Although alcohol consumption is the cause of over 30% of traumatic brain injuries (TBI's), a new study indicates that low to moderate blood alcohol levels may decrease the chance of death after a head trauma. The study published today in the Archives of Surgery show results that link low to moderate levels of alcohol to TBI recovery. TBI patients with high levels of alcohol are more likely to die from their injuries, while patients with zero to moderate levels of alcohol in their system have a greater chance for survival.

Data from January 1, 1988 to December 31, 2003 was collected on individuals suffering TBI's in several hospitals, and 1,158 individuals were used for the study. Three blood alcohol concentration (BAC) levels were analyzed: no BAC (0 mg/dL); low to moderate (230 mg/dL or less); and high (greater than 230 mg/dL). After considering all other factors that could influence the risk of death (e.g. other trauma and severity of the TBI), it was found that those with low to moderate BAC's were 24% less likely to suffer a fatality than those with no BAC. It was also found that those with high BAC's were 73% more likely to die than those with no BAC.

The study's researchers deduced that when BAC levels are high TBI's become more difficult for the body to manage. High BAC's prevent the body from recuperating from a severe TBI because of secondary head injuries that occur after the initial TBI. On the other hand, low to moderate levels of alcohol may work with brain cells to protect the brain and body against a fatality. The alcohol appears to work as a resuscitative fluid in patients suffering from TBI's. The researchers are careful to warn that the study was conducted on individuals that were already hospitalized and that alcohol consumption must always be done in moderation for safety purposes.

Posted by Kerry N. Jardine at 03:21 PM | Permalink | Comments (0) | TrackBacks (0)

"We consider this a big victory for the fans," said Janet Abaray, a shareholder in the Cincinnati office of Burg Simpson who represented six fans who sued the Cincinnati Bengals.

The case stems from a brochure sent to fans in 1997 regarding club seats in the new stadium. The brochure explained that buyers would be required to buy a $150 seat license and pick a package that locked in seat prices for six, eight or 10 years. The brochure further explained that if a person didn't continue to buy tickets, the seat license would lapse and the $150 fee would be forfeited.

The Bengals later sent another document, a license agreement, that said canceling was not an option. It warned that fans who failed to pay would be liable for immediate and full payment of the cost of season tickets for the entire period.

Abaray argued that the initial brochure, which fans signed before mailing it in, made no mention of mandatory ticket purchases.

Judge Mark Painter of the Ohio 1st District Court of Appeals wrote in a concurring opinion Friday, December 23, 2006 that "while the Bengals may have intended otherwise, they were bound by the language they wrote," and that "the rules cannot be changed once the game is over."

Posted by Kerry N. Jardine at 03:52 PM | Permalink | Comments (0) | TrackBacks (0)

An FDA Advisory Committee has recommended that Pfizer be allowed to market Celebrex to children ages 2 and older who suffer from Juvenile Rheumatoid Arthritis (JRA). The panel voted 15-1 that the drug was an effective treatment and that its benefits outweighed its risks. The panel members split on the issue of safety, voting 8-7 (with one abstention) that available data does not demonstrate safety. The panel strongly recommends that the safety of Celebrex in children be monitored for 10-20 years, possibly by creating a registry of patients. Panel member Dr. Joan Bathon, rheumatologist at Johns Hopkins, said, "The feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known." The FDA is not required to take the advice of its expert panels, but it usually does.

Posted by Seth A. Katz at 03:19 PM | Permalink | Comments (0) | TrackBacks (0)

Two FDA advisory committees agreed on December 15, 2006, that the antibiotic Ketek (telithromycin) should have new black box warnings added to its label about several serious side effects which have been associated with it. "Black box" is the strongest warning the FDA can mandate. Further, the committees recommended that Ketek be limited to second-line therapy for community-acquired pneumonia only, rather than allowing it to be prescribed for acute bacterial bronchitis and acute bacterial sinusitis for which it's currently approved.

According to a December 16, 2006 article in The Wall Street Journal (WSJ) by Anna Wilde Mathews:

Several committee members said they worried that Ketek's use in the milder conditions wasn't justified. "The risk of the drug seems to me to make it not appropriate to keep on using" for those infections, said Carl Norden, a professor at the University of Medicine and Dentistry of New Jersey.

Additional recommendations by the advisory committee included a medication guide to be given to patients taking Ketek. The committees' recommendations are non-binding, which means that the FDA is not bound to take the their advice, though it most often does.

Ketek has been associated with hepatoxicity (liver damage and/or failure), blurred vision, loss of consciousness, and exacerbation of myasthenia gravis.

Dr. David Ross, a former FDA employee who reviewed Ketek, said in an interview with CBS News, "Based upon the data available to me, I believe this drug is far more dangerous than other drugs that fight the same infections."

Dr. Ross says he warned his superiors at the FDA that the drug was a "time bomb" and was shocked when Dr. Andrew Von Eschenbach, acting head of the FDA, told employees to keep their concerns internal and out of the press or risk losing their jobs. Dr. Ross quit the FDA in disgust.

Senator Charles Grassley is conducting a Senate Finance Committee investigation of Ketek and commented, "The leaders of an agency should not be holding a meeting to suggest dissenters should be kicked off the team, particularly when the life of American people are at stake."

Posted by Seth A. Katz at 03:17 PM | Permalink | Comments (0) | TrackBacks (0)

Traumatic brain injuries (TBI's) are among the most common brain disorders in the US. TBI's occur when a sudden force makes contact with the head and causes damage to the brain. Every year, nearly 1.5 million Americans suffer from a TBI. Memory loss is the most common injury sustained after a TBI and currently over 5 million Americans are living with some sort of memory loss linked to a TBI.

Researchers from New York University School of Medicine and Boston University School of Medicine recently conducted a study involving 134 individuals with memory loss due to TBI's. Half of the study's participants were given the Alzheimer's drug rivastigmine; the other half received a placebo. After 12 weeks of drug administration, those taking rivastigmine performed better on visual and verbal memory tests than those taking the placebo. Results showed that the drug worked better on individuals with moderate to severe memory loss.

Rivastigmine helps with memory loss by enhancing the function of a neurotransmitter involved in memory and learning. The drug induces more production of the neurotransmitter so that it can stay in the gaps between cells and act as a chemical messenger. Researchers say that more studies need to be done to determine how effective rivastigmine really is in patients with TBI's and memory loss.

Posted by Kerry N. Jardine at 03:10 PM | Permalink | Comments (0) | TrackBacks (0)

Defibrillator manufacturer Medtronic asked the US District Court of Minnesota to consider a motion for summary judgement. Their request was based on the claim that federal preemption barred the plaintiffs' claims. The plaintiffs' main complaint sites state law product liability claims sounding in negligence and strict liability. Other claims include violations of state Consumer Protection Statutes, violations of Minnesota false advertising and deceptive trade practices statutes, and misrepresentation by omission. The plaintiffs' seek damages for personal injuries that resulted from their use of Medtronic devices.

The Supremacy Clause of the US Constitution establishes the premise for federal preemption. The clause indicates that any state law conflicting with a federal law or regulation is preempted. Any court considering a preemption challenge is not to pass judgement on the state policy's reasoning, but rather must decide if the policy conflicts with or stands in the way of the purpose and execution of a the federal law.

After thoroughly investigating Minnesota state law, FDA approval requirements, evidence brought forth by the plaintiffs, and other preemption cases, the US District Court of Minnesota found Medtronic failed to show that the plaintiffs' claims were preempted by federal law. Medtronic's motion for summary judgement was denied on November 28, 2006.

Posted by David P. Hersh at 08:46 AM | Permalink | Comments (0) | TrackBacks (0)

According to Medtronic's website, "Medtronic is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world." Medtronic manufactures cardiac resynchronization therapy defibrillators (CRT-D's) and implantable cardioverter-defibrillators (ICD's). These devices are used on patients with heart conditions and are surgically implanted into the chest. ICD's work by monitoring a patient's heart rhythm and shock the heart when the rhythm becomes abnormal to regulate the patient's heart. CRT-D's work in a similar fashion by sending electrical pulses to the heart under failure conditions.

On February 11, 2005, Medtronic released a public advisory warning physicians and users of a malfunctioning battery found in some of their ICD and CRT-D models. The faulty batteries rapidly deplete because of a shortening mechanism found in the batteries. Medtronic reported that less than .5% of the batteries tested had this shortening mechanism, but that the mechanism can cause a loss of function in the devices. A loss of function can cause serious injury to the device's users but no patient injuries or deaths were reported at the time of the public advisory release.

Although Medtronic fulfilled its obligation to inform healthcare providers and users with information regarding their products' potential risks and faults, court records show that Medtronic discovered the shortening mechanism in their batteries in early 2003 during routine testing. The FDA requires that a manufacturer must submit a report to the FDA "no later than 30 calender days" after it "become[s] aware of information, from any source, that reasonably suggests that a device [it] markets has malfunctioned and this device . . . would be likely to cause or contribute to a death or serious injury." Despite their knowledge of the malfunctioning battery, Medtronic waited over 2 years to report their findings to the FDA. Medtronic's faulty battery has led to several law suits against the company with plaintiffs seeking damages for personal injuries that resulted from their use of Medtronic's devices.

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

The medical director of polytrauma at McGuire Veterans Medical Center said, "Traumatic brain injury is the signature injury of [the Iraq] war." Roughly 62% of the troops injured in Iraq suffer a traumatic brain injury (TBI). TBI's occur when the head is unexpectedly and forcibly hit with an object. In severe cases, the object pierces the skull and enters the brain tissue. Depending the object's impact on the skull, TBI sufferers may experience a variety of symptoms. Symptoms include headache, blurred vision, fatigue, behavioral changes, convulsions and/or seizures, slurred speech, and loss of coordination.

More and more American troops are suffering TBI's because of insurgents' use of improvised explosive devises (IED). IED's are bombs made out of lethal, noxious chemicals that are designed to destroy or injure enemy personnel or vehicles. The insurgents of the current Iraq War have made IED's, also referred to as roadside bombs, one of their main weapons against coalition forces.

The large number of TBI's in American troops and the increased use of IED's in the war in Iraq has caused many doctors to look at the standard helmets issued to the troops. Prior to 2003, army doctors determined that the issued helmets did not provide enough protection against TBI's because they were not padded well enough. When there is not enough padding injuries such as mild concussions are more likely to occur. Mild concussions often go undetected and several undiagnosed instances of mild TBI's puts an individual at risk for permanent brain damage. Since 2003, the army has issued new helmets that provide better protection against TBI's by using more padding. In 2006, the Marines followed suit.

Posted by Kerry N. Jardine at 04:17 PM | Permalink | Comments (0) | TrackBacks (0)

The American College of Obstetricians and Gynecologists (ACOG) has recently published an opinion regarding the use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for treatment of depression during pregnancy. ACOG warns that a particular SSRI known as Paxil (generic: paroxetine) should be avoided when possible by pregnant women or women who plan to become pregnant, due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.

ACOG's press release goes on to say that "...exposure to SSRIs late in pregnancy has been associated with short-term complications in newborns including jitteriness, mild respiratory distress, excessively rapid respiration, weak cry, poor muscle tone, and admission to the neonatal intensive care unit. Unpublished data regarding the use of Paxil during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations."

In September, 2005, FDA's Medwatch issued a Paxil Safety Information Alert, and GlaxoSmithKline, the maker of Paxil, wrote a letter to health care professionals stating, "Preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants....The most common cardiovascular malformations observed in the study were
ventricular septal defects."

For women exposed to Paxil during early pregnancy, ACOG recommends that a fetal echocardiography be considered.

Posted by Seth A. Katz at 11:18 AM | Permalink | Comments (0) | TrackBacks (0)