Friday, August 20, 2010
Wednesday, August 18, 2010
International Symposium on Critical Bleeding 2010
International Symposium on Critical Bleeding 2010
September 6-7, 2010 Copenhagen Denmark
Main sessions:
Critical bleeding – overview of concepts
Coagulopathy of Critical Bleeding
Coagulopathy of Trauma - a new entity or an old tale?
Monitoring of haemostasis
Blood products and critical bleeding – what is the evidence?
Case discussions
Alternatives to Blood transfusion
Resuscitation strategies for massive haemorrhage – how I do it
Surgeons and critical bleeding – State of the Art
Antithrombotics and critical bleeding
September 6-7, 2010 Copenhagen Denmark
Main sessions:
Critical bleeding – overview of concepts
Coagulopathy of Critical Bleeding
Coagulopathy of Trauma - a new entity or an old tale?
Monitoring of haemostasis
Blood products and critical bleeding – what is the evidence?
Case discussions
Alternatives to Blood transfusion
Resuscitation strategies for massive haemorrhage – how I do it
Surgeons and critical bleeding – State of the Art
Antithrombotics and critical bleeding
Website HERE
Combat casualty care conference shows promising research returns
Top scientists gathered this week at an annual conference to discuss therapies for traumatic brain injuries and lifesaving medical tools to deploy to the battlefield. The annual Advanced Technology Applications for Combat Casualty Care Conference, which is being held this week in St. Pete Beach, Fla., includes presentations on topics ranging from regenerative medicine to pain control to more sensitive vital system monitors. But the two biggest issues talked about were traumatic brain injury and hemorrhage research, said Col. Dallas Hack, director of the Combat Casualty Care Research Program in the U.S. Army Medical and Materiel Command at Fort Detrick.
"We want to save the most lives we can, and that's hemorrhage," Hack said during a phone conference Tuesday morning.
Col. Lorne Blackbourne, commander of the U.S. Army Institute of Surgical Research in San Antonio, Texas, said his command presented a paper on Monday showing that half of the service members who died of injuries suffered "potentially survivable" wounds. Eighty percent of those were hemorrhages, Blackbourne said. Of those hemorrhages, 30 percent were in the legs and arms, where a tourniquet can be used to stop bleeding; 20 percent were in the neck, groin, armpit and areas where a tourniquet cannot be used but pressure can be applied to stop bleeding; and 50 percent were in the chest or abdomen, where pressure cannot stop the bleeding.
Blackbourne said combat medics are better trained than ever before and the tourniquet technique, in use for about 300 years, is "the most valuable piece of equipment" in the battlefield. He said the more certain way of saving lives is to find ways of bringing blood products to the field though.
In the civilian world, bleeding patients may be pumped with salt water or other clear liquids to keep their blood pressure up until they reach the hospital in a matter of minutes. In a combat zone, on the other hand, bad weather or enemy fire may keep a bleeding service member from being airlifted to a hospital for hours. Without plasma to promote clotting, or a blood transfusion, the patient can bleed to death before reaching the hospital.
Hack said two products showcased at the conference, which is sponsored by the Department of Defense, may be approved for use within a few years. Freeze-dried plasma is already in human trials, and spray-dried plasma is about six months behind, he said.
"We want to save the most lives we can, and that's hemorrhage," Hack said during a phone conference Tuesday morning.
Col. Lorne Blackbourne, commander of the U.S. Army Institute of Surgical Research in San Antonio, Texas, said his command presented a paper on Monday showing that half of the service members who died of injuries suffered "potentially survivable" wounds. Eighty percent of those were hemorrhages, Blackbourne said. Of those hemorrhages, 30 percent were in the legs and arms, where a tourniquet can be used to stop bleeding; 20 percent were in the neck, groin, armpit and areas where a tourniquet cannot be used but pressure can be applied to stop bleeding; and 50 percent were in the chest or abdomen, where pressure cannot stop the bleeding.
Blackbourne said combat medics are better trained than ever before and the tourniquet technique, in use for about 300 years, is "the most valuable piece of equipment" in the battlefield. He said the more certain way of saving lives is to find ways of bringing blood products to the field though.
In the civilian world, bleeding patients may be pumped with salt water or other clear liquids to keep their blood pressure up until they reach the hospital in a matter of minutes. In a combat zone, on the other hand, bad weather or enemy fire may keep a bleeding service member from being airlifted to a hospital for hours. Without plasma to promote clotting, or a blood transfusion, the patient can bleed to death before reaching the hospital.
Hack said two products showcased at the conference, which is sponsored by the Department of Defense, may be approved for use within a few years. Freeze-dried plasma is already in human trials, and spray-dried plasma is about six months behind, he said.
Tuesday, August 17, 2010
Call for Abstracts: 4th International Symposium on Women’s Health Issues in Thrombosis and Haemostasis
Call for Abstracts: 4th International Symposium on Women’s Health Issues in Thrombosis and Haemostasis
February 4-6, 2011 Berlin, Germany
Participants are requested to submit an abstract to the secretariat no later than October 5, 2010 together with the registration form and fees. Authors will be notified regarding abstract acceptance. Accepted abstracts will be presented during a poster session. Abstracts selected by the Scientific Committee will be presented as short Oral Communications during the symposia. All accepted abstracts will be printed in the Book of Abstracts that will be distributed at the Symposium.
Secretariat and Symposium Organizers
Palex Tours Ltd. Israel
59 Ha'atzmaut Road, PO Box 33018, Haifa 33033, Israel
Tel: +972 - 4666 - 0510/11; Fax: +972 - 4852 - 2491
E-mail: whith2011@palex.co.il
Website: www.palexconventions.co.il/whith2011
February 4-6, 2011 Berlin, Germany
Participants are requested to submit an abstract to the secretariat no later than October 5, 2010 together with the registration form and fees. Authors will be notified regarding abstract acceptance. Accepted abstracts will be presented during a poster session. Abstracts selected by the Scientific Committee will be presented as short Oral Communications during the symposia. All accepted abstracts will be printed in the Book of Abstracts that will be distributed at the Symposium.
Secretariat and Symposium Organizers
Palex Tours Ltd. Israel
59 Ha'atzmaut Road, PO Box 33018, Haifa 33033, Israel
Tel: +972 - 4666 - 0510/11; Fax: +972 - 4852 - 2491
E-mail: whith2011@palex.co.il
Website: www.palexconventions.co.il/whith2011
Cutting back on blood use could halt infections, illness — and even death
SEATTLE — As a doctor and a patient, Dale Reisner knows the value of donated blood. But when the Seattle obstetrician had to have heart surgery four years ago, she did everything possible not to get a single drop.
“I don’t have any religious problems with it. If I was near death, I definitely would have taken blood, no question,” said Reisner, who is fine now at age 62. “But if I could avoid a transfusion by better pre-op preparation, then I was interested.”
Dr. Dale Reisner actively avoided a blood transfusion during surgery to repair a mitral valve in her heart.
Long dominated by Jehovah’s Witnesses — whose faith forbids blood transfusions — bloodless surgeries and blood conservation programs are now attracting mainstream patients worried about what some experts say are clear risks, including more infections, longer recuperation, increased illness and even death.
"The best blood is in your own veins,” said Dr. Lori Heller, medical director of the blood management program at Swedish Medical Center in Seattle, where Reisner had her surgery — without any transfusion. “We want to think before we transfuse.”
Decades of experience with Jehovah’s Witness patients, including 1.5 million members in the United States, has helped propel the new emphasis on blood management, said Sherri Ozawa, clinical director of the Institute for Patient Blood Management at Englewood Hospital and Medical Center in New Jersey.
“In the early days, it was, ‘We have Witness patients, what in the world do we do with them?’” she recalled. “Now we believe it should be the standard of care.”
More doctors, from cardiac surgeons to orthopedists, are offering patients ways to conserve their own blood and avoid transfusions. From drugs that boost blood levels before surgery to cell salvage and blood diversion techniques during operations and lower thresholds for giving blood at all, the techniques are a sea change in the attitude that more blood is always better.
“I don’t have any religious problems with it. If I was near death, I definitely would have taken blood, no question,” said Reisner, who is fine now at age 62. “But if I could avoid a transfusion by better pre-op preparation, then I was interested.”
Dr. Dale Reisner actively avoided a blood transfusion during surgery to repair a mitral valve in her heart.
Long dominated by Jehovah’s Witnesses — whose faith forbids blood transfusions — bloodless surgeries and blood conservation programs are now attracting mainstream patients worried about what some experts say are clear risks, including more infections, longer recuperation, increased illness and even death.
"The best blood is in your own veins,” said Dr. Lori Heller, medical director of the blood management program at Swedish Medical Center in Seattle, where Reisner had her surgery — without any transfusion. “We want to think before we transfuse.”
Decades of experience with Jehovah’s Witness patients, including 1.5 million members in the United States, has helped propel the new emphasis on blood management, said Sherri Ozawa, clinical director of the Institute for Patient Blood Management at Englewood Hospital and Medical Center in New Jersey.
“In the early days, it was, ‘We have Witness patients, what in the world do we do with them?’” she recalled. “Now we believe it should be the standard of care.”
More doctors, from cardiac surgeons to orthopedists, are offering patients ways to conserve their own blood and avoid transfusions. From drugs that boost blood levels before surgery to cell salvage and blood diversion techniques during operations and lower thresholds for giving blood at all, the techniques are a sea change in the attitude that more blood is always better.
Saturday, August 14, 2010
Interesting Thrombin Paper
Clinical use of Topical Thrombin as a Surgical Hemostat. Click to Enlarge - includes commentary on Oxidised Cellulose, Collagen and Gelfoam.
Wednesday, August 11, 2010
Egypt - Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission
The Arab Republic of Egypt has the highest rates of new hepatitis C virus (HCV) infection in the world, according to a new study published today in the prestigious Proceedings of the National Academy of Sciences. The study also estimates more than 500,000 new HCV infections occur in Egypt every year, likely signaling an epidemic in a country of more than 77 million people. This high rate of HCV transmission may be due to the lack of sufficient standard safety precautions in medical and dental facilities, the authors suggest. “Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission. This is the highest level of HCV transmission ever recorded at a national level for a blood borne infectious disease transmitted parenterally, that is, by use of non-sterile medical instruments,” said Dr. F. DeWolfe Miller, lead author of this study and professor of epidemiology at the Department of Tropical Medicine and Medical Microbiology and Pharmacology at the University of Hawaii.Although the high prevalence of hepatitis C in Egypt has been well established for many years, and linked in part to limited safety measures during anti-bilharzia campaigns, published estimates of prevalence from different Egyptian communities failed to provide a nationwide picture of the magnitude of ongoing HCV infection transmission.
To estimate the rate of new HCV cases of infection in Egypt, the authors of the study performed epidemiologic modeling of data from a range of studies, including a 2008 national HCV survey with a representative sample and well-documented study design.“The study opened our eyes to a disease burden similar in scale and challenge to the HIV problem in sub-Saharan Africa: Millions of cases of an infection for which there is no vaccine, no effective treatment, and where case management is so expensive that it is beyond the reach of most patients,” said Dr. Laith J. Abu-Raddad, co-author of the study and assistant professor of public health at the Infectious Disease Epidemiology Group at the Weill Cornell Medical College–Qatar.
The study necessitates not only further analysis of HCV transmission in Egypt but also justifies the immediate increase of resources to strengthen public health measures aimed at reducing the transmission of HCV in clinical and non-clinical settings, according to the authors. Failure to address this problem will result in a massive disease burden in the nation in terms of HCV infection complications, including active liver disease, liver failure, or liver cancer.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.
FDA APPROVES 8 MG VIAL OF NOVOSEVEN®
Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).
NovoSeven® RT is specially formulated to treat people with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30 percent of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.
"When I get a bleed, I want to infuse my treatment right away. The faster I treat a bleed, the sooner I can continue with my daily routine," said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition. "Using fewer vials will be a positive change for patients." Hoyt has been living with hemophilia with inhibitors most of his life.
For many people living with hemophilia with inhibitors, the 8 mg vial will allow for faster reconstitution - the time it takes to prepare the injection - than their current NovoSeven® RT regimen. Those who previously had to use three vials to deliver an 8 mg dose will now have to reconstitute only one vial. Though the amount of powder in the 8 mg vial is larger than the 5 mg vial, the vial will be the same size and will have a yellow cap to distinguish it from the smaller dose.
"We have heard from patients and physicians alike that when they are treating a bleed, every second counts. We at Novo Nordisk are committed to improving the lives of people living with hemophilia with inhibitors," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "The NovoSeven® RT 8 mg vial will allow patients to get the medicine they need much faster when experiencing a bleed, without having to manage multiple vials. We're also pleased that it will have a positive environmental impact as well - fewer vials may mean less waste."
The new vial size is expected to be available by November.
NovoSeven® RT is specially formulated to treat people with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30 percent of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.
"When I get a bleed, I want to infuse my treatment right away. The faster I treat a bleed, the sooner I can continue with my daily routine," said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition. "Using fewer vials will be a positive change for patients." Hoyt has been living with hemophilia with inhibitors most of his life.
For many people living with hemophilia with inhibitors, the 8 mg vial will allow for faster reconstitution - the time it takes to prepare the injection - than their current NovoSeven® RT regimen. Those who previously had to use three vials to deliver an 8 mg dose will now have to reconstitute only one vial. Though the amount of powder in the 8 mg vial is larger than the 5 mg vial, the vial will be the same size and will have a yellow cap to distinguish it from the smaller dose.
"We have heard from patients and physicians alike that when they are treating a bleed, every second counts. We at Novo Nordisk are committed to improving the lives of people living with hemophilia with inhibitors," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "The NovoSeven® RT 8 mg vial will allow patients to get the medicine they need much faster when experiencing a bleed, without having to manage multiple vials. We're also pleased that it will have a positive environmental impact as well - fewer vials may mean less waste."
The new vial size is expected to be available by November.
Monday, August 9, 2010
King Pharmaceuticals - Edited
Net sales of THROMBIN-JMI were $37 million, unchanged from the sales level of the first quarter of this year and were below last year’s second quarter sales of $49 million.
...THROMBIN revenues were flat versus the first quarter, we continue to diligently work with the hospital sales force to manage the lifecycle of this highly competitive and commoditized market.
William Tanner – Lazard Capital Markets
Brian, I know you had a couple 483 letters, at least, certainly this year. I wonder if you could give us a rundown on any outstanding issues that there may be at any of your plants or others relevant to King? Just a second question on the Purdue settlement, was there an attempt to encompass the oxycodone NT with that or is that something likely you have to revis in the future?
Brian Markison
Bill, thank you for the question on the Purdue settlement, but we really can’t and will not add much too it than what we’ve already said, but I appreciate the question. With the 483s, I’ll let Joe speak to that.
Joe Squicciarino
As you point out, we had two of our plants underwent inspection earlier this year, one in Rochester, Michigan, where we manufacture Bicillin, and the other is in Middleton, Wisconsin, where Thrombin-JMI is manufactured. So the outcome of the Rochester, Michigan 483s, we had relatively low number of observations. All of the corrective actions pertaining to those observations have been completed. We submitted the final report to the Detroit office of the FDA about a month ago. So nothing earth shattering there and we feel good about that audit and the outcome.
In Middleton Wisconsin, we had slightly higher number of observations; many of them or some of them I should say pertaining to process validation and a couple of other issues. We have addressed about half of the observations in Middleton. So they’re complete and the remaining observations that are yet to be addressed pertain to future production run, so we won’t be able to address those until those future production runs take place, but in both cases we’re in a good shape.
William Tanner – Lazard Capital Markets
Then just nothing else subsequent to those?
Joe Squicciarino
When you say, no, nothing…
William Tanner – Lazard Capital Markets
In terms of the other 43 letters?
Joe Squicciarino
No, no, we have not received any.
Brian Markison
Keep in mind, the Rochester facility is a single purpose plant for Bicillin only, and as Joe mentioned the Middleton facility is a single purpose plant for THROMBIN-JMI. Again, we believe that the Company’s management or the process is going to accept those steps well.
Sunday, August 8, 2010
Zymogenetics Q2 Edited
Doug Williams
RECOTHROM. Net sales of RECOTHROM were up substantially compared to Q1 of 2010, and were nearly double the net sales in the same quarter last year. Hospital demand for RECOTHROM is continuing to increase steadily, as is our market share. Consistent with our business plan, we're now successfully converting large hospital groups over to RECOTHROM and in parallel have put in place programs to accelerate the actual conversion process inside an institution once this decision has been made. We began to see the positive impact of these programs in June.
Jim Johnson
Net sales of RECOTHROM were $11.9 million for the quarter, nearly doubling from $6 million in the second quarter of 2009. And compared to the first quarter of this year, net sales were up by 32%. The increase was driven by positive trends in hospital demand and market share, plus two other important factors. One was wholesaler inventory patterns. There was no significant change in wholesale or inventory levels in the second quarter, but there was a decrease in the first quarter that reduced our reported net sales and contributed to a higher percentage increase in Q2.
The other important factor was a temporary program designed to accelerate customer conversion, instituted in June, which added approximately $700,000 to our second quarter net sales.
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