Panel votes to keep GSK's diabetes drug on market

Avandia, the blockbuster diabetes treatment owned by GlaxoSmithKline, was yesterday given the green light to stay on the market despite data suggesting an increased incidence of heart attacks among those taking the drug.

Two committees at the US Food & Drug Administration, the Washington-based pharmaceuticals regulator, voted 22 to 1 in favour of recommending that American doctors be allowed to continue prescribing the drug to diabetes sufferers. It is not yet known who voted against.

The recommendation - which is usually followed by the FDA - will come as a relief to GlaxoSmithKline which last year made Pounds 1.4 billion in sales from the drug globally, of which Pounds1 billion was made in the USA. The treatment, which makes the body more sensitive to insulin, is the pharmaceutical company's second biggest selling drug after Advair, its asthma treatment.

Members of the panels, which included world experts on diabetes and scientists who specialise in analysing clinical trial data, were asked to vote on whether they believed that available data supported a conclusion that Avandia increased the risk of cardiac arrest. Seventeen members of the 23-man panel said they thought that the figures showed a "suggested" risk but still voted to keep the drug on the market.

The panel did not explicitly recommend that Glaxo change its labelling of the drug, although some members of the panel suggested that label changes could be made in some circumstances.

The FDA will now collate the comments from the members of the panel and publish its decision which could include a ruling to make Glaxo change the labelling on Avandia.

The row over the drug erupted in May when an American medical journal reported a 43 pc increased risk of a heart attacks from diabetes sufferers taking the drug. The drug has also been linked, subsequently, with increased numbers of bone fractures in women taking the drug.

Glaxo has maintained that if the drug is carefully prescribed, the benefits to diabetes sufferers outweigh the risks. It also claims that during the course of its own extensive trials, it found that there was no increased incidence of heart problems compared with diabetes sufferers taking rival treatments such as Actos, a Japanese drug.

More than 21 million people in the US suffer from diabetes, which is the leading cause of new cases of blindness. Diabetes sufferers either do not produce enough insulin to break down sugar, or their insulin fails to work properly. Unlike a number of older, generic drugs to treat diabetes which try to kick start the pancreas to produce more insulin, Avandia makes the body more sensitive to the insulin it already produces.

Worldwide sales in the three months to June dropped to £349 million from £477 million a year ago, the company reported last week.

Source:business.timesonline.co.uk

Hundreds of hospital fatalities 'avoidable'

One third of deaths in hospital investigated by a patient safety watchdog could have been avoided, claims a report released today.

The National Patient Safety Agency looked into 1,804 fatal hospital incidents reported to it in 2005. It found that 576 were "potentially avoidable" if there had been better communication between staff, faster recognition of the patient's deteriorating state, improved training and more accurate interpretation of test results.

Some 425 of the deaths investigated by the NPSA in 2005 were in acute or general hospitals. Of these, 71 were reported to be related to diagnostic errors, in 64 cases the patient's deteriorating condition was not recognised or not acted upon, and 43 involved a problem with resuscitation after cardiac arrest.The remainder were connected to medication errors, suicide or still-birth.

In 14 of the patients who deteriorated, no checks had been made on them for a prolonged time and changes in their vital signs such as blood pressure, heart rate or temperature were not detected.

In a further 30 cases, the checks had been made but staff either did not recognise the patient's worsening condition or they did not act. In 17 other cases help was sought but there was a delay.

Professor Richard Thomson, the NPSA's director of epidemiology and research, said: "These are not new concerns but more effort is needed to recognise and act upon them.

"This work helps us to further raise the profile of these issues and support a programme of activities involving a range of national organisations and individual experts. Every preventable death is a tragedy, not only for the family but for the staff involved."

The report says all staff should be trained in dealing with cardiac arrest. Among the 43 deaths involving resuscitation, the study found that many of the incidents suggested that "medical and nursing staff did not have the depth of knowledge and skills required".

It said: "In most cases the delay in starting the resuscitation was reported to be because staff did not recognise the acute situation, failed to call the resuscitation team or did not make an attempt themselves to resuscitate the patient."

Fourteen reported incidents related to the use of equipment. One such report said: "During a cardiac arrest, defibrillator found not to have the correct leads and paddle to fit the defibrillator. This caused a delay of approx five minutes during the arrest."

During 2006, the Medicines and Healthcare products Regulatory Agency (MHRA) received 141 reports of adverse incidents involving defibrillators. Many were related to problems with electrodes or batteries.

In the first six months of 2007, the MHRA received 86 reports and receives an average of 14 incident reports a month on these devices, some of which are duplicate reports from manufacturers.

The NPSA report said: "Several of these incidents occurred in resuscitation situations, when user error may have contributed to the incident, for example, incorrect connection of suctioning tubes."

The report stresses that there may be many similar cases which have not been reported to the NPSA.

Researchers said that about 13 million people are admitted to hospitals in England and Wales each year.

The findings come as the National Institute for health and Clinical Excellence releases guidance to clinicians on how to manage patients in hospital who deteriorate rapidly.

It emphasises making a complete medical assessment of the patient, regular monitoring and improving communication between staff.

Source:www.telegraph.co.uk

What Is Sudden Cardiac Death

If you can still remember, three young high profile professional athletes: Reggie Lewis (basketball player), Darryl Kile (baseball pitcher), and Marc Vivien Foe (football player) all died of sudden cardiac death or sudden death due to a fatal heart rhythm called ventricular fibrillation.

Sudden cardiac death is sudden and unexpected with death occurring within minutes after collapse. It is more common to older folks with serious heart ailments although it sometimes does happen to those young and healthy people with no outward sign of heart disease.

It is not the same as heart attack but a heart attack may actually cause sudden cardiac death either during the first few hours of the heart attack or many years after the attack. To differentiate the two, one can think of sudden cardiac death as an electrical malfunction and heart attack as one that is caused by blocked arteries (plumbing malfunction). To be more precise, sudden cardiac death arises when millions of “short-circuits” occur in the heart, causing the heart pump to fail and cease to deliver life-sustaining blood, oxygen and nutrients. The person thus becomes unconscious. Death can occur just within minutes if the situation is not remedies.

The only chance of survival for a victim of sudden cardiac death is to “re-start” his or her heart by an electrical shock from a machine known as a defibrillator. There are few types of defibrillators, namely manual external defibrillators (MED), automatic external defibrillators (AED), and implantable defibrillators (ICD).

Only trained personnel such as doctors, nurses, or paramedics can operate MED whereas AED can be operated by lay persons with minimal training. These machines automatically recognized heart rhythms that are treatable by electrical shock, and prompt the user to press the “shock” button. The machines are easy to operate and have been used successfully in airports, casinos and other public places to resuscitate victims of cardiac arrest.

ICD is implanted into a person’s body by surgery. It is fully automatic, and it can recognize and treat ventricular tachycardia and fibrillation without any external intervention, usually even before the person has lost consciousness.

In order to prevent sudden cardiac death, it is necessary to take a complete medical history, including a detailed family history of any cardiovascular disease, and carry out a thorough physical examination. If any symptom of heart disease, such as palpitations, fainting spells, chest pain, or breathlessness on physical exertion, is evident, and then further investigation that includes an electrocardiogram and echocardiogram is compulsory.

Source:pr-gb.com

Cardiac arrest not noticed by hospital staff, suit claims

Paul and Beth Werner of Belleville are seeking in excess of $100,000 from Memorial Hospital of Belleville, claiming the hospital's emergency staff failed to recognize Paul Werner was having cardiac arrest during a visit on July 9, 2005.

According to a lawsuit filed July 9 in St. Clair County Circuit Court, Werner suffered loss of mental capacity, paralysis and loss of consciousness and memory.

He also claims he incurred medical expenses and pain and suffering as the result of his injuries.

The suit alleges the hospital violated the standard of care for a patient by failing to provide timely CPR and resistive services to Werner.

Beth Werner is seeking damages for loss of consortium.

The Werners are represented by James R. Williams of Williams, Caponi and Associates of Belleville.

Source:www.madisonrecord.com

Article; Four-Year Old Dies Of A Cardiac Arrest After Being Hit By Truck In Sydney

A four-year old girl has died after being hit by a truck at a pedestrian crossing in Sydney on Tuesday.

The child's mother was carrying her when they were hit by a truck on Botany Road making a left-hand turn from McEvoy Street in Alexandria about noon. The girl went into a cardiac arrest after being struck.

A Spokesman for the crash investigation unit said both mother and daughter were on a pedestrian crossing at the time of the incident. A witness called triple-o emergency for an ambulance and said the child had been knocked out of her mother's arms.

She was taken to the Randwick's Sydney Children's Hospital in a critical condition and died soon after. The mother has suffered injuries to the head and leg. She was taken to the Royal Prince Alfred Hospital where she is in a serious but stable condition.

The driver of the work truck was not hurt and was taken to Redfern police station for questioning. Crash investigation unit officers spoke to witnesses at the scene.

Source:www.allheadlinenews.com

ICDs Effective In Helping To Prevent Sudden Cardiac Death In Patients With Certain Heart Disorder

High-risk patients with hypertrophic cardiomyopathyappear to have reduced risk of sudden cardiac death with an implantable cardioverter-defibrillator that terminates dangerous heart rhythm disorders, according to a study in the July 25 issue of JAMA.
Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden cardiac death in young people, including trained athletes. HCM is a genetic disease in which the heart muscle thickens abnormally, which can interfere with the heart's electrical system, increasing the risk for life-threatening abnormal heartbeats (arrhythmias).

Only in the last few years has the implantable cardioverter-defibrillator (ICD) been systematically used as a potentially life-saving treatment in high-risk patients with HCM, according to background information in the article. An ICD is a device designed to quickly detect a life-threatening, abnormal heart rhythm, and attempt to convert the rhythm back to normal by delivering an electrical shock to the heart. The effectiveness and appropriate selection of HCM patients for this therapy is not certain.

Barry J. Maron, M.D., of the Minneapolis Heart Institute Foundation, Minneapolis, and colleagues examined the clinical risk profile and incidence and effectiveness of ICD intervention in patients with HCM. The researchers analyzed data from a multicenter registry of ICDs implanted between 1986 and 2003 in 506 patients with HCM, average age 42 years. Patients were judged to be at high risk for sudden death. Average follow-up was 3.7 years.

Risk factors analyzed included history of premature HCM-related sudden death in 1 or more first-degree or other relatives younger than 50 years; massive left ventricular hypertrophy (enlargement); a certain type of nonsustained ventricular tachycardia (abnormally rapid heart rhythm); and prior unexplained syncope (temporary loss of consciousness).

Of the 506 patients, 20 percent experienced 1 or more appropriate device interventions, in which the ICD terminated ventricular fibrillation (severely abnormal heart rhythm that results in cardiac arrest) or ventricular tachycardia. Intervention rates were 10.6 percent per year for secondary prevention after cardiac arrest (5-year cumulative probability, 39 percent), and 3.6 percent per year for primary prevention (5-year probability, 17 percent).

Time to first appropriate discharge was up to 10 years, with a 27 percent probability 5 years or more after implantation. For primary prevention, 35 percent of the patients with appropriate ICD interventions had undergone implantation for only a single risk factor; likelihood of appropriate discharge was similar in patients with 1, 2, or 3 or more risk markers.

"The results of this international, multicenter study show the effectiveness and reliability of the ICD in prevention of sudden cardiac death in high-risk patients with HCM," the authors write. "An important proportion of these device interventions occurred in patients who had undergone prophylactic ICD implantation for a single risk factor. Therefore, a single marker of high-risk status may justify consideration for a primary prevention defibrillator in selected patients with HCM."

Reference: JAMA. 2007;298(4):405-412.

Editorial: Hypertrophic Cardiomyopathy, Sudden Death, and Implantable Cardiac Defibrillators -- How Low the Bar?

In an accompanying editorial, Rick A. Nishimura, M.D., and Steve R. Ommen, M.D., of the Mayo Clinic College of Medicine, Rochester, Minn., comment on the findings of the study by Maron and colleagues.

"Patients who have experienced cardiac arrest or documented sustained ventricular tachycardia definitely should be considered for implantation of an ICD. Patients with 2 or more risk factors likely present a high enough risk to warrant implantation of an ICD. However, the decision to implant an ICD in any patient, especially one with a single risk factor, must include a thorough and earnest discussion of the accuracy of the current risk assessment tools, the risks and benefits of ICD therapy, and the individual patient's viewpoints on procedures, devices, and death. Such an approach will allow the patient-physician team to arrive at an individualized decision regarding ICD implantation."

Source:www.sciencedaily.com

Newsweek Cover Story Examines Benefits of Lowering Body Temperature in Cardiac Arrest Victims

Cardium Therapeutics (OTCBB:CDTP) and its operating unit, InnerCool Therapies, today announced that temperature modulation therapy in cardiac arrest patients was featured in Newsweek's July 23 cover story. The article, "This Man Was Dead. He Isn't Anymore" (http://www.msnbc.msn.com/id/19751440/site/newsweek/), examines how physicians at the University of Pennsylvania are using mild hypothermia to treat sudden cardiac arrest patients.

Patient temperature modulation is a rapidly-advancing field focused on preserving ischemic tissue and improving patient outcomes following major medical events such as heart attack, cardiac arrest and stroke, as well as in the management of patients experiencing trauma or fever. Internal or endovascular temperature modulation is intended to rapidly cool patients from within their bodies in order to reduce cell death and damage caused by acute ischemic events in which blood flow to critical organs such as the heart or brain is restricted, and to prevent or reduce associated injuries such as adverse neurologic outcomes. External or surface-based temperature modulation is designed to cool or warm patients from outside of their bodies and is intended for use in less acute settings such as in-hospital fever management.

"Temperature modulation therapy to safely and effectively cool patients represents an important new tool now being explored for protecting the brain from ischemia, especially in post cardiac arrest patients who are at higher risk of brain tissue damage due to the prolonged lack of blood flow. With the increase in survival of cardiac arrest victims resulting from the advent of automated external defibrillators, cooling patients is the next logical therapeutic approach especially in light of the large body of supporting scientific literature, and guidelines issued by the American Heart Association and the International Liaison Committee on Resuscitation recommending that cardiac arrest victims be treated with induced hypothermia. With an estimated 225 hospitals out of approximately 5,700 in the United States beginning to utilize hypothermia systems, temperature modulation therapies are now considered to represent a significant and growing market opportunity," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics and InnerCool Therapies.

"InnerCool's new cost-effective CoolBlue Surface System and next-generation, high performance RapidBlue Endovascular System, both of which are expected to be launched within the next quarter, will establish InnerCool as the first and only comprehensive provider of temperature control solutions," added Reinhard. "Providing hospitals and clinicians with a one-source approach to effective patient temperature modulation should allow the medical community to expand the use of InnerCool systems for current indications and facilitate ongoing research regarding the potential uses of temperature modulation in a number of different patient populations that could benefit from these new therapies."

CoolBlue(TM) - Convenient Surface System

InnerCool's new easy-to-use, nurse-friendly CoolBlue(TM) surface temperature modulation system includes a console and a disposable CoolBlue(TM) vest with upper thigh pads, which is designed to provide a complementary tool for use in less acute patients or in clinical settings best suited to prolonged temperature management. InnerCool's CoolBlue vest and thigh pads, which effectively wrap the body without requiring any adhesives contacting the skin, is expected to enable cooling rates of around 1 degree Celsius per hour, similar to those of currently-marketed surface cooling systems and lower-performing endovascular systems using medium-sized, inflatable plastic balloon-based catheters.

RapidBlue(TM) - High-Performance Endovascular System

InnerCool's approach to endovascular temperature modulation makes use of a thin flexible catheter designed to facilitate quick deployment and minimize vascular occlusion - while at the same time accelerating and optimizing patient cooling and re-warming. InnerCool's next-generation RapidBlue(TM) system for high-performance endovascular temperature modulation includes a programmable console with an integrated easy to insert cassette, enhanced touch-screen user interface and a catheter designed to quickly modulate patient temperature in association with surgery or other medical procedures. The RapidBlue system powers InnerCool's Accutrol(TM) catheter, which has a flexible, low profile metallic temperature control element and a built-in temperature feedback sensor to provide fast, precise and reliable patient temperature control. Cooling rates with the RapidBlue system range from 4-5 degrees Celsius per hour which is 3-4 times as rapid as the CoolBlue and other surface or leading endovascular balloon-based technologies currently on the market.

InnerCool's "total solutions approach" also allows physicians to employ a rapid-cooling endovascular system for acute needs, followed by surface cooling for prolonged temperature management of patients remaining in intensive care units. InnerCool's novel approach to total temperature management is designed to provide clinicians with a comprehensive product portfolio to meet all of their temperature modulation needs.

About Patient Temperature Modulation

Numerous scientific and medical articles have described the usefulness of temperature modulation, such as induced hypothermia (cooling), which is designed to protect endangered cells, prevent tissue death and preserve organ function following acute events associated with severe oxygen deprivation such as stroke or cardiac arrest. Therapeutic hypothermia is believed to work by protecting critical tissues and organs (such as the brain, heart and kidneys) following ischemic or inflammatory events, by lowering metabolism and preserving cellular energy stores, thereby potentially stabilizing cellular structure and preventing or reducing injuries at the cellular, tissue and organ level. Two international clinical trials on hypothermia after cardiac arrest published in The New England Journal of Medicine demonstrated that induced hypothermia reduced mortality and improved long-term neurological function. Based on these and other results, the American Heart Association (AHA) and the International Liaison Committee on Resuscitation (ILCOR) have issued guidelines recommending that cardiac arrest victims be treated with induced hypothermia.

Ischemic diseases constitute the largest segment of the medical market in the United States and in almost all developed countries worldwide. In the U.S. and other developed countries, an estimated 1.4 million people experience cardiac arrest each year, of which an increasing number (currently about 350,000) survive to receive advanced care. The AHA guidelines now recommend the use of therapeutic cooling as part of the critical care procedures for patients with an out-of-hospital cardiac arrest following ventricular fibrillation. With respect to heart attacks, an estimated 325,000 people in the U.S., and approximately 375,000 people outside the U.S., receive emergency angioplasty or anti-clotting treatment as first-line care.

About InnerCool

InnerCool Therapies, Inc., a subsidiary of Cardium Therapeutics, Inc., is a San Diego-based medical technology company in the emerging field of patient temperature modulation, which is designed to rapidly and controllably cool the body in order to reduce cell death and damage following acute ischemic events such as cardiac arrest or stroke, and to potentially lessen or prevent associated injuries such as adverse neurological outcomes.

InnerCool's endovascular approach to patient temperature modulation is based on a single-use flexible metallic catheter and a fully-integrated cooling system, which allows for rapid and controlled cooling and re-warming. InnerCool's endovascular system integrates a number of desirable features including a slim catheter profile, a highly efficient flexible metallic thermal transfer element, a built-in temperature monitoring sensor, and a programmable console capable of rapidly and controllably inducing, maintaining and reversing therapeutic cooling. InnerCool's endovascular catheter-based Celsius Control System has received FDA 510(k) clearance for use in inducing, maintaining and reversing mild hypothermia in neurosurgical patients, both in surgery and in recovery or intensive care. The system has also received FDA clearance for use in cardiac patients in order to achieve or maintain normal body temperatures during surgery and in recovery/intensive care, and as an adjunctive treatment for fever control in patients with cerebral infarction and intracerebral hemorrhage. Potential additional applications of the technology include endovascular cooling for cardiac arrest, acute ischemic stroke and myocardial infarction (heart attack).

Source:www.genengnews.com

Mosquera recovering after cardiac arrest during training with German club

Colombian forward John Jairo Mosquera is recovering after a cardiac arrest during training with Germany's Carl Zeiss Jena.

The second division club said 19-year-old Mosquera collapsed suddenly on Wednesday. He was revived by club doctor Heribert Zitzmann and taken in stable condition to the hospital in nearby Gifhorn.

"(He is) doing well at the moment," Dr. Ruediger Wacker said at the hospital.

Mosquera will now undergo checks to determine the cause of the heart problem.

The Colombian is on trial with Jena after being loaned to Wacker Burghausen last season by Werder Bremen.

Source:www.iht.com

Player dies after cardiac arrest

A footballer in his 20s has died after suffering a cardiac arrest during a match in Warwickshire.

Several people and an off-duty nurse at the Recreation Ground, Victoria Road, Nuneaton, carried out resuscitation techniques before ambulances arrived.

The player was taken to George Eliot Hospital where he was pronounced dead.

"The quick actions of those at the match (on Saturday) gave the man the best possible chance of survival," an ambulance service spokesman said.

Source:news.bbc.co.uk

Police cars should have defibrillators to deal with cardiac arrest

With the recent attention on sudden cardiac arrests, one Member of Parliament is advocating that police patrol cars be equipped with automated external defibrillators, or AED.

MP Fatimah Lateef, who is also a member of the National Taskforce for Pre-hospital Care Medicine, said this could greatly improve the survival chances of a cardiac arrest victim.

Medical experts say that if you experience sudden cardiac arrest outside the hospital, your rate of survival is only 2.7 percent.

Mass exercise events are increasingly popular among Singaporeans.

Even Senior Minister Goh Chok Tong gave his support at the community run at East Coast Park on Sunday and, with the recent attention on the level of sports safety, the organisers did not take any chances.

Ambulances, medical staff and first-aid volunteers were on standby at the event as well as an AED, a machine which can resuscitate the victim of sudden cardiac arrest.

But medical professionals say outside of such sporting events, Singaporeans are woefully unprepared to react.

Dr Charles Johnson, HOPE Ambulance Service, said: "Often we don't call for help early enough, or we call the wrong people. Working in the emergency department, a lot of times when somebody collapses at home, the first call for help is to uncle, auntie, children, then somewhere along the way, 'Oh yes, we haven't called the ambulance yet! Better call now', that kind of thing.

"People have to realise that calling for help is not the answer. You still have to do cardio-pulmonary resuscitation (CPR) until professional help arrives."

With the survival rate falling by an average of 10 per cent with every minute that passed, the experts say using an AED at the scene can mean the difference between life and death.

But there are other problems as well.

Dr Charles Johnson said: "From the time of call to the actual time of arrival at scene, there are problems, for example in terms of locating the exact block, which lift to take.

"We also have to realise that HDB lifts tend to be small. It is not easy to institute emergency medical care in the lift to a patient in a sitting position, because the standard lying down stretcher does not fit in a HDB lift door."

MP Fatimah Lateef believes one way to improve the survival rate of cardiac arrests here is to equip the police with AED sets.

She said: "Sometimes they do arrive before the paramedics or the ambulances arrive. So it will be good if the police who's first on scene could help with the assessment of patient, and assess whether there's a need to do CPR, or even to defibrillate. That would save time as well."

She noted that while many policemen could apply CPR and work the defibrillator, she felt there should be a training programme for all policemen.

Dr Fatimah added that CPR skills should be taught to more Singaporeans - even from as young as 12.

She estimated that at least 20 per cent of the population need to be trained before a one per cent change can be effected in the survival rate.

Dr Fatimah said another idea is to increase the number of AED sets at Changi Airport, which sees a large number of human traffic daily.

She cites a recent study done at Chicago's O'Hare International Airport, which gives the public access to AEDs within one minute in any direction.

Source:www.channelnewsasia.com

Heavy Hearts And The Risk Of Sudden Death

Those with heavy hearts -- in the literal not figurative sense -- long have been known to be prone to cardiac arrest and sudden death. But many are not, and who among them is subject to serious risk is a mystery. To find clues to the puzzle, the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health has just awarded $2 million to Sumeet Chugh, M.D., director of Oregon Health & Science University's cardiac arrhythmia center in the division of cardiovascular medicine.The condition known as left ventricular hypertrophy (LVH), or a thickening and swelling of the heart wall, can be found, by some estimates, in up to 20 percent of the middle-aged population with heart disease in the United States. Some $3 billion to $5 billion worth of pocket defibrillators are being implanted under Medicare guidelines annually to jump start hearts at risk of a cardiac arrest. Yet research studies show that only one out of 15 of the devices ever will be needed to save a life, which is why pinpointing who among those with LVH is at greatest risk of cardiac arrest is a multibillion dollar priority.

The five-year NHLBI grant will provide funds for Chugh, the principal investigator and an associate professor in the cardiovascular division of the OHSU School of Medicine, along with his team of clinicians, scientists and researchers, to continue the landmark Oregon Sudden Unexpected Death Study (Ore-SUDS), which Chugh initiated five years ago. The Ore-SUDS study is a community-based effort that includes a partnership with the emergency medical response system (Jonathan Jui, M.D., professor of emergency medicine, OHSU School of Medicine) the state medical examiner network (Karen Gunson, M.D.) and 16 area hospitals, thus enabling a systematic study of all sudden cardiac arrests that occur in the Portland metropolitan area.

Several findings have been published earlier including the only U.S. data on the current burden of cardiac arrest obtained in a prospective manner. A separate collaborative effort with the Donald W. Reynolds Cardiovascular Clinical Research Center at Johns Hopkins University Reynolds Cardiovascular Center (Eduardo Marban, M.D., Ph.D., director) focusing on the link between cardiac arrest and the human genome is also ongoing.

"We found in analyzing the Ore-SUDS data," said Chugh, "that if you have left ventricular hypertrophy in Multnomah County your risk of cardiac arrest is increased at least twofold and, in combination with specific other conditions such as a weakened pumping ability of the heart muscle, the risk can be much higher. But that doesn't mean everybody with the condition is at risk. Left ventricular hypertrophy is associated with high blood pressure, and lots of people have high blood pressure but not all of them are prone to cardiac arrest.

Chugh reported in the Journal of the American College of Cardiology in March that less than a third of the sudden cardiac deaths where left ventricular dysfunction had previously been evaluated in the Ore-SUDS data had dysfunction that was severe enough to warrant implantation of a cardioverter-defibrillator. "These findings support the aggressive development of alternative screening methods to enhance identification of patients at risk," Chugh wrote.

Speaking about his team's plans going forward, Chugh said: "We want to figure out what will significantly improve our ability to predict cardiac arrest," Chugh continued. "Our ultimate aim is to nip it in the bud, which for patients that will suffer cardiac arrest means averting disaster before it happens. The evaluation of information that we have gathered in Ore-SUDS combined with what we learn at the bedside from patients together with bench research we are doing on the molecular mechanisms involved represent a comprehensive approach that we think hold great promise of solving the puzzle. If we can predict who the high risk patient with left ventricular hypertrophy is, that is likely to have huge significance for our patients."

According to the American Heart Association, about 250,000 Americans succumb each year to sudden cardiac death, which is defined as death within one hour of the time a person displays symptoms such as chest pain or difficult breathing. About half have shown no prior evidence of heart disease and about 40 percent are under age 65. In most cases, cardiac arrest results from arrhythmia, or abnormal heart rhythm. The survival rate ranges between 5 percent and 10 percent despite improvement in emergency medical services and widespread training in application of CPR.

Source:www.sciencedaily.com

Sudden Cardiac Arrest Coalition Launches Advocacy

SCA occurs when the heart stops working and no blood can be pumped to the rest of the body. In essence, the heart's electrical system malfunctions. One common misconception among the general public is that SCA is the same as a heart attack. It is not a heart attack, also known as a myocardial infarction, which is actually when a blockage in a blood vessel interrupts the flow of oxygen-rich blood to the heart, causing the heart muscle to die. 95% of all victims of SCA die because they do not receive life-saving defibrillation within 4 -- 6 minutes, before brain and permanent death start to occur. While the federal government has already made great strides in research, awareness, and treatment advances for many of our nation's major health threats -- like breast cancer, lung cancer, stroke and AIDS -- with SCA claiming more than 250,000 lives each year, the government must focus resources on a killer that takes more lives each year than any of those diseases. Sudden Cardiac Arrest Coalition

Source:/www.earthtimes.org

Comprehensive Site to Educate Public, Mobilize Supporters and Arm Decision-makers with Facts on this Leading Killer

About Sudden Cardiac Arrest

SCA occurs when the heart stops working and no blood can be pumped to the rest of the body. In essence, the heart's electrical system malfunctions. One common misconception among the general public is that SCA is the same as a heart attack. It is not a heart attack, also known as a myocardial infarction, which is actually when a blockage in a blood vessel interrupts the flow of oxygen-rich blood to the heart, causing the heart muscle to die. 95% of all victims of SCA die because they do not receive life-saving defibrillation within 4 -- 6 minutes, before brain and permanent death start to occur. While the federal government has already made great strides in research, awareness, and treatment advances for many of our nation's major health threats -- like breast cancer, lung cancer, stroke and AIDS -- with SCA claiming more than 250,000 lives each year, the government must focus resources on a killer that takes more lives each year than any of those diseases.

Source:sev.prnewswire.com

Medcool Inc. Receives FDA Clearance for Its RapidCool (TM) System

Medcool Inc. of Wellesley, MA, an emerging provider of non-invasive systems for therapeutic hypothermia and temperature management, announced today that its RapidCool(TM) System has received 510(K) clearance by the FDA to be marketed in U.S. for temperature reduction therapy.

The RapidCool System is indicated for use for "temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and for monitoring of patient temperature."

The RapidCool System uses an innovative and patented disposable helmet that directs agitated cold water to the scalp, plus more standard body and neck pads, to rapidly cool the head and body of patients for whom cooling is indicated. The system rapidly reduces head and body temperature to a set point in the range of 32-37 degrees C, is non-invasive and does not interfere with cardiac catheterization and other hospital procedures.

A growing body of research indicates that mild hypothermia, in the range of 32-34 degrees C, could potentially have a protective effect, reducing damage from cardiac arrest, stroke, brain injury, and other traumatic events. Rapid cooling is believed to be important in reducing injury to the brain following these events. The recent cover article in Newsweek describes the evolving use of hypothermia following cardiac arrest (http://www.msnbc.msn.com/id/19751440/site/newsweek/).

"We are very pleased to be cleared for marketing in the U.S.," said Joe Caruso, Medcool CEO, "and are actively looking for strategic and distribution partners for this unique technology."

The Company's helmet design makes use of the fact that the body responds to decreasing temperature by increasing blood flow to the scalp while reducing blood flow to the periphery. As a result, the RapidCool System is capable of high rates of cooling compared to standard non-invasive cooling systems -- and directs most of its cooling to the head where it is most needed.

Source:www.earthtimes.org

Bristol-Myers Squibb And ImClone Systems Significantly Expand ERBITUX Clinical Development Program

ImClone Systems Incorporated and Bristol-Myers Squibb Company recently announced that the companies have amended the terms of their agreement for the co- development and co-promotion of ERBITUX (Cetuximab) in North America. Under this amendment, the companies have jointly agreed to expand the investment in the ongoing clinical development plan for ERBITUX by up to several hundred million dollars. Development costs, up to a threshold value, will be the sole responsibility of Bristol-Myers Squibb; costs in excess of this threshold will be shared by both companies according to a pre-determined ratio.

With this additional funding, the companies will seek to add numerous Phase II and Phase III clinical trials that will further explore the activity of ERBITUX in a wide variety of therapeutic settings. The companies intend to utilize the results of these studies to support new registrational opportunities for ERBITUX. The comprehensive clinical program will supplement the significant body of clinical data existing for ERBITUX in colorectal and head and neck cancers by exploring the use of ERBITUX in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate.

"By broadening the ERBITUX development program with ImClone Systems and utilizing pharmacogenomic markers and other screening technologies, we intend to enhance cancer patient outcomes which may further differentiate ERBITUX from other commercially available antibodies," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "This plan further demonstrates Bristol-Myers Squibb's focus on the development of innovative compounds, like ERBITUX, and highlights our company's dedication to partnerships that can maximize the potential of products in our portfolio."

"This new commitment to ERBITUX represents one of the largest and broadest cancer-focused development programs for any antibody. The agreement aligns the development and commercialization of ERBITUX at ImClone Systems and Bristol- Myers Squibb to benefit both companies' shareholders, and most importantly, cancer patients," stated Alexander J. Denner, Ph.D., Chairman, Executive Committee of ImClone Systems Incorporated. "We are very pleased by this agreement and look forward to the two companies working in harmony."

Jim Cornelius, Chief Executive Officer, Bristol-Myers Squibb, stated, "We value our partnership with ImClone Systems -- and this new agreement confirms our strong commitment to oncology patients and the importance of ERBITUX to our business."

Carl Icahn, Chairman of the Board, ImClone Systems Incorporated, stated, "As the new Chairman, I am happy that Bristol-Myers Squibb and ImClone Systems have come to this very amicable agreement which I have every hope should benefit greatly both parties."

Source:www.pharmaceuticalonline.com