, and brain disease advocacy all over the world. The organization's mission is to accelerate cures for brain and nervous system diseases by promoting the neurotechnology industry's progress, advocating the industry's position to government officials, and providing business development services to their members.

In related news, Sen. Hillary Rodham Clinton announced at a press conference today that she will be introducing new legislation to improve the treatment of soldiers with TBI's. Her initiative calls for better TBI screening methods, more support systems for families of victims, and new treatment options and programs.


March 28, 2007

Pesticide Caused TBI 10 Years Ago

On March 26, 2007, 16 year old Christian Ward was rushed to the hospital after being exposed to the pesticide diazinon. Ward was exposed to the pesticide when her hair was washed with it to treat hair lice. She cried in pain immediately after diazinon was poured into her hair and went into cardiac arrest shortly thereafter. After being admitted to the hospital, Christian Ward remained in a coma for 5 days. Doctors told her family that she suffered a traumatic brain injury so severe that she would probably be in a vegetative state for the rest of her life.

Miraculously, 10 years later Christian is just a normal 16 year old girl. Doctors said that she would probably never be able to even breath on her own but now Christian is getting ready to learn to drive - like all regular teens her age. Christian's mother is thankful that her daughter had such a miraculous recovery and has spoken out about the misuse of household products over the years.

Diazinon is an organophosphorous pesticide used to control insets in soil, plants, and crops. Since the Wards' incident the U.S. Environmental Protection Agency has banned the use of diazinon from residential use. It is now illegal to sell diazinon products (outdoor and non-agricultural) in the US. Further investigation found that diazinon affects the nervous system - no matter what part of the body is exposed to the harmful pesticide.


Sleeping Pill Helps Individuals in Vegetative States

In 1996 Louis Viljoen was struck by a truck while riding his bicycle in South Africa. He sustained a severe traumatic brain injury (TBI) and has been in a persistent vegetative state ever since. In 1999 Viljoen's primary doctor prescribed the sleeping pill Zolpidem to cure his restlessness.
After giving her son the first dose of Zolpidem Vilojoen's mother did not expect anything out of the ordinary to occur. Instead she was surprised by the sound of her son's voice 20 minutes after his first ingestion of the pill. For 2 hours, Louis remained completely lucid and spoke to his mother before falling back into a vegetative state.

Dr. Ralf Clauss, a nuclear medicine physician in the UK, was intrigued by this phenomenon and flew to South Africa to scan Vilojoen's brain. He found that before the pill was given to Vilojoen, 30% of his brain was abnormal and did not light up during the scan. After the pill was administered the abnormal parts of Vilojoen's brain lit up like a normal brain. Since this miraculous discovery there have been numerous other similar cases in the UK, South Africa, and the US.

Zolpidem is still classified as a sleeping pill and cannot be prescribed to cure comatose patients until more research is done. It has taken eight years of research for Dr. Clauss to reach a hypothesis of how Zolpidem affects brain injury. "The drug is a GABA agonist, which means in normal tissue it stimulates GABA receptors and normally they put you to sleep," he explains. "But in Louis's brain, for example, these GABA receptors are abnormal and overactive. They keep Louis's brain in a sleeping or dormant state all the time. The drug distorts these abnormal receptors which put Louis to sleep, dormancy is switched off and the brain returns back to normal."

Zolpidem's manufacturer says that even more studies must be done before the drug can be used specifically for brain injury and comatose patients. Experts in the field do not expect Zolpidem to be used for brain injuries for another several years.


Brain Injuries Have Far-Reaching Effects

A year after a motor vehicle accident, a Maryland woman struggles to regain what she lost. Last year, Dawn Seminuk was a mother and nurse when a drunk driver changed it in an instant. March 30 marks one year since the horrific car accident that dramatically altered Dawn's life. "She'd see people and say don't ever let me get like that, and now she's there," said Kristine Bacon, Dawn's sister. Dawn lives at the Spa Creek Nursing Home in Annapolis. The former emergency room nurse now depends on around-the-clock care. When Dawn's car was struck by a drunk driver, her brain sustained irreversible injury. "Not only was her brain shaken up in her skull, her skull also hit the windshield and created multiple damage," said Diane Triplett with the Brain Association of Maryland.

Traumatic brain injury affects more than a million Americans every year. In Maryland, about 6,000 people have an injury serious enough to be transported to a trauma center. Most cases are caused by falls, motor vehicle accidents and being struck. "It's not just the injury, but period of time that follows during and after, that there's damage to the brain," Triplett said. Triplett said some brain injury patients like TV newsman Bob Woodruff make a significant recovery. Many are not as fortunate.

Dawn's family says they lack the insurance and resources to provide daily therapy. Without it, the improvements she initially made are quickly fading. "It's very frustrating as a mother to see your child going backwards," Barbara Seminuk, Dawn's mother, said. Dawn's mother says her goal is to bring her daughter home in two years when she can retire. Her main concern is that during that time Dawn will decline ever farther.


New Technology for Traumatic Brain Injury Detection in the war zone

Guardian Technologies International, Inc., a leading technology developer of intelligent imaging informatics solutions, for the homeland security and healthcare industries, has submitted a $3 million research and development proposal request to the U.S. Government for grant funding to expand the current capabilities of Signature Mapping™ and to engage in a customization initiative of its Signature Mapping™ technology for battlefield applications.

Acceptance of the proposal would provide the research and development funding necessary to improve detection of traumatic brain injury (TBI) on the battlefield. The War on Terror has yielded a radical change in the type of battlefield injuries U.S. soldiers are likely to sustain and has significantly complicated the field doctors' ability to accurately diagnose and triage patients in the field. Most of the soldiers wounded in action and subsequently evacuated are injured by explosions. Between 2003 and 2005, 28% of all battle injuries included TBI. The majority of those injuries were closed TBI (the injury was not surface detectable). Closed head injury is often difficult to identify in the field, particularly when it is combined with other serious and more obvious and sometimes life-threatening injuries. Confronted with this new medical problem, the Army through the Department of Defense is searching for technologies to address these clinical battlefield challenges.

http://www.redorbit.com/news/health/876828/guardian_technologies_signature_mappingtm_technologies_for_traumatic_brain_injury_detection/index.html?source=r_health">Using Signature Mapping™ generates many advantages over other image processing methodologies, particularly with TBI detection in the field, such as: 1) it is capable of differentiating and detecting brain hemorrhages with a high degree of certainty -- high sensitivity with a low rate of false positives; 2) the technology is able to detect small amounts of brain hemorrhage which may go undetected by normal trained observers; 3) it successfully differentiates very difficult-to-distinguish or difficult-to-classify image object types within the same image, such as blood versus x-ray artifacts (known as bone-hardening artifacts); 4) it can also detect cerebral spinal fluid and has been shown to accurately measure the size and shape of the ventricles; 5) it can provide quantitative measurement tools to track targeted defects or changes over time; and, 6) it does not rely solely on prior knowledge of an object's shape, volume, texture or density to be able to locate and identify bleeding in an image.


ConAgra reports 3Q profit despite peanut butter recall

ConAgra Foods Inc. earned $192.6 million in the third quarter despite a massive recall of all of its peanut butter products after they were linked to a salmonella outbreak, the company reported. This year's results were considerably better than a year ago, when ConAgra posted a loss of $25.2 million because of one-time charges related to restructuring. The Omaha, Nebraska based company said its earnings amounted to 38 cents per share in the quarter that ended Feb. 25, versus a loss of 5 cents a share a year ago. Its latest results included one cent a share from discontinued operations.

ConAgra has yet to resume production at its only peanut butter plant, in Sylvester, Georgia. The company has said the recall would cost between $50 and $60 million dollars. Chief Executive Gary Rodkin said Thursday that about $48 million of the recall costs, or 5 cents per share, were included in the third quarter.


March 27, 2007

Oklahoma officials testing whether man's death linked to peanut butter

State officials in Tulsa Oklahoma are trying to determine whether a salmonella outbreak traced to the peanut butter recall played a role in a Tulsa man's death. Assistant laboratory director for the Oklahoma Department of Agriculture, said a peanut butter sample provided by the man's wife was tested and matched to Salmonella Tennessee (the strain that caused illnesses in hundreds of people across the country. The state is conducting more tests to determine whether the suspected organisms found in the peanut butter were present in the man's body. The director told the state Board of Agriculture the man was already suffering from an undisclosed illness before his death this month.

Although federal officials have received reports that hundreds of people became ill and dozens were hospitalized after consuming the contaminated peanut butter, there have been no documented deaths. Oklahoma had 12 confirmed cases of peanut butter poisoning between October and February, but no deaths, said director of the state Health Department's Communicable Disease Division. Oklahoma's cases include 10 women and two men ranging in age from 1 to 80. The most recent case involved a 53-year-old man in Jefferson County in early February.


Majority of brain traumas called preventable in Utah

On average, across Utah, there are five nonfatal traumatic brain injuries a day and one that kills, according to the Utah Department of Health. They result primarily from motor vehicle crashes and falls, and the majority are preventable. Wednesday Mar 21, the department released a study of traumatic brain injuries that occurred from 2000 to 2003. It found that TBIs were nearly twice as common among males as females and that the rate of TBIs in rural Utah is 53 percent higher than in urban Utah. "We don't believe the numbers are any different today than the study period," said Kevin Condra, a spokesman in the Violence and Injury Prevention Program. "The most common are motor vehicles, centering on seat belt use and having children in proper restraints. The next most common is hazards," he said. Among Utahns 60 and older, the common cause of TBI is a fall, usually at home. Condra cited loose rugs, clutter around stairways and poorly lighted pathways as among factors contributing to the falls and subsequent brain injuries.

Among younger Utahns, the brain traumas are most common in the 15-24 age group and typically involve a motor vehicle. That includes injuries to motorcyclists who didn't wear helmets and drivers and passengers who were not properly restrained, including children. For the study period, 4,403 males and 2,612 females were hospitalized because of TBIs. Another 1,047 males and 287 females died before being admitted. Those admitted to an emergency department, the report said, are not considered a "hospital inpatient." The report excluded patients treated and released from the emergency department. In cases where hospital discharge information was known, most went home to care for themselves or receive assistance. "Also, approximately one-fifth (24.3 percent for males and 15.5 percent for females) of all TBI subjects died before admission or during hospitalization because of the injury," the report said. The department's goal, said Condra, is to raise awareness and reduce the number of preventable injuries.


Indianapolis traffic fine could help disabled

In Indianapolis a fine you pay for your next speeding ticket might be a few dollars higher, but advocates for the disabled say the increase ultimately could bring hope to Hoosiers who suffer from spinal cord injury or traumatic brain injury. Tucked deep within the House budget bill is a section creating the state's first spinal-cord and head-injury research fund. Increased fines motorists pay for speeding, driving while intoxicated or other violations would fund the research, conducted in Indiana.

To persuade senators to approve that section in the House budget, a group of Hoosiers in wheelchairs sat outside the state Senate, handing out leaflets and lobbying Thursday. Greg Bedan who suffered paralysis in a high school football injury in 1976 but went on to work in state government, noted that the injury-research funds would boost Indiana's life sciences industry. Additionally research has the potential to help disabled Hoosiers re-enter the work force. "There's a lot of servicemen coming back with traumatic injuries, not just to the head, but amputees and spinal cord injuries," Bedan said. "It will improve their lives as well." Derek Deckman, who was injured in an auto accident two weeks before his 18th birthday, was on Medicaid for 10 years until he completed his education and could support himself through employment. Now he is an account representative for a technology firm. "The biggest challenge is breaking down the stereotype that people with disabilities don't have value to add to the work force," he said.

Although she does not use a wheelchair, Darcy Keith is a survivor of a traumatic brain injury again, from an auto accident. "We're called the walking wounded," Keith said, because her injury is not immediately apparent to others. She hoped that having a group of disabled advocates lobby for the proposal would register with legislators considering the bill. The advocates noted motor vehicle accidents are the leading cause of spinal cord injuries and of traumatic brain injuries for those ages 16 to 24. Lifetime medical costs for such patients can reach $2 million, and many end up on Medicaid. In light of the correlation between certain traffic violations and injuries, the proposal calls for increasing fines by $18 for speeding, driving while intoxicated, running a red light, and failure to yield, for example. Motorcycle registration fees also would go up by $10, to $27, the proposal says. Together, that would generate an estimated $19.1 million a year in motor-vehicle fees for the injury research fund. Indiana University and Purdue University each would get $500,000 a year for spinal cord and brain injury research. And a nine-member board would screen research projects and award grants from the remaining funds.


Nationwide class action lawsuit against ConAgra Foods, Inc.

In Rome, Georgia Plaintiffs' counsel Kathryn E. Barnett announced that 32 consumers, including the parents of nine children that became seriously ill after eating Peter Pan or Great Value peanut butter, spanning 16 states filed an amended class action complaint against the international food conglomerate ConAgra Foods, Inc. The proposed class consists of all persons nationwide that contracted Salmonella Tennessee from eating ConAgra's contaminated peanut butter

"This case shows that the number of 425 persons made ill from eating Salmonella tainted peanut butter as reported by the Center for Diseases Control constitutes a gross underestimate," stated Kathryn Barnett of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP. "We believe thousands of consumers have been made sick over the past two years. Since the recall was announced in February, our law firm alone has been contacted by over a thousand persons that have reported symptoms of Salmonella poisoning, including fever, stomach cramps and severe diarrhea which in many cases required hospitalization."

"My husband and I were terrified when our son became so sick. We called our pediatrician and raced to the Emergency Room with him," stated plaintiff Kelli Hamman of Flomaton, Alabama. "I never dreamed it could have been caused by peanut butter. I don't understand why my son and other children had to suffer like this, and I hope ConAgra will take responsibility and answer to every family that has suffered." Ms. Barnett advised consumers: "If you have suffered symptoms of contaminated peanut butter, do not discard the evidence; instead mark the peanut butter with 'Do Not Eat' or 'Contaminated' and make certain the jar is stored in a safe place that is beyond the reach of children. The peanut butter can be tested for the presence of Salmonella."


March 26, 2007

Doctors ask Nevada lawmakers to pass 'I'm sorry' law

Doctors asked Nevada lawmakers to pass a law that would let them say they're sorry for medical mistakes. Doctors are usually told not to because of fears an apology could be used against them later in court. Several doctors and the head of the Nevada State Medical Association asked the Senate Judiciary Committee to pass SB174, an "I'm sorry" measure to prevent any expression of compassion, regret, or fault for what happened to a patient from being used as evidence in any civil court proceedings. Sponsored by Sen. Joseph Heck, R-Henderson, who is also an osteopathic physician, the bill is similar to laws already passed in 29 other states.

Doctors often are told by medical educators and attorneys not to apologize to patients for medical errors out of fear that the apology will be seen as an admission of negligence, Heck said. "This advice, which has been heeded by many physicians, results in a chilling and straining of the patient-physician relationship at the very time when the patient is most in need," said Heck. Apologies can actually reduce the chances of a lawsuit being filed, some doctors testified. What most patients and their families really want is to understand what happened when mistakes are made, said Dr. David Fiore, a Reno family physician. "What we really need this for isn't so much the malpractice," said Fiore. "We need it for the healing." Larry Matheis, executive director of the Nevada State Medical Association, said passing the bill is vital now that medical schools are increasingly stressing communication skills. "This absence of communication has to be bridged," said Matheis. "Most of it is going to have to be bridged by people being free to talk to each other, and talk to each other frankly."

Bill Bradley, a Reno medical malpractice attorney, testified against the bill. If an apology is retracted when litigation begins, it could be even more devastating to a patient than not receiving an apology, he said. "Any sincere attempt to reconnect with the victims should start with a thorough explanation of the event," said Bradley. "If litigation follows, the thorough and accurate explanation those patients got should be able to stand in court, because the truth is the truth." Heck agreed that withdrawing an apology in court would do harm, but said that's exactly why his bill should be passed. If the doctor's earlier apology is inadmissible, there's no need to deny the apology took place, he said.


Malpractice victim uses grief and anger to assist others

When Tresa E. Speer died, her daughter, Mary Crabtree, didn't know where or to whom to turn. In March 2003, Speer, 75, went into the hospital for a routine knee replacement and never came out. Crabtree sued the doctor for malpractice and the case was settled out of court. Crabtree found little solace in the money, however. Crabtree didn't allow herself to wallow in her misery. Channeling her grief, she created a lasting, living tribute to her mother. Crabtree has created The Tresa E. Speer Medical Malpractice Support Group for Malpractice Survivors and Families. It's a Web site devoted to offering support and information about medical malpractice.

For those contemplating surgery or already a victim, the site raises public awareness on how to become proactive in making better health-care choices. It has tips on what to look for when choosing a surgeon and how to investigate their backgrounds. It allows victims to share personal stories of medical malpractice and offers resources that enable easier navigation through the justice system. There are also resource referrals and an on-line support system connecting other people who are going through similar situations. Victims can tell their stories knowing there are others out there facing similar confusion and emotional pain.


Majority of Medical Malpractice Claims in Seven States Closed Without Compensation Payments

The majority of medical malpractice claims in a study of seven states were closed without any compensation paid to those claiming a medical injury, the Justice Department's Bureau of Justice Statistics (BJS) announced. BJS conducted a study of medical malpractice insurance claims that were closed from 2000 through 2004 in Florida, Illinois, Maine, Massachusetts, Missouri, Nevada and Texas. These states were identified as having comprehensive medical malpractice insurance claims databases, some of which extend back to the early 1990s.

About one-third of the medical malpractice insurance claims closed in Maine, Missouri and Nevada resulted in a payout. In Illinois about 12 percent of closed claims ended in a payout. Few medical malpractice insurance claims produced payouts that exceeded $1 million. Less than 10 percent of the claims in Florida, Maine, Missouri and Nevada had payouts of $1 million or more. In Florida, Maine and Missouri, about two-thirds of the claims were closed with insurance payouts of less than $250,000. Among persons receiving compensation, insurance payouts were highest for claimants who suffered lifelong major or grave permanent injuries. In Florida and Missouri, claimants with these types of injuries received median payouts ranging from $278,000 to $350,000. Insurance payouts were lowest for claimants who suffered temporary or emotional injuries. In Florida and Missouri, claimants who suffered these types of injuries received median payouts ranging from $5,000 to $79,000.

Medical malpractice insurance payouts increased as the insurance claims advanced through the legal system. Payouts were typically lowest for claims closed prior to the filing of a lawsuit and highest for claims closed after trial. In Florida, Nevada and Texas, claims decided by trial resulted in median payouts that were at least two and a half times larger than claims that were settled. Claims closed after a trial also cost more for insurance firms to defend than claims settled at or prior to a trial. In Florida, Nevada and Texas, 95 percent or more of medical malpractice claims were settled prior to a trial decision before a jury or judge.


Increasing Rate of TBI's Alarms Medical Community

In 2004 statisticians found that nearly 204,000 Americans were admitted to hospitals for traumatic brain injuries (TBI's). This came with a $3.2 billion price tag. Of the 204,000 TBI sufferers surveyed in 2004, 40% were caused by accidental falls, 26% due to car accidents, 4% were caused by bicycle and other recreational accidents, and 2% were due to shootings. Most of the TBI sufferers were 65 or older or between the ages of 18-44. Only 15% of the TBI sufferers were children. The 2004 survey also found that 13% died in the hospital and nearly 30% were transferred to long-term care facilities.

These results also show that there has been a 38% increase in hospital admissions related to TBI's from 2001 to 2004. This is an alarming finding because previous research showed a steady decrease in the amount of TBI's for the past 10 years. Dr. Claudia Steiner of the Agency for Healthcare Research and Quality finds this information extremely troubling. She hopes that the release of the new information will urge TBI experts and lawmakers to further investigate the phenomenon and find the cause of this trend.

The findings of the survey do not account for war veterans treated at VA hospitals or any other military personnel. They also do not include information regarding individuals who died before they were admitted to the hospital


Senior Citizens Lead Hospitalizations for Serious Head Injury

Senior citizens led hospital admissions for the most serious category of head injury, Type 1 traumatic brain injury, which increased for all ages nearly 38 percent between 2001 and 2004 after a decade of decline, according to the latest News and Numbers from the Agency for Healthcare Research and Quality. People age 65 and older accounted for nearly 36 percent of hospitalizations for Type 1 injuries, followed by people age 18 to 44 (about 31 percent). People ages 45 to 64 comprised 19 percent of the cases and adolescents and children accounted for 15 percent.

In 2004, there were nearly 204,000 hospitalizations for traumatic brain injury at a cost of $3.2 billion, and seven of 10 of these involved patients with a Type 1 injury. Inpatient hospital care for these patients cost $2.7 billion. Forty percent of patients with Type 1 injuries were caused by falls, such as down stairs, off ladders, or on ice. Other common reasons for Type 1 injury hospitalizations included motor vehicle accidents (26 percent), being hit while playing sports or having a falling object hit the head (8 percent), bicycle or other transportation accidents (4 percent), and shootings (2 percent). About 13 percent of Type 1 patients died while hospitalized and nearly 28 percent were transferred to a nursing home or other type of rehabilitation facility. By comparison, less than 1 percent of other head injury patients died while hospitalized and about 8 percent were discharged to a nursing home or other type of rehabilitation facility.

This News and Numbers is based on data in Hospital Admissions for Traumatic Brain Injuries, 2004. The report uses statistics from the Nationwide Inpatient Sample, a database of hospital inpatient stays that is nationally representative of all short-term, non-federal hospitals. The data are drawn from hospitals that comprise 90 percent of all discharges in the United States and include all patients, regardless of insurance type as well as the uninsured.


Neuropsychiatric Aspects of Traumatic Brain Injury

Risk factors for TBI include substance abuse and psychiatric conditions associated with impulsive behaviors, such as bipolar disorder, cluster B personality disorders, and attention-deficit/ hyperactivity disorder (ADHD). These pre-injury psychiatric conditions are associated with high-risk behaviors that can lead to TBI. More than 50% of TBIs involve alcohol intoxication, and 30% to 60% of patients are intoxicated at the time of injury. An initial score on the Glasgow Coma Scale of 13 to 15 constitutes a mild TBI, while a score of 9 to 12 represents moderate TBI, and a score below 9 is severe TBI. Mild TBI accounts for about 80% of all cases, with moderate and severe cases each being responsible for 10%. The American Congress of Rehabilitation Medicine has further refined the definition of mild TBI, stating that it is any traumatically induced disruption of brain function with limited loss of consciousness (30 minutes or less) or post-traumatic amnesia for less than 24 hours.

Patients who sustain multiple head injuries over time appear to demonstrate increased irritability with each subsequent injury, particularly when the injuries are associated with loss of consciousness. Risk factors for aggression include a history of impulsive aggression, arrest and substance abuse. Aggression is also frequently encountered in post-TBI mania, which occurs in 7% to 9% of patients independent of severity of injury, cognitive impairment, or physical disability. While post-TBI manic syndromes may resemble the classic manic syndrome of euphoria, elation, increased energy, and grandiosity, a more common presentation is a mixed bipolar syndrome. Treatment of post-TBI aggression aims to reduce disruptive behaviors without negatively impacting other areas of functioning. Anticonvulsants appear to be effective and well-tolerated in treating these disorders, although cognitive impairment may occur at higher doses.

The prevalence of major depression following TBI ranges from 15% to 61%. Some investigators noted that fatigue, frustration, poor concentration, boredom, and distractibility were common in depressed TBI patients. However, feeling sad or blue was not as common. Additionally it has been found that feelings of depression and sadness did, in fact, discriminate between depressed and non-depressed patients and suggested that cognitive impairment and fatigue were not useful diagnostic symptoms. Treatment of post-TBI depression with antidepressants appears to be effective, as is psychotherapy and, when necessary, electroconvulsive therapy. Effective treatment is considered crucial to maximizing cognitive and psychosocial functioning, which are often compromised by depressive symptoms.


March 23, 2007

Ortho Evra Patch Caused Daughter’s Death

"My daughter took the Ortho Evra patch in 2004," says April. "She started to have chest pains but her doctor thought it was just an infection." Eryn was only 24 years old when she passed away. "Eryn went to the doctor a few times but he said it was an upper respiratory problem," says April (not her real name pending a lawsuit). Eryn had left the house to dog-sit for her brother on January 27th. Through a series of phone conversations I had with her that night, I knew that something wasn't right. When we found her at my son's house, she was pale white (I thought she was dead) and unconscious. I grabbed her and I yelled at her; she came to for a bit but not enough to know what was going on.

My fiancé and I drove her to the hospital only two miles away. When we got there, they immediately thought it was a drug overdose. They had a hard time finding a vein but started an IV. Then we watched her blood pressure go from 110/70 to 250/180 and they rushed her to a CAT Scan. They found two bleeds on her brain. The hospital didn't have a neurosurgeon or an ICU to handle her, so she was intubated. She fought like crazy, she didn't want the tubes down her throat, but that was the only way she could be flown out by helicopter. Eryn never woke up. She was in a comatose state for two weeks; she had a feeding tube in her stomach. She had two major strokes that left her paralyzed. She had MRIs and CAT Scans done daily. On February 8th, she was coded blue and had two heart attacks in front of us. The second heart attack left her brain dead because she was without oxygen for 15 minutes. Another CAT Scan was done the next morning and the hospital said that she couldn't be moved again because her body was riddled with blood clots. We sat with her the whole morning and at 10 a.m. the neurosurgeon said there was nothing more that anyone could do. At 6.30 that night they asked us to sign a DNR. By then we watched her fingernails turn blue and the rest of her body was shutting down. At 1 a.m. the following morning she had a cerebral fever: her arms were frozen stiff because there was no circulation. At 3 a.m. we spoke with the doctors again and they suggested we take her off the machine. We didn't know how long she would last -she was full of morphine. They shut the machine down at 4.12 a.m. and at 4.15 a.m. she passed away.

It was the second day of her hospitalization that we determined Ortho Evra was to blame. She wasn't on any other medication. They took the patch off her right away at the first hospital. The neurologist wasn't convinced at the time, thinking she had some rare brain disease. Tests were flown out everywhere but she had no infectious diseases. She never smoked and gave blood every few months. A couple of the nurses suggested that Ortho Evra was to blame. Then I found a lawyer and I sent him all of her medical records. He said that their pathologist, hematologist, cardiologist and neurologist all confirmed that her death was caused by the Ortho Evra Patch.


Long Island couple sues fertility clinic, citing toddler's complexion

After they saw a baby girl they had gone to a fertility clinic to conceive, her parents became convinced something was wrong, according to court papers. The girl's skin was darker than either parent's, a judge wrote in allowing the parents to proceed with a lawsuit that claims the clinic botched the insemination of the wife's eggs. "While we love Baby Jessica as our own, we are reminded of this terrible mistake each and every time we look at her; it is simply impossible to ignore," state Supreme Court Justice Sheila Abdus-Salaam's decision quoted parents Thomas and Nancy Andrews as saying. "We are conscious of and distressed by this mistake each and every time we appear in public," the judge quoted the Andrews' affidavit as saying.

The couple sued New York Medical Services for Reproductive Medicine, accusing the Manhattan clinic of medical malpractice and other offenses. The Andrews' court papers say that on the advice of Dr. Martin Keltz, the couple agreed to in vitro fertilization of the eggs with Thomas Andrews' sperm so they could have a child who was biologically their own. However, their court papers say, the clinic was negligent and used another man's sperm. Three DNA tests _ a home kit and two professional laboratory tests _ confirmed that Thomas Andrews was not the baby's father. The judge said the Andrews’ complain that they have been forced to raise a child who is "not even the same race, nationality, color ... as they are." The mother was born in the Dominican Republic "and has a complexion, skin coloration and facial characteristics typical of that region," while the father is Caucasian, the judge quoted the Andrews' papers as saying. Nancy Andrews asked Keltz about the "abnormality" of the child's complexion, the judge said, and the physician told her the condition was normal, that the in vitro fertilization was done properly and that the child would "get lighter over time."

The lawsuit, which seeks unspecified damages, came to light after the judge issued a decision that allows the Andrews’ to proceed with parts of the suit while dismissing other parts. The judge dismissed the lawsuit against Keltz, who had advised the procedure and had performed the embryo implantation. She allowed the case to proceed against Dr. Reginald Puckett as owner of the clinic but threw out the case against him as an individual. Puckett has already been found liable for the alleged blunder. In trying to have the lawsuit against Puckett personally and as clinic owner dismissed, his lawyer, Martin B. Adams, told the court that Puckett "did not examine, communicate with, care for or treat plaintiffs." The judge found Carlo Acosta, the non-physician embryologist who processed the egg and sperm for creation of an embryo, liable for the alleged blunder. She said his response to the Andrews' claims "could not be weaker _ it is nonexistent."


Anemia Drugs May Harm Some Cancer and Kidney Patients

New studies are raising questions about whether certain drugs which are used by millions of cancer patients are actually harming them rather than helping. The drugs are used to treat anemia caused by chemotherapy, reducing the need for blood transfusions and giving the patient more energy. The drugs in question are: Aranesp and Epogen, both sold by Amgen, and Procrit, sold by Johnson and Johnson. Also known as EPO drugs, all three are versions of erythropoietin, a substance made by human kidneys that increases levels of hemoglobin, the component of red blood cells that carries oxygen. The new doubts about cancer safety augment concerns about the drugs' other major use--to treat anemia caused by kidney disease.

A study published in the New England Journal of Medicine in November found that patients treated aggressively with Procrit were more likely to have heart problems or die than those treated less aggressively. In January, Amgen reported that in one of its clinical trials, patients treated with Aranesp had a higher risk of death than those treated with a placebo. In February, a Danish study of head and neck cancer was reportedly stopped early because patients being treated with Aranesp had a higher incidence of recurrence of their cancer. Most recently, a Canadian study of lung cancer patients was halted early because patients treated with Eprex (the Canadian version of Procrit) were dying sooner.

It's not known why the drugs are causing problems, and some experts said that the studies linking EPO drugs with problems were flawed and couldn't be relied upon. Nevertheless, Dr. Eric Winer, director of breast oncology center at the Dana-Farber Cancer Institute in Boston said, "These are drugs that were presumed to be entirely safe, given for supportive care and to improve quality of life [not to treat the cancer itself]. So any concern that they could shorten someone's life are taken quite seriously."

Meanwhile, on March 20, 2007, House Commerce Committee Chairman John Dingell faxed letters to Amgen and Johnson and Johnson, asking that they cease all direct-to-consumer advertising of EPO drugs and all "physician incentives" related to the marketing of Epogen and Aranesp until the FDA can determine whether measures "need to be taken to protect the public from unnecessary risks to human life from these products." Chairman Dingell's concerns relate to alleged rebates provided to oncologists who buy the drug and then administer it in their offices. Although Amgen denied giving "financial incentives to doctors in order for them to increase prescriptions of our products," they did acknowledge providing discounts, which some doctors refer to as rebates, to oncologists for purchases of Aranesp. Doctors have told Forbes magazine that such rebates increase in size as the dollar volume of Amgen products increases.


After brain injury a silent struggle to start over

Without the calendar taped to the refrigerator in her parents’ kitchen, Kim Valentini wouldn’t know where her dad was. It’s not that he travels far or even that he’s hard to reach. It’s because she can’t remember from hour to hour, sometimes minute to minute, where he’s told her he’ll be. Before she started inscribing his answers on the kitchen calendar, the 36-year-old New Jersey woman would find herself calling as many as seven times in a single afternoon to ask the same question: “Where are you, Daddy?” Eleven years after a devastating car wreck, Valentini still lives with a brain injury that’s left her short-term memory spotty while whole sections of her long-term memory seem to have been erased.

She remembers she once worked as a contract administrator, but she can’t recall exactly what she did in her job. She remembers she used to like to ski and to dance, but she can’t recall why she liked to do either. She remembers an “old Kim” who was successful and confident, with a foolproof memory and a quick mind, but she can’t recall how to be that person now. She remembers that there was a car accident, but can’t recall the details of the night when, she says, “the old Kim died.” “There are countless ‘walking wounded’ who look just fine on the outside, but who aren’t the same on the inside,” says Jonathan Lifshitz, an assistant professor at the Spinal Cord and Brain Injury Research Center at the University of Kentucky Chandler Medical Center. Most cases of traumatic brain injury, like Valentini's, happen far from the war zone. More than 40 percent of TBIs are the result of traffic accidents, the most common cause of this type of injury. Ironically, advances in protective equipment, seatbelts, airbags and helmets may have led to increases in TBIs over the past decade or so, Lifshitz says. That’s because people who once would have died from injuries in an accident now live, but with badly wounded brains.

A TBI can result in changes to mental processing that are profound, profuse and permanent. Thinking can be slowed, attention dulled, memory muddled and judgment impaired, says Keith Cicerone, director of neuropsychology at the JFK Johnson Rehabilitation Institute in Edison, N.J. Therapy can help people cope with the changes, but it doesn’t repair the damage. Brain damage is forever, Cicerone says, likening TBI to the loss of a limb. “If you lose a leg, you wouldn’t expect it to regrow,” he explains. “It’s a long road going from the injury to learning to live a fulfilling life, but with limitations. “We’re not looking to make you who you were. We’re trying to teach you to live with the person you’ve become, who you are now.”


Salmonella found in roaster and cleaning supplies at ConAgra

FDA investigators have details on the location of the Salmonella outbreak that shut down the Sylvester ConAgra Foods plant five weeks ago. It could be the end of May before production resumes. The clean up will begin now that the FDA has pin-pointed the cause. "The two environmental positives that we did find were, one of them was in relation to the roaster and the other was on some cleaning equipment," said Dr. David Acheson. Since it was found twice in the environment, the FDA investigators assume it may be in other places and recommend a complete cleanup. ConAgra is working with a microbiologist on a plan to resume operations. Employees continue the clean up effort.

FDA inspectors are gone from the plant now, but will return once the cleanup is complete to make sure there are no future problems. The Centers for Disease Control stopped updating the number of reported Salmonella cases. The CDC reported 425 people in 44 states were sickened by the peanut butter. Twenty percent of those illnesses were serious enough to require hospitalization.


March 22, 2007

Kaiser Daily Health Policy Report Features Medical Malpractice News from Three States

Newspapers recently reported on developments related to medical practice in three states. The Honolulu Advertiser reports the Hawaii legislation that would have put a $250,000 cap on non-economic damages in medical malpractice cases failed to pass Hawaii's House Judiciary Committee earlier this month. Gov. Linda Lingle (R) proposed the bill as a way to improve access to care in rural areas that are experiencing a shortage of specialty physicians because of high malpractice insurance premiums. After reviewing testimony in support and opposition to the bill, lawmakers could not agree on a dollar amount to cap damages that they considered to be "fair".

In Iowa The Des Moines Register profiled United Medical Liability Insurance, a small start-up medical malpractice insurer based in Iowa that educates physicians "on their bedside manners in hopes that a little kindness will create fewer legal problems for its policyholders." According to company President and CEO James Krist, physicians who communicate effectively with their patients can reduce their risks of being sued. The company typically works with physicians on record keeping and procedure management, "which are important defenses when a complaint arises," in addition to coaching sessions aimed at enhancing communication skills, the Register reports.

Las Vegas Review-Journal report the Nevada legislature is considering a bill that would allow physicians to offer patients an apology or expression of regret for medical mistakes without having it used against them in court. The bill is based on similar legislation from 29 other states, and it aims to reduce the number of medical malpractice lawsuits.


FDA announces new draft guidance

On March 21, 2007, the FDA announced new draft guidance that would lead to restrictions on who can serve on an FDA Advisory Committee in an attempt to reduce potential conflicts of interest. Advisory Committees are those committees that provide the FDA with "independent advice from outside experts" on issues relating to drugs or devices being considered by the FDA. Often the issue being considered is whether the product should be removed from the market. Thus, membership on an Advisory Committee is a prestigious position with significant influence over the continued marketability of a product.

The proposed new rule would disqualify an individual from serving on an Advisory Committee if he or she has a financial interest with a combined value of greater than $50,000. This means that if an individual has received more than $50,000 from the products "sponsor" (what the FDA calls the pharmaceutical company) in the preceding calendar year they would be disqualified from serving on an Advisory Committee that reviews that sponsor's products. There are, however, exceptions to this disqualification, which may serve to permit an expert to serve as a non-voting member of an Advisory Committee.

This new "guidance" will not become final until after the close of the 60 comment period. Open questions remain, including whether the exceptions will swallow the rule and whether there will be loopholes that permit those who receive more than $50,000 (through indirect payments or other forms of compensation) to serve on Advisory Committees evaluating the products of sponsors who pay them.

Keep an eye out for these developments and if you have comments you would like to share with the FDA, there is a process to do so during the 60-day comment period posted on the FDA's Web site.



After initial brain injury, damage continues

Researchers predict that one day an emergency treatment will emerge that can halt much of the damage resulting from a traumatic brain injury. For years scientists assumed that the brain damage resulting from a head injury occurred instantly, that nerve cells were killed in the initial impact. However, over the past decade researchers have learned that much of the injury to brain cells occurs in slow motion. They now know that the initial injury sets off a sequence of events that takes anywhere from hours to days to complete. Scientists now say traumatic brain injury sets processes in motion that continue throughout a person’s life.

Beyond the bruising that occurs when the brain slams up against the skull, damage is caused by the brain’s own reaction to the trauma. Hosts of brain chemicals are released and while these neurotransmitters are normally present in small amounts in the brain, the flood resulting from a TBI fries brain circuits, says Dr. Douglas H. Smith, director of the Center for Brain Injury and Repair at the University of Pennsylvania. Additionally, another type of damage occurs as individual nerve cells stretch and twist. Rips form in the axons (long, slender, cable like structures that project from the center of the nerve cell and carry information to the cell’s body). When an axon rips open, chemicals rush in and cause it to swell. Proteins released in response to the tearing can chew the cell up from the inside out, leading to its eventual destruction. Recent research shows these processes can lead to long-term brain injury that looks very much like the damage associated with Alzheimer’s disease. However, the damage isn’t inevitable. Scientists are working to identify a chemical, or a combination of chemicals, to slow or halt these secondary effects of TBI. While certain medications seemed to help in animal studies, they haven’t worked when tested in humans, says Dr. Douglas I. Katz, medical director of the Traumatic Brain Injury Program at Braintree Rehabilitation Hospital in Braintree, Mass. Still, Katz says, “I think there will be something in the next five to 10 years.” It's likely any such therapy would have to be given right away similar to the treatments given to minimize the brain damage suffered by stroke victims.

In the meantime, studies have shown that certain drugs, which are already on the market, can be used to improve the functioning of injured brains, says Katz, also an associate professor of neurology at Boston University School of Medicine. Stimulants can speed mental processing and a drug used to treat Alzheimer’s disease can sharpen memory and improve attention. And certain medications that have been used to treat depression appear to improve a TBI patient’s ability to reason and make judgments. As it turns out, these types of medications “appear to enhance brain function in normal people,” Katz explains. “So they may just be tuning the brain up and thus helping compensate for deficits in patients with brain damage.”


Banged up snowboarder could be charged

The snowboarder who broke his pelvis and a vertebra after colliding with a snowmobile at Snowmass could face criminal charges stemming from drinking the day of the accident. The Snowmass Village Police Department completed its investigation of the Feb. 24 accident that sent Largo, Fla., resident Steve Rath to Aspen Valley Hospital, where he underwent treatment for seven broken bones and a splinter fracture to one of his legs. Police Chief Art Smythe said that the department will turn the investigation’s findings over to chief deputy district attorney Gail Nichols, who will decide whether to prosecute 39 year old Rath. Rath’s blood-alcohol content was checked after the accident, but the police chief declined to reveal it. Police reports also say Rath had alcohol on his breath at the time of the collision. Accident reports, both from Snowmass ski patrol and Colorado State Parks, indicate that the snowmobile, which had a trailer attached to it, was stationary when Rath collided with it. The driver, K.C. Steury, wrote in a witness statement that he stopped the snowmobile in order to avoid a collision with Rath. “He was going fast, and he tried to jump the trailer,” Steury wrote. Another report also suggested that Rath’s speed may also have been a factor.

“Witnesses at scene claimed snowboarder was going very fast,” Rick Kelly, a ski patroller who responded to the collision, wrote in a statement that is part of the ski patrol’s accident report. “Observations revealed over 600 feet of straight-line snowboard track down ... into accident site.” Kelly’s report also suggested that Rath had been drinking before the crash, a claim supported in a Colorado State Parks Snowmobile Report, which states: “Paramedics from Snowmass Wildcat Ambulance reported the smell of alcohol on the injured party’s breath.”

One person keeping a keen eye on the developments is Snowmass attorney Cynthia Tester, whom Rath recently enlisted to explore the possibility of a negligence lawsuit against the Aspen Skiing Co. The snowmobiler was a company employee and the collision happened in the Burlingame Flats area, near the superpipe for the Honda Ski Tour. Tester claimed the ski company initiated the investigation the day after the accident in an effort to pin blame on Rath. She also noted that it is “ironic” Rath could face criminal charges for drinking while snowboarding, given the on-mountain party atmosphere Aspen sanctioned during the Honda Ski Tour. “They were pouring booze so heavily, and the next minute this guy’s getting investigated?” she said. Company attorney David Bellack said Tester is off base. “This whole notion that we are behind the investigation reveals a complete misunderstanding of the criminal justice system,” he said. “There’s no structure whereby someone requests that someone be charged.”


Bill to call for safety standards for ski and snowboard helmets

A proposed federal law would prohibit helmets for winter sports such as skiing and snowboarding if they do not meet Canadian safety standards. Hockey and lacrosse helmets that don't meet the Canadian Standards Association's criteria are already banned as hazardous products, but helmets used in snowboarding, skiing, and in-line skating are not. Dr. Hedy Fry, Liberal opposition critic for sport and the Vancouver Olympics, is introducing a private member's bill that would ban the advertising, sale and import of unsafe helmets in Canada. As a physician, Fry said she has seen how catastrophic injuries can be when people don't wear proper headgear. "We know the brain is protected by a very thin layer of bone, and we know that head injuries can be fatal and can produce a lifetime disability," Fry said. "I would have thought everything that was going to protect the brain would have done so, but quite often, things slip under the radar screen."

The lack of a minimum standard for ski and snowboard helmets in Canada has alarmed Richard Kinar, a long-time safety advocate at the Brain Injury Association of Canada. "A report by Ski Canada tells us that some ski and snowboard helmets for sale in Canada offer no more protection than putting a bag of milk over your head," said Kinar. It is estimated that head injuries sustained during recreation cost Canadians taxpayers more than $100 million a year. Traditionally, it's difficult for a private member's bill to become a federal law. In a minority government, Fry's bill faces a better chance.


PLAY GAMES FOR A HEALTHIER BRAIN

Brain training games such as Sodoku and Tetris have been gaining popularity among all age groups over the past few years. In a generation full of young gamers, research shows that the brains of adults in their 40’s and 50’s and those with brain injuries could benefit from playing “brain games” on a regular basis.

After experiencing his first “senior moment” in his 40’s, Bruce Friedman launched a website full of “brain games.” Friedman’s site, MyBrainTrainer.com, offers games that promise to increase brain power and quicken reflexes for people of all ages. "The whole idea is that, with time and with playing every day, you're going to see improvement. It's not just improvement making you a better video game player, but everyday activities," Friedman said.

Research of the subject is still new and scarce, but some studies who that there may be some plasticity in older brains. This suggests that forgotten processes can be re-taught in older brains. The study showed that TBI victims returning from the Iraq War experienced significant improvements in lost functions after training with “brain games.” This finding supports research by Marian C. Diamond who found that brains that are consistently stimulated and taught could grow and flex like muscles.

Friedman hopes to study the effects of his brain games in clinical studies by the end of the year.


March 21, 2007

Link between MRI contrast agent and Nephrogenic Systemic Fibrosis

Research has shown a possible association between a popular magnetic resonance imaging (MRI) contrast agent and the incidence of a rare disease called nephrogenic systemic fibrosis (NSF) in patients with kidney disease, according to an editorial appearing in the March issue of Radiology. "We recommend avoiding the use of gadodiamide in patients with any degree of renal disease," said Phillip H. Kuo, M.D., Ph.D., assistant clinical professor of diagnostic radiology at Yale University School of Medicine in New Haven, Conn. "At this point, the data clearly show the vast majority of NSF cases are associated with the use of gadodiamide." Approximately 400 cases of NSF have been reported worldwide. While gadolinium-based agents have not been definitively shown to cause NSF, as many as 90 percent of known NSF patients had previously received gadodiamide, and a recent survey of approximately 100 NSF patients revealed that more than 95 percent were exposed to a gadolinium agent within two to three months prior to disease onset. Other evidence linking gadolinium with NSF includes residual gadolinium in a skin biopsy of an NSF patient 11 months after the contrast agent was administered. Studies investigating the relationship between NSF and gadolinium are currently underway at Yale, as well as the Centers for Disease Control, U.S. Food and Drug Administration (FDA) and the medical regulatory agencies of the European Union. In the meantime, the FDA advises cautionary use of all gadolinium-based contrast agents in patients with moderate to advanced renal disease.

NSF, an emerging systemic disorder characterized by widespread tissue fibrosis, has been diagnosed in patients who were previously administered gadodiamide (Omniscan) and other gadolinium-based MRI contrast agents. While the precise cause of NSF is unknown, the disorder has only been observed in patients with kidney disease, especially those requiring dialysis. "So far, NSF has only been reported in patients with renal failure," Dr. Kuo said. "Gadolinium contrast agents do not appear to cause NSF in patients with normal kidney function." Patients with NSF experience an increase of collagen in the tissues, causing thickening and hardening of the skin of the extremities and often resulting in immobility and tightening or deformity of the joints. NSF can develop rapidly and may result in patients becoming wheelchair-bound within just a few weeks. In some cases, there is involvement of other tissues, including the lungs, heart, diaphragm, esophagus and skeletal muscle. No consistently effective therapy exists.

"While I appreciate the conservative approach of the FDA," Dr. Kuo said, "my colleagues and I are concerned that expanding the warning to millions of patients with only moderate renal disease might have a negative impact on patient care." Dr. Kuo noted that only three percent of patients with renal failure who are given gadolinium agents will develop NSF, and that an overwhelming majority of the reported cases of NSF are tied specifically to gadodiamide. "That leaves a large percentage of patients who can gain the benefits of a contrast-enhanced scan without developing NSF," he said. Dr. Kuo and colleagues recommend not using gadodiamide in patients with kidney disease, but he pointed out that there are circumstances where the benefits of other gadolinium-based agents outweigh the risks. "MRI with contrast is simply the best exam in many situations," Dr. Kuo said. "One has to wonder if excluding large numbers of patients with moderate renal failure from the best exam would do more harm than good."


Peanut Butter Scare Keeping Doctors Busy

There are 13 confirmed cases of Salmonella in Indiana that have been linked to the peanut butter recall. The hospitals in and the health department have learned this is a fairly new strand of Salmonella and has people on edge. Doctors at Deaconess Hospital say they have been busy since the recall was announced. Dr. Patrick Fouts says the hospital is waiting for lab results on several other patients who had symptoms.

"The main species of Salmonella that we see that do affect humans, mainly comes from chicken, turkey, or eggs. This is the first time they have possibly associated it with a product like peanut butter. If you have symptoms that persist for more than three days, you should definitely contact your physician,"
says Denise Cory, Director of Communicable Diseases with the Health Department. The Vanderburgh County Health Department says there are less than five documented cases of Salmonella since January.

Snowboarder in bad shape after crash

A snowboarder who was in a collision with a snowmobile at Snowmass spent a weekend in intensive care, according to friends who were vacationing with him in Snowmass Village. Steve Rath of Largo, Fla., broke seven bones in the accident. Rath spent the weekend in intensive care at Aspen Valley Hospital and was discharged to a regular room, but too heavily medicated to speak. Rath broke his pelvis and a vertebra, and suffered a splinter fracture to one of his legs. He suffered internal bleeding as well

Kristin Rust, spokeswoman for the Aspen Skiing Co., confirmed that the accident happened but could not give many details. "A male snowboarder collided with a snowmobile Saturday, Feb. 24, at 4 p.m. on Snowmass near the superpipe at The Honda Ski Tour venue," Rust said in an e-mail. "An Aspen Skiing Company employee was on the snowmobile transporting equipment from the venue to another area. The employee approached the trail, looked uphill, saw the oncoming snowboarder and stopped. The snowboarder then collided with the snowmobile." Rust offered sympathy on behalf of the skiing company in her e-mail: "The entire staff of Aspen Skiing Company sends their best wishes to [Rath]."


Cerebellar Atrophy after Moderate-to-Severe Pediatric Traumatic Brain Injury Study

Although the cerebellum has not attracted the same degree of attention as cortical areas and the hippocampus in traumatic brain injury (TBI) literature, there is limited evidence that the cerebellum is also vulnerable to insult. The cerebellum is emerging as part of a fronto-cerebellar system that, when disrupted, results in significant cognitive and behavioral consequences. It has been hypothesized that cerebellar volume would be reduced in children following TBI and the wish is to examine the relation between the cerebellum, prefrontal cortex, thalamus, and pons.

Quantitative MR imaging is used to measure cerebellar volumes 1–10 years following TBI in 16 children 9–16 years of age and 16 demographically matched typically developing children 9–16 years of age. Cerebellar volumes were also compared with volumetric data from other brain regions to which the cerebellum projects. A significant group difference was found in cerebellar volume, with children in the TBI group consistently exhibiting smaller volumes. Repeating the analysis after excluding children with focal cerebellar lesions revealed that significant group differences still remained for cerebellar matter. It was also found there is a relation between the cerebellum and projection areas, including the dorsolateral prefrontal cortex, thalamus, and pons in 1 or both groups. The finding of reduced cerebellar matter volume in children with TBI is consistent with evidence from experimental studies suggesting that the cerebellum and its related areas are highly vulnerable to fiber degeneration following traumatic insult.


ANIMALS HELP WITH BRAIN INJURIES

Severe traumatic brain injuries (TBI’s) leave survivors with a long road to recovery. TBI’s can leave victims with altered appearances, cognitive disabilities, memory impairment, mobility limitations, and various psychological problems. Researchers have been trying to find an effective treatment to decrease the severity of certain brain injuries and quicken the recovery period for years, yet no scientifically sound treatment exists. Many researchers have come close to finding the “miracle” treatment but none have been approved by the FDA.

As TBI sufferers wait for researchers for the “miracle” treatment, they can rest assured that a non-medicinal treatment exists. http://www.psychiatrictimes.com/p990243.html">Studies show that companion animals may play an important role in the rehabilitation of TBI victims. New research focuses on the therapeutic effects of companion animals and has made companion animals an increasingly popular TBI treatment. The studies’ results show that companion animals help TBI victims reintegrate themselves into society - one of the most important steps to a brain injury sufferer’s recovery.

Companion animals positively influence a brain injury sufferer’s recovery period by simply providing companionship and eliminating the feeling of isolation. With the help of companion animals, TBI victims showed significant improvements in communication, social interaction, and sensory stimulation. They showed signs of decreased memory loss and mobility problems.

One study participant believes her successful recovery was all thanks to the dog given to her after the brain injury. "With my dog I feel safe and capable, and I am no longer afraid of the future. Everyone needs someone to care for, and we care for each other with dignity."


March 20, 2007

Nephrogenic Systemic Fibrosis Mimicking Inflammatory Breast Carcinoma

Nephrogenic systemic fibrosis, previously known as nephrogenic fibrosing dermopathy, is a newly recognized systemic fibrosing disorder primarily affecting patients with chronic renal failure. Patients with skin involvement often develop papules and plaques with peau d'orange surface changes. The lower extremities and trunk are most commonly affected. The most important histologic differential diagnosis is with scleromyxedema. This is possibly the first report of a case of nephrogenic systemic fibrosis involving the breasts of a 61-year-old woman with end-stage renal disease. Clinically, it mimics inflammatory breast carcinoma. Nephrogenic systemic fibrosis (NSF) is a recently described systemic fibrosing disorder primarily affecting patients with chronic renal insufficiency. Although the exact cause is unknown, bone marrow–derived circulating fibrocytes are suspected to be involved in the pathogenesis of this rare condition. Skin involvement in NSF frequently presents on the extremities as erythematous papules or plaques, often with peau d'orange surface changes and woody induration. Upper body involvement is less common, and breast involvement has not previously been reported.

Here is a report of a case of a woman with advanced renal disease who presented with bilateral breast swelling leading to the clinical impression of inflammatory breast carcinoma. Biopsy of one of the breasts revealed NSF.

The 61-year-old patient is a woman with end-stage renal disease on hemodialysis who presented with tense swelling and “dimpling” of both breasts. The patient's medical history includes diabetes mellitus. She had no palpable breast mass on physical examination. The clinical impression was inflammatory breast carcinoma, for which a biopsy was performed. The referring pathologist noted “an infiltrating pattern of fibroblastic cells” and submitted the slides for consultation to rule out fibromatosis. The biopsy specimen showed marked thickening of the skin.

Nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy is not restricted to patients undergoing dialysis for chronic renal insufficiency, and the terminology proposed by Jimenez and coworkers, “dialysis-associated systemic sclerosis,” is no longer recommended. Clinical improvement in NSF/NFD may occur in cases where the renal dysfunction is successfully reversed— usually early in the course of the disease before contracture development. Therefore, it is important for physicians to be aware of this disease since early diagnosis may lead to beneficial intervention.


Ortho Evra Patch Lucky to be Alive

http://www.lawyersandsettlements.com/articles/00677/othro-evra-embolism.html"It amazes me that Ortho-McNeil, makers of the Ortho Evra birth control patch, are still putting this product on the market," says Linda Hall. "After what I went through, I am so lucky to be here and thank god I am alive." In January 2004, nobody knew the dangerous side effects from the patch. "I was told that it was safer than the pill and a lot more convenient. If you put this on, you didn't have to worry about taking a daily pill," says Hall (not her real name pending a lawsuit). "I was put on the patch because I was having heavy periods. I was 36 years old and stayed on it for four months. I had no problems, no side effects. I was scheduled to have surgery because of my periods, but one week beforehand I woke up with, what I thought, were gas pains. I called in sick that day; as the day went on the pain increased -- it would come and go. I tried to lie down later on that night but it took my breath away. I propped myself up in bed but by 2 a.m. I could barely breathe and the pain was terrible. At that point I knew something was wrong. I have two young girls so I called a friend to come over and I drove myself to the hospital. As soon as I got to ER and explained my symptoms, they did an EKG and the results were normal. They thought it might be a pulmonary embolism so I had a CAT Scan and sure enough, they found two embolisms- one in each lung. I didn't know, even then, how serious this was. The worst part was that they gave me pain medication and my heart rate dropped so much I thought I was going to pass out. They brought in the 'crash cart' to resuscitate me. My mother had passed away a year before and I remember saying to myself, 'Mum, I'm not ready.' I really thought this was it. My second thought was this: What are my kids gonna do without me? Then my heart rate came back. That was the scariest day of my life.

They sent me for an ultrasound to see where the embolisms came from and found deep vein thrombosis - DVT. At that point I was admitted and had to stay completely still in critical care. I stayed on complete bed rest for about five days and stayed in hospital for a week. I was on heprin and coumadin, very high doses of blood thinners. The pain was still excruciating and I was very scared. I had many doctors visit, including my gynecologist. He came by because I was scheduled for surgery the following week. Of course the surgery was cancelled. He knew I was on the patch and mentioned that it could have been the cause of the embolisms. To be honest, I still didn't think much about it -- I didn't file a complaint until this year. Lots of people told me that I should seek legal action but I didn't. Then I finally came to my senses and realized that I don't want others to have to go through the pain that I suffered. I also thought a lot about my kids through all this - they could be without their Mum right now. At the time they were 11 and 7; they were too young to realize how ill I was.

I believe that I am one of the lucky ones - I read a lot of articles about the Ortho Evra patch and saw that a lot of women didn't survive. I want people to know they should not take this. It amazes me that it hasn't been banned! One other thing I want to mention: I found out that if the FDA knew of the side effects, the patch would never have been approved. But the drug company knew; they knew how much more estrogen was in their product. So why haven't they taken it off the market? Because they are making millions of dollars. But is it worth a life? Put the drug makers in our shoes: would they want their wives and daughters on the Ortho Evra patch?


Anxious but happy that her son is alive

Julian Mallein's mother has been at his side since the 12-year-old was badly injured by an SUV. Hours after a sport utility vehicle struck her 12-year-old son and sent him flying 30 feet through the air, Madelyn Mallein got her first up-close look at the boy. A half-dozen tubes snaked into Julian Mallein's 79-pound body. Staples held together a flap of skin above his hairline. His thin, bare chest was visibly bruised and a machine breathed for him. Those were just the injuries she could see. The sixth grade boy was crossing a road on Nov. 11 with his best friend when they were struck by a black Nissan Murano. The SUV hit Julian straight-on. The impact put Julian into a coma. The night that Julian was flown by helicopter to Albany Medical Center, doctors were noncommittal about the boy's chances of survival, never mind recovery. Julian's brain was swelling and his lungs were full of blood. His wrist and leg were broken, but he wasn't on pain medication for fear it would push him deeper into the coma. When nurses pinched him, he reacted to the pain, but his body was limp and his lids closed over his blue eyes. As blood pooled between the outer membranes of his brain, doctors drilled a hole in his skull and implanted a bolt to monitor the pressure. Early on, the doctors told Mallein Julian's physical injuries would heal but they were unsure of his brain function.

A week after the accident, Julian opened his eyes. "But it wasn't really him. It was a blank stare," his mother said. It was a slow and miserable process. Julian trembled. He pulled IVs out of his body and had to be restrained. He struggled to keep his eyes open and could not speak. He knew his mom's voice. "Look at me, Julian" and he would. "Squeeze my hand," he did. Eighteen days after the accident, Julian was ready to move to a rehabilitation hospital. The Albany Med doctors and medical students gathered around his bed and a doctor gingerly pulled the bandages off his stomach incisions. "Ouuucch!" Julian yelled. Mallein screamed with delight. It was his first word since the accident. Julian arrived at rehab unable to walk, talk, dress, bath or feed himself. He was sleepy and easily fatigued. On his second day, Mallein was spoon-feeding pureed pancakes to Julian when he spoke again. "More syrup, please," he said quietly. "Then I knew he was fine. His mind was there," said Mallein. But the battle had just begun. Julian didn't know where he was or why he was there. His mother tried to explain to him.

"It's not that I don't believe you," he told her, "but can I see a nurse?" "So we'd bring one in and he'd say, 'Can I see another?' Sometimes, we'd have two to three of the nursing staff coming in every 10 or 15 minutes," Mallein said. They took pictures of the nurses and taped them to the foot of his bed, and the staff draped a banner in his room that said "You are at Sunnyview Rehabilitation Hospital." Six or seven times a day, Mallein relived the accident as she explained it to Julian. It was exhausting. Mallein spent all but two nights at Julian's bedside. He learned to dress himself, go to the bathroom and walk with a walker. Still, his short-term memory was severely impaired. A doctor and psychologist pulled Mallein aside and warned her Julian's brain injury was serious and some of these deficits might be permanent. After six weeks in rehab, Julian went home. His leg is weak, but he walks easily and wrestles and throws snowballs with his brothers when his mother isn't looking.The cheery, charming side of Julian is back. His eyes are bright and his smile impish. He talks fluently in his high-pitched voice, and his buzz cut nearly hides the scar on his scalp. Like the doctors said, his physical injuries are mending, but his brain is still traumatized. He's hyperactive, less inhibited and his short-term memory is still weak. His motor skills are poor and he is easily disoriented.

"There are aspects to his personality that haven't returned at all, like his ability to be serious, to have real conversations, meaningful ones that connect on a deeper level," Mallein said. "That hasn't come back at all. I miss that."


Peanut Butter Recall Slows Down Food Bank

Jars of peanut butter have the people at the Tri-State Food Bank searching for all the extra hands they can find. 35-thousand pounds of food packed and ready to ship out, but volunteers with the Tri-State Food Bank have to sort through all of the boxes, just to find the recalled peanut butter. The FDA warns the jars may be tainted with Salmonella. "One of the items we always stress that we need because it's high in protein, is peanut butter so now we're concerned we might have some peanut butter that came through and we want to make sure none of it gets out of the building," says Mary Blair, Executive Director of the Tri-State Food Bank.

Volunteers with the Tri-State Food Bank have to sort through 12-hundred boxes of food to search for jars of Peter Pan and Great Value peanut butter for serial numbers beginning with 2-1-1-1. "There's going to be considerable more work. All of these cases already had volunteers come in and these were sorted and ready to go out the door. So we have to completely go through it again," says Blair. Blair says the warning will slow down the Food Bank's distribution to more than 22-thousand people in 33 counties, but by how much remains to be seen. "Hopefully not very long. It just depends on how many volunteers or people that can find time to come in and help us. We got a lot of work to do quickly because we don't want anyone to go hungry."


TBI SUFFERERS WILL BENEFIT FROM NEW CELL STUDY

http://www.utdallas.edu/biology/faculty/profiles/dmello.htmlThe Institute of Neurological Diseases and Stroke awarded a $1.63 million research grant to Santosh DMello. DMello is a professor of molecular and cell biology at the School of Brain and Behavioral Science. The focus of his research is the process of programmed cell death to discard unwanted and dysfunctional cells from the body (apoptosis).

Abnormal apoptosis in the brain causes neurodegenerative diseases such as Alzheimers, Lou Gehrighs, Parkinsons, ischemic stroke, and traumatic brain injuries (TBIs). The grant will help fund a study that will research if a newly discovered family of proteins that enhance the survival of neurons in the brain can prevent abnormal apoptosis. "Every year, billions of dollars are spent to take care of patients suffering from neurodegenerative diseases, with no cure or treatment strategy in place," D'Mello said. "A better understanding of controlled apoptosis in the brain will lead to the development of strategies to treat or cure these diseases."

DMello will study the proteins effect on apoptosis by over-expressing the protein in neurons and observing the levels of the cells' reactions. "The future goal of the project is to build an animal model wherein we recapitulate the disease in mice and try to compare mice with the increased level of the protein with the ones without the protein and probably try to develop a drug to cure the mice," stated a colleague of DMello.


March 19, 2007

Fatal surgery results in $1 million malpractice verdict

A fatal mistake in a gastric bypass surgery resulted in a $1 million medical malpractice verdict. Karin Lobaina, whose husband died following surgery at Northern Michigan Hospital about four years ago, won the verdict, though a last-minute settlement will reduce the true amount she receives, her attorney said. Physician Bruce Deckinga offered to settle about 15 minutes before jurors returned a verdict, said attorney Robert Sickels. Sickels declined to divulge the settlement, but said it was for the maximum limit of Deckinga's insurance policy, which he described as "quite modest.” "His liability under the (jury) verdict would have been significantly higher,” Sickels said. Jurors would have had Deckinga on the hook for 40 percent of the total $1.17 million verdict, which they calculated by multiplying Lobaina's annual income by the number of years he could have worked until age 62, plus $200,000 for "non-economic” damages. In addition to Deckinga's liability, jurors assigned 40 percent of the liability to Thomas Wertz, a physician at Grayling Mercy Hospital who was in charge of the emergency room when Lobaina's family reported to the hospital following the surgery. Sickels argued that Wertz, who made the decision to transfer Lobaina to Northern Michigan Hospital, should have recognized that the man was too sick for an hour-long ambulance ride.

Court records show Deckinga performed the gastric bypass surgery on March 31, 2003, to reduce the size of Lobaina's gastric pouch. Lobaina died a week later of an internal infection. He was 44. An autopsy revealed that Deckinga mistakenly connected the wrong body parts. Lobaina's esophagus had been patched directly to the intestinal tract. It was supposed to have been connected to the gastric pouch, which in turn connects to the intestine.


Health Canada issues contrasting agent advisory

Health Canada has notified Canadian hospitals about safety concerns over contrast agents containing gadolinium which are used primarily in MRIs and have been linked to a condition called nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy, or NSF/NFD. To date, 109 cases of NSF/NFD associated with gadolinium-containing contrast agents have been reported worldwide, although none has been reported in Canada. So far, NSF/NFD has been observed only in patients with serious kidney disease, Health Canada said yesterday in an advisory.

NSF/NFD may develop over a period of a few days to several weeks, with lesions on the skin the most visible effect. The skin becomes thickened with a woody texture, restricting joint movement and resulting in the shortening or distortion of muscle tissue. Internal organs such as the heart may also be affected," Health Canada said. "A skin biopsy is necessary to accurately diagnose this disease."

The seven gadolinium-containing contrast agents sold in Canada are Omniscan, Magnevist, Optimark, Gadovist, ProHance, MultiHance and Vasovist. The federal department recommends that patients with serious kidney disease consult their health-care professionals to minimize the risk of developing NSF/NFD following an imaging procedure.


Food Safety Network aims to stop food contamination

Seven major food recalls since July inlude E. coli in spinach, Salmonella in peanut butter and Listeria in hot dogs. The Food Safety Network located at Kansas State University, is dedicated to stopping food contamination, which sickens 76 million people, one out of every four Americans and kills 5,000 each year. The network combines public awareness with an Internet-based information service and research projects in an effort to educate growers, consumers and workers. Microbiologist Doug Powell started the organization more than a decade ago at the University of Guelph in Canada. Now an associate professor of food safety in Kansas State's College of Veterinary Medicine, Powell is outspoken on good farming practices and good worker hygiene and blunt about what needs to be done. "It boils down to three words," he said. "Don't eat poop." Simple as Powell's advice sounds, food safety is far more complicated, he admits. Microbial contamination, such as E. coli or salmonella is not visible, and has no taste and no smell. It can come from any number of sources along a chain of growing, harvesting, processing, packaging and selling. It can come from water that drains from a livestock operation and runs through a field after a rain. It can come from irrigation water drawn from a contaminated pond. It can come from processing vats, storage bags, tools, or workers' hair, skin or saliva. "What needs to happen is that people need to stop the pretty talk about 'natural, locally grown, fresh, organic produce' and get serious about microbes," Powell said. "Forget about wholesome whatever and farm sunshine. What we need is bacteria-free produce."

While food scientists agree that proper cooking will kill most kinds of harmful bacteria, nobody is convinced that the bulk of consumers know what proper cooking is. "Most people just open the package and stick it the microwave for a couple of minutes," Powell said. "If it's steaming, it's done. "The only way to be sure of the internal temperature of food is to measure it with a thermometer. But how often do people really do that? And even if they do use a thermometer, do they know the right way to insert it to get an accurate reading?" The Food Safety Network will soon begin a research project to try to answer some of those questions. The two-year effort, funded by a grant from the American Meat Institute, will study consumer behavior using uncooked, frozen, breaded poultry products. However, the knowledge gained will be relevant to all types of food processors, said Randy Phebus, a food microbiologist and professor of food safety who is Powell's partner on the project. "We will bring people into a test kitchen, hand them the products and tell them to cook it like they would at home," Powell said. "We'll have a video camera in the room to document what they do for later study."

Public education is another of the Food Safety Network's goals. The network sells T-shirts that say "Don't Eat Poop" on the front and "Wash Your Hands, Food Safety Network" on the back. It also has printed and distributed fliers to restaurants, using catchy art and humor to reinforce the simple message of "Wash Your Hands," and has put videos on popular entertainment sites, including YouTube and MySpace. The idea, Powell said, is to make people think and ask about safe food.


After TBI Woman Leads Second Life

There was a time when Abigail Baglione had life figured out. She was a senior in college planning on becoming a psychologist. That all changed in an instant. Six years ago, Baglione was in the back seat of a car as it was broadsided. The damage to her body was devastating. "She was hooked up to every imaginable life-saving piece of equipment," said her mother, Mary Baglione. "But she looked like a doll. She was beautiful, lying there, and it was hard to believe that she was so badly injured." But one of the greatest injuries Baglione suffered couldn't be seen. It was inside her head. When Baglione awoke after seven weeks in a coma, it was clear the effects on her brain had been severe. In an interview with ABC News' "Primetime" three weeks after the accident, she acknowledged that she couldn't talk without help. "It has affected me physically, like, obviously I can't walk myself," she said. "I can't talk myself."

She is learning about new limitations. Physical and cognitive therapy has since helped Baglione's brain rewire to compensate for some of what she lost. "It may always take a little longer to do certain things, but the brain is amazing," she told ABC News' Bob Woodruff. Today, Baglione, like Woodruff, is one of the millions of Americans faced with the long-term challenges of living with a traumatic brain injury. "I've been told that my fundamental intelligence is the same," she said. "But things like my attention, my short-term memory, they have all been affected. So the result of that is that I don't seem intelligent." But Baglione is fortunate. Many brain-injured people never recover to the degree she has, and 50,000 people die each year from traumatic brain injury. One of Baglione's biggest challenges has been learning to accept how much the injury has changed her. For one, she can't dance anymore. She said that it is almost as if she has had two separate lives. "I don't think going back, simply going back to your old way, is possible," she said. "And only somebody with this injury would understand that."


More Benefits of Exercise for the Brain

Researchers and exercise fanatics have stressed the positive effects of exercise on the body and brain for years. It is well known that exercise induces an “endorphin high” that creates a euphoric feeling that lasts hours after intense physical activity. During intense physically activity the pituitary gland releases endorphins that block sensations of pain and boost the mood of exercisers.

Researchers now say that exercise has even more effects. Most of the effects studied before showed short-term effects, and now many long-term effects have been discovered. Studies show that exercise improves mood, improves sleep patterns, improves stress issues, decreases anxiety, increases self-esteem, and promotes cell growth.

Physical exercise produces many beneficial biological changes in the body. Blood and energy supplies travel more readily to the brain and genes in nerve cells signal the production of growth factors. Growth factors in the brain induce nerve cell growth, create better communication between the brain and nerve cells, and promote new nerve cell development. These functions are important for adaptation and learning processes of the brain - processes that are often slowed down by age and traumatic brain injuries (TBI’s). With physical exercise, the negative effects of age and TBI’s on the brain may be improved.

A study conducted by researchers at the University of Colorado at Boulder show that the sooner a TBI sufferer exercises, the faster recovery occurs and more improvements can be seen. The study’s results showed that those who exercised sooner after the injury experienced improvements in attention and concentration, visual and perception deficits, language, and memory.


March 16, 2007

New Study Shows Warfarin May Increase Death Rate

A new international study of the blood-thinner warfarin concludes that the majority of patients receiving it had improper clotting levels, leading to an increased death rate. The drug is given to many patients with an abnormal heart rhythm, who are at risk for blood clots which cause strokes. Warfarin reduces their chance of stroke by 60 percent.

The study, reported in the Archives of Internal Medicine, found that two-thirds of the 3,000+ patients in the study had blood-clotting levels outside the recommended range about 75 percent of the time. Those with poor control of their blood's consistency had an annual death rate of 4.2 percent, compared with 1.7 percent among those with good control.

Clotting levels in patients taking warfarin could be affected by other medicines, by eating foods including broccoli, and by individual variability. Professor Harvey White, of Auckland City Hospital in New Zealand, was one of the researchers in the study and said "In some patients [clotting levels are] all over the place the whole time." Dr. White indicated that results are much worse in the community than in the trial and that a newer anti-clotting drug is needed. Already involved in a study of one such newer drug, rivaroxiban, Dr. White said, "It looks very promising, but we would need to prove that."


Medical Malpractice Politics in the Doctor's Waiting Room is a Bad Idea

An article appeared last week in the Kingston Daily Freeman about a postcard/poster campaign by the Medical Society of New York State, accusing trial lawyers of causing excessive malpractice insurance rates and driving doctors out of practice. What about those posters and fliers? It's a bad idea for doctors for three reasons.

First, the single biggest reason that unhappy patients call lawyers is bad bedside manner. A complication or bad result of some type occurred, and the patient didn't get answers they deemed satisfactory. They are angry.
Brochures complaining about lawyers is not what unhappy patients want, they want answers. Second, a lawsuit is not the first thing on many patients' minds when something goes awry. There is no shortage of people who contact a lawyer years after the acts they complain of, often after the statute of limitations has passed, and only after a discussion with a friend or neighbor put the idea in their head. Placing the idea of malpractice front and foremost while they wait to see a doctor may be very counterproductive for these patients. Third, complaining about an expense of the medical practice (insurance, which is the subject of the political campaign) simply invites a discussion of revenues. An expense that is 3% of revenues, for example, is different than one that is 30% of revenues. Do doctors want to answer questions about their revenues?

Just a few things to think about, all of which become ever more important depending on the amount of time spent in the waiting room, and the amount of face time spent with the physician. If waits are long and face time is short, the physicians may be doing themselves a disservice with this type of politicking.


Botched Surgery Leaves Nurse Disabled Unable To Work

At the peak of her nursing career, Dana Stinson was permanently disabled by a disastrous surgery and the doctor's subsequent attempt to cover up her mistakes. Now, Dana will never care for another patient. Dana went in for her yearly OB/GYN visit in 2002. Her doctor discovered abnormal growths in her uterus and recommended a hysterectomy. It was a big step, but Dana decided to have the operation. She checked into her own hospital for the surgery. When she woke up after the hysterectomy, no one told her there had been any complications. They said she had some internal bleeding, but that it would fade back to normal soon. But Dana felt horrible. She couldn't get out of bed and her abdomen was pierced with shooting pains. The doctor told her the bleeding in her abdomen would stop and nothing needed to be done. By the third day after surgery, Dana was falling in and out of consciousness. Her stomach was hugely bloated, hard and red. She was hallucinating. She started phoning family members to tell them she was dying. On the sixth day, when Dana was nearly comatose, the hospital finally did emergency scans. Though the results were abnormal, Dana's doctor still wanted to postpone surgery.

As her stay in the hospital grew longer, the nurses had begun to express their concerns to Dana's family. That night they came to her rescue, transferring Dana to the intensive care unit on their own authority and convincing a team of specialists to come to the hospital and save her with emergency surgery in the middle of the night. The specialists discovered that Dana's surgeon had sewn her organs together during the hysterectomy. A seven centimeter gash in her colon had been leaking into her system for six days. The extensive damage, and the doctor's cover-up of what had really happened, nearly cost Dana her life. She remained in the hospital for two more months, recuperating from the toxicity and the other problems the mistake had caused, and continues to return for repair procedures.

Dana sued, and the doctor admitted she was negligent. The state declared her disability permanent. Nevertheless, the doctor's insurance company refused to pay lost wages for the work Dana can never do again. Because the arbitration agreement Dana signed when she went in for surgery took away her right to go to court, she must live with the decision of an arbitrator that cannot be challenged. The arbitrator sided with the insurance company and limited Dana's compensation - for all of her injuries, the constant pain, and inability to work again - to $283,000 for life. Dana has still not recovered from the terrible damage done to her body that day. The internal injuries and scarring have left her in daily pain. She has lost kidney, thyroid and other organ functions. Her doctors have difficulty deciding how to treat her, because each correction could also make things worse. Though permanently disabled, she is happy to be alive.


NeuroHealing Pharmaceuticals Presents Clinical Data for NH001 in Coma

NeuroHealing Pharmaceuticals, Inc., a clinical stage private company developing products for individuals with hronic brain injuries, announced March 12th that it had presented new clinical data for its coma recovery compound, NH001, at the American Society for Experimental NeuroTherapeutics (ASENT) 9th annual meeting held in Washington, D.C. NH001 is a dopaminergic agent designed to accelerate the recovery and improve the functional outcome of patients from a coma, vegetative or minimally conscious state following a traumatic brain injury. The findings presented include the response to NH001 treatment of eight patients with a traumatic brain injury who were in a vegetative or minimally conscious state for 1-4 months and neurologically stable for weeks prior to beginning of NH001 treatment. Seven of the eight patients had previously received, and failed to respond to, commonly used stimulant drugs such as l-dopa, amantadine and bromocriptine. The responses to NH001 treatment were rapid and observed in the first 2-4 weeks. Five of seven patients showed a progressive and continuous improvement with clinically significant changes in consciousness, functional recovery and reached an independent walking ability. The responses were maintained after NH001 discontinuation. NH001 was well tolerated.

Patients fared better than expected in this historic outcome. Consistent with previously released clinical data, the new data provides further support that NH001 may be a safe and an effective treatment to accelerate the emergence of consciousness following a TBI. Presently, there is no approved treatment for post-traumatic patients who remain in a vegetative state or minimally conscious state. Each year in the U.S., 50,000 to 75,000 patients survive a severe TBI but remain in an altered consciousness state, such as coma, vegetative state (VS) and minimally conscious state (MCS), for an extended period of time. These 'altered consciousness states' are
characterized by the lack of awareness and lack of interaction with the environment. Diffuse axonal injury, a neural pathology occurring in post-TBI patients, is associated with a disruption of dopamine pathways. There is some evidence suggesting that dopamine agonists may have a role in regaining consciousness, facilitating rehabilitation and improving outcome.

The Science of Nh001: NeuroHealing's proprietary therapy NH001 is a potent dopaminergic agonist with well-established human safety data, appropriate pharmacokinetic profile and convenient route of administration. It is a
direct-acting dopamine agonist on both D1 and D2 receptors, and it has been reported to stimulate post-synaptic dopamine receptors independent of pre-synaptic dopamine synthesis or stores. It rapidly crosses the blood
brain barrier and reaches a concentration in the brain eight times higher than that in plasma. Because dopaminergic function appears to be of importance in executive central nervous system function, such as arousal and
memory, NH001 may stimulate recovery from a coma. NeuroHealing has received authorization from the FDA to begin a double-blind Phase II trial, under an open IND. NH001 is eligible for fast track approval at the FDA.


Military docs give up too quickly on brain damaged vets

When Staff Sgt. Jarod Behee was asked to select a paint color for the customized wheelchair that was going to be his future, his young wife seethed. The government, Marissa Behee believed, was giving up on her husband just five months after he took a sniper's bullet to the head during his second tour of duty in Iraq. Ms. Behee, a sunny Californian who was just completing a degree in interior design, possessed a keen faith in her husband's potential to be rehabilitated from a severe brain injury. She refused to accept what she perceived to be the more limited expectations of the Veterans Affairs hospital in Palo Alto, Calif. "The hospital continually told me that Jarod was not making adequate progress and that the next step was a nursing home," Ms. Behee said. "I just felt that it was unfair for them to throw in the towel on him. I said, 'We're out of here.' " Ms. Behee had successfully resisted the Army's efforts to retire her husband into the V.A. health care system and it turned out that his military insurance policy covered private care. So she moved him to a community rehabilitation center. Three months later, Sergeant Behee was walking unassisted and abandoned his government-provided wheelchair. Now 28, he works as a volunteer in the center's outpatient gym, wiping down equipment and handing out towels. It is not the police job that he aspired to; his cognitive impairments are serious. But it is not a nursing home, either.

Like the spouses of many other soldiers with severe brain injury, Ms. Behee, also 28, transformed herself into a kind of warrior wife to get her husband the care she thought he deserved. In the eyes of five other families interviewed the military health care system has been scrambling to deal with an unanticipated volume of traumatic brain-injury cases that it is not equipped to handle. In general, these caregivers relatives said that their grievously wounded soldiers had either been written off prematurely or not given aggressive rehabilitation or options for care. From the beginning, they said, the government should have joined forces with civilian rehabilitation centers instead of trying to ramp up its limited brain-injury treatment program alone during a time of war. That way, soldiers would have had access to top-quality care at civilian institutions that were already operating at full throttle and might be closer to home. In fact, many soldiers do have that access. But unlike Ms. Behee, many caregivers only belatedly come to understand how to negotiate the daunting military health care system.


March 15, 2007

Mediation helps hospitals steer clear of courtrooms

The University of Pittsburgh Medical Center's pioneering formal mediation process not only helps settle malpractice claims before they go to court, but it also allows both sides to think about creative ways to work things out. Besides monetary awards, patients have had plaques, monuments or hospital rooms named in their honor. "It's a nontraditional way of doing things that you don't do through the courthouse," said Richard Kidwell, associate counsel and director of patient safety and risk management at UPMC. He helped launch its mediation program in 2004.

Jury Verdict Research said the median medical malpractice settlement was $1 million in 2004 (the latest year for which it had data) compared with a median jury award of $1.045 million. Mr. Kidwell estimates an average $50,000 in legal expenses is saved in each case that is mediated rather than tried in court. From late 2004 through mid-January, UPMC mediated 77 cases and settled 68 of them, said Mr. Kidwell, a national expert in hospital mediation. The UPMC program grew out of efforts by the state Supreme Court and Gov. Ed Rendell to reduce the costs of medical malpractice suits.

At UPMC, patients sign an agreement prior to treatment saying that if they later pursue a claim against the facility, they must attempt to resolve it through mediation before filing a lawsuit. The patients do not waive their rights to a jury trial if mediation fails. The process is voluntary and confidential.. UPMC's mediation system involves one mediator who listens to statements from plaintiffs, defendants and their attorneys in a joint session prior to working with each side individually to reach a resolution. "It gives the patient his or her day in court because they sit down across from us," said Mr. Kidwell. For the hospital, he said, it provides a setting to discuss what happened, why it happened and how the institution can implement changes. Mediation also allows the hospital to apologize for errors, "something we can't do in court," Mr. Kidwell said. Carol Liebman, a mediation expert at Columbia University Law School in New York, characterized UPMC's program as "terrifically sensible and sophisticated" and said the medical system was among a handful of institutions nationwide that have pioneered the practice. The others include Johns Hopkins, Drexel University and the University of Michigan. "Mediation is growing but not nearly as fast as it should be," she said. "In general, it's a better way to solve conflicts."


Lab Violations led to injuries

Subcontractors for Los Alamos National Laboratory did not follow lab safety procedures before a construction accident last year that injured two lab workers, an internal lab investigation found. The June 28 accident could have been prevented, but lab officials failed to correct unsafe working conditions, did not effectively enforce safety requirements and failed to consider the history of one of its subcontractors, Magnum Steel Constructors, the report said. In 2003, a Magnum worker died in a work-related accident in Bernalillo, and the company was cited by the Occupational Safety and Health Administration for six serious violations, investigators said.

Magnum workers were using a crane to move a 1,500-pound metal staircase at the lab's Radioactive Liquid Waste Treatment Facility last summer when the structure slipped from its rigging, fell more than 50 feet and struck two men. One of the workers received leg injuries and the other suffered multiple leg fractures and a broken pelvis, the report says. Representatives with Magnum and Pace Iron Works (a lab subcontractor that hired Magnum to help on the project) said they hadn't seen the report but insisted the accident was unavoidable. "They worked like they normally work at a job site, as far as I'm concerned," said Shaun Myers, a quality control officer with Pace. "Nobody wants to get hurt. They deal with steel all day long. They don't want to do it in an unsafe manner." Investigators, however, found that a "poor rigging technique" was directly responsible for the accident, which "very easily could have resulted in two fatalities."

In the past, federal oversight officials in the Department of Energy and National Nuclear Security Administration have investigated serious lab accidents. But NNSA, which is giving more oversight responsibilities to the lab's new corporate manager, opted last summer to let the lab take the lead on last summer's investigation. Lab spokesman Kevin Roark said the report should demonstrate that the lab's internal investigations are as rigorous, if not more so, than the government's. "We're harder on ourselves than the DOE is," Roark said.


New approach needed in DOD response to TBI

The Pentagon needs to overhaul its approach to treating the tens of thousands of U.S. troops who might have traumatic brain injury according to a previously undisclosed Department of Defense memorandum obtained by USA Today. The memo was released in response to a Freedom of Information Act request by USA Today. According to the Aug. 11, 2006, memo signed by Wayne Lednar, an epidemiologist, and Gregory Poland, chief of the Defense Health Board, troops with mild and moderate brain injury are of the greatest concern because their injuries are difficult to recognize and can limit mental performance. According to the memo, "There remains a need to better understand the unique characteristics of blast-associated TBI and to reduce the health risk and complications from mild or moderate forms of brain injury." The memo noted that the Pentagon's best work on TBI involved the most severe injuries.

The memo recommended that the Pentagon improve protective gear for troops; standardize battlefield methods to recognize brain injuries; develop better methods to determine when an injured soldier can return to duty; and screen all returning troops for brain injury. In response to the memo, the Pentagon said that it will allocate $14 million to fund more research on blast injuries and provide combat zone medics with evaluation forms to diagnose mild brain injuries. Pentagon spokesperson Cynthia Smith said, "Our goal is to identify TBI as soon as possible."


March 14, 2007

Health Canada Advises Issues Related to Gadolinium

Health Canada is advising consumers of a notice sent to Canadian hospitals advising relevant health care professionals of safety concerns related to contrast agents containing gadolinium. A contrast agent is a liquid that is injected into the body to make certain tissues more visible during imaging procedures. To date, 109 cases of NSF/NFD associated with gadolinium-containing contrast agents have been reported worldwide. There are no reported cases of NSF/NFD in Canada. So far, NSF/NFD has only been observed in patients with serious kidney disease. The seven gadolinium-containing contrast agents authorized for sale in Canada are Omniscan, Magnevist, Optimark, Gadovist, ProHance, MultiHance, and Vasovist. Health Canada will be working with the marketing authorization holders of the gadolinium-containing contrast agents authorized for sale in Canada to update the product information for these agents.

Health Canada recommends that patients with serious kidney disease consult their health care professionals regarding their individual needs in order to minimize the risk of developing NSF/NFD following an imaging procedure. Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. They are to be reported with the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada.


Sleep-Driving: A Rare, but Serious Side-Effect of Sleep Medications

On March 14th, the FDA warned that all sleep medications may sometimes cause a bizarre side-effect -- sleep driving. Sleep driving is comparable to sleep walking, driving while fully awake, with no memory of having done so. The FDA ordered the makers of 13 sleep medications to strengthen the warning labels on their packaging about two rare, serious side-effects: Sleep-driving and other complex sleep-related behaviors like sleep-eating and making phone calls while asleep AND life-threatening allergic reactions and severe facial swelling, both of which can occur the first time the pills are taken.

The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.


Brain Not Able to Communicate After Stroke and Other TBI's

Researchers have linked common post-stroke symptoms to impaired communication between brain regions. Neuroscientists at the Washington University School of Medicine report that there is distinct correlation between the severity of the brain damage due to stroke and the degree of communication lost in the brain.

"For more than a century, we have linked neurological deficits and their recovery to the damage done to neurons directly affected by a stroke or other injury," says senior author Maurizio Corbetta func M.D., the Norman J. Stupp Professor of Neurology. "However, we are learning that a lesion in one part of the brain can impair the function of brain regions not directly harmed by the lesion. We need to promote use of this more dynamic view of brain changes after damage."

In the study, eleven patients' brains were scanned within a month after stroke and again more than six months later. The brain was scanned after 6 or more months because this is the period when the symptoms of spatial neglect often start to fade. Some stroke and TBI victims begin to become unaware of one side of their body (e.g. inability to recognize their left arm or leg). During the study particular attention was paid to the connection between two brain networks that help control attention and the part of the stream of sensory inputs the brain most tightly focuses on.

The results of the study further reinforce a theory about the effects of brain injury that Corbetta and his colleagues have been building for years. The theory contends that brain injury can damage give-and-take processes between brain regions that are essential for the specific regions' proper function.

Corbetta hopes to continue studying this phenomenon to see if the approach can be applied to other brain injury conditions.


Xytis Enrolls First Patient in Phase II Clinical Study with Anatibant (XY2405) for Traumatic Brain Injury

Xytis announced it has enrolled the first patient in the Company's Phase II clinical trial with Anatibant for the treatment of traumatic brain injury (TBI). "We plan to enroll 400 patients with moderate to severe closed head TBI in 9 countries over the next 12 months," said Vincent F. Simmon, Ph.D., President and CEO of Xytis. "We are working with the London School of Hygiene and Tropical Medicine (LSHTM), which has considerable and unique experience in enrolling patients with TBI in highly-recruiting centers throughout the world. Patients with moderate to severe TBI will receive one of three doses of anatibant or placebo for 5 days. Endpoints for the trial include safety and tolerability, mortality as well as functional assessment at days 6 and 15 post-injury."

Anatibant is a selective, very potent, small-molecule Bradykinin B2 receptor antagonist that has been shown to be safe and effective in animal models of TBI. Phase I clinical trials with anatibant in healthy volunteers and patients with TBI demonstrated a favorable clinical safety, tolerability and pharmokinetic profile. "A previous study gave strong support validating Bradykinin B2 as the appropriate target for reducing the secondary damage that occurs due to inflammation and increased permeability of the blood brain barrier, leading to increased intracranial pressure. Anatibant is one thousand times more potent than Bradycor, the compound used in that previous study, and has a much better pharmacodynamic profile," said Rowland Furcha, project manager for Xytis.

"Our decision to undertake this clinical trial was based on several factors," stated Simmon. "There are no therapeutics for TBI despite the fact that the CDC estimates that in the US there are 1.4 million TBI cases per year of which 50,000 patients die and 235,000 are hospitalized with moderate to severe TBI. Among survivors, 5.2 million people require assistance in performing daily activities, resulting in costs of $60 billion. Worldwide the incidence is estimated to be 10 million cases per year with 1 million of these occurring in the US, Europe and Japan. Therefore a successful drug in TBI will be extremely valuable for patients and its developer."


Oklahoman Sickened By Peanut Butter

The number of Oklahomans sickened by peanut butter contaminated with salmonella has increased to 12, state health officials reported. The discovery of an additional person sickened by the peanut butter prompted the state Department of Health to warn people again of the potential danger posed by the tainted product. "Nearly every family has a jar of peanut butter in their pantry, so we want Oklahomans to take this product recall very seriously," said State Health Commissioner Dr. Mike Crutcher. "If you still have jars of Peter Pan or Great Value peanut butter with the product code beginning with 2111, throw them away."

At least 425 people in 44 states have been sickened. Product testing conducted by the Oklahoma State Department of Health has confirmed the presence of salmonella in jars of opened peanut butter obtained from some of the people who got sick. An Oklahoma City couple are among those who have sued ConAgra. Their lawsuit in Oklahoma County District Court seeks more than $500,000 in damages from ConAgra Foods, which they blame for their 15-year-old son's illness; he was hospitalized Aug. 10-12 after getting sick.


Some lawyers warn about medical waiver

A medical waiver utilized by a northeastern Pennsylvania hospital has come under fire from two attorneys who fear patients may be unwittingly signing away their rights to seek a jury trial if they are injured through malpractice. Kindred Hospital of Wyoming Valley, a long term acute care facility, has been asking patients to sign a waiver that would mandate any claim for injuries go through mediation or binding arbitration, alternative legal processes that can be utilized in lieu of filing a lawsuit.

The hospital maintains the voluntary waiver benefits both patients and the hospital by allowing for faster resolution of malpractice claims. However, attorneys who reviewed the document say they’re concerned it’s being presented to patients who, because they’re under duress due to their illness, may not understand its implications.


March 13, 2007

ACR Releases Updated MR Safety Guidelines

http://www.ajronline.org/aheadofprint/AJR_06_1616.dtlThe American College of Radiology (ACR) has updated its MR safe practice guidelines in a whitepaper titled ACR Guidance Document for Safe MR Practices: 2007. The whitepaper is available on the American Journal of Roentgenology Web site.

The 2007 version represents a virtual rewrite of the entire document and contains information on, among other topics, nephrogenic systemic fibrosis (NSF), a reaction to gadolinium that has been noted in patients with renal disease. Each section has been re-evaluated and updated, with several entirely new sections and appendices including guidelines on MR facility safety design and facility emergency preparedness. First published in 2002, the safety guidelines were revised in 2004.

To read ACR Guidance Document for Safe MR Practices: 2007 in its entirety as published in the AJR go to this link:
http://www.ajronline.org/aheadofprint/AJR_06_1616.dtl


Oregon malpractice claims among nation's lowest

Medical malpractice claim payouts in Oregon are lower than those in all but seven other states despite the elimination of a cap on such awards in 1999, a new study shows. The study researchers tried to measure the effects of various malpractice changes and were surprised how little difference the changes made on the amount and frequency of malpractice awards. It said some states with caps on damages still had higher-than-average costs from claims while some, including Oregon, retained comparatively low payout rates without caps. In Oregon the state Supreme Court revoked a cap on damages in 1999 for non-economic losses such as pain and suffering. Doctors and insurance companies spent $5.2 million in 2004 trying to reinstate a cap but voters rejected it. Some states require expert witnesses to practice or to have training in the type of medicine involved. These laws had about three to four times the effect of caps on damage awards, researchers concluded. Oregon does not have such a program but eight of the 15 states with the lowest malpractice payments do.

Time limits for suing emerged as the second most influential factor. Oregon's statute of limitations gives patients two years from the date of discovery of an injury and five years from the date of the treatment. States with the lowest malpractice awards all had such time limits, researchers found, while the most expensive states either had none or longer ones. The Oregon Medical Association is backing a bill to require both sides in malpractice cases to disclose who their expert witnesses will be, hoping to encourage earlier settlements and limit frivolous lawsuits.

Jim Dorigan, chief executive officer of Northwest Physicians Insurance Co., one of the state's largest malpractice carriers, said the study may have underestimated the cost and frequency of malpractice claims in Oregon. Dorigan said that in his company's experience, the number of claims per physician is about twice the rate reported in the study, and the average payment was about 50 percent greater for 1999-2003. Dorigan also questioned the study's findings about the impact of damage caps. Malpractice insurance costs are high but are falling for many doctors. From 2000 to 2004, malpractice insurers raised prices by 30 percent or more a year. But in 2005, Northwest Physicians Insurance lowered average rates for Oregon doctors by 8.3 percent and in January, the company reduced them by 10 percent. Dorigan said the number of claims has been falling for reasons that are unclear. Oregon internists pay $6,000 to $12,000 a year for coverage, less than one-fourth the average price in the five most expensive states. Ob-gyn doctors pay $41,000 to $75,000, or about a third the price in the most expensive states, according Medical Liability Monitor, an industry newsletter.


Peanut butter recall widens

U.S. food safety authorities extended a recall of peanut butter linked to a salmonella outbreak to include products bought as early as October 2004. Initially, the U.S. Food and Drug Administration said all Peter Pan peanut butter bought since May 2006, and all of Wal-Mart Inc.'s Great Value peanut butter with the batch code 2111 should be discarded. ConAgra Foods Inc. makes both, and has recalled all potentially contaminated batches.

On Friday 9Mar, the FDA said ConAgra had said all Peter Pan and Great Value peanut butter beginning with product code 2111, including peanut butter toppings, back to October 2004, were being recalled. "Consumers who have purchased any of the products since October 2004 should discard them," the FDA said.



Ohio taxpayers might miss catastrophic injured vets' fund

Last year The Ohio Department of Taxation has offered a new and different charitable category to appear with others: the Ohio Military Injury Relief Fund. The fund was signed into law in late 2005 and has been in place since last year’s tax cycle. It was created to give money directly to Ohio veterans who fought in Iraq and Afghanistan and are severely wounded with catastrophic injuries such as loss of limb, blindness, brain damage or disfigurement. It’s likely to get even more notice as national news focuses on complaints about the treatment of injured vets.

In its debut appearance on last year’s tax forms, the Military Injury Relief Fund had the fewest contributors of the three donation options but amassed the most money, with 35,334 filers contributing a total of $531,971. The average donation for the veterans fund was more than $5 higher than the average for either nature fund for the preservation of scenic rivers and Ohio wildlife., according to statistics provided by the Ohio Department of Job and Family Services, which administers it. The fund itself is actually pretty simple. It makes cash available to veterans of the military operations in Afghanistan or Iraq who have suffered a catastrophic injury. No money from the fund has been distributed yet. The plan is to divvy the entire pot evenly among eligible veterans who apply. The ODJFS will launch its initial application process in July.

The fund was the brainchild of state Rep. John Boccieri, a Democrat from eastern Ohio, who sponsored it before moving on to the Ohio Senate. A major in the Air Force Reserves, Boccieri came up with the idea after piloting a C-130 plane full of injured vets home from Iraq. “It seems like the (Bush) administration talks a lot about helping the troops, but the level of commitment hasn’t been there,” Boccieri said this week. “The VA funding has been slashed.” He believes recent revelations about substandard care at the Walter Reed Army Medical Center hammer home his message. “I’ve heard stories of injured soldiers having to pay for their own meals at Walter Reed,” he said. “I just think it’s sad when we have these types of things happening.”


ACR Releases Updated MR Safety Guidelines

The American College of Radiology (ACR) has updated its MR safe practice guidelines in a whitepaper titled ACR Guidance Document for Safe MR Practices: 2007. The whitepaper is available on the American Journal of Roentgenology Web site.

The 2007 version represents a virtual rewrite of the entire document and contains information on, among other topics, nephrogenic systemic fibrosis (NSF), a reaction to gadolinium that has been noted in patients with renal disease. Each section has been re-evaluated and updated, with several entirely new sections and appendices including guidelines on MR facility safety design and facility emergency preparedness. First published in 2002, the safety guidelines were revised in 2004.

To read ACR Guidance Document for Safe MR Practices: 2007 in its entirety as published in the AJR go to this link:
http://www.ajronline.org/aheadofprint/AJR_06_1616.dtl


TBI Drug Developer Begins Phase II Clinical Studies

Xytis announced it has enrolled its first patient for phase II clinical studies for its traumatic brain injury drug (TBI) Anatibant. Xytis is a private biopharmaceutical company that specializes in central nervous system drugs. The pharmaceutical company focuses its research on central nervous system targets GABA-A receptors and acetylcholine receptors. Xytis recently completed clinical studies on a drug used to treat schizophrenia and are awaiting FDA approval.

Xytis' newest endeavor is a drug researchers hope will help TBI sufferers. Anatibant is a potent, small-molecule Bradykinin B2 receptor antagonist. The potent molecule works by targeting the Bradykinin B2 receptor to reduce secondary damage that is often detrimental TBI victims. By targeting the Bradykinin B2 receptor, Anatibant increases the permeability of the blood brain barrier which promotes the transport of oxygen molecules to the brain. Transporting oxygen to the brain as quickly as possible after a brain injury is crucial in the brain's recovery.

The president and CEO of Xytis hopes to enroll 400 patients with moderate to severe TBI's over the next year. Study participants will receive 3 doses of Anatibant or a placebo for 5 days. Researchers hope to investigate any adverse effects Anatibant may have and how the drug affects the mortality rate in TBI victims 6-16 days after injury.

"Our decision to undertake this clinical trial was based on several factors," said the president and CEO of Xytis. "There are no therapeutics for TBI despite the fact that the CDC estimates that in the US there are 1.4 million TBI cases per year of which 50,000 patients die and 235,000 are hospitalized with moderate to severe TBI. Among survivors, 5.2 million people require assistance in performing daily activities, resulting in costs of $60 billion. Worldwide the incidence is estimated to be 10 million cases per year with 1 million of these occurring in the US, Europe and Japan. Therefore a successful drug in TBI will be extremely valuable for patients and its developer."


March 12, 2007

What is tort law for?

Here is an abstract of an article published last year in the Vanderbilt Law Review by John C. P. Goldberg of Vanderbilt, and entitled, "What Are We Reforming?: Tort Theory’s Place in Debates over Malpractice Reform": This Essay explains why lawyers, policy-makers and scholars interested in medical malpractice reform and tort reform more generally must attend to tort theory. Theory does not provide answers to policy questions. Rather, it frames and guides analysis. The Essay uses two examples to make its point.

The first concerns the phenomenon of “under-litigation,” which is typically treated by commentators as a symptom of tort law's deficiencies as a scheme for deterring undesirable behavior and/or compensating injury victims. This evaluation presupposes, of course, that tort law is properly theorized as a scheme for deterring and/or compensating. An alternative and more satisfactory conception of tort treats it as a law that empowers victims of wrongs to respond to those wrongs by seeking redress from their wrongdoers. Given this alternative conception, we will want to know much more about why malpractice victims tend not to sue. For if they are knowingly and voluntary choosing not to pursue claims that the law has made available to them, then, on a wrongs-and-redress theory, there is nothing at all wrong with the tort system.

The second example concerns the constitutionality of reform measures that cut back on malpractice liability in the name of making medical services more readily available or cheaper. If tort law is conceived as public regulation of bad medical practices, i.e., enforcement actions brought by plaintiffs playing the role of private attorneys general, then courts probably should assess the constitutionality of malpractice reform measures under toothless rational basis analysis. If, by contrast, tort is understood as a law for the redress of wrongs, courts will be entitled to deploy a more robust form of judicial review.


CSX Train tank cars explode in upstate N.Y.

A train carrying liquefied propane derailed in the morning of 12Mar, setting off an explosion and fire that forced evacuations from Oneida, a small central New York city and shut down a section of highway. The 7 a.m. blast sent a huge fireball into the dawn sky. Thick smoke continued pouring out hours later as about half a dozen propane tanker cars burned. The explosion followed the derailment of about 15 of the train's 80 cars. Fire crews fought to keep the flames from spreading to other tanker cars, about half of which carried propane. "There is danger of further explosions," said Fire Department Lt. Kevin Salerno. There were no immediate reports of injuries or fatalities.

The derailment occurred in an unpopulated area on Oneida's north side. Officials were evacuating an area of about a one-mile radius, covering most of the downtown area of the city of 10,000. Up to 4,000 people live within that area, but the evacuation was mandatory only for homes closest to the blast. A 23-mile stretch of the state Thruway, which passes within a mile of the explosion, was closed in both directions as a precaution, said Patrick Noonan, a spokesman for the Thruway Authority.

Amtrak suspended service between Syracuse and Albany. The CSX Corp. train that derailed was headed from Buffalo to Selkirk, just south of Albany, said company spokesman Robert Sullivan. He said the cause of the accident hadn't been determined. Sullivan said that in addition to propane, two cars were carrying hazardous materials. One contained a flammable liquid and the other carried a corrosive, but he had no other details on the materials.


TBI a Life-altering condition

Long before the wars in Iraq and Afghanistan made TBI a household acronym for Traumatic Brain Injury, millions of Americans were already struggling with lifelong disabilities brought on by head injury. Commonly known as "the silent epidemic," TBI, caused by a blow to the head or a penetrating injury, is a leading cause of death and disability in children and young adults. Brain injury can produce a smorgasbord of symptoms, from debilitating fatigue and memory loss to difficulty concentrating and problem-solving. Anxiety and depression come with the territory. Severe complications, including epilepsy, aren't unusual after severe brain injury.

What statistics omit is even more troubling. Acquired brain injury, typically caused by strokes, aneurisms or lack of oxygen, isn't included. Neither are blast injuries sustained by troops in combat, age-induced dementia or undiagnosed head injuries never treated in a hospital. "If you put them into one category, it would blow the ceiling off. It's a huge problem," said Wes Gravelle, injury program coordinator for the Division of Injury and Violence Prevention at the S.C. Department of Health and Environmental Control. "It tears families apart," he said. "Caregivers don't always know that [behavioral] changes are due to head injury. Sometimes they don't know why this person has changed." Joan Graham, executive director of Horry County Disabilities and Special Needs, said commonplace activities may require Herculean effort for individuals who've sustained a brain injury. "They look normal, but their short-term memory, impulse control, anger and sequencing is so altered, it's hard for someone to comprehend it," she said.


TBI Recovery Compound May Help Those in Vegetative States

Each year 50,000 - 75,000 Americans are left in an altered of consciousness after surviving a severe traumatic brain injury (TBI). Altered states of consciousness are characterized by a lack of awareness and lack of interaction with the environment. Altered consciousness is mostly a result of diffuse axonal injuries that occur during a TBI. Axonal diffuse injuries disrupt dopamine pathways which put many TBI sufferers in comas or vegetative states. Thanks to NeuroHealing Pharmaceuticals, Inc. there may be a new treatment available for TBI sufferers in altered states of consciousness.

NeuroHealing Pharmaceuticals, Inc. is a private company that specializes in the development of products for patients with chronic TBI's. The company recently released clinical data for a new drug they say could help TBI sufferers in altered states of consciousness. The new drug, NH001, is a coma recovery compound that is made of a dopaminergic agent. The dopaminergic agent helps the drug accelerate recovery and improves the functional outcome of patients in comas or vegetative states after a TBI event.

Eight TBI patients were administered NH001 and 5 of the 8 showed signs of progressive improvement with clinically significant changes in consciousness. The improvements continued even after patients were taken off of NH001. The results are historic since 7 of the 8 patients had previously received commonly used stimulant drugs and showed no response. The principal investigator of the clinical study, noted that "patients who had tried and failed to respond to the standard medications, responded promptly to the NH001 treatment, and their outcomes were surprisingly better than predicted considering the severity of the brain damage."

There are currently no approved treatments available for post- TBI patients in vegetative states. NH001 was well tolerated by the patients and could prove to be a new, safe, and effective treatment for chronic TBI sufferers.


Potential MRI Risk for Some Patients - NSF

A professor at the Yale New Haven hospital in Connecticut is a world-renowned expert on a rare disease that may be more common than anyone thought. His most recent research also points to a very "popular medical test" as the "cause" of the disease.

Dr. Shawn Cowper defined this disease seven years ago and has been studying it ever since. It's called Nephrogenic Systemic Fibrosis or NSF. "Like being encased in plaster and when that happens their joints are fixed in a position. Sometimes it's not a usable position." Dr. Cowper is studying slides of more than 225 cases from around the world. Nearly all had gadolinium which is a metal used in MRI's. Doctors say MRI's are safe for healthy people, but Nick and all of the other patients diagnosed also have kidney disease. Dr. Cowper believes the failing kidneys are not able to get rid of the gadolinium and it builds up in the body. Dr. Cowper is hoping to change the way hospitals perform MRI's, making sure everyone with kidney disease has a warning beforehand. He's even making the argument to the FDA to raise awareness about preventing this debilitating disease.


March 09, 2007

Ski area cited and fined for accident resulting in serious injuries

The Oregon Occupational Safety and Health Division has recommended five citations and $15,700 in fines against Mt. Bachelor Inc. for an October chairlift maintenance accident that hurt four people and could have been prevented, according to a report released March 5th. The accident, which seriously injured one of the Mt. Bachelor maintenance employees, occurred while the four were attempting to splice a cable on the Sunshine Accelerator lift. "This accident was an accumulation of a breakdown in the maintenance procedure process over a number of years and Mt. Bachelor taking shortcuts in completing splicing, which finally resulted in an injury accident," the agency, commonly called OR-OSHA, stated in its report. Mt. Bachelor disagrees with some of the findings and has appealed three of the five citations, said Carly Carmichael, marketing director for the ski area located west of Bend.

Lift maintenance worker Howard Dunlap, 40, was the most severely hurt. Dunlap was standing up the hill when the flailing cable line struck him on the right side and under the right arm. He was thrown into the air approximately 15 feet and landed on his face and head. Dunlap suffered two fractured vertebrae, a fractured right arm at the shoulder socket, a fractured left leg between the ankle and knee, a dislocated right shoulder, torn ligaments and tendons in the right arm and shoulder and cracked ribs and severe bruising. Dunlap is still undergoing rehabilitation. Two other employees, Owen Evans and Micah Holzhouser, also were struck by the cable, suffering primarily bruising, fractures and torn ligaments. Both were treated and released the day of the accident. A fourth worker, Sara Magness, was standing under the lift when the accident occurred and was hit with fragments of shrapnel that had exploded from the clamp when it failed. Magness suffered minor injuries and was treated and released the same day as the incident.

On Oct. 20, the four Mt. Bachelor lift maintenance employees were trying to do a "shortening splice," a procedure that involves stretching a cable so that workers may trim the slack and then splice the cable line back together. On the day of the accident, a clamp anchored one end of the steel cable to the ground while employees used a D-9 Cat to pull the other end of the cable toward the clamped end. As the workers pulled the cable taut, putting an estimated 20,000 pounds of tension on the anchoring clamp, they noticed that the anchor clamp appeared to be slipping. When the employees notified their supervisors about the problem, the supervisors directed the employees to tighten the bolts on the clamp. As they did, the clamp violently broke away from the ground, whipping the heavy cable into the air like an unattended garden hose, striking three of the workers. The state listed all of the five violations as serious.


Woman dies after peanut butter ingestion

Law firms file their second lawsuit against ConAgra Foods Inc. on behalf of victims of salmonella poisoning derived from contaminated Peter Pan brand peanut butter. This case was filed on behalf of the daughter of a woman who died after ingesting contaminated Peter Pan peanut butter. Two firms have filed a lawsuit against ConAgra Foods Inc. on behalf of the daughter of a woman who died from Salmonella poisoning after eating Peter Pan peanut butter. The case was filed March 5, 2007 in the U.S. District Court for the Northern District of Mississippi Delta Division. The suit alleges, amongst other things, that ConAgra's negligence, and its failure to comply with the requirements of the Federal Food, Drug & Cosmetics Act contributed to the peanut butter contamination and subsequent outbreak of Salmonella. The firms have been contacted by thousands of people who became sick after ingesting contaminated peanut butter manufactured by ConAgra.

Prior to the February 14, 2007 recall, the decedent ingested Peter Pan peanut butter with a product code beginning with 2111. Shortly after consuming the peanut butter the decedent began developing symptoms, including fever, vomiting and diarrhea and was hospitalized at the Methodist German Town Hospital in Memphis, Tennessee. Treatment options were unsuccessful and the woman died from salmonella related complications on February 15, 2007. In addition to the pain and suffering the decedent’s family continues to endure, they have also incurred significant medical expenses as a result of this illness and death.

On March 1, 2007, the FDA announced it found the strain of salmonella that tainted peanut butter made at the ConAgra Foods plant in Sylvester, Georgia. Government and industry officials have said the contamination may have been caused by dirty jars or equipment. On February 14, 2007, ConAgra Foods recalled lots of Peter Pan and Great Value peanut butter due to salmonella contamination and widespread reports of related illness in multiple states. The FDA warned the public not to eat Peter Pan or Great Value (a Wal-Mart brand manufactured by ConAgra) to avoid becoming sick with Salmonellosis. The recalled peanut butter jars have a product code beginning with "2111" on the jar lid. Consumers are being advised to avoid the recalled peanut butter. This lot of peanut butter was 1st manufactured in May 2006 and continued through the February, 2007 recall. ConAgra manufactures both the Peter Pan and Great Value brands in the company's Sylvester, Georgia facility. The FDA has sent investigators to ConAgra's processing plant in Sylvester, Georgia to review records, collect product samples and conduct tests for Salmonella Tennessee.


Senators, Bush vow to overhaul care for vets

Senators pledged Tuesday March 6th to consider all options to fix a broken system of caring for wounded troops, while President Bush announced a new commission will look into the problem. Sen. Bill Nelson, D-Fla., also raised questions about care at a Tampa Veterans hospital, where active-duty trauma patients are treated, during a Senate Armed Services Committee grilling of top defense officials about problems at Walter Reed Army Medical Center. The James A. Haley Veterans Hospital in Tampa is one of four VA hospitals in the country that specialize in traumatic brain injury and handle veterans and active-duty military. Nelson said there have been delays in getting rehabilitation for troops with brain injuries, sometimes postponing care until the patient is moved from active duty to veteran status. "A soldier shouldn't be a Ping-Pong ball," Nelson said during the hearing. Nelson cited a report showing that at model hospitals the delay in starting rehabilitation was slightly more than two weeks, but for the VA it was six weeks. David S. Chu, undersecretary of defense, said there is an agreement between the VA and Department of Defense to treat each other's patients, so there should not have been long delays at the Tampa hospital. "I'll look into it," Chu said. "It should not have happened, bottom line."

Gen. Peter Schoomaker, Army chief of staff, said such delays are "unacceptable." He added that he had visited the Tampa facility and called it an "extraordinary" hospital. Carolyn Clark, spokeswoman for the James A. Haley facility, disagreed with Nelson's conclusions, saying the hospital provides state-of-the-art care for traumatic brain-injury patients. Clark said the Tampa VA hospital uses "an interdisciplinary team consisting of physicians, rehabilitation therapists, audiologists, speech pathologists, neuro-psychologists, psychologists, social workers and other disciplines" to meet the patient's needs. "In addition to the great care we provide, we have two DOD liaisons on site to assist with the transition from military status to veteran," she said.

Lt. Gen. Kevin C. Kiley, surgeon general of the Army, said the Army has put ombudsmen in the four centers that deal with traumatic brain injury to coordinate the care of active-duty troops being treated in those VA hospitals. Experts said some troops who receive traumatic brain injuries aren't immediately aware that they have them. "We're just recognizing the depth and extent of the challenges associated with these very mild but extremely challenging conditions," Kiley said. Meanwhile, Bush said former Sen. Bob Dole, an injured war veteran, and former health secretary Donna Shalala, who is now president of the University of Miami, will lead the administration's investigation into problems of poor conditions at Walter Reed. "We have a moral obligation to provide the best possible care and treatment to the men and women who served our country," Bush said in a speech to the American Legion. "They deserve it, and they're going to get it."


$30 million verdict against Lexington Medical Center is overturned

Circuit Judge Diane Goodstein orders new trial in suit involving death at Lexington Medical Center saying a jury’s $30 million award last August against LMC “shocks” her conscience. She has issued an order overturning the verdict and ordered a new trial. “The jury’s verdict in this case shocks the conscience of this Court,” wrote Goodstein, who presided over the month long trial in Lexington. The jury found the hospital and an anesthesiologist responsible in the death of a local surgeon, Dr. Asif Sheikh in 2002. In her order, Goodstein said she relied on a legal doctrine known as the “13th juror,” which allows a judge to nullify a jury award if she considers it grossly out of proportion with the case’s facts. Goodstein wrote that trial evidence indicated a more reasonable award would have been at most, in the $5 million range. That would cover actual damages for the loss of the patient’s income and companionship. The jury’s tacking on an extra $25 million in damages “can only be explained upon the basis of sympathy, passion or caprice” she wrote.

Goodstein made another crucial ruling during trial that some say had influenced the jury. That was Goodstein’s decision to allow hospital attorney Johnson and Fieger to reach what is called a “high-low” deal. It meant the hospital’s exposure, regardless of the jury verdict, would be limited to a range of about $300,000 to $1.1 million. It also meant that Johnson agreed to put on a limited defense without the jury’s knowledge. Johnson did little cross-examination and was limited to a 10-minute closing argument. John Smith, a lawyer for the anesthesiologist in the case, said Thursday that Goodstein’s trial ruling to keep the Fieger-Johnson deal secret from the jury was unfair to the jury and harmful to his client. Once the jury saw that Johnson was not vigorously defending the hospital, the jury assumed the worst about both the hospital and the anesthesiologist, Smith said. Smith, a former circuit judge, said such secret deals, in which the jury is forbidden to know one defendant has agreed to stop putting up a vigorous defense, are rare. The issue would have been a major focus of any appeal he would have filed, he said. “It’s a staged trial,” Smith said, and that’s why some states outlaw such agreements.

The high-stakes, high-profile case involved the unexpected death of Dr. Asif Sheikh, the prominent local surgeon who was in the hospital for a routine double-knee replacement. Sheikh, 58, who held a top post at Lexington Medical, was in apparent excellent health, but died at the hospital while recovering 17 hours after surgery. Geoffrey Fieger, the Sheikh family’s lawyer, said Thursday he was “disappointed” with the order but would not contest it. “Judge Goodstein is one of the fairest and brightest judges I’ve ever seen,” said Fieger, of Detroit. “I don’t mind a bit if we try the case again in front of her. When we win another $30 million verdict, I don’t think she will take the position that that will be unreasonable.”


March 08, 2007

Are Ortho Evra Patch users at more risk for cancer?

According to the FDA found on their label site describing Ortho Evra or Patch use numerous epidemiological studies give conflicting reports on the relationship between breast cancer and COC (combination oral contraceptives) use. The risk of having breast cancer diagnosed may be slightly increased among current and recent users of the combination oral contraceptives. However, this excess risk appears to decrease over time after COC discontinuation and by 10 years after cessation the increased risk disappears. With a 60% increase of hormones released through Ortho Evra does that increase cancer risk? Some studies report an increased risk with duration of use while other studies do not and no consistent relationships have been found with dose of type of steroid. Some studies have found a small increase in risk for women who first use COCs before age 20. Most studies show a similar pattern of risk with COC use regardless of a womans’s reproductive history or her family breast cancer history.

In addition, breast cancers diagnosed in current or ever oral contraceptive users may be less clinically advanced than in never-users. Woman who currently have or have had breast cancer should not use hormonal contraceptives because breast cancer is usually a hormonally sensitive tumor. Some studies suggest that combination oral contraceptive use has been associate with an increase in the risk of cervical intraepithelial neoplasia in some population of women 45-48. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. In spite of many studies of the relationship between oral contraceptive use and breast and cervical cancers, a cause-and –effect relationship has not been established. It is not know whether Ortho Evra is distinct from oral contraceptives with regard to above statements.


Move by PRMC to avoid Med-Mal charges

At least 25 patients may have received unnecessary heart stent procedures at Peninsula Regional Medical Center last year, and the hospital is conducting an independent review to determine if any more are at risk. The incidents have compelled the hospital to conduct stronger audits of operating room procedures. While medical staff confirmed that the procedure, along with the subsequent office visits and consultations can be profitable to a doctor, the hospital said it is not looking to file any medical malpractice or criminal charges at this time. The operations under review were conducted by Dr. John R. McLean, a Salisbury cardiologist. Medical center officials said McLean suffers from a visual problem, which could have led the doctor to misdiagnose arterial blockages and require the procedures. Hospital officials did not say whether McLean's vision problems caused him to make any miscalculations during other heart procedures. PRMC said it would rectify the situation by paying back full medical fees to patients and their health insurance providers for the procedure. Subsequent costs and legitimate procedures are not available for a refund.

Stent use is popular because it is an alternative to bypass surgery and several stents can be implanted to safely remove clots. The disclosure of the possibly unnecessary stent procedures comes at a time when the stent devices are being used about 5 percent to 10 percent less by cardiologists nationwide. Medical experts fear stents can cause arterial scar tissue that eventually blocks arteries as much as the harmful plaque the stents are designed to remove. The Food and Drug Administration issued a warning last year that said there is a "higher, elevated risk of a blood clot" in a small percentage of patients, an agency spokesperson said. Other local doctors, however, said stents are safe when used properly.

"We sincerely regret this unfortunate event," the PRMC statement said. "In addition, the medical center's administration and medical staff will continue its review of this matter to ensure that our patients receive the high quality care they have come to expect." At issue with McLean's patients is that many of them did not meet a minimum 70 percent blockage guideline that the hospital uses to determine a patient's stent need. Even though all of McLean's patients had some degree of coronary artery disease, they may not have needed the expensive device and procedure that can total several thousand dollars. Besides the operation's four-figure bill, follow-up visits and additional blood-thinning drugs such as Plavix, a $2 to $6 daily pill, are needed after most procedures. To determine the extent of the problem, the hospital has initiated its own internal review by its cardiologists, as well as hiring an outside consultant from Chicago to conduct an independent analysis. The hospital would not release the name of the external investigator.


NFL STUDIES EFFECT OF CONCUSSIONS ON BRAIN FUNCTION

Just days after Dr. Elliot Pellman stepped down from his position as chairman of the NFL concussion committee, the NFL has announced that it will begin a new study focusing on the brain's functions after a concussion. The study will look at the effects of multiple concussion on the brain's fuctions. Dr. Ira Casson, co-chairman of the committee says the study's main goal is to answer the question "of whether or not a career in the NFL results in any kind of chronic brain injury." Recent tragic events that have marred the NFL, such as the suicide of NFL player Andre Waters, seem to answer that question already.

Former Chicago Bears player Merril Hoge was forced to retire after suffering from 2 concussions in a 42-day period. Hoge states that he was never evaluated after sustaining the initial check-ups and was allowed to go back on the field. He now knows the dangers of sustaining multiple traumas to the head and feels fortunate that he did not experience second impact syndrome and is still alive.

Pellsman's 2005 report on concussions in the NFL received great criticism after its release. Under his direction, the study reported that there is "no evidence of worsening injury or chronic cumulative effects of multiple concussion in NFL players." The Pellman committe also reported that NFL players continued playing after a concussion were not at a "significant risk of a second injury either in the same game or during the season."

Criticism for Pellman's report ran rampant after the University of North Carolina released the findings of their own study involving retired NFL players and concussions. Critics hope the NFL will do a better job reporting on the effects of concussions on NFL players.


Increased Awareness Will Improve Brain-Injury Treatment, Officials Say

Traumatic brain injury is receiving increased emphasis from Defense Department leaders and the military medical community. DoD has made great strides in treating severe traumatic brain injuries. The challenge lies in better identifying and treating mild brain injury. These injuries, which can be caused by repeated concussions or indirect exposure to a bomb blast, are hard to diagnose because soldiers may not recognize their own symptoms, and screening tests can't always capture the full range of possible symptoms. Treatment of traumatic brain injury is an emerging field, because the use of improvised explosive devices is greater in this conflict than it has been in any other, said Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs. Recent increased attention on traumatic brain injury is positive, Winkenwerder said, because it teaches service members, commanders and medical personnel that subtle brain trauma is something that needs to be taken seriously and treated.

In late 2006, DoD implemented a thorough screening process, based on one used for professional athletes, for soldiers and Marines who suffer head injuries. The post-deployment health assessment all service members must go through also includes questions about mental and psychological symptoms. Even with these processes in place, not all service members who suffer from mild traumatic brain injury are identified. DoD needs to develop tests that will measure service members' cognitive functions to establish a baseline for comparison when injuries occur. DoD also is refining its screening processes to better identify mild symptoms that are hard to spot, but awareness needs to be increased to help soldiers recognize their own problems. "We will try to identify all of them that we can, using objective tests," Winkenwerder said. "But we need to be very open to service members coming to us telling us that they perceive that they have an issue and treating them as if we had diagnosed them, because they may be more sensitive in their knowledge of themselves than we could be with objective tests." "Everyone's antenna are raised at this point about the need to look for the subtle cases, those who might not have been immediately in a blast zone, but could have been near, or that they might have experienced this kind of event two or three times," Winkenwerder said. "In those cases, they need to be looked at very carefully." Many cases of mild traumatic brain injury don't get reported because service members don't recognize the symptoms or are too embarrassed to admit to problems with memory or other mental functions, said Navy Vice Adm. Donald C. Arthur, surgeon general of the Navy. Arthur said he himself suffered a traumatic brain injury a year and a half ago and was initially embarrassed to talk about the problems he was having as a result. After he underwent basic cognitive tests, he said, medical personnel thought he was fine because they didn't have a baseline of his mental functioning before his injury to compare.

Another thing that can complicate the diagnosis of traumatic brain injuries is the residual effect of injuries that occurred at the same time as the brain trauma or medication that service members may be taking, Arthur said. Post-traumatic stress disorder also can affect mental functioning and may be confused for traumatic brain injury, he said. "It's important for us to go back and look at what are the components of the brain injury that are left, after the medications, after the combat stress, and after the other injuries are cared for," he said. DoD, in partnership with the Department of Veterans Affairs, is a leader in traumatic brain injury research, spending about $14 million so far in the area, he said. DoD is looking at enhancing that research effort in hopes of learning as much as possible quickly and applying that knowledge in the field, he said. "We're never satisfied," he said. "We do not believe at any one point in time that we've reached the best. It's a continual striving, and as we learn and deal with new situations, new circumstances, ... it's our obligation to respond and to learn and to get better."


Congressional Bill to help TBI victims

Sens. Orrin G. Hatch (R-Utah) and Edward Kennedy (D-Mass.) today introduced legislation to reauthorize the only federal law specifically addressing issues faced by 5.3 million Americans who live with a long-term disability as a result of traumatic brain injury, or TBI. Hatch and Kennedy were the principal authors of the original TBI law in 1996. “Those suffering from a traumatic brain injury deserve the best care possible,” Hatch said. “This bill couldn’t be more timely or important, it will help the thousands of soldiers coming home from Iraq and Afghanistan with traumatic brain injuries,” Kennedy said. The TBI Act would continue essential federal funding for programs within the Centers for Disease Control (CDC), National Institutes of Health (NIH), and Health Resources and Services Administration (HRSA) to conduct research on TBI, provide education and prevention programs and make available protection and advocacy services. The bill would reauthorize these programs through 2011, authorize a new study through CDC and NIH to determine the incidence and prevalence of TBI and instruct HRSA and the Administration on Developmental Disabilities to coordinate data collection regarding protection and advocacy services.

In Summary:
The bill expands the existing law enacted in 2000, with respect to TBI the reauthorization is crucial to essential federal funding for a range of TBI programs including reauthorize grants that have been assisting States, Territories, and the District of Columbia in building or enhancing coordinated systems of community-based services and support for children and adults with TBI. It will extend the ability to apply for these grants to American Indian consortia. When Congress first authorized the TBI Act as part of the Children’s Health Act of 2000 it included funding for a protection and advocacy programs for individuals with TBI. This program is needed because persons with TBI have an array of needs including assistance in returning to work, finding a place to live, obtaining needed support and services such as attendant care assistive technology, and mental health, substance abuse, and rehabilitation services. Often, these patients are forced to remain in extremely expensive institution far longer than necessary because community-based support and service are not available. Effective protection and advocacy services for people with TBI will lead to reduced government expenditures and increased productivity, independence and community integration. The Advocates must possess specialized skills, and their work is often time-intensive.

The reauthorization:
The Bill extends the authorization of such sums as are necessary for CDC research, public education and state registry programs; NIH research; and programs through 2011. It establishes a new study through CDC and NIH to determine the incidence and prevalence of TBI identify common therapeutic interventions, and develop rehabilitation guidelines. As well as amending the HRSA demonstration project program so that American Indian consortia can apply for funding. Projects are redefined to improve access to rehabilitation, and grants are limited to 3 years. It requires the Administrator of HRSA and the ADA Commissioner to coordinate data collection on protection and advocacy. It stipulates that, in any year in which at least $6 million is appropriated for the HRSA protection and advocacy services, 2% must be used for grants for training and technical assistance to protection and advocacy programs.


March 07, 2007

CDC warns of rare skin disease risk to kidney patients

Federal health officials are warning doctors that certain types of metallic dye injected for MRI scans have been linked to a rare and dangerous skin disease in kidney patients. More than two dozen dialysis patients in St. Louis over a four-year period contracted the unusual skin ailment, which causes burning and itching that can lead to discoloration and stiffening of the skin. The U.S. Centers for Disease Control and Prevention investigated a number of the cases last year and found the illnesses were tied to a contrasting agent used for magnetic resonance imaging tests. The disease occurred in patients with advanced kidney disease who had undergone an MRI or a similar test.

''To the general public, it's not a big concern. But to somebody with kidney disease, we want to warn them not to get an MRI with the contrasting agent,'' said CDC spokeswoman Jennifer Morcone. The dyes in question contain gadolinium, and are used in MRI scans that provide detailed pictures of internal organs and in similar scans that image blood vessels. The contrasting agents have been on the market since 1988.

Last year, the U.S. Food and Drug Administration issued a public health advisory following European reports of a rare skin disease in Austrian and Danish kidney patients who were given the agent.

The skin disease, called nephrogenic systemic fibrosis, is rare, but doctors think it may be under-recognized. A registry at Yale University has recorded about 215 cases to date. Steroid treatments or kidney transplants have helped some patients recover. The researchers noted that patients on peritoneal dialysis were more likely to develop the condition that those than on hemodialysis. CDC officials believe stricken patients weren't able to clear the contrasting agent from their body.


Bicyclists say raise bad-driver fines

Arizona bicyclists are calling for heftier fines for drivers who seriously injure or kill cyclists and pedestrians. It is a response, in part, to two recent accidents in Ahwatukee Foothills. The Coalition of Arizona Bicyclists is pushing for legislation to make hitting a cyclist in the right of way a crime punishable by a minimum fine of $1,000. "We need that, because we're getting killed out there, and it doesn't mean anything," Bill Lazenby, co-president of the group, said of current law. Two Republican legislators said they would support increasing fines for drivers at fault in such accidents. "Absolutely," Rep. John McComish of Ahwatukee said. "One thousand dollars doesn't sound like much of a hit . . . much of a penalty." Rep. Bob Robson, who also represents the area, said he favors increasing penalties but giving judges leeway in sentencing drivers. "I think what should happen is leaving it in the hands of a judge," he said.

The move comes several weeks after Phoenix picked Ahwatukee to unveil new bike safety signs warning drivers that they must give cyclists at least three feet of roadway. It also comes two years after cyclist Don Anselmo was struck and killed during his daily ride. The driver walked away without a ticket, outraging fellow cyclists and other Valley residents. Anselmo's widow recently filed a civil suit against the driver, Clinton Cabanillas, who was 18 at the time. Phoenix police investigators determined that Cabanillas wasn't speeding or impaired when he hit Anselmo. More recently, triathletes George and Jane Esahak-Gage were riding toward Ahwatukee when José Juarez hit them after leaving the freeway. The cyclists had a green light while off-ramp traffic from I-10 had a red light, according to the Arizona Department of Public Safety. Juarez, 23, was cited for failing to control his speed and driving without insurance and without a driver's license. A Chandler court sentenced him to pay $367 for the accident. He is making payments on the fine.

George Esahak-Gage said Juarez's fine was too small, especially considering the long-term medical injuries for which he is still undergoing intensive rehabilitation. The cost on "my life, my ability to enjoy the activities I used to enjoy and my work are my own problem," Esahak-Gage said this week. He and his wife have created a foundation to educate people about bicycle safety. A lawyer by training, George Esahak-Gage said he hopes the foundation and other groups will also increase the penalties on drivers who hit cyclists with the right of way. "My view is probably simplistic: The laws should protect non-motorists as long as they're in the right of way. The law, in my situation, should penalize someone," he said. Esahak-Gage said he doesn't expect to be finished with daily rehabilitation for at least a year. He has damage to his brain and teeth, among other things.


Another Lawsuit filed in peanut butter case

A part-time Pinellas County Florida resident filed a $5 million class action federal lawsuit against ConAgra Foods and Wal-Mart stores because of a salmonella outbreak believed to be caused by peanut butter products three weeks ago. Marion Caldarera filed the lawsuit on behalf of her and more than 500 others who ate tainted peanut butter processed by ConAgra in Sylvester, Ga., and sold by retailers across the country. According to public records, ConAgra has been sued 12 times since the outbreak was announced and the second such filed in Florida. A Palm Beach man filed a class action lawsuit in the Southern District of Florida on Feb. 23. Caldarera’s attorney, Edward Zebersky of Hollywood said she has suffered classic symptoms of salmonella poisoning for weeks.

On Thursday March 1st, the FDA linked the salmonella to the ConAgra plant in Sylvester and also warned customers to discard other products that may have been tainted by the peanut butter, including Sonic ice cream sundae toppings, Carvel ice cream toppings and J. Hungerford Smith dessert toppings. The FDA said those companies used the topping until Feb. 16, when the product was recalled.


TBI's Newest Treatment: Better Blood

http://www.popsci.com/popsci/science/9e367f36fca9e010vgnvcm1000004eecbccdrcrd.html Traumatic brain injuries (TBI's) are a common injury found in the US, yet there are no treatments available to effectively address brain trauma. Over 1 million Americans suffer from TBI's each year, with an estimated 30% dying from brain trauma. Nine months ago, Jamie Robertson nearly died after tripping and falling onto the back of his head. His brain was severely bruised which causes several blood clots. Immediate surgery was needed and Robertson attributes his survival and miraculous recovery to a new treatment created by Dr. Bruce Spiess.

Spiess, a cardiac anesthesiologist at VCU Medical Center in Richmond, VA, created a blood substitute to carry quickly carry oxygen to the brain. When the brain in is in trauma it swells and red blood cells that are needed for repair are too large to move into the damaged tissue. "There is no magic pill or treatment for traumatic brain injury in terms of salvaging brain tissue. If you can get oxygen to that tissue, you can salvage a lot of tissue," says Spiess. Fluoride particles were attached to carbon atoms to create a new particle, Oxycytes, that is capable of moving more oxygen to the damaged brain. Oxycytes are 1/50 to 1/100 of the size of red blood cells and carry 50 times more oxygen than red blood cells.

Oxycytes have a structure similar to the substance found on nonstick pans. TBI patients that were given Oxycytes immediately after a head trauma experienced a 3-fold increase in oxygen levels within 40 minutes of administration.

If approved by the FDA in the US, Oxycytes could become the first approved drug to treat TBI's in the US. Speiss also hopes to us Oxycytes in patients with spinal cord injuries, heart attacks, and stroke.


Scandalous treatment of Veterans

Right before Christmas, President Bush headed to Walter Reed Hospital for a photo shoot. Surrounded by an audience of soldiers who'd been seriously wounded in Iraq and Afghanistan, Bush proclaimed: "We owe them all that we can give them, not only when they're in harm's way, but when they come home to help them adjust if they have wounds." Yet soldiers who have suffered catastrophic injuries have not returned to a hero's treatment. Rather, they have been dumped at Walter Reed and other military hospitals around the country. They have been left to recover in rooms infested with mice and roaches, where walls and ceilings are falling apart and covered with mold. These are abysmal conditions that we wouldn't tolerate for a killer on Death Row. How could we, as a nation, treat a wounded soldier with such disrespect? Instead of doing everything possible to help these grievously injured young men and women begin to piece together their shattered lives, arrogant army brass and Veterans Affairs officials have made them jump through hoops to get the help they so desperately need.

The Washington Post, which broke the shocking news, has shone the spotlight on the Bush administration's betrayal of those who gave so much in service of our country. Injured soldiers and their family members tell of officials refusing to give them disability benefits. Officials rejected one soldier's disability claim for a preposterous reason that is nothing short of criminal. He was rejected because he had taken remedial math in high school so the benefits specialist reasoned that he had a preexisting mental condition. Therefore, even though he had suffered a severe head injury during an explosion in Iraq, he hadn't had a fully working brain to begin with.

Paperwork is repeatedly lost by incompetent bureaucrats, delaying benefits for months on end. There is no one to help the wounded navigate the complex bureaucracy. People who are unable to think clearly because of brain trauma and those who've lost limbs are left to fend for themselves. That is an outrage. Top administration officials knew about the problems at Walter Reed for years and did nothing about them. After the scandal began to gain steam, Defense Secretary Robert Gates sacked the Army Secretary, but he shouldn't be the only one to go. How about the head of Veterans Affairs who was supposed to oversee the military's health care system? How is it that a former commander at Walter Reed, who did nothing about the complaints during his tenure, has been appointed by Bush to head a panel looking into what can be done to immediately improve conditions there? That panel's first recommendation should be replacing its own chief.


March 06, 2007

Bausch & Lomb announces a limited recall of its ReNu MultiPlus Contact Lens Solution

Bausch & Lomb announced on March 6, 2007 a limited recall of its ReNu MultiPlus contact lens solution. This limited recall comes just 10 months after a worldwide recall of its ReNu with MoistureLoc contact lens solution. According to Bausch & Lomb, the MultiPlus solution contained traces of iron, which can lead to discoloration and a shorter shelf life. Bausch & Lomb believes that the majority of the product, manufactured about a year ago, has already been used by consumers. The recall includes approximately 1 million bottles that were distributed within the US and about 500,000 that were distributed in Canada, Latin America, Korea and Taiwan.


US Department of Defense Vows to Improve TBI Treatment

Although the US Department of Defense prides itself as one of the leading institutions in the area of traumatic brain injuries (TBI's), Defense officials recognize that more must be done. As the US is in an uproar after the Washington Post's report on poor conditions at Walter Reed, the Department of Defense has announced it will increase research efforts to better serve returning wounded veterans.

Record numbers of vets are returning from the frontlines with TBI's as the use of roadside bombs increasing in the Iraq War. Many severe TBI's are not the direct result of one major blow to the head. Rather, these TBI's are the result of several mild concussions and indirect exposure to the blasts caused by roadside bombs. These TBI's are extremely difficult to diagnose because symptoms often go unrecognized or are ignored by service members. The Surgeon General of the US Navy, Donald C. Arthur suffered a TBI over a year ago. He said initially embarrassed of his injury and was not diagnosed immediately due to poor cognitive tests. Arthur says that the Department of Defense must develop better cognitive tests to recognize the early signs of TBI. He also says they must raise awareness of how debilitating brain injuries can be so that service members are not embarrassed to share their symptoms.

The Department's research efforts will focus on refining their screening process. This effort will also include mandatory TBI screening for all wounded returning vets. "We're never satisfied," said Arthur. "We do not believe at any one point in time that we've reached the best. It's a continual striving, and as we learn and deal with new situations, new circumstances, ... it's our obligation to respond and to learn and to get better."

The Department of Defense plans to put more than $14 million into TBI research.


NFL's concussion adviser steps down

Dr. Elliot Pellman, who directed the NFL's concussion committee since its inception in 1994, has stepped down in the wake of mounting criticism from experts in the field of brain injury. Last fall, ESPN The Magazine documented that Pellman was selective in what injury reports he used to reach his conclusions and omitted large numbers of players from the league's study. He will be replaced by co-chairmen of the league's mild traumatic brain injury committee. Dr. Ira Casson, a neurologist from Nassau, N.Y., and Dr. David Viano, a biomechanical engineer from Wayne State University, will head the committee According to NFL spokesman Greg Aiello, Pellman asked to be relieved of his duties as chairman. Neither doctor is affiliated with an NFL team. Aiello said Pellman "will continue as a member of the committee and will continue to be the administrative liaison with our office."

In recent months, Pellman has been the subject of a critical article in ESPN The Magazine and been assailed for his lack of expertise in the area of brain injury that he has overseen for the last 13 years. "My perspective is that he was the wrong person to chair the committee from a scientific perspective and the right person from the league's perspective," said Dr. Kevin Guskiewicz, research director of the Center for the Study of Retired Athletes at the University of North Carolina. Guskiewicz said that recent papers published by the NFL's concussion committee were not well received in the medical community because they went against information that had been learned in other studies. "We found this at the high school level, the college level and the professional level, that once you had a concussion or two you are at increased risk for future concussions," said Guskiewicz, who has directed research on those three tiers of football. "He's continued to say on the record that's not what they find and there's no truth to it. "Basically, he says these guys [professional football players] recover differently than other people." Michael Kaplen, a New York attorney who specializes in representation of concussion and traumatic brain injury victims, takes his criticism even further. "This person is a rheumatologist, not qualified to be an expert on brain injuries," Kaplen said. "He's not a neurologist, neuropsychologist, neurosurgeon, and has no training in this area at all."


NSF…what is it?

Nephrogenic Systemic Fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), is a condition that, so far has occurred only in people with kidney disease. There is no convincing evidence that NSF is caused by a medication, a microorganism, or by dialysis. There have been no cases identified prior to early 1997. At this point it appears NSF is a systemic disorder with its most prominent and visible effects in the skin. For this reason, Nephrogenic Systemic Fibrosis has been suggested as an equivalent terminology in those previously diagnosed with NFD, and is preferred in that it more accurately reflects the current understanding of the disorder. Neither the duration of kidney disease nor its underlying cause are related to the development of NSF. Some patients with NSF develop skin tightening in the earliest stages of kidney disease, and others may have had kidney disease for years. Specific triggers for the development of NSF are still being investigated. Recent reports have strongly correlated the development of NSF with exposure to gadolinium-containing MRI contrast agents. GE healthcare is one manufacturer of gadolinium-containing MRI contrast.


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

The associated conditions enumerated in the preceding paragraph are frequently used to justify the use of gadolinium-enhanced MRI or MRA studies. Whether the recently announced association of NSF with gadolinium exposure is the common denominator of all NSF cases is still under investigation. A verifiable cause and effect relationship has not yet been established, but active efforts to prove or refute this relationship are underway. Two recent papers have verified the presence of gadolinium in the tissue of some patients with NSF, however, the study designs do not allow for determining whether the gadolinium caused the NSF.


March 05, 2007

Injured Vets Look Forward to Better Care

US Army Secretary Francis Harvey resigned after poor conditions at Walter Reed were exposed by a Washington Post report. US Defense Secretary Robert Gates requested Harvey's resignation because he felt that some Army officials were not taking the poor treatment of war veterans seriously. The Washington Post report consisted of a 2-part series that unveiled a faulty vet medical system that often left brain injury victims to fend for themselves. The report was also a major blow to President Bush and his administration. As Bush's approval ratings reach another all-time low, Walter Reed's poor conditions only exacerbate the current negative attitude toward the administration.

Bush announced that a bipartisan committee would be put together to investigate the poor conditions at Walter Reed. "Some of our troops at Walter Reed have experienced bureaucratic delays and living conditions that are less than they deserve," said Bush. " It is is unacceptable to me, it is unacceptable to our country, and it's not going to continue." The committee will evaluate the treatment of wounded vets from the moment they leave the front-lines to the moment they return to their previous everyday lives. Bush hopes this will uncover areas that need improvement and he plans to implement improvements in the near future.

As House panel hearings regarding the conditions at Walter Reed began today, many vets and their family members told their horrific stories. One vet's wife described the anguish her husband endured as doctors at Walter Reed refused to attribute her husbands brain injury to the war. She said that the Army is holding her husbands difficulties with learning certain subjects against him and will not acknowledge his injury. Many lawmakers are also sharing their opinions of Walter Reed's squalid conditions. Senator Joe Lieberman said, "There is not enough staff with the right skills to treat and care for the severely injured troops. And, rooms where some soldiers lived were found to be moldy and infested with rodents. Our nation has no greater moral and patriotic responsibility than to ensure that these brave Americans receive first class treatment, not only immediately after their injuries, but for their entire lives, through the Veterans Administration."


Contractor not liable for worker's injuries

A building contractor is not liable for injuries suffered by a brick mason who is permanently disabled after falling 12 feet from a scaffold a jury decided. Robert E. England, 30, suffered a serious head injury on Nov. 27, 2000, when he fell from a scaffold that did not have a safety railing installed, contrary to safety standards. England was 24 at the time and was building a block wall. In the fall, England struck his head on concrete, suffered a skull fracture, a brain stem injury, brain swelling, along with having his spleen removed. He has incurred more than $700,000 in medical expenses and is unable to live on his own. According to the Englands' attorney, John Daly of Indianapolis, Robert suffers from permanent balance and hearing impairments and walks with the assistance of a cane or walker. Daly said it takes England two hours to get dressed; he wears glasses to correct double vision, and he cannot be left alone for more than a couple of hours. Bob England said the change in his son's demeanor since suffering the injury is most striking. "Robb's changed in personality," Bob England said. "If he walked in a room, he would light up the room. Now, he's quiet. That's what bothers me the most."

England's parents and guardians, Deloris and Bob England, had sought $15 million from Fairfield, arguing that the general contractor had failed to maintain safety on the work site. "We'll keep trying to work with workman's comp," Deloris England said. "It's like food stamps or welfare. It's not something you want," Bob England said. "It's a safety net. It's a minimum thing. It wasn't designed for catastrophic injuries." Deloris England has given up her job to become Robert's primary caregiver. But the Englands are worried about how Robert's needs will be met after they are unable to care for him.

Rick Meils, the attorney representing Fairfield, argued successfully that England himself and Ed Muller Masonry bore most of the responsibility for England's injuries. "He had used this equipment before. He had experience putting it together," Meils said of Robert England. "All he has to do is go around the corner, get that railing and put it on, and we don't have an issue today." The jury's first order of business was to determine whether Fairfield bore any responsibility for the accident. If jurors found that Robert England himself bore more than half of the fault, the Englands could not recover damages. The jury's verdict was not specific about how it apportioned fault in the case, merely stating that the jury found for the defendant.


Hospitalizations for Traumatic Brain Injury on the Rise

In 2003, the rate of hospitalization for traumatic brain injury (TBI) in nine U.S. states was 87.9 people per 100,000, compared with 79.0 per 100,000 in 12 states in 2002, says a study in Friday's Morbidity and Mortality Weekly Report, published by the U.S. Centers for Disease Control and Prevention. The 2003 rate is based on figures reported by nine states reporting to the agency's TBI surveillance system. In those nine states, a total of 28,819 people were hospitalized for traumatic brain injury in 2003. Among the nine states, Arizona had the highest rate (105 per 100,000), while Nebraska had the lowest rate (51.8 per 100,000). Rates in the other seven states were: South Carolina (69.6); Utah (83.1); Minnesota (89.5); Oklahoma (90.5); Colorado and Maryland (91.8); and Alaska (93.3).

Motor vehicle traffic accidents and falls were the leading cause of hospitalization for traumatic brain injury. Prevention measures should focus on these two leading causes in order to reduce rates of traumatic brain injury, the study said. Each year in the United States, traumatic brain injury results in about 1.1 million hospital emergency room visits, 235,000 hospitalizations, and 50,000 deaths, according to the U.S. government.


Peanut Butter Toppings Part of Recall

FDA has learned that the ConAgra plant in Sylvester, GA, sent bulk Peter Pan peanut butter to its plant in Humboldt, TN. The three brands of toppings described below are part of the original Peter Pan recall. These brands have been recalled and are no longer being sold. However, some consumers may still have these products in their home. Consumers who have any of the products listed below should discard them. Individuals who are not sure if the purchased product contains the recalled peanut butter topping should contact the store where the product was purchased. The company's recall extends to products made since December 2005.

The bulk peanut butter was used to make the following toppings:

* Sonic Brand Ready-To-Use Peanut Butter Topping in 6 lb. 10.5 oz cans. Sonic outlets used the topping until 2/16/07, when the product was recalled.
The topping was used in the following Sonic products:
- Peanut Butter Shake
- Peanut Butter Fudge Shake
- Peanut Butter Sundae
- Peanut Butter Fudge Sundae

* Carvel Peanut Butter Topping in 6 lb. 10 oz. cans. Carvel used the topping until 2/16/07, when the product was recalled.
The topping was used in the following Carvel ice cream products:
- Chocolate Peanut Butter
- Peanut Butter Treasure
- Peanut Butter & Jelly
- Reese's Peanut Butter Cup Sundae Dasher
- Any other customized products containing the Peanut Butter Topping, including peanut butter flavored ice cream in ice cream cakes

* J. Hungerford Smith Peanut Butter Dessert Topping in 6 lb. 10 oz. cans: This topping may be used by retail and restaurant outlets throughout the United States but is not available for direct purchase by the public.


What side affects should be reported after Gadolinium injections?

The FDA urges patients to call their doctor right away if any time after the gadolinium injection the following conditions occur:

Skin and eyes: Swelling, hardening and tightening of the skin, reddened or darkened patches on the skin, burning or itching of the skin and yellow raised spots on the whites of the eyes.

Bones and muscles: Stiffness in joints; problems moving or straightening arms, hands, legs, or feet, pain deep in hip bones or ribs and muscle weakness.

What should healthcare providers do in response to this new information?

According to the FDA, physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis.

What additional actions are likely to follow?

The FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options.


What side affects should be reported after Gadolinium injections?

The FDA is urging patients to call their doctor right away if any time after the gadolinium injection the following conditions happen.

Skin and eyes: Swelling, hardening and tightening of skin, reddened or darkened patches on the skin, burning or itching of skin and yellow raised spots on the whites of the eyes.

Bones and muscles: Stiffness in joints; problems moving or straightening arms, hands, legs, or feet, pain deep in hip bones or ribs and muscle weakness.

What should healthcare providers do in response to this new information?

According to the FDA, physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis.

What additional actions are likely to follow?

The FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options.

Where can I find more information about gadolinium-based agents and about NSF/NFD?

The package inserts provide additional information about each of the approved gadolinium-based agents.


March 02, 2007

FDA Warns Companies Marketing Unapproved Ergotamine Tartrate

The FDA recently warned 20 companies to stop marketing unapproved drug products containing ergotamine tartrate, a product used to treat vascular headaches, including migraines. As part of the FDA's continued efforts to combat the marketing of unapproved drugs, the agency sent warning letters to eight manufacturers and twelve distributors, warning them that they are subject to further enforcement action if they do not stop manufacturing and distributing these products.

The agency urges consumers who are using ergotamine products and have questions or concerns to contact their health care provider. This action does not affect FDA-approved products containing ergotamine, which will remain on the market.

"Unapproved drugs pose real risks to the American public," said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Because they have not been subject to FDA review, the safety, effectiveness, and quality of such products are unknown. We remain dedicated to tackling this problem through education and outreach, as well as enforcement actions like these. It is central to our mission to ensure a safe and effective drug supply for the American public."


Woman Sues Abortion Clinic for Malpractice

A Newark woman who said she spent a month in a coma after undergoing an abortion at a Bergen County clinic sued the facility and several doctors there on Thursday. The lawsuit was filed in Superior Court in against Metropolitan Medical Associates. The clinic was ordered closed last Friday by state health officials until it corrects the "immediate and serious" risks. Rasheedah Dinkins, who is still recovering in a hospital, said she regrets having ended her pregnancy. "I think it's horrible what I had to go through," she told The Associated Press from her hospital bed Thursday morning. In retrospect, she added, "I probably wouldn't have made this choice." Dinkins said she was told by her mother and personnel at the hospital that she actually died in the ambulance on the way there, and was revived en route to the facility. She said she only regained the ability to speak on Tuesday. Dinkins, 20, felt ill after undergoing the abortion, and had to be rushed to a hospital by ambulance after she passed out at her home, her family said. At the hospital, she was given blood transfusions and had her uterus removed, Slater said. The attorney also said Dinkins suffered a stroke due to serious blood loss, and one of her lungs collapsed.

"We expect to get to the bottom of why this incredibly horrible result could have happened from such a simple procedure," her lawyer, Adam Slater, said. The shutdown order cites problems involving infection control, instruments and equipment used for sterilization. The clinic's Web site says its physicians have a complication rate of less than 1 per 1,000 procedures, calling its staff "the finest in the state of New Jersey."

Gloria Mozas of Cliffside Park is also suing the clinic, claiming doctors there wrongly diagnosed her tubal pregnancy in 2003 and told her she had miscarried, when in fact, she was carrying two live fetuses. She said a doctor there performed an abortion on her, telling her he was removing dead tissue from her womb. About a week later, she said she had to undergo a second procedure to remove the remaining fetus after she developed severe internal bleeding. She said she was heartened the state had shut the clinic down.


Class action suit filed against peanut butter maker

The massive peanut butter recall brought hundreds of phone calls to a Fort Myers law firm. Now, a class action complaint has been filed with one of the firm's offices in Hendry County. However, it will represent people across the state. Hundreds of kids and adults are part of a statewide class action suit. Scott Weinstein, with the law firm of Morgan and Morgan, filed the complaint against peanut butter company ConAgra. "There are hundreds of individual files," said Weinstein. "If people can show they had medical expenses like going to the hospital or doctor because they had salmonella and a stomach problem, or prescriptions they needed to get, they need to be reimbursed."

But the biggest concern for Weinstein is that many people threw away the evidence because of an FDA recommendation. "I think it would be fair for people, for consumers, if they want to sign an affidavit and swear that they threw away peanut butter. Why not believe them?" asked Weinstein. But Weinstein says for some, it may already be too late. "We have a lady in Orlando who unfortunately died. It's going to take some medical investigation to link it with the peanut butter," said Weinstein. So far, officials with the Centers for Disease Control have only four confirmed contamination cases of salmonella poisoning in Florida and most were in the Tampa area.


An Unforseen Cost of War -vets returning with TBI

Jarod Behee was shot in the head in Iraq. He survived, but is still suffering from the aftereffects of a traumatic brain injury. The Department of Veterans Affairs estimates that Behee is one of several thousand veterans returning from Iraq and Afghanistan with some kind of mental disorder or brain injury, but veterans advocacy groups place that number even higher. Behee's wife, Marissa, was so frustrated with the care that her husband had received at the VA in Palo Alto, Calif., that she pulled her husband out and put him in a private facility. "For the first month, I thought this isn't the way he should be treated," she told "Good Morning America." The VA in Palo Alto said that Behee's injury was complex, and that the Behees needed to be more patient. It broke my heart to see the other guys there not getting the care, but they didn't have their family there to fight for them," Marissa Behee said.

"What you have are two sets of books," said Paul Sullivan, a spokesman for Veterans for America. "The Department Of Defense saying that there's 23,000 wounded from the wars in Iraq and Afghanistan, but the Department Of Veterans Affairs is actually treating 205,000 veterans from these two wars," Sullivan said. The VA contends that the 205,000 is for treating all veterans, including the standard care that returning soldiers are allowed to receive for life. However, by its estimates, 73,000 soldiers returning from Iraq and Afghanistan have suffered from some kind of brain injury or mental disorder. It is an unforeseen cost of war that has overburdened the VA system, according to recent reports in Newsweek and congressional hearings on the subject. Veterans seeking treatment face red tape, weeks of waiting, and often to have to pay for outside experts in order to have their disability claims processed.

Jim Nicholson, a spokesman for the Department of Veterans Affairs, acknowledges that there are delays in the system, but says the department is struggling to overcome a lack of knowledge about TBIs. "This is a relatively new phenomenon. We are all doing intense research on it," Nicholson said. After six years of conflict in Iraq and Afghanistan, however, veterans' affairs advocates are asking why the VA did not take action sooner. Nicholson says that the VA is making a priority of the issue and pushing the claims of returnees from Iraq and Afghanistan to the top of its claims list. He said the VA also had requested $87 billion from the federal budget to help fund an expansion in TBI treatment and research.


Kidney Patients At Risk From MRI Dye

Federal health officials are warning doctors that certain types of metallic dye injected for MRI scans have been linked to a rare and dangerous skin disease in kidney patients. More than two dozen dialysis patients in St. Louis over a four-year period contracted the unusual skin ailment, which causes burning and itching that can lead to discoloration and stiffening of the skin. Steroid treatments or kidney transplants have helped some patients recover. The researchers noted that patients on peritoneal dialysis were more likely to develop the condition than those than on hemodialysis. CDC officials believe stricken patients weren't able to clear the contrasting agent from their body.

The U.S. Centers for Disease Control and Prevention investigated a number of the cases last year and found the illnesses were tied to a contrasting agent, basically a metallic dye, used for magnetic resonance imaging (MRI) tests. The disease occurred in patients with advanced kidney disease who had undergone an MRI or a similar test. "To the general public, it's not a big concern. But to somebody with kidney disease, we want to warn them not to get an MRI with the contrasting agent," said CDC spokeswoman Jennifer Morcone.

The dyes in question contain gadolinium, and are used in MRI scans that provide detailed pictures of internal organs and in similar scans that image blood vessels. The contrasting agents have been on the market since 1988. Last year, the U.S. Food and Drug Administration issued a public health advisory following European reports of a rare skin disease in Austrian and Danish kidney patients who were given the agent. The skin disease, called nephrogenic systemic fibrosis, is rare, but doctors think it may be under-recognized. A registry at Yale University has recorded about 215 cases to date.


March 01, 2007

Young Athletes Need to Beware of Head Injuries

Many young athletes put their well-being in danger when playing competitive sports. Coaches often stress qualities such as enthusiasm, endurance, and an ability to play through pain to their young athletes - the same qualities that may also put them at a greater risk for concussions and other TBI's. "When it comes to sports injuries, specifically concussions, younger athletes have a tendency to downplay their symptoms," said Dr. Joel Becker, a consulting neuropsychologist at Day Kimball. "And if they continue to play, without sufficient recovery, there is significant possibility of an additional, more severe injury."

Over 300,000 cases of concussions in young athletes are reported each year. This number does not even take into account the numerous head injuries that go undiagnosed and are ignored. An estimated 600,000 go unreported annually. This is a serious problem since many young athletes and their parents assume that all brain injuries are caused by a direct blow to the head. Sports related brain injuries and concussions may occur after a simple fall and most do not involve a loss of consciousness or any other obvious symptoms. Some symptoms may surface hours and even days after the initial injury.

After any hard fall, parents and coaches of young athletes should monitor the youth's behavior closely. Signs of severe injury include: aggravated headaches, nausea and vomiting, episodes of unconsciousness, dilated pupils, confusion, slurred speech, and impaired motor functions. If any of the aforementioned behaviors are witnessed any time after a fall, medical care should be sought immediately.


Salmonella cases from peanut butter rise to 370

The number of illnesses resulting from salmonella contamination in jars of peanut butter has climbed to 370, federal health officials said Tuesday. The number is up from 329 confirmed cases last week. Forty-two states have confirmed cases and sixty people have been hospitalized, but there have been no deaths, according to the U.S. Centers for Disease Control and Prevention. The recall has been widely reported and prompted lawsuits. It's likely that additional cases are due to raised awareness and not recent illnesses, said CDC spokesman Dave Daigle. "There may be a few weeks from when a case occurs to when it is officially reported, so we would attribute this rise in the case count to a reporting phenomenon rather than a new spike in cases," he said.

Government and industry officials have said the contamination may have been caused by dirty jars or equipment. Peanuts are usually heated to high, germ-killing temperatures during the manufacturing process. The only known salmonella outbreak in peanut butter was in Australia during the mid-1990s and it was blamed on unsanitary plant conditions.


BIA Partners with ABC Anchor Bob Woodruff to assist TBI Veterans

The Brain Injury Association of America (BIAA) has entered into a partnership with ABC Anchor Bob Woodruff and his family to raise awareness of traumatic brain injury (TBI) and to administer the newly created Bob Woodruff Family Fund for TBI to assist servicemen and women and their families affected by the war in Iraq and Afghanistan. The announcement was made today by Susan Connors, president and CEO of the Brain Injury Association of America.

In an effort to "give back" to the people who saved Bob's life, the family has established the Bob Woodruff Family Fund for TBI (www.bobwoodrufffamilyfund.org). The Fund will raise money through events and other activities. Donations will be used to make grants to nonprofit organizations serving members of the military who have sustained a TBI. In some circumstances, funds may be used to provide direct financial assistance to military personnel and their families and/or grants for medical research, public education, awareness and prevention of TBI.

Woodruff will also file a series of reports for ABC's World News Tonight, Good Morning America and Nightline throughout the month of March. The reports will cover various aspects of brain injury and will include some of the individuals featured in BIAA's Brain Injury Awareness Month campaign, "Living with Brain Injury: As Diverse as We Are." "We are honored to assist Bob and Lee as they embark upon their mission to assist returning veterans with TBI and their families," said Connors. "Their actions are a rallying point for both military and non-military TBI survivors and their families to finally receive the kind of support and cognitive treatment services they so desperately need."

Founded in 1980, the mission of the Brain Injury Association of America is to create a better future through brain injury prevention, research, education and advocacy. BIAA and its nationwide network of state affiliates, chapters and support groups represent the 5.3 million Americans who live with a lifelong disability as a result of traumatic brain injury, as well as their families and the researchers, clinicians and professionals who provide treatment and long-term care. For more information about brain injury or the BIAA, visit www.biausa.org.


Surgeries overseas could save thousands of dollars

A growing number of Americans who can’t afford health care are getting around that problem by going overseas to have surgery, and the term "medical tourism" could be changing American medical care. There are an estimated 45 million uninsured people in the United States. Last year, 500,000 people, primarily those uninsured, traveled overseas for medical treatment. PlanetHospital.com arranges for medical procedures in hospitals in Mexico, Costa Rica, India, Singapore and Thailand. Doctors perform everything from cosmetic to open heart surgery at a fraction of the cost. For example, a $75,000 heart bypass surgery in the United States costs just $7,000 in India; A gastric bypass operation that costs $25,000 here costs $6,000 in Costa Rica; and a $47,000 knee replacement surgery costs $26,000 in Singapore.

Do you receive the same quality of care in a developing country that you would get in the United States? "I think, in many cases, there are very high quality facilities that are giving us a run for our money in this country," said Dr. Dana Forgione, a business professor at the University of Texas at San Antonio. Forgione, an expert on health care, recommends making sure foreign doctors are U.S. board certified and that the hospitals have accreditation from American medical boards. The downside to care in a Third World country is that, "your doctor may be terrific, but maybe an orderly or a nurse or a housekeeping person is going to a home where a person has exposure to malaria, which is not uncommon in that country," Forgione said. Forgione continues, if something goes wrong, it will be difficult to sue in a foreign court, where malpractice claims are rare. And, if there are complications with the procedure, you can't run back to the doctor's office when it's thousands of miles away. The overseas competition could lead to lower medical costs in the United States. "I think this is an up-and-coming area, and one that deserves a lot of attention," Forgione said. Although most traveling overseas for treatment are uninsured, a few insurance companies are offering trips to foreign hospitals as a cost-cutting option in medical plans.

Robin Kinney recently traveled to India to have knee surgery. "Ten days in the hospital, have surgery, everything was included, $2,800," she said. In the United States, that surgery would have cost $8,000. Kinney does not have health insurance, so she contacted the company PlanetHospital.com, which arranges for Americans to travel overseas for medical care. Kinney's doctor in India and PlanetHospital.com arranged for her physical therapy in Texas. If she develops problems, she plans to go to a local emergency room. However, if she ever needs major surgery again, she said she won't hesitate to go overseas. "They cared more about me as a person, and my knee, than what my insurance was," she said. Tom and Merri Borta also traveled to India for surgery. Tom had a blocked artery, the same artery operated on three years ago at a U.S. hospital that charged full price. "It was over $35,000, and even to this day, we're still paying on it," Tom said. Doctors in India removed the blockage in a surgery that cost only $7,000. "$28,000 difference, for the exact same thing that I had done," he said. .


Gadolinium Contrast Agents for MRI vs. MRA

The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. There are five gadolinium-containing contrast agents FDA-approved for use during magnetic resonance imaging (MRI). They are: OptiMARK, Magnevist, ProHance, and MultiHance. However, the FDA has not approved them for the use in MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI.

The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium-containing contrast agent, and took the MRA test. Worldwide, there are approximately 200 reports of NSF/NFD. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD. The disease appears to occur in patients with kidney failure along with high levels of acid in body fluids a condition known as acidosis that is common in patients with kidney failure. Patients with NSF/NFD have tight and rigid skin making it difficult to bend joints. NSF/NFD may also result in fibrosis, or scarring, of body organs resulting in the inability of body organs to work properly and can lead to death. Scientists first identified NSF/NFD in 1997 and the cause of NSF/NFD is unknown.


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