Archive for January, 2007

FDA Approves Drug To Treat Obesity In Dogs

Wednesday, January 17th, 2007

The U.S. Food and Drug Administration (FDA) issued its approval of the first-ever drug to treat canine obesity, a condition that affects approximately 5 percent of dogs in the United States.

The new drug, called Slentrol (generic: dirlotapide), is manufactured by Pfizer, Inc. and, according to the FDA, it “reduces appetite and fat absorption to produce weight loss” in canines. “This is a welcome addition to animal therapies, because dog obesity appears to be increasing,” said Dr. Stephen Sundlof, director of the FDA’s Center for Veterinary Medicine. “Veterinarians are well aware that overweight pets are at a higher risk of developing serious health problems, from cardiovascular conditions to diabetes to joint problems.”

Slentrol is as a “selective microsomal triglyceride transfer protein inhibitor.” The drug blocks the assembly and release of lipoproteins into the bloodstream, which leads to reduced fat absorption and a “satiety signal” from lipid-filled cells lining the intestine. The recommended regimen consists of an initial 14-day prescription, which is then adjusted month by month until the dog reaches the desired weight level. Once that happens, Pfizer recommends continuing Slentrol treatment for an additional three months in order to stabilize the dog’s weight. However, adverse reactions may include vomiting, loose stools, diarrhea, lethargy, and loss of appetite.

It should be noted that Slentrol is not approved for human use. The label notes quite clearly: “Not for use in humans. Keep this and all drugs out of reach of children.” Humans who disregard that warning may be susceptible to abdominal distention, abdominal pain, diarrhea, flatulence, headache, nausea, and vomiting.

Study: Cold Medicines Dangerous To Infants

Wednesday, January 17th, 2007

A new study has found that over-the-counter cold medications can be hazardous and even deadly to infants.

The government research found that more than 1,500 children under two years old were admitted to emergency rooms for problems caused by taking these medications. Three infants less than six months old died.

“Cough and cold medicines can be harmful, and even fatal, and should be used with caution in children under 2 years of age,” said the study’s author and officer in the Epidemic Intelligence Service at the U.S. Centers for Disease Control and Prevention, Dr. Adam Cohen. “They are drugs, so they have risks as well as benefits.”

The study was published in the Jan. 12 issue of Morbidity and Mortality Weekly Report .

These types of drugs are only FDA approved for use by children over two years old. Studies have concluded that they are not effective for children under two.

“Cold and cough medications, especially medications containing pseudoephedrine, have never been shown to have any beneficial effect on children less than 2 years of age, yet they clearly can have significant harmful effects,” said director of pediatric pulmonology, allergy and immunology at the Maimonides Infants & Children’s Hospital in New York City, Dr. Michael Marcus.

The American Academy of Pediatrics, the American College of Chest Physicians, and other professional groups have recommended caution giving these medications to young children.

“Patients should absolutely avoid these medication sunless they are being supervised by a physician,” Marcus said. “Parents should realize that non-prescription medications may contain similar products to medications that the pediatrician is also prescribing, therefore, they should let the pediatrician know all treatments the children is receiving when discussing a child’s treatment.”

“Parents should never give medicine without consulting a health-care provider, even over-the-counter,” added Dr. Cohen. “Many over-the-counter medicines may be marketed for infants, and there are no approved dosing recommendations from the FDA for this age group. There’s very little evidence that they help in children under 2.”

Court Orders Review Of Vioxx Action

Wednesday, January 17th, 2007

A New Jersey appellate court panel on Tuesday opened the door to a potential class action lawsuit against Merck & Co. on behalf of people who took its now-withdrawn painkiller Vioxx and want the company to pay for tests to detect possible heart ailments.

The ruling by the Appellate Division of the Superior Court of New Jersey came as jury selection began in Atlantic City for the next product liability trial over Merck’s one-time blockbuster arthritis pill.

That trial, before Superior Court Judge Carol Higbee, is slated to begin with opening arguments Monday. It includes two plaintiffs: the estate of a man who died of a heart attack after taking Vioxx and a retrial for a man who survived a heart attack, lost his first trial against Merck and was granted a retrial because of new evidence.

The ruling by a three-judge panel overturned a decision by Higbee last May in a case that sought to include patients who have not suffered medical problems but took Vioxx for at least six consecutive weeks before Whitehouse Station-based Merck pulled the drug from the market. That move in 2004 came after Merck’s own research showed Vioxx doubled the risk of heart attacks and strokes.

Tuesday’s decision said the lower court dismissing the case “prematurely terminated plaintiffs’ opportunity” to prove they have a legal claim.

“Historically, medical monitoring cases have primarily been in environmental and other chemical exposure cases” in New Jersey, said Esther Berezofsky, lead attorney for the plaintiffs.

She said the appellate ruling allows plaintiffs to bring suit again to seek medical monitoring in cases involving medications. Berezofsky said the case would now go back to Higbee for the judge to decide whether to grant class-action status to an undetermined number of former Vioxx users around the country.

“It would be obviously in the tens, potentially hundreds of thousands” of people, Berezofsky said, adding that any who had suffered “silent heart attacks” might need medication or other treatment to prevent another heart attack.

Ted Mayer, a Merck lawyer, said in a statement that the appellate ruling only “instructs a lower court to reconsider the validity of plaintiffs’ claims after more fact gathering is completed.”

“There is no medical science supporting the plaintiffs’ position that they need to be monitored for cardiovascular conditions two years after Vioxx was voluntarily taken off the market,” Mayer stated.

He said Merck is considering asking the New Jersey Supreme Court to review the appellate ruling.

Merck faces more than 27,000 personal injury lawsuits over Vioxx - more than half of them in Higbee’s court - plus about 265 potential class-action suits. At least 14,000 additional plaintiffs have entered agreements with Merck suspending the time limit for lawsuits.

Merck has won the last four Vioxx trials, three in federal court in New Orleans and one in state court in Alabama. Of the 13 cases that reached verdicts, Merck has won eight, lost four and faces a retrial in one.

Merck had won that case, against Frederick “Mike” Humeston, one of the two plaintiffs in the latest Atlantic City trial. Last August, Higbee overturned that verdict, ruling the jury might have been swayed by information, disclosed after the trial, indicating relatively short-term use of Vioxx increased heart risks despite Merck’s claims the risk only increased after 18 months’ use.

Attorneys for Merck say pre-existing heart problems and various risk factors caused the heart attacks suffered by Humeston, now 61, and by Brian Hermans, who died of a heart attack at 44.

Hermans’ attorney, Mark Lanier, said the man had some signs of hardening of the arteries but was “a world-class racquetball player” whose autopsy showed a heart artery blocked by a large blood clot. Lanier argues Vioxx fostered formation of the clot and thus Hermans’ fatal heart attack.

In afternoon trading on the New York Stock Exchange, Merck shares were up 13 cents at $44.92.

 

Teen Has Struggled To Walk, Care For New Daughter Since An Overdose During Labor

Wednesday, January 17th, 2007

Most high school seniors spend time hanging out with friends and fighting “senioritis.”

Most new mothers care for their babies 24 hours a day.
Not Amber Baise.
Baise, 18, was given an incorrect dosage of a painkiller during childbirth at Methodist Hospital in October, leaving her unable to walk on her own.
Now, three months later, Baise, a senior at Manual High School, is in and out of the hospital with pain so bad, she says, that she pulls her hair and bites and scratches herself — all to divert her mind from the burning in her lower back. She can’t rock her baby daughter, Kylie, or pick her up from her bassinet.
Amber’s mother, Deanna Baise, is frustrated because doctors say they don’t know why her daughter is suffering. They say they can do little besides try to ease her pain. Dr. James Fleck, one of Baise’s neurologists, did not return several phone calls.
During childbirth on Oct. 8, Methodist officials said, Baise received the wrong dose of an epidural painkiller. In one hour, she got a dose that was supposed to be given over 10 to 12 hours. Initially, it left her unable to walk and with severely limited leg movement.
Mistakes like this one are rare, research shows, and epidurals are common — more than 50 percent of women giving birth at hospitals use them, the American Pregnancy Association says.
Since the incident, all epidural infusions at Methodist have been run through a system to identify and prevent incorrect doses, said Jon Mills, spokesman for Clarian Health Partners, the network that runs Methodist, Indiana University and Riley hospitals. In the past, only some drugs could be flagged for dose problems by the system. Also, other clinical staff now verify and oversee the infusions.
In the past three months, Baise has regained considerable movement and can walk short distances with leg braces and a walker. But an unexplained pain in her lower back has brought her back to Methodist five times.
Now, after almost two weeks in the hospital, the family is exploring other medical facilities, where her mother hopes her daughter can get relief from nearly constant pain.
During an interview in her hospital room last week, Baise spoke softly about her problem but then grew quiet. Soon, she was crying, squeezing the hospital bed railings, twisting her legs back and forth and saying, “I want my daddy. Call my daddy.”
“It comes on fast,” said Deanna Baise from her daughter’s bedside as she urged her not to bite herself.
Attorney Nathaniel Lee, who represents the family, is seeking damages. He submitted a complaint on Oct. 20 to the Indiana Department of Insurance against the anesthesiologist, Dr. Gloria Lee, and Clarian Health Partners. The doctor did not return calls, and her attorney, Daniel Fagan, declined to comment.
In Indiana, patients must first go through a complaint process and wait for a ruling from a physicians panel before filing a malpractice lawsuit.
Bill Stephan, senior vice president for corporate communications at Clarian, said in October, “We believe human error entered into the equation.”
Mills wouldn’t comment on the family’s complaint or say whether Clarian is handling all of Baise’s medical bills. But he added that Clarian “stands by most of the comments made last fall.
“We’ve done a number of things for them already,” Mills said, declining to specify. “Our ultimate goal is to help her rehab fully, and we’re working with her to achieve that goal.”
But Lee, the family’s attorney, countered: “In the legal case, they’ve not taken responsibility.”
After Baise gets out of the hospital, Lee said, he intends to have a neurosurgeon and another doctor examine her to try to find a reason — and remedy — for her pain.
“It never goes away completely,” Baise said. “My skin gets hot. On a one-to-10 scale, it stays around a five or six a lot and sometimes gets to a nine or 10.”
When she’s at home, Baise takes care of Kylie as much as possible, feeding her bottles, changing her. But even that is limited.
Between hospital visits, Baise has been able to do school work at home, but she only attended school two days in a wheelchair. She needs fewer than five credits to graduate.
The incident has changed her in more ways than one, her mother says. “She was always on the go. She drove a car, went to school, played basketball,” said Deanna Baise.
Now, her mother can’t get her to go outside. She doesn’t want to see friends or go places. Sometimes she won’t talk to anyone — not her mother, not her doctor.
Deanna Baise doesn’t leave her daughter alone, out of fear she’ll try to hurt herself. “Amber feels at times she doesn’t want to be with us anymore. There’s a lot of anger and depression.”
Last week, Amber Baise started seeing a pain therapist. She says he’s helping her deal with pain spiritually, emotionally and psychologically. She is also talking with a mental health specialist.
Baise, who has started to write a book about what happened to her, said her goal is to graduate this spring.
“I’m working real hard so I can walk down the aisle without my braces.”

Woman Sustained Fractured Femur, Torn Achilles Tendon In Crash

Wednesday, January 17th, 2007

On Oct. 6, 2006, in Boca Raton at about 9 p.m., plaintiff Sharon Block, 50s, retail clothing store worker, was driving her sedan northbound through an intersection on St. Andrews Boulevard. and Potomac Boulevard. Joshua Olson was driving his sedan southbound through the intersection when he made a left turn, when they collided. Olson’s car was owned by his father Robert Olson.Block claimed the Olsons were liable for negligent operation of a motor vehicle and vicarious liability. She also sought underinsured benefits from her carrier, Geico.Plaintiff’s counsel argued that Olson did not properly evaluate traffic conditions prior to making the left turn, thus causing the accident.Block fractured her right femur and tore her right Achilles tendon in the accident. She was transported to Delray Medical Center, where she underwent two surgeries to repair the femur and one surgery to repair the torn Achilles tendon. She was hospitalized for three weeks and also underwent a post-surgical period of inpatient rehab.

Block has not returned to her job as a retail clothing sales manager following the accident because of her injuries. Plaintiff’s counsel indicated that it is too early to ascertain the long-term effects of Block’s injuries on her future health and lifestyle.

A settlement was reached for a total of $1.26 million. Allstate paid $1.25 million, with $250,000 bodily injury policy limits and $1 million umbrella policy limits. Geico paid $10,000 representing Block’s underinsured motorist policy limits.

 

 

Court Action Denies Widow Chance To Collect $5 Million Jury Verdict

Wednesday, January 17th, 2007

The Supreme Court blocked the widow of a man who died in a Texas jail from pursuing a $5 million jury verdict.Without comment, the court refused on Tuesday to consider the appeal of Jessie Dorado, whose husband died in an El Paso jail after being denied medication to control seizures. Eduardo Miranda, a Mexican national, was a physician arrested in 1997 on a two-year-old drunk driving charge. He died 74 hours later.

Miranda lived legally in El Paso, but practiced medicine in Juarez, Mexico.

His family invoked a federal civil rights law authorizing suits against state and local government officials who violate a person’s constitutional rights. A jury awarded Dorado $5 million after deciding that the jail’s doctor knew of Miranda’s medical needs and failed to minister to him.

A Texas appeals court threw out the verdict. The court said the jail doctor had not acted with deliberate indifference. The appeals court also said Miranda’s lawyers presented little evidence that the jail doctor set policy at the facility, a threshold plaintiffs often must cross in civil rights lawsuits against government officials.

BP Failed To Emphasize Safety At U.S. Plants Before Deadly Explosion, Panel Report Says

Wednesday, January 17th, 2007

British oil company BP failed to emphasize safety at its U.S. refineries before the 2005 Texas City explosion that killed 15, according to a report released Tuesday by an independent panel led by former U.S. Secretary of State James A. Baker III.The panel, in a statement summarizing its 300-plus page report on BP PLC’s operations, said the company had made strides in personal accident prevention but came up short on the bigger picture.

“The panel maintains a central theme that prior to the Texas City tragedy BP emphasized personal safety and had achieved significant improvements in personal injury rates, but the company did not emphasize process safety,” the statement said. “BP mistakenly interpreted improving personal injury rates as an indication of acceptable process safety performance at its U.S. refineries.”

The 11-member panel made 10 recommendations, including that an independent monitor report to the company’s board of directors for five years.

“BP gets it and I get it, too,” BP CEO John Browne told reporters by video link from London. “I recognize the need for improvement.”

Browne, who got the report from Baker on Sunday, called the report a “hard-hitting and critical analysis that focused on deficiencies and negatives.”

Browne defended the company’s overall safety record, which the Baker report acknowledged was sufficient in terms of personal injury prevention and environmental safety.

But on so-called process safety, “it wasn’t excellent enough,” Browne said. “And the standard is excellence.”

The chief executive said the company would implement the panel’s recommendations, including the independent monitor. But he said the company needs to compare Baker’s report with a companywide safety examination that began soon after the Texas City explosion and gave no time frame for making the changes Baker’s group suggested.

Baker has led the panel investigating corporate management at Houston-based BP Products North America following the March 2005 blast that killed 15 people and injured more than 170 others.

The U.S. Chemical Safety and Hazard Investigation Board, known as the CSB, urged BP in August 2005 to hire outside experts to look at the company’s oversight of safety management systems and make its findings public - similar to an investigation at NASA following the space shuttle Columbia tragedy.

The panel, announced in October 2005, has traveled to BP’s five U.S. refineries and interviewed hundreds of employees.

“BP tended to have a short-term focus in its U.S. refining operations, and its decentralized management system and entrepreneurial culture delegated substantial discretion to U.S. refinery plant managers without clearly defining process safety expectations, responsibilities or accountabilities,” the panel said in the report.

Baker, a senior partner at the Houston-based Baker Botts law firm, was White House chief of staff and treasury secretary in the Reagan administration and secretary of state in the first Bush administration. The release of the BP report was twice delayed because of his work with the Iraq Study Group, which made its recommendations to President George W. Bush last month on how to revamp U.S. policy in Iraq.

The release of the report comes less than a week after London-based BP said Chief Executive John Browne would step down by the end of July, more than a year ahead of schedule.

BP said Friday that Browne, 58, will be succeeded by Tony Hayward, the head of exploration and production, who will assume the task of trying to repair the company’s reputation with the public and investors. Problems stem from a series of well-publicized mishaps that include the Texas explosion and last year’s giant oil spill in Alaska.

Browne said Tuesday the report had “nothing to do” with his decision to retire earlier than expected, noting that he decided in December that when the company’s board found a successor, he would step aside.

John Manzoni, the company’s head of refining and marketing, said Tuesday he had no plans to resign.

The 2005 explosion has so far cost the company around $2 billion in compensation payouts, repairs and lost profits. BP has settled hundreds of lawsuits related to the accident, putting aside $1.6 billion just to resolve legal disputes.

Based on its investigation, the CSB has criticized BP for its safety systems at Texas City, about 40 miles (65 kilometers) southeast of Houston, finding the company fostered bad management at the plant and failed to fix problems.

In September 2005, the U.S. Occupational Safety and Health Administration found BP committed more than 300 willful violations of its rules and fined the company $21.3 million. 

BP’s own December 2005 report blamed failures by management at the refinery, saying it didn’t make safety a priority, tolerated risks and failed to communicate. But BP added it “found no evidence of anyone consciously or intentionally taking actions or decisions that put others at risk.”

The CSB has credited BP for cooperating with its investigation, making sweeping changes in how it recognizes potential hazards and hiring the Baker panel.

BP has said it will invest about $1 billion over five years to improve and maintain the Texas City site. BP also operates refineries in California, Indiana, Washington and Ohio.

BP shares fell 1.5 percent to close at 541 pence ($10.62), on the London Stock Exchange.

Work Injury And Supreme Court Judgment Puts Worker’s Compensation On “Slippery Slope”

Tuesday, January 16th, 2007

In December 2006, the Ohio Supreme Court ruled that due to a worker’s extreme negligence in his own work injury, he would not be eligible to receive full Worker’s Compensation benefits for his injuries. The teenager was fired from a KFC after he cleaned a gas pressure cooker using a method that super-heated water within the appliance – an act that was expressly forbidden. When the teenager removed the lid of the fryer, steam shot out burning him and two other employees.

“You were warned one time previous to the accident by [supervisor] Adrian LeBlanc … not to fill the fryer with water for cleaning, as this could result in injuries,” the work injury report reads. “Also, on the night of the accident, you were instructed, by your supervisor, to drain the water from the fryer.” The accident report also mentions that a warning sticker on the fryer states that the lid should not be closed with water or cleaning agents inside the cooker. However, “for reasons known only to you” the report continues, the employee ignored all warnings and ultimately injured himself and two others.

The KFC franchise owner petitioned the Industrial Commission of Ohio to stop disability payments on the grounds that willfully ignoring the rules was equal to voluntarily leaving the company since it was clearly stated that it was an offense that would get the employee fired. The commission agreed, but the teenager brought the case to the Franklin County Court of Appeals and had the decision reversed. Finally the Ohio Supreme Court supported the original ruling based on the grounds that willfully ignoring warnings is not the same as simple negligence. In other words, the teenager’s work injury was his own fault.

The case and the court ruling presents a number problems. Most importantly, it seems to ignore the fact that Workers’ Compensation is designed to remove all fault from accidents and support employees who have experienced job injury regardless of cause. In a dissenting paper, Justice Evelyn Stratton wrote that this puts the whole system on a “slippery slope” towards assigning blame. “[The employee] was a teenager at the time of the accident and, most likely, he was immature and naïve,” she wrote. “He suffered serious injuries as a consequence of his actions. However, the purpose behind workers’ compensation is to protect those who suffer work-related injuries regardless of their own negligence or fault.”

Even in this case, where the employee obviously caused his own work injury, it could still be argued that the shift supervisor could share in some or even most of the blame. The employee could have been suspended on the spot for attempting to break the rules, before the incident occurred. And, as the name implies, the supervisor is there to supervise – an especially important job when teenagers and youths are employed.

Amniotic Stem Cells New Line of Hope For Spinal Cord Injury

Tuesday, January 16th, 2007

A team of research scientists from the Wake Forest University School of Medicine have found that stem cells in the amniotic fluid and placenta can be captured and used for stem cell research. Amniotic fluid, which surrounds and protects the baby during pregnancy (the “water” that breaks shortly before birth), is commonly withdrawn from expectant mothers to test for Down Syndrome and other conditions. Although regularly discarded, the amniotic fluid and the placenta may be a new line of stem cells to help people with a variety of injuries and illnesses including spinal cord injury, Parkinson’s Disease, and Alzheimer’s.

Spinal cord injuries, which can lead to paraplegia or quadriplegia, do not naturally heal themselves as other injuries to the body do. A cut on the finger, for example, triggers the body to produce more cells to close the wound. Scientists believe that in theory, stem cells injected and activated at the injury site could similarly trigger healing and reconnect the nerves in spinal cord injury.

Embryonic stem cells offer the best hope for this. These cells, formed in the first few days after conception, have the ability to turn into any type of cell in the body. However ethical issues and the presidential ban on developing new lines of embryonic stem cells has severely hindered any real research into how this might work, and how it could help conditions like spinal cord injury.

Adult stem cells, on the other hand, are free from ethical debates but do not have the same abilities to change, which would limit their uses and/or usefulness. Amniotic stem cells fall somewhere in between these two types and present the best of both worlds: no ethical issues and a great ability to change.

“It’s still in its early stages, but long-term our goal would be to develop these cells to provide therapy for patients,” said Dr. Anthony Atala, lead scientist of the study. The researchers found that nerve cells could be produced from these “amniotic fluid-derived stem (AFS) cells,” which is crucial for treating spinal cord injury.

Geron On The Road To Treating Spinal Cord Injury

Tuesday, January 16th, 2007

In January 2007, a research team from Wake University announced that it had obtained stem cells from amniotic fluid and the placenta left over from pregnancy. This breakthrough was seen to be a new line of hope for patients with a variety of ailments including spinal cord injury and degenerative brain diseases. Stem cells have the potential to heal these areas of the body that do not naturally heal themselves, but a presidential ban on embryonic stem cells had severely hindered research efforts into researching the cells and eventually developing stem cells treatments.

At least one bio-tech company, Geron Corporation in Menlo Park, CA, showed positive results using amniotic fluid-derived stem cells six months before this announcement. One of its products in development was shown to help repair spinal cord injury in rats. Treated rats had 2.5 times more neurons near the injury site than untreated rats, which suggested to the scientists that not only does the treatment help prevent nerve damage, but it actually helps the nerves repair themselves, “potentially allowing new pathways for nerve conduction past the injury.”

During these studies, the researchers also identified the presence of a specific protein. Although this chemical was previously known, like most proteins scientists do not know its full function in the body. Finding the protein at the injury site of the treated rats suggests that it somehow helps in the healing process.

“The progress sets Geron apart in terms of leveraging our human embryonic stem cell platform into the development of multiple therapeutic products,” said Thomas B. Okarma, Ph.D., M.D., president and chief executive officer. “We are hopeful that these cell types will also demonstrate significant, long-term regenerative capacity in animal models, setting the stage for clinical trials in patients.”

The company is also developing a number of other stem cell-related treatments including a possible “cure” for diabetes, a treatment to help repair heart muscle in heart attack patients, and a treatment to help heal broken bones like hip fractures in the elderly.

However, the Geron Corporation said, its spinal cord treatment is the furthest along in studies. Even so, it is unlikely to reach the market for years.