By Michael Smith, North American Correspondent, MedPage Today
Published: August 13, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine,
Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner Earn CME/CE credit for reading medical news.
The number of biopsies using less-invasive percutaneous methods nearly doubled over a decade, according to researchers.
And, because of the shift to image-guided procedures, radiologists are now performing half of all procedures, and 70% of lymph node biopsies, according to Sharon Kwan, MD, of the University of California San Francisco, and colleagues.
But practice patterns are still evolving and in some areas, nonradiologists are increasing their share of biopsies, Kwan and colleagues reported online in Radiology.
The first percutaneous needle biopsy of the liver was reported in 1932, but the advent of new imaging techniques in recent years suggests that image-guided percutaneous procedures -- performed by radiologists -- would have largely replaced more invasive procedures.
To investigate the issue, Kwan and colleagues analyzed Medicare claims data from 1997 through 2008, which showed that biopsies using all procedures rose from 1,380 to 1,945 procedures per 100,000 Medicare enrollees between 1997 and 2008.
That change represents a compound annual growth rate of 3%, the researchers reported.
During the study period, they found, percutaneous needle biopsies did increase -- from 59% to 67% of all biopsies (with the exception of breast biopsies, where a coding change in 2001 affected the reported distribution of open versus percutaneous procedures).
The use of percutaneous needle biopsies rose from 295,836 in 1997 to 573,397 in 2008 -- equivalent to an increase from 953 to 1,645 biopsies per 100,000 Medicare enrollees, for a compound annual growth rate of 5%.
On the other hand, the researchers reported, biopsies performed with nonpercutaneous approaches had a compound annual growth rate of minus 3% over the same time period.
But the choice of method varied widely with anatomic site, they found. On one hand, percutaneous needle biopsies were the dominant choice for kidney and liver, representing 96% and 90%, respectively, of all biopsies in these sites in 2008.
On the other hand, percutaneous needle biopsies were the minority in the superficial lymph nodes and musculoskeletal soft tissues, at 46% and 30%, respectively, they reported.
Most Current Procedural Terminology codes don't distinguish between percutaneous procedures performed with and without image guidance, the researchers noted, but for two areas that do -- percutaneous core biopsies of the breast and fine needle aspirations -- there was an increase in the use of imaging.
For breast biopsies, image guidance rose from 85% in 2002 to 95% in 2008, while for fine needle aspirations, the increase was even greater -- from 54% in 2004 to 77% in 2008, they found.
Over the study period, the top three specialties performing biopsies were radiology, general surgery, and pulmonology. Members of those specialties together performed 75% of all biopsies during the period.
Radiologists' share, however, increased steadily, from 35% in 1997 to 56% in 2008, while general surgeons and pulmonologists saw their shares decrease from 21% to 15% and 10% to 5%, respectively, Kwan and colleagues reported.
The most rapid growth, according to anatomic region, occurred in lymph node biopsies, where radiologists' share increased from 12% to 70%, for a compound annual growth rate of 22%.
Radiologists' share of fine needle aspirations also increased -- from 4% to 44%, for a compound annual growth rate of 37%.
The researchers noted that one limitation of Medicare data is that they mainly involve an elderly population, so the findings may not apply to a younger population.
Also, they reported, the precision of the analysis was limited by the "idiosyncrasies" of Current Procedural Terminology coding, which was used to calculate numbers and types of procedures.
The study was supported by the National Institute of Biomedical Imaging and Bioengineering.
The authors declared they had no financial relationships to disclose.
Primary source: Radiology
Source reference:
Kwan SW, et al "Effect of advanced imaging technology on how biopsies are done and who does them" Radiology 2010; DOI: 10.1148/radiol.10092130.
Source
August 14, 2010
Vietnam veteran running out of options
A bronze star awarded to Frank Tate of Drums rests next to a map of where the chemical Agent Orange was applied during the Vietnam war. Tate, who saved another Marine's life during the war, and served in areas where Agent Orange was utilized, has cirrhosis of the liver that the Department of Veterans Affairs will not acknowledge as a disease caused by the foliage-destroying chemical.
By JILL WHALEN (Staff Writer)
Published: August 9, 2010
Frank Tate received the prestigious Bronze Star Medal for dragging two seriously injured Marines across fire-swept terrain in Vietnam as machine gun bullets sailed past him.
More than 30 years later, Tate's own life needs saving.
The Drums man's liver has all but completely failed. His body is filling with fluids, and his skin has already turned yellow - a telltale sign of jaundice.
Doctors told him he needs a liver transplant, said his wife, Carol Tate. But none will attempt the procedure, saying the former Marine's health is too depleted and thus, an operation is too risky.
Frank has seen many doctors, Carol said, and many of them agree: the 59-year-old's liver cirrhosis was caused by his exposure to Agent Orange, the name given to the herbicide used by the United States during the Vietnam War to destroy foliage that provided cover for the enemy.
What's frustrating, Frank said, is that the Department of Veterans Affairs doesn't acknowledge cirrhosis as a disease caused by Agent Orange.
"They won't admit to it," Frank said.
It's a tough pill for the Tates to swallow.
Tate said he lived a healthy life, leaving his Lattimer home in 1968 to serve during the Vietnam War with the Fox Company, 2nd Battalion, 7th Marines, First Marine Division. He was attached to a tank division and later dispatched to serve in the field, and eventually achieved the rank of lance corporal.
It was during the height of a 1969 battle in Vietnam's Que Son Valley that Tate came across two seriously wounded Marines lying in an exposed area, according to the citation accompanying Frank's military medal. He scooped up the first and carried him to a covered area, then dodged enemy fire again to drag the second Marine to a rice paddy dike. He also faced bullets again as he ran to retrieve additional medical supplies for the wounded.
A year after the heroic rescues, the 1968 Hazleton High School graduate returned home.
"Even when I came back from Vietnam, my liver count was always high. I was close to 21. My family doctor at that time - or anyone who sent me for blood work - always said that I have high liver counts," Frank recalled. "It was the only test that did not come back good."
Not a concern
Doctors, however, never seemed to press Frank to go for more tests to determine what was causing high readings of alkaline phosphatase in his liver, he said. With no reason for alarm, Frank and Carol, who have been married 36 years, never pursued the issue, they said.
Frank's health seemed mostly solid until 2000 when he needed a triple bypass. He had been working at the former Allsteel in Valmont Industrial Park for 33 years, where he served as president of the United Auto Workers union.
Then, another difficult blow came in 2007 when tests following gallbladder surgery revealed he had cirrhosis.
"I had no idea I was sick or that I had cirrhosis," he said. "It was as if all of a sudden I needed a liver."
No doctor could pinpoint what caused the disease, Frank explained.
His local doctor, Dr. Eugene Stish, Conyngham, said it's his "personal opinion" that Frank's cirrhosis was caused by Agent Orange exposure. "However, I have absolutely no proof that that is what caused it," he said.
But Stish said Frank did not have any history of alcohol abuse or exposure to other dangerous chemicals - two typical causes of the disease.
Exposure to Agent Orange is "the most logical reason" that Tate developed the disease, Stish said.
Following the diagnosis, Frank recalled each day brought more weakness. He went to Thomas Jefferson University hospitals, Philadelphia, to determine whether he was eligible for a liver transplant.
"I was down there for 11 days," Frank said of his stay earlier this year. "They did all kinds of tests on me."
Carol said it appeared her husband would be approved for a transplant until a last-minute evaluation by an anesthesiologist ruined his chances.
"They didn't think I would survive the operation, or if I did survive the operation, it wouldn't be for very long," Frank said. The unchecked liver disease caused other organs in his body - his heart, lungs and kidneys - to deteriorate and weaken.
During subsequent visits to Geisinger Medical Center, Danville, and Veterans Administration hospitals, the Tates said they were told the same bad news.
Since Frank's diagnosis, the couple have learned others who served in Vietnam have had similar problems.
"A cousin of my wife died of liver disease," Frank said. "He was in Vietnam."
As a young serviceman, Frank said he "wasn't aware" of Agent Orange. But in 1984, he received a letter from the office of Gov. Dick Thornburgh along with a map of where the toxic herbicide was applied. Frank said he served in some of those places.
The letter began with "Dear Pennsylvania Vietnam Veteran" and asked all 200,000 Vietnam-era veterans from the commonwealth to complete a questionnaire with military and health information "related to possible exposure to Agent Orange and other herbicides."
It's the only piece of correspondence Frank has received that hints at possible exposure. Carol noted that while her husband does receive disability benefits from the Veterans Administration, he does not receive Agent Orange compensation.
"The government just seems like it doesn't want to admit anything," she said.
'Thing of the past'
Steve and Lisa Krouse, the neighbors the Tates consider family, have taken the Tates to medical appointments and check on the couple daily.
At least one of the out-of-area doctors who has treated Frank gave the impression the government considers Agent Orange "a thing of the past" and as such, is not investing in research or cures for it, Steve Krouse said.
"They might feel that everyone who was exposed to it is weaning away and they're not putting too much effort into helping the people who were exposed to Agent Orange," Krouse said.
Calls to the Department of Veterans Affairs regarding Agent Orange were not returned to the Standard-Speaker. But a department-released list does not classify cirrhosis as a disease caused by exposure to the chemical.
At this point, the Tates and Krouses say they're hoping for a miracle.
"We're not giving up hope for him," Krouse said. "Western medicine might say he's done. But there is eastern medicine, there are stem cell transplants."
Krouse has been researching possible cures and treatments and said he learned stem cell transplants for those with liver diseases are proving successful in the United Kingdom and Germany.
And, through additional research, he's learned of an ongoing study by the University of California-San Diego and Veterans Affairs-San Diego that is proving it's possible to halt and reverse cirrhosis. There's also a drug being used successfully in a British study that nurses diseased livers back to normal, he said.
Krouse said he would love if Frank could somehow get a stem cell transplant - although it wouldn't be covered by his insurance - or be involved in one of the studies.
"He fought bravely," Krouse said, "and he's still fighting, only this time for his own life, and with only one very strong weapon - hope. And just maybe a little divine intervention too. It is what's keeping him alive right now."
Both Carol and Frank are hoping to find an answer soon, and said they wanted to share Frank's story to see if anyone else can help.
"Right now, you are reaching for time, and the time is going so fast. And I'm scared stiff," Carol said.
Frank can be contacted at greedy@ptd.net.
jwhalen@standardspeaker.com
Source
USM Studies Palm Oil Extract For Chronic Disease
August 10, 2010 16:58 PM
GEORGE TOWN, Aug 10 (Bernama) -- Universiti Sains Malaysia (USM) is in the midst of studying the use of the palm oil extract known as tocotrienol in the treatment of chronic diseases such as non-alcoholic fatty liver disease (NAFLD).
One of the researchers, Prof Lutfi Shuaib said the research started in 2007 and expected to be completed by the year end.
He said that 60 adults with high-cholesterol problems volunteered for the study and received 200mg of tocotrienol for a year.
"Initial finding shows that 50 per cent of the volunteers show positive results.
"The finding will be tabled soon at the meeting of the American Association for the Study of Liver Diseases in Boston, the United States," he said in a briefing for Plantation Industries and Commodities Minister Tan Sri Bernard Dompok.
Lutfi said the study was to prove that tocotrienol as a food supplement could be used to treat the NAFLD.
"Malaysia is the second biggest palm oil producer and tocotrienol production could potentially become an important economic activity," he said.
-- BERNAMA
Source
GEORGE TOWN, Aug 10 (Bernama) -- Universiti Sains Malaysia (USM) is in the midst of studying the use of the palm oil extract known as tocotrienol in the treatment of chronic diseases such as non-alcoholic fatty liver disease (NAFLD).
One of the researchers, Prof Lutfi Shuaib said the research started in 2007 and expected to be completed by the year end.
He said that 60 adults with high-cholesterol problems volunteered for the study and received 200mg of tocotrienol for a year.
"Initial finding shows that 50 per cent of the volunteers show positive results.
"The finding will be tabled soon at the meeting of the American Association for the Study of Liver Diseases in Boston, the United States," he said in a briefing for Plantation Industries and Commodities Minister Tan Sri Bernard Dompok.
Lutfi said the study was to prove that tocotrienol as a food supplement could be used to treat the NAFLD.
"Malaysia is the second biggest palm oil producer and tocotrienol production could potentially become an important economic activity," he said.
-- BERNAMA
Source
No science backs up 'miracle cure'
By JOE SCHWARCZ, Freelance August 14, 2010
Malaria, AIDS, hepatitis, herpes, cancer. Terrible diseases. That's why thousands and thousands of scientists around the world, armed with advanced degrees, are engaged in research projects aimed at finding a cure.
Now, ask yourself this question: What is the chance of a gold prospector, with no training in the health sciences, tackling a problem and finding an answer that has eluded the world's most renowned researchers? Furthermore, it's simple to administer, readily available and destroys the H1N1 virus, clears up acne, eliminates heavy metals and cures the common cold to boot. I can tell you what probability I would attach to this miracle solution performing as claimed. Let me see now, how does "zero" sound?
There's nothing subtle about the name of this purported wonder: "Miracle Mineral Solution (MMS)!" Well, there are no miracles to be had. Or minerals. Admittedly, however, there is a solution. Not a solution to any problem, but a solution in the sense of a substance being dissolved in water. And that substance is sodium chlorite, a common disinfectant and bleaching agent. Its chief promoter, Jim Humble, is either a brilliant inventor, a self-delusional scientifically-bewildered simpleton or a cunning scoundrel. Take your pick. I know which box I would tick off.
In a decidedly non-humble fashion, Humble claims that "this breakthrough can save your life, or the life of a loved one." He then brags that his discovery is "the answer to AIDS, hepatitis A, B and C, malaria, herpes, TB, most cancers and many more of mankind's worse diseases."
Of course you may not have heard of this revolutionary treatment, because it is being hidden from the public by those devilish pharmaceutical companies whose profits would be destroyed if the word got out about all diseases being cured in such a simple fashion.
Let's just trace how this visionary, this wonder worker, this mental colossus, discovered the gift "that would shift the course of human health history forever."
Incidentally, MMS wasn't this amazing philanthropist's first gift to humanity. That was the automatic garage door opener, which humble Humble supposedly invented, although I can't find any documented evidence for this claim.
In any case, the MMS saga begins in the South American jungle where our hero was prospecting for gold when two of his men fell ill with malaria. With no prospects for immediate medical help, Humble had to resort to his razor-sharp wits.
The sodium chlorite solution they had brought along to disinfect water obviously killed bacteria, maybe it would also destroy whatever was causing the malaria. So, he gave the men some of the solution and was stunned to see their symptoms vanish in just four hours. I bet he was!
Now Humble had a new calling: rid the world of malaria.
He started to treat sick South Americans but found that the sodium chlorite solution was only effective 70 per cent of the time. Not good enough for this dazzling mind!
He began to experiment with his concoction and discovered that when mixed with citric acid, the chlorite would be converted to chlorine dioxide, which turned out to be a superior product. Wow!
Before long, Humble claimed to have registered 75,000 successful treatments of malaria with his miracle product.
Strange, but I can't find any of these spectacular results documented in the scientific literature. Wouldn't you think that the discovery of such a simple cure for malaria would merit publication? Surely a Nobel Prize would be in the offing! Ah, I know. It must be those dastardly jealous scientists, or the evil pharmaceutical companies that are preventing publication. Yup. Must be.
As a supporter explains, "Humble had become so famous that two drug companies contacted the Minister of Health (in an unnamed country) and threatened to quit shipping drugs to the local hospitals if she didn't do something about the person claiming to be able to cure malaria."
Those fiendish companies! It's a wonder they have allowed Humble to live.
Actually, maybe they haven't. Attempts to contact him have repeatedly failed. I'm told he is "travelling" the world, busily helping people. Helping them lighten their wallets, I suspect.
If you want to know the details of his discovery -that is "how to manufacture it in your own kitchen, how to use it intravenously, how to cure colds in an hour, how to cure the worst of flu in 12 hours, how to treat cancer, AIDS and hundreds of other problems" -you have to buy his book.
I'm not sure how to describe that epic work, but "comedic" comes to mind.
Discussions about how chlorine dioxide "elongates the electron shell" of pathogens, and how its safety is confirmed by the fact that its "oxidation strength" of 0.95 volts is less than oxygen's 1.30 volts, amount to no more than mindless chemical chatter. I don't buy it. More importantly, Health Canada and the U.S. Food and Drug Administration don't buy it, either. And both urge consumers not to buy any version of Miracle Mineral Supplement.
Not only is there no evidence of efficacy for any condition, there is evidence of possible harm. Nausea, vomiting, and a life-threatening drop in blood pressure have been reported.
Humble actually maintains that nausea is a good thing because it means the body is eliminating toxins, but if bothered, he suggests it can be controlled "by eating cold apple slices that will absorb stomach toxins that have been dumped there." Like I said, comedic.
But what is decidedly not comedic is the advice on some MMS websites that AIDS patients give up their drugs and resort to intravenous MMS.
Jim Humble went out looking for gold and it seems that at least figuratively he has found it. But it is fool's gold.
MMS is not based on any reasonable science, has not been tested in any sort of randomized trials, and amounts to no more than a scheme to capitalize on the gullibility of the scientifically challenged and the desperate.
Promoting the sale of this product is criminal.
Joe Schwarcz is director of McGill University's Office for Science and Society ( http://www.oss.mcgill.ca/).
He can be heard every Sunday from 3-4 p.m. on CJAD radio.
joe.schwarcz@mcgill.ca
© Copyright (c) The Montreal Gazette
Source
Also See: Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
Malaria, AIDS, hepatitis, herpes, cancer. Terrible diseases. That's why thousands and thousands of scientists around the world, armed with advanced degrees, are engaged in research projects aimed at finding a cure.
Now, ask yourself this question: What is the chance of a gold prospector, with no training in the health sciences, tackling a problem and finding an answer that has eluded the world's most renowned researchers? Furthermore, it's simple to administer, readily available and destroys the H1N1 virus, clears up acne, eliminates heavy metals and cures the common cold to boot. I can tell you what probability I would attach to this miracle solution performing as claimed. Let me see now, how does "zero" sound?
There's nothing subtle about the name of this purported wonder: "Miracle Mineral Solution (MMS)!" Well, there are no miracles to be had. Or minerals. Admittedly, however, there is a solution. Not a solution to any problem, but a solution in the sense of a substance being dissolved in water. And that substance is sodium chlorite, a common disinfectant and bleaching agent. Its chief promoter, Jim Humble, is either a brilliant inventor, a self-delusional scientifically-bewildered simpleton or a cunning scoundrel. Take your pick. I know which box I would tick off.
In a decidedly non-humble fashion, Humble claims that "this breakthrough can save your life, or the life of a loved one." He then brags that his discovery is "the answer to AIDS, hepatitis A, B and C, malaria, herpes, TB, most cancers and many more of mankind's worse diseases."
Of course you may not have heard of this revolutionary treatment, because it is being hidden from the public by those devilish pharmaceutical companies whose profits would be destroyed if the word got out about all diseases being cured in such a simple fashion.
Let's just trace how this visionary, this wonder worker, this mental colossus, discovered the gift "that would shift the course of human health history forever."
Incidentally, MMS wasn't this amazing philanthropist's first gift to humanity. That was the automatic garage door opener, which humble Humble supposedly invented, although I can't find any documented evidence for this claim.
In any case, the MMS saga begins in the South American jungle where our hero was prospecting for gold when two of his men fell ill with malaria. With no prospects for immediate medical help, Humble had to resort to his razor-sharp wits.
The sodium chlorite solution they had brought along to disinfect water obviously killed bacteria, maybe it would also destroy whatever was causing the malaria. So, he gave the men some of the solution and was stunned to see their symptoms vanish in just four hours. I bet he was!
Now Humble had a new calling: rid the world of malaria.
He started to treat sick South Americans but found that the sodium chlorite solution was only effective 70 per cent of the time. Not good enough for this dazzling mind!
He began to experiment with his concoction and discovered that when mixed with citric acid, the chlorite would be converted to chlorine dioxide, which turned out to be a superior product. Wow!
Before long, Humble claimed to have registered 75,000 successful treatments of malaria with his miracle product.
Strange, but I can't find any of these spectacular results documented in the scientific literature. Wouldn't you think that the discovery of such a simple cure for malaria would merit publication? Surely a Nobel Prize would be in the offing! Ah, I know. It must be those dastardly jealous scientists, or the evil pharmaceutical companies that are preventing publication. Yup. Must be.
As a supporter explains, "Humble had become so famous that two drug companies contacted the Minister of Health (in an unnamed country) and threatened to quit shipping drugs to the local hospitals if she didn't do something about the person claiming to be able to cure malaria."
Those fiendish companies! It's a wonder they have allowed Humble to live.
Actually, maybe they haven't. Attempts to contact him have repeatedly failed. I'm told he is "travelling" the world, busily helping people. Helping them lighten their wallets, I suspect.
If you want to know the details of his discovery -that is "how to manufacture it in your own kitchen, how to use it intravenously, how to cure colds in an hour, how to cure the worst of flu in 12 hours, how to treat cancer, AIDS and hundreds of other problems" -you have to buy his book.
I'm not sure how to describe that epic work, but "comedic" comes to mind.
Discussions about how chlorine dioxide "elongates the electron shell" of pathogens, and how its safety is confirmed by the fact that its "oxidation strength" of 0.95 volts is less than oxygen's 1.30 volts, amount to no more than mindless chemical chatter. I don't buy it. More importantly, Health Canada and the U.S. Food and Drug Administration don't buy it, either. And both urge consumers not to buy any version of Miracle Mineral Supplement.
Not only is there no evidence of efficacy for any condition, there is evidence of possible harm. Nausea, vomiting, and a life-threatening drop in blood pressure have been reported.
Humble actually maintains that nausea is a good thing because it means the body is eliminating toxins, but if bothered, he suggests it can be controlled "by eating cold apple slices that will absorb stomach toxins that have been dumped there." Like I said, comedic.
But what is decidedly not comedic is the advice on some MMS websites that AIDS patients give up their drugs and resort to intravenous MMS.
Jim Humble went out looking for gold and it seems that at least figuratively he has found it. But it is fool's gold.
MMS is not based on any reasonable science, has not been tested in any sort of randomized trials, and amounts to no more than a scheme to capitalize on the gullibility of the scientifically challenged and the desperate.
Promoting the sale of this product is criminal.
Joe Schwarcz is director of McGill University's Office for Science and Society ( http://www.oss.mcgill.ca/).
He can be heard every Sunday from 3-4 p.m. on CJAD radio.
joe.schwarcz@mcgill.ca
© Copyright (c) The Montreal Gazette
Source
Also See: Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
A New Syringe Is First to Have Automatic Spring Mechanism Protecting Nurses
According to TransMedia, A New Syringe Is First to Have Automatic Spring Mechanism Protecting Nurses
A new safety syringe that can save lives is coming soon to a hospital near you. And one U.S. Marine combat veteran who became a nurse after wounded in Vietnam couldn't be happier.
The newly patented safety syringe from Protectus Medical Devices, Inc. (OTCQB: PTMD) will be the first to protect on-the-go healthcare workers from sometimes deadly needlestick accidents that occur all too frequently when giving injections.
And it does it automatically!
"The Protectus Automatic Self-sheathing Safety Syringe will be to nurses what seat belts and air bags are to motorists," said former Marine Marc Barbanell who has been taking the syringe on test drives and finding it incredibly safe. "Even when patients jerk their arm during an injection and send the syringe flying, it can't hurt anyone," said Barbanell, a Silver Star recipient who has since given thousands of injections to private patients.
"If a nurse were to lose control of this syringe or have it knocked out of her hands, she'd automatically be protected as a spring-activated plastic sheath instantly covers the needle, rendering it harmless and incapable of sticking anyone accidentally.
According to most recent statistics, nearly a million needlestick injuries are reported annually among U.S. healthcare workers costing healthcare system over $3 billion a year.
Workers at U.S. hospitals on average incur approximately 30 needlestick injuries per 100 beds annually. Studies show nurses sustain most of these injuries and one in seven U.S. healthcare workers is accidentally stuck by a contaminated sharp every year, while it is believed only one in three needlesticks is even reported.
From these sharps injuries there have been scores of documented cases of HIV seroconversion among healthcare personnel and 2,000 workers a year become infected with hepatitis C, and 400 contract hepatitis B. More than 20 additional types of infectious agents have been transmitted through needlesticks, including tuberculosis, syphilis, malaria, herpes, diphtheria, gonorrhea, typhus, and Rocky Mountain spotted fever.
The CDC estimates more than 80 percent of needlestick injuries can be prevented by the use of safer medical devices, such as the Protectus syringe. Needlesticks occur most in fast-paced, stressful and often understaffed facilities.
Source: TransMedia Group
Source
A new safety syringe that can save lives is coming soon to a hospital near you. And one U.S. Marine combat veteran who became a nurse after wounded in Vietnam couldn't be happier.
The newly patented safety syringe from Protectus Medical Devices, Inc. (OTCQB: PTMD) will be the first to protect on-the-go healthcare workers from sometimes deadly needlestick accidents that occur all too frequently when giving injections.
And it does it automatically!
"The Protectus Automatic Self-sheathing Safety Syringe will be to nurses what seat belts and air bags are to motorists," said former Marine Marc Barbanell who has been taking the syringe on test drives and finding it incredibly safe. "Even when patients jerk their arm during an injection and send the syringe flying, it can't hurt anyone," said Barbanell, a Silver Star recipient who has since given thousands of injections to private patients.
"If a nurse were to lose control of this syringe or have it knocked out of her hands, she'd automatically be protected as a spring-activated plastic sheath instantly covers the needle, rendering it harmless and incapable of sticking anyone accidentally.
According to most recent statistics, nearly a million needlestick injuries are reported annually among U.S. healthcare workers costing healthcare system over $3 billion a year.
Workers at U.S. hospitals on average incur approximately 30 needlestick injuries per 100 beds annually. Studies show nurses sustain most of these injuries and one in seven U.S. healthcare workers is accidentally stuck by a contaminated sharp every year, while it is believed only one in three needlesticks is even reported.
From these sharps injuries there have been scores of documented cases of HIV seroconversion among healthcare personnel and 2,000 workers a year become infected with hepatitis C, and 400 contract hepatitis B. More than 20 additional types of infectious agents have been transmitted through needlesticks, including tuberculosis, syphilis, malaria, herpes, diphtheria, gonorrhea, typhus, and Rocky Mountain spotted fever.
The CDC estimates more than 80 percent of needlestick injuries can be prevented by the use of safer medical devices, such as the Protectus syringe. Needlesticks occur most in fast-paced, stressful and often understaffed facilities.
Source: TransMedia Group
Source
August 13, 2010
Pioneering hospital halts live liver transplants
By Keith Coffman
DENVER
Fri Aug 13, 2010 8:41pm EDT
DENVER (Reuters) - A Colorado hospital that pioneered liver transplants using tissue from healthy donors has suspended further surgeries of that type following two recent deaths of U.S. donors.
"We are conducting an internal review and will also have outside experts in the field do an external review," University of Colorado Hospital spokeswoman Erika Matich said on Friday. "We will make any changes or improvements if needed."
Ryan Arnold, 34, died on August 2 at the Colorado hospital days after donating a portion of his liver to his older brother, Chad, 38, who was suffering from liver failure.
Rod Arnold, another brother, told Reuters that Ryan went into cardiac arrest two days after the surgery, was resuscitated by medical personnel and placed on life support. Testing revealed he had no brain activity and he died two days later.
The University of Colorado has long been at the forefront of liver transplants. Surgeons there conducted the world's first successful cadaver transplant in the early 1960s.
The university also conducted the first successful transplant using liver tissue from a healthy donor -- a technique known as a live liver transplant -- in the United States in 1997. It has performed 141 successful live liver transplants since then, Matich said.
Arnold is the fourth donor to die in the United States following a live liver transplant operation and the second this year.
In May, a donor died at the Lahey Clinic in Massachusetts after undergoing the operation.
Rod Arnold said Chad Arnold is still recovering from the transplant, and that the family wanted people to know that it was a "natural decision" by Ryan to try and save his brother's life.
"Ryan took care of people his whole life," Rod Arnold said of his brother, who leaves behind a wife and three young sons.
(Editing by Steve Gorman and Bill Trott)
Source
DENVER
Fri Aug 13, 2010 8:41pm EDT
DENVER (Reuters) - A Colorado hospital that pioneered liver transplants using tissue from healthy donors has suspended further surgeries of that type following two recent deaths of U.S. donors.
"We are conducting an internal review and will also have outside experts in the field do an external review," University of Colorado Hospital spokeswoman Erika Matich said on Friday. "We will make any changes or improvements if needed."
Ryan Arnold, 34, died on August 2 at the Colorado hospital days after donating a portion of his liver to his older brother, Chad, 38, who was suffering from liver failure.
Rod Arnold, another brother, told Reuters that Ryan went into cardiac arrest two days after the surgery, was resuscitated by medical personnel and placed on life support. Testing revealed he had no brain activity and he died two days later.
The University of Colorado has long been at the forefront of liver transplants. Surgeons there conducted the world's first successful cadaver transplant in the early 1960s.
The university also conducted the first successful transplant using liver tissue from a healthy donor -- a technique known as a live liver transplant -- in the United States in 1997. It has performed 141 successful live liver transplants since then, Matich said.
Arnold is the fourth donor to die in the United States following a live liver transplant operation and the second this year.
In May, a donor died at the Lahey Clinic in Massachusetts after undergoing the operation.
Rod Arnold said Chad Arnold is still recovering from the transplant, and that the family wanted people to know that it was a "natural decision" by Ryan to try and save his brother's life.
"Ryan took care of people his whole life," Rod Arnold said of his brother, who leaves behind a wife and three young sons.
(Editing by Steve Gorman and Bill Trott)
Source
Histologic outcomes in hepatitis C–infected patients with varying degrees of virologic response to interferon-based treatments
Paul J. Pockros 1,*,‡, Fayez M. Hamzeh 2, Paul Martin 3, Ellen Lentz 2, Xiaolei Zhou 4, Sugantha Govindarajan 5, Anna S. Lok 6
DOI: 10.1002/hep.23809
Copyright © 2010 American Association for the Study of Liver Diseases
Author Information
1 Scripps Clinic, La Jolla, CA
2 Genentech, Inc., South San Francisco, CA
3 Miller School of Medicine, University of Miami, Miami, FL
4 RTI Health Solutions, Research Triangle Park, NC
5 University of Southern California–Keck School of Medicine and Liver Research Laboratory, Downey, CA
6 University of Michigan Medical Center, Ann Arbor, MI
Email: Paul J. Pockros (Pockros.Paul@scrippshealth.org)
*Correspondence: Paul J. Pockros, Division of Gastroenterology/Hepatology, Scripps Clinic, 10666, North Torrey Pines Road, La Jolla, CA 92037
†Potential conflict of interest: Nothing to report.
‡fax: 858-554-8065
Publication History
Article first published online: 23 JUL 2010
Accepted manuscript online: 16 JUN 2010 12:00AM EST
Manuscript Accepted: 7 JUN 2010
Manuscript Received: 25 JAN 2010
Funded by
Roche, Nutley, NJ
Abstract
Patients with chronic hepatitis C with partial virologic response or nonresponse to interferon-based therapies can experience treatment-related improvements in liver histology. This retrospective analysis assessed the histologic response to treatment in patients with varying degrees of virologic response (sustained virologic response [SVR], breakthrough, relapse, or nonresponse), time to hepatitis C virus (HCV) RNA undetectability, and duration of viral suppression. Patients (HCV genotypes 1-6) with baseline and follow-up liver biopsies from eight phase 2 to phase 4 interferon-based trials were analyzed. Blinded biopsies were evaluated by a single pathologist. Improvements or worsening of METAVIR necroinflammatory activity and fibrosis were defined as increase or decrease of ≥1 grading category from baseline to 24 weeks after end of treatment. A majority of the 1571 patients with paired biopsy data were white, male, with HCV genotype 1/4, baseline HCV RNA levels >800,000 IU/mL, and baseline alanine aminotransferase levels ≤3 × upper limit of the normal range; mean baseline activity and fibrosis scores were 1.8 and 1.7, respectively. Overall, 80% of patients received peginterferon alfa-2a monotherapy or peginterferon alfa-2a/ribavirin combination therapy. Mean treatment duration was 46 weeks. There was a positive correlation between the degree of virologic response and improvements in METAVIR activity and fibrosis, and an inverse correlation with worsening activity and fibrosis (all comparisons, P < 0.0001). Patients with SVR had the greatest histologic benefit. As a combined group, relapsers and patients with breakthrough had significantly greater benefits than nonresponders (activity, P = 0.0001; fibrosis, P = 0.003). Consistent with these results, a better histologic response was correlated with a shorter time to undetectable HCV RNA and a longer duration of viral suppression (all comparisons, P < 0.0001). Conclusion: In patients with chronic hepatitis C who were treated with interferon-based therapies, histologic benefits may be observed even in the absence of an SVR. (HEPATOLOGY 2010;)
Source
DOI: 10.1002/hep.23809
Copyright © 2010 American Association for the Study of Liver Diseases
Author Information
1 Scripps Clinic, La Jolla, CA
2 Genentech, Inc., South San Francisco, CA
3 Miller School of Medicine, University of Miami, Miami, FL
4 RTI Health Solutions, Research Triangle Park, NC
5 University of Southern California–Keck School of Medicine and Liver Research Laboratory, Downey, CA
6 University of Michigan Medical Center, Ann Arbor, MI
Email: Paul J. Pockros (Pockros.Paul@scrippshealth.org)
*Correspondence: Paul J. Pockros, Division of Gastroenterology/Hepatology, Scripps Clinic, 10666, North Torrey Pines Road, La Jolla, CA 92037
†Potential conflict of interest: Nothing to report.
‡fax: 858-554-8065
Publication History
Article first published online: 23 JUL 2010
Accepted manuscript online: 16 JUN 2010 12:00AM EST
Manuscript Accepted: 7 JUN 2010
Manuscript Received: 25 JAN 2010
Funded by
Roche, Nutley, NJ
Abstract
Patients with chronic hepatitis C with partial virologic response or nonresponse to interferon-based therapies can experience treatment-related improvements in liver histology. This retrospective analysis assessed the histologic response to treatment in patients with varying degrees of virologic response (sustained virologic response [SVR], breakthrough, relapse, or nonresponse), time to hepatitis C virus (HCV) RNA undetectability, and duration of viral suppression. Patients (HCV genotypes 1-6) with baseline and follow-up liver biopsies from eight phase 2 to phase 4 interferon-based trials were analyzed. Blinded biopsies were evaluated by a single pathologist. Improvements or worsening of METAVIR necroinflammatory activity and fibrosis were defined as increase or decrease of ≥1 grading category from baseline to 24 weeks after end of treatment. A majority of the 1571 patients with paired biopsy data were white, male, with HCV genotype 1/4, baseline HCV RNA levels >800,000 IU/mL, and baseline alanine aminotransferase levels ≤3 × upper limit of the normal range; mean baseline activity and fibrosis scores were 1.8 and 1.7, respectively. Overall, 80% of patients received peginterferon alfa-2a monotherapy or peginterferon alfa-2a/ribavirin combination therapy. Mean treatment duration was 46 weeks. There was a positive correlation between the degree of virologic response and improvements in METAVIR activity and fibrosis, and an inverse correlation with worsening activity and fibrosis (all comparisons, P < 0.0001). Patients with SVR had the greatest histologic benefit. As a combined group, relapsers and patients with breakthrough had significantly greater benefits than nonresponders (activity, P = 0.0001; fibrosis, P = 0.003). Consistent with these results, a better histologic response was correlated with a shorter time to undetectable HCV RNA and a longer duration of viral suppression (all comparisons, P < 0.0001). Conclusion: In patients with chronic hepatitis C who were treated with interferon-based therapies, histologic benefits may be observed even in the absence of an SVR. (HEPATOLOGY 2010;)
Source
Ideal Diet for Hepatitis C
Hepatitis C (HCV), a viral liver disease that leads to the inflammation of the liver, affects about 3.9 million Americans. Hepatitis C is a condition within a class of hepatitis diseases, considered the most serious and life-threatening of them all.
While there is medical treatment available for those with hepatitis that can delay the progress of the disease, diet is an important factor in keeping the person’s immune system strong and healthy.
A diet for a person with HCV is not that much different than a diet that is recommended for anyone who wants to stay fit, strong and maintain a healthy body weight.
Here are nutrition and health guidelines for a person with hepatitis C:
1. Avoid alcohol - Because of alcohol’s known damaging effects on the liver, a person with HCV should avoid alcohol entirely.
2. Eat lots of fresh foods - A healthy diet that is comprised of mostly plant-based foods like vegetables, fruits, legumes, nuts and seeds helps keep the immune system healthy and strong. While anyone is all the more wise (and healthy) to follow such a diet, for a person with HCV, taking the appropriate dietary steps to strengthen the body’s immune system may be a key factor in preventing the progression of liver damage caused by the hepatitis virus.
3. Consider milk thistle - The herb milk thistle has traditionally been used as a healing liver tonic. While current scientific studies yield mixed results in relation to milk thistle and liver health, if you are interested in taking it, talk to your medical practitioner first. Milk thistle can be taken in a capsule, tincture or extract form.
4. Maintain a healthy body weight – Since a person with hepatitis C wants to protect their liver as much as they can, they also want to maintain a healthy body weight, especially if they are prone to carrying weight in their mid-section. Being overweight is linked to a term known as “fatty liver,” where fat deposits around the liver. Having a fatty liver and being hepatitis C positive has been associated with an increased risk for cirrhosis and with a higher viral load, even for those taking antiviral treatments.
5. Avoid excess salt - Following a low-sodium diet is sound dietary advice for anyone, but for a person with any kind of a liver disease, like hepatitis C or cirrhosis, it is a mandatory part of their treatment plan. Salt causes the body to retain water and can incite conditions like extremely low pressure, blood vessel complications, edema and abdominal swelling. Physicians typically advise limiting salt intake to 4-5 grams per day (2,000 mg of sodium) or less.
For hepatitis C-sufferers who are being treated with interferon, nausea, a side effect of the medication, may inhibit the ability to eat a healthy and balanced diet. In addition, individuals with hepatitis C and cirrhosis may also lose their appetite and become too tired and lethargic to eat. In both of these cases, it is important to work with your doctor and a registered dietitian to outline an eating plan that takes into account these additional factors.
Also read:
Foods for a Healthy Liver
August 13th, 2010
Tags: hepatitis, liver, low sodium diet
Source
While there is medical treatment available for those with hepatitis that can delay the progress of the disease, diet is an important factor in keeping the person’s immune system strong and healthy.
A diet for a person with HCV is not that much different than a diet that is recommended for anyone who wants to stay fit, strong and maintain a healthy body weight.
Here are nutrition and health guidelines for a person with hepatitis C:
1. Avoid alcohol - Because of alcohol’s known damaging effects on the liver, a person with HCV should avoid alcohol entirely.
2. Eat lots of fresh foods - A healthy diet that is comprised of mostly plant-based foods like vegetables, fruits, legumes, nuts and seeds helps keep the immune system healthy and strong. While anyone is all the more wise (and healthy) to follow such a diet, for a person with HCV, taking the appropriate dietary steps to strengthen the body’s immune system may be a key factor in preventing the progression of liver damage caused by the hepatitis virus.
3. Consider milk thistle - The herb milk thistle has traditionally been used as a healing liver tonic. While current scientific studies yield mixed results in relation to milk thistle and liver health, if you are interested in taking it, talk to your medical practitioner first. Milk thistle can be taken in a capsule, tincture or extract form.
4. Maintain a healthy body weight – Since a person with hepatitis C wants to protect their liver as much as they can, they also want to maintain a healthy body weight, especially if they are prone to carrying weight in their mid-section. Being overweight is linked to a term known as “fatty liver,” where fat deposits around the liver. Having a fatty liver and being hepatitis C positive has been associated with an increased risk for cirrhosis and with a higher viral load, even for those taking antiviral treatments.
5. Avoid excess salt - Following a low-sodium diet is sound dietary advice for anyone, but for a person with any kind of a liver disease, like hepatitis C or cirrhosis, it is a mandatory part of their treatment plan. Salt causes the body to retain water and can incite conditions like extremely low pressure, blood vessel complications, edema and abdominal swelling. Physicians typically advise limiting salt intake to 4-5 grams per day (2,000 mg of sodium) or less.
For hepatitis C-sufferers who are being treated with interferon, nausea, a side effect of the medication, may inhibit the ability to eat a healthy and balanced diet. In addition, individuals with hepatitis C and cirrhosis may also lose their appetite and become too tired and lethargic to eat. In both of these cases, it is important to work with your doctor and a registered dietitian to outline an eating plan that takes into account these additional factors.
Also read:
Foods for a Healthy Liver
August 13th, 2010
Tags: hepatitis, liver, low sodium diet
Source
Fibrosis Progression and the Pros and Cons of Antiviral Therapy for Hepatitis C Virus Recurrence After Liver Transplantation: A Review
Volume 42, Issue 6, Pages 2223-2225 (July 2010)
E. De Martin a, M. Senzolo a, M. Gambato a, G. Germani a, A. Vitale b, F.R. Russo a, P. Burra a
Abstract
The progression of fibrosis due to hepatitis C virus (HCV) recurrence after liver transplantation (OLT) is faster than in the pretransplant setting, leading to histologically documented cirrhosis within 5 years in 25% to 30% of cases. Whether it is associated with biliary complications or previous alcohol abuse, recurrent HCV is the main cause of graft failure and death after OLT. The most important donor risk factor for HCV recurrence is advanced donor age. The disease's course is even more aggressive if it is associated with anti-HCV positivity or graft steatosis. The type of calcineurin inhibitor does not seem to influence HCV recurrence. Avoiding or slowly tapering steroids has been associated with less disease recurrence, while steroid pulses to treat acute rejection episodes have been associated with a worse progression of fibrosis. Antiviral therapy (AT) is not always recommended in OLT patients, but is of some benefit. Fibrosis has been shown to ameliorate in sustained virological responders to AT and to progress significantly more in nonresponders. Using long-term maintenance, AT has recently been shown to increase the probability of biochemical and histological responses, regardless of the timing of the HCV recurrence. In conclusion, the donor- recipient match should be assessed to limit HCV recurrences and their severity; AT is recommended to reduce or reverse the progression of fibrosis.
a Gastroenterology, Multivisceral Transplant Unit, Department of Surgical and Gastroenterological Sciences, Padua University, Padua, Italy
b Oncological Surgery Unit, IOV (Istituto Oncologico Veneto), Padua University, Padua, Italy
Address reprint requests to Patrizia Burra, MD, PhD, Gastroenterology—Multivisceral Transplant Unit, Department of Surgical and Gastroenterological Sciences, Padua University Hospital, Via Giustiniani 2, 35128 Padova, Italy
PII: S0041-1345(10)00693-7
doi:10.1016/j.transproceed.2010.05.035
© 2010 Published by Elsevier Inc.
Source
E. De Martin a, M. Senzolo a, M. Gambato a, G. Germani a, A. Vitale b, F.R. Russo a, P. Burra a
Abstract
The progression of fibrosis due to hepatitis C virus (HCV) recurrence after liver transplantation (OLT) is faster than in the pretransplant setting, leading to histologically documented cirrhosis within 5 years in 25% to 30% of cases. Whether it is associated with biliary complications or previous alcohol abuse, recurrent HCV is the main cause of graft failure and death after OLT. The most important donor risk factor for HCV recurrence is advanced donor age. The disease's course is even more aggressive if it is associated with anti-HCV positivity or graft steatosis. The type of calcineurin inhibitor does not seem to influence HCV recurrence. Avoiding or slowly tapering steroids has been associated with less disease recurrence, while steroid pulses to treat acute rejection episodes have been associated with a worse progression of fibrosis. Antiviral therapy (AT) is not always recommended in OLT patients, but is of some benefit. Fibrosis has been shown to ameliorate in sustained virological responders to AT and to progress significantly more in nonresponders. Using long-term maintenance, AT has recently been shown to increase the probability of biochemical and histological responses, regardless of the timing of the HCV recurrence. In conclusion, the donor- recipient match should be assessed to limit HCV recurrences and their severity; AT is recommended to reduce or reverse the progression of fibrosis.
a Gastroenterology, Multivisceral Transplant Unit, Department of Surgical and Gastroenterological Sciences, Padua University, Padua, Italy
b Oncological Surgery Unit, IOV (Istituto Oncologico Veneto), Padua University, Padua, Italy
Address reprint requests to Patrizia Burra, MD, PhD, Gastroenterology—Multivisceral Transplant Unit, Department of Surgical and Gastroenterological Sciences, Padua University Hospital, Via Giustiniani 2, 35128 Padova, Italy
PII: S0041-1345(10)00693-7
doi:10.1016/j.transproceed.2010.05.035
© 2010 Published by Elsevier Inc.
Source
Role of treatment for depressive symptoms in relieving the impact of fatigue in HIV-HCV co-infected patients: ANRS Co13 Hepavih, France, 2006-2008
Authors: Michel, L.; Villes, V.; Dabis, F.1; Spire, B.; Winnock, M.1; Loko, M.-A.1; Poizot-Martin, I.2; Valantin, M. A.; Bonnard, P.3; Salmon-Céron, D.; Carrieri, M. P.
Source: Journal of Viral Hepatitis, Volume 17, Number 9, September 2010 , pp. 650-660(11)
Publisher: Wiley-Blackwell
Abstract:
Summary.
Fatigue is a major component of quality of life (QOL) and is associated with depression in HIV-HCV co-infected individuals. We investigated whether treating depressive symptoms (DS) could mitigate the impact of fatigue on daily functioning in co-infected patients, even those at an advanced stage of disease. The analysis was conducted on enrolment data of 328 HIV-HCV co-infected patients recruited in the French nationwide ANRS CO 13 HEPAVIH cohort. Data collection was based on medical records and self-administered questionnaires which included items on socio-behavioural data, the fatigue impact scale (FIS) in three domains (cognitive, physical and social functioning), depressive symptoms (CES-D classification) and use of treatments for depressive symptoms (TDS). After multiple adjustment for gender and unemployment, CD4 cell count <200 per mm3 was associated with a negative impact of fatigue on the physical functioning dimension (P = 0.002). A higher number of symptoms causing discomfort significantly predicted a higher impact of fatigue on all three dimensions (P < 0.001). This was also true for patients with DS receiving TDS when compared with those with no DS but receiving TDS. A significant decreasing linear trend (P < 0.001) of the impact of fatigue was found across the categories `DS/TDS', `DS/no TDS', `no DS/TDS' and `no DS/no TDS'. Despite limitations related to the cross-sectional nature of this study, our results suggest that routine screening and treatment for DS can reduce the impact of fatigue on the daily functioning of HIV-HCV co-infected patients and relieve the burden of their dual infection.
Keywords: ART; depression; fatigue; hepatitis C; quality of life
Document Type: Research article
DOI: 10.1111/j.1365-2893.2009.01223.x
Affiliations: 1: INSERM U897, ISPED, Université Victor Segalen, Bordeaux, France 2: CHU Sainte Marguerite, Marseille, France 3: Hôpital Tenon, Paris, France
Source
Source: Journal of Viral Hepatitis, Volume 17, Number 9, September 2010 , pp. 650-660(11)
Publisher: Wiley-Blackwell
Abstract:
Summary.
Fatigue is a major component of quality of life (QOL) and is associated with depression in HIV-HCV co-infected individuals. We investigated whether treating depressive symptoms (DS) could mitigate the impact of fatigue on daily functioning in co-infected patients, even those at an advanced stage of disease. The analysis was conducted on enrolment data of 328 HIV-HCV co-infected patients recruited in the French nationwide ANRS CO 13 HEPAVIH cohort. Data collection was based on medical records and self-administered questionnaires which included items on socio-behavioural data, the fatigue impact scale (FIS) in three domains (cognitive, physical and social functioning), depressive symptoms (CES-D classification) and use of treatments for depressive symptoms (TDS). After multiple adjustment for gender and unemployment, CD4 cell count <200 per mm3 was associated with a negative impact of fatigue on the physical functioning dimension (P = 0.002). A higher number of symptoms causing discomfort significantly predicted a higher impact of fatigue on all three dimensions (P < 0.001). This was also true for patients with DS receiving TDS when compared with those with no DS but receiving TDS. A significant decreasing linear trend (P < 0.001) of the impact of fatigue was found across the categories `DS/TDS', `DS/no TDS', `no DS/TDS' and `no DS/no TDS'. Despite limitations related to the cross-sectional nature of this study, our results suggest that routine screening and treatment for DS can reduce the impact of fatigue on the daily functioning of HIV-HCV co-infected patients and relieve the burden of their dual infection.
Keywords: ART; depression; fatigue; hepatitis C; quality of life
Document Type: Research article
DOI: 10.1111/j.1365-2893.2009.01223.x
Affiliations: 1: INSERM U897, ISPED, Université Victor Segalen, Bordeaux, France 2: CHU Sainte Marguerite, Marseille, France 3: Hôpital Tenon, Paris, France
Source
A simple, noninvasive test for the diagnosis of liver fibrosis in patients with hepatitis C recurrence after liver transplantation
Authors: Cross, T. J. S.; Calvaruso, V.1; Foxton, M. R.2; Manousou, P.1; Quaglia, A.2; Grillo, F.1; Dhillon, A. P.1; Nolan, J.2; Chang, T. P.1; O'Grady, J.2; Heneghan, M. A.2; O'Beirne, J. P.1; Burroughs, A. K.1; Harrison, P. M.3
Source: Journal of Viral Hepatitis, Volume 17, Number 9, September 2010 , pp. 640-649(10)
Publisher: Wiley-Blackwell
Abstract:
Summary.
Recurrent hepatitis C is a common cause of graft loss in patients undergoing liver transplantation, and serial protocol liver biopsies have been used to identify patients at risk of graft loss from rapid fibrosis progression. The aim of this study was to derive a simple noninvasive index to predict fibrosis in patients with recurrent hepatitis C post-transplant. A retrospective study was performed assessing serial liver biopsies for post-transplant chronic hepatitis C infection. One hundred eighty-five patients were included in the analysis; median age 53 years (interquartile range 48-59) and 140 (76%) were male. Liver histology showed 53 (29%) had Ishak fibrosis stages F0/F1, 31 (17%) had F2, 29 (16%) had F3, 19 (10%) had F4 and 53 (29%) had F5/F6. The London Transplant Centres' (LTC) score was derived combining aspartate aminotransferase (AST IU/L), time from liver transplant (TFLT months), international normalized ratio and platelets. Diagnostic accuracy of the LTC score was assessed using area under receiver-operating characteristic (ROC) curves. The area under the ROC curve for moderate fibrosis (F ≥ 2) was 0.78 (95% CI, 0.70-0.86; P < 0.0001), for advanced fibrosis (F4-6) was 0.80 (95% CI, 0.72-0.87; P < 0.0001) and for cirrhosis was 0.80 (95% CI, 0.72-0.88; P < 0.0001). An optimal cut-off value of 6.3 distinguished patients with no or mild fibrosis (F ≤ 1) odds ratio 10.8 (95% CI, 5.1-22.9); P < 0.0001), sensitivity 88%, specificity 60%, negative predictive value 67% and positive predictive value 84%. The LTC score can identify patients with Hepatitis C virus recurrence following liver transplant with a low risk of significant fibrosis, thus avoiding the need for protocol biopsy.
Keywords: fibrosis; hepatitis C; liver transplantation; noninvasive marker
Document Type: Research article
DOI: 10.1111/j.1365-2893.2009.01222.x
Affiliations: 1: Department of Hepatology and Liver Transplantation, The Royal Free Hospital, Pond Street, London, UK 2: Institute of Liver Studies, King's College Hospital, Denmark Hill, London, UK 3: Division of Gene and Cell-based Therapy, Department of Liver Studies and Transplantation, King's College London, Denmark Hill Campus, Bessemer Road, London, UK
Source
Source: Journal of Viral Hepatitis, Volume 17, Number 9, September 2010 , pp. 640-649(10)
Publisher: Wiley-Blackwell
Abstract:
Summary.
Recurrent hepatitis C is a common cause of graft loss in patients undergoing liver transplantation, and serial protocol liver biopsies have been used to identify patients at risk of graft loss from rapid fibrosis progression. The aim of this study was to derive a simple noninvasive index to predict fibrosis in patients with recurrent hepatitis C post-transplant. A retrospective study was performed assessing serial liver biopsies for post-transplant chronic hepatitis C infection. One hundred eighty-five patients were included in the analysis; median age 53 years (interquartile range 48-59) and 140 (76%) were male. Liver histology showed 53 (29%) had Ishak fibrosis stages F0/F1, 31 (17%) had F2, 29 (16%) had F3, 19 (10%) had F4 and 53 (29%) had F5/F6. The London Transplant Centres' (LTC) score was derived combining aspartate aminotransferase (AST IU/L), time from liver transplant (TFLT months), international normalized ratio and platelets. Diagnostic accuracy of the LTC score was assessed using area under receiver-operating characteristic (ROC) curves. The area under the ROC curve for moderate fibrosis (F ≥ 2) was 0.78 (95% CI, 0.70-0.86; P < 0.0001), for advanced fibrosis (F4-6) was 0.80 (95% CI, 0.72-0.87; P < 0.0001) and for cirrhosis was 0.80 (95% CI, 0.72-0.88; P < 0.0001). An optimal cut-off value of 6.3 distinguished patients with no or mild fibrosis (F ≤ 1) odds ratio 10.8 (95% CI, 5.1-22.9); P < 0.0001), sensitivity 88%, specificity 60%, negative predictive value 67% and positive predictive value 84%. The LTC score can identify patients with Hepatitis C virus recurrence following liver transplant with a low risk of significant fibrosis, thus avoiding the need for protocol biopsy.
Keywords: fibrosis; hepatitis C; liver transplantation; noninvasive marker
Document Type: Research article
DOI: 10.1111/j.1365-2893.2009.01222.x
Affiliations: 1: Department of Hepatology and Liver Transplantation, The Royal Free Hospital, Pond Street, London, UK 2: Institute of Liver Studies, King's College Hospital, Denmark Hill, London, UK 3: Division of Gene and Cell-based Therapy, Department of Liver Studies and Transplantation, King's College London, Denmark Hill Campus, Bessemer Road, London, UK
Source
New Hepatitis Therapy Could Be Vertex's Windfall
August 13, 2010
By Michael Fitzhugh
Vertex Pharmaceutical (VRTX) says a new trial shows that its late-stage hepatitis C therapy, telaprevir, can help some people tackle the virus in half the time the current treatment takes. A quicker cure, one slashing typical treatment times to 24 weeks from 48 weeks, could help millions of infected people stick to their treatment regimens and represent a windfall for Vertex.
Knowing that it’s possible to treat infected patients in less time could “provide important information to motivate people to continue therapy,” says the trial’s principal investigator, Kenneth Sherman, a professor at the University of Cincinnati College of Medicine.
The trial, dubbed ILLUMINATE, was designed to evaluate whether there was any benefit to extending therapy from 24 weeks to 48 weeks in people whose hepatitis C virus was undetectable at weeks 4 and 12 of treatment. Vertex's analysis of the study's results found there was not.
Hepatitis C can lead to liver cancer and scarring and is thought to be carried by more than 4 million people in the United States and 180 million people worldwide, according to the National Institute of Allergy and Infectious Diseases. Between 55 percent and 85 percent of those people will develop chronic infection, and 75 percent of those with chronic infection will develop chronic liver disease, according to the Institute.
Analysts predict telaprevir sales could peak at more than $3 billion annually in the United States, garnering another $1 billion in peak annual sales overseas. Vertex's main competition in becoming the next standard of care for hepatitis C will be Merck's boceprevir. Telaprevir's efficacy has yet to be compared to boceprevir in a scientific study.
Vertex and its partners, Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma, plan to submit the positive trial results to support a new drug application for telaprevir to the U.S. Food and Drug Administration in the form of a rolling submission, a process that could accelerate the agency's review of the drug. A decision is expected in early 2011.
Source
By Michael Fitzhugh
Vertex Pharmaceutical (VRTX) says a new trial shows that its late-stage hepatitis C therapy, telaprevir, can help some people tackle the virus in half the time the current treatment takes. A quicker cure, one slashing typical treatment times to 24 weeks from 48 weeks, could help millions of infected people stick to their treatment regimens and represent a windfall for Vertex.
Knowing that it’s possible to treat infected patients in less time could “provide important information to motivate people to continue therapy,” says the trial’s principal investigator, Kenneth Sherman, a professor at the University of Cincinnati College of Medicine.
The trial, dubbed ILLUMINATE, was designed to evaluate whether there was any benefit to extending therapy from 24 weeks to 48 weeks in people whose hepatitis C virus was undetectable at weeks 4 and 12 of treatment. Vertex's analysis of the study's results found there was not.
Hepatitis C can lead to liver cancer and scarring and is thought to be carried by more than 4 million people in the United States and 180 million people worldwide, according to the National Institute of Allergy and Infectious Diseases. Between 55 percent and 85 percent of those people will develop chronic infection, and 75 percent of those with chronic infection will develop chronic liver disease, according to the Institute.
Analysts predict telaprevir sales could peak at more than $3 billion annually in the United States, garnering another $1 billion in peak annual sales overseas. Vertex's main competition in becoming the next standard of care for hepatitis C will be Merck's boceprevir. Telaprevir's efficacy has yet to be compared to boceprevir in a scientific study.
Vertex and its partners, Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma, plan to submit the positive trial results to support a new drug application for telaprevir to the U.S. Food and Drug Administration in the form of a rolling submission, a process that could accelerate the agency's review of the drug. A decision is expected in early 2011.
Source
Thai activists call for treatment for hepatitis C for people with HIV
Carole Leach-Lemens
Published: 13 August 2010
Treating co-infection of HIV and hepatitis C (HCV) in Thailand makes sound economic sense, Noah Methany argues in a policy paper published by the Thai AIDS Treatment Action Group (TATAG) on July 28, 2010, in recognition of World Hepatitis Day.
Outlining the public health crisis of HIV and HCV co-infection faced by people who inject drugs in Thailand, the paper makes recommendations to the government to help stop and reverse this dual epidemic.
While Thailand boasts a universal health care system that claims healthcare for all without discrimination, people living with HIV who are co-infected with HCV, notably current or former drug injectors, face unique barriers to effective treatment, notes the author.
Increased access to antiretroviral treatment in low- and middle-income countries has increased life expectancy and improved the quality of life of people living with HIV. But many find they are now dealing with other chronic health problems, of which hepatitis C is one.
Hepatitis C, a blood-borne viral infection, spreads easily through the sharing of injecting equipment, and disproportionately affects injecting drug users (IDUs).
HCV is transmitted when infected blood from one person enters another’s bloodstream through any kind of contact. Unlike HIV it can live outside of the body for a long period of time, making it ten times more infectious than HIV, notes Methany.
HCV is the world’s leading cause of liver disease. It can progress silently from fibrosis (mild scarring of the liver) to cirrhosis (severe scarring). Those with cirrhosis are at increased risk for liver cancer and liver failure. People living with HIV have weakened immune systems so HCV progresses more rapidly than in people who are HIV-negative.
End-stage liver disease is becoming a growing cause of death among people living with HIV. Additionally, Methany notes, “HCV complicates a person living with HIV’s treatment because it can triple the risk of antiretroviral-associated liver toxicity.”
There is a general lack of awareness of the disease amongst the medical community as well as those at risk. Diagnosis, management and treatment are complex and costly and are considered the main barriers to improving access to treatment.
“It is incredibly ironic that we have dramatically altered the prognosis for HIV – a currently incurable disease – only to see co-infected people dying from complications of hepatitis C, a disease that we can cure,” noted Tracy Swan of New York’s Treatment Action Group, the paper’s editor.
IDUs may also have to face other problems when trying to access health care that include denial of, or discriminatory treatment and a lack of confidentiality.
WHO estimates that three percent of the world’s population or 180 million people have been infected with HCV, with an additional three to four million newly infected each year, many of whom remain undiagnosed.
WHO estimates 32.3 million people living in South East Asia are infected with HCV. An estimated two to nine million IDUs are living in the Asia-Pacific region, of which 750,000 are estimated to be living with HIV. While there are few epidemiological studies on the prevalence of HIV and HCV co-infection in Asia, an estimated 60-90% of IDUs are living with HIV.
According to WHO and UNAIDS 610,000 Thais are living with HIV/AIDS; 5 to 10% are estimated to have got it from injecting drugs and at least half of all injecting drug users in Thailand are living with HIV/AIDS.
The International Harm Reduction Association estimates up to 90% of injecting drug users in Thailand have become infected with HCV, notes Methany.
A two-step process is required to determine infection with HCV. The first part-an antibody test shows if a person is or has been infected. A viral load test is then needed to determine whether infection is chronic or not. Liver enzyme levels are needed to monitor people with HCV. Length of treatment is determined by genotypic testing. Methany notes that while there are at least six different genetic versions of hepatitis C virus, genotypes 1,3 and 6 are the most common in Thailand.
A three to twelve month course of treatment with a combination of two drugs – pegylated interferon (PEG-IFN) and ribavirin (RBV) – is the current standard of care. While generally there is a 50% treatment success rate, response varies and is related to genotype.
Ribavirin is available as a generic product, whereas the two versions of pegylated interferon are still under patent. The current costs of treating hepatitis C is approximately US $38,000 for a 48-week course of treatment, prohibitive for many health care systems. In Thailand these drugs are not on the Thai National Essential Drugs List and so are not included in the Thai universal coverage scheme.
Contrary to arguments that treating HCV and HIV co-infection in Thailand is too expensive, the author cites two studies that showed treating people with ribavirin and pegylated interferon to be cost-effective and increased life expectancy.
Researchers showed that treating Thai HCV (genotypes 2 and 3) patients compared to no treatment resulted in a lifetime cost saving of 556,862 baht (US$16,784). Noah Methany argues that not only is it Thailand’s constitutional and moral obligation to provide treatment for Thai HCV patients but it also makes economic sense.
Methany proposes the following policy recommendations to address the challenges faced by Thais, current or former injecting drug users, who are co-infected with HIV and HCV.
Methany, N and Swan, T (ed) Illuminating a hidden epidemic: the public health crisis of HIV/HCV co-infection among injecting drug users (IDU) in Thailand. Thai AIDS Treatment Action Group (TTAG) Foundation, July 28, 2010. http://www.ttag.info/
Source
Published: 13 August 2010
Treating co-infection of HIV and hepatitis C (HCV) in Thailand makes sound economic sense, Noah Methany argues in a policy paper published by the Thai AIDS Treatment Action Group (TATAG) on July 28, 2010, in recognition of World Hepatitis Day.
Outlining the public health crisis of HIV and HCV co-infection faced by people who inject drugs in Thailand, the paper makes recommendations to the government to help stop and reverse this dual epidemic.
While Thailand boasts a universal health care system that claims healthcare for all without discrimination, people living with HIV who are co-infected with HCV, notably current or former drug injectors, face unique barriers to effective treatment, notes the author.
Increased access to antiretroviral treatment in low- and middle-income countries has increased life expectancy and improved the quality of life of people living with HIV. But many find they are now dealing with other chronic health problems, of which hepatitis C is one.
Hepatitis C, a blood-borne viral infection, spreads easily through the sharing of injecting equipment, and disproportionately affects injecting drug users (IDUs).
HCV is transmitted when infected blood from one person enters another’s bloodstream through any kind of contact. Unlike HIV it can live outside of the body for a long period of time, making it ten times more infectious than HIV, notes Methany.
HCV is the world’s leading cause of liver disease. It can progress silently from fibrosis (mild scarring of the liver) to cirrhosis (severe scarring). Those with cirrhosis are at increased risk for liver cancer and liver failure. People living with HIV have weakened immune systems so HCV progresses more rapidly than in people who are HIV-negative.
End-stage liver disease is becoming a growing cause of death among people living with HIV. Additionally, Methany notes, “HCV complicates a person living with HIV’s treatment because it can triple the risk of antiretroviral-associated liver toxicity.”
There is a general lack of awareness of the disease amongst the medical community as well as those at risk. Diagnosis, management and treatment are complex and costly and are considered the main barriers to improving access to treatment.
“It is incredibly ironic that we have dramatically altered the prognosis for HIV – a currently incurable disease – only to see co-infected people dying from complications of hepatitis C, a disease that we can cure,” noted Tracy Swan of New York’s Treatment Action Group, the paper’s editor.
IDUs may also have to face other problems when trying to access health care that include denial of, or discriminatory treatment and a lack of confidentiality.
WHO estimates that three percent of the world’s population or 180 million people have been infected with HCV, with an additional three to four million newly infected each year, many of whom remain undiagnosed.
WHO estimates 32.3 million people living in South East Asia are infected with HCV. An estimated two to nine million IDUs are living in the Asia-Pacific region, of which 750,000 are estimated to be living with HIV. While there are few epidemiological studies on the prevalence of HIV and HCV co-infection in Asia, an estimated 60-90% of IDUs are living with HIV.
According to WHO and UNAIDS 610,000 Thais are living with HIV/AIDS; 5 to 10% are estimated to have got it from injecting drugs and at least half of all injecting drug users in Thailand are living with HIV/AIDS.
The International Harm Reduction Association estimates up to 90% of injecting drug users in Thailand have become infected with HCV, notes Methany.
A two-step process is required to determine infection with HCV. The first part-an antibody test shows if a person is or has been infected. A viral load test is then needed to determine whether infection is chronic or not. Liver enzyme levels are needed to monitor people with HCV. Length of treatment is determined by genotypic testing. Methany notes that while there are at least six different genetic versions of hepatitis C virus, genotypes 1,3 and 6 are the most common in Thailand.
A three to twelve month course of treatment with a combination of two drugs – pegylated interferon (PEG-IFN) and ribavirin (RBV) – is the current standard of care. While generally there is a 50% treatment success rate, response varies and is related to genotype.
Ribavirin is available as a generic product, whereas the two versions of pegylated interferon are still under patent. The current costs of treating hepatitis C is approximately US $38,000 for a 48-week course of treatment, prohibitive for many health care systems. In Thailand these drugs are not on the Thai National Essential Drugs List and so are not included in the Thai universal coverage scheme.
Contrary to arguments that treating HCV and HIV co-infection in Thailand is too expensive, the author cites two studies that showed treating people with ribavirin and pegylated interferon to be cost-effective and increased life expectancy.
Researchers showed that treating Thai HCV (genotypes 2 and 3) patients compared to no treatment resulted in a lifetime cost saving of 556,862 baht (US$16,784). Noah Methany argues that not only is it Thailand’s constitutional and moral obligation to provide treatment for Thai HCV patients but it also makes economic sense.
Methany proposes the following policy recommendations to address the challenges faced by Thais, current or former injecting drug users, who are co-infected with HIV and HCV.
- Immediately scale up of evidence-based harm reduction programmes that promote access to clean injecting equipment/sterile syringes, which prevent new HCV infection.
- Increase support for Thai civil society involvement in HCV awareness campaigns through promotion of capacity building and education of advocates, patients, healthcare providers and policymakers.
- Provide universal access to free testing for HCV and offer follow-up diagnostic tests on a routine basis to IDUs who test positive for HIV.
- Provide national level data collection on HCv incidence and prevalence among Thais living with HIV/AIDS.
- Include pegylated interferon and ribavirin on WHO and Thai Essential Medicines List.
- Develop Thai-language national guidelines based on international best practices for HCV treatment and care.
- Increase political support for the Thai Government Pharmaceutical Organization (GPO) to produce generic versions of pegylated interferon and ribavirin, and
- Increase political support for Thai government officials to exercise legal, TRIPS flexibilities (such as compulsory licences and parallel importation) to gain access to cheaper HCV treatment.
Methany, N and Swan, T (ed) Illuminating a hidden epidemic: the public health crisis of HIV/HCV co-infection among injecting drug users (IDU) in Thailand. Thai AIDS Treatment Action Group (TTAG) Foundation, July 28, 2010. http://www.ttag.info/
Source
Acquisition May Create Headaches for Merck in Foreign Corruption Probe
By Jim Edwards August 13, 2010
EDITOR’S NOTE: This is a revised version of an earlier BNET column. Merck objected to our characterizations of a Department of Justice and the SEC investigation in that article, and BNET regrets any errors or false implications.
Merck (MRK) disclosed in its quarterly 10-Q filing that it is the subject of an investigation by the Department of Justice and the SEC for possible violations of the Foreign Corrupt Practices Act (which prohibits paying bribes to do business in foreign countries). The investigation comes with a bit of unspoken history — and some potential risk created by Merck’s recent acquisition of Schering-Plough.
Merck says “this inquiry is part of a broader review of pharmaceutical industry practice.” That’s true: at least 10 other companies are suspected of doing the same thing, and an 11th — SciClone (SCLN.O) popped up Tuesday.
However, the fuller context is that the letters are more serious than a “review.” A DOJ assistant attorney general warned an assemblage of pharma industry lawyers last year that DOJ “will be intensely focused on rooting out foreign bribery in your industry.” A similar criminal investigation has already led to the imprisonment of one executive at Johnson & Johnson (JNJ) in the U.K., and J&J admitted in its most recent 10-Q that it had violated anti-corruption laws and that investigations are under way in several nations, including the United States.
The U.S. investigation is ongoing, and Merck told BNET it’s cooperating with authorities. While emphasizing that it has an FCPA compliance program in place, Merck’s 10-Q says that the company has not been charged with any FCPA violations:
The company has received letters from the DOJ and the SEC that seek information about activities in a number of countries and reference the Foreign Corrupt Practices Act. The company is cooperating with the agencies in their requests and believes that this inquiry is part of a broader review of pharmaceutical industry practices in foreign countries.
Despite its public assurances and FCPA compliance programs, Merck nevertheless may have significant exposure in the investigation. The biggest source of vulnerability may be Schering-Plough, which Merck acquired in 2009. One ominous sign is that Schering-Plough has already been named in connection with an alleged foreign kickback scheme to promote the Hepatitis C drug PegIntron in Vietnam.
Schering-Plough stands accused of offering Vietnamese doctors a kickback of 10 to 30 percent of the medicine’s price, according to Vietnam’s English-language press. Vietnam’s Health Ministry investigated those reports, and in March 2010, the prime minister demanded penalties be imposed on Schering for paying monthly commissions of $26,300 to doctors who prescribed PegIntron. One doctor at a medical school was rumored, according to the local press, to also be a marketing director at Schering.
As Schering’s new parent, Merck assumes responsibility for any missteps Schering made prior to its acquisition.
While there’s no evidence of wrongdoing at Merck, the company would not have needed to make the disclosure at all if it believed the probe would never become “material” to its financial statements. So what is the potential exposure? As the Vietnam incident suggests, the business practices of Schering-Plough prior to its acquisition by Merck stand out as a potential wildcard.
In response to BNET’s queries about potential liabilities resulting from Schering-Plough’s pre-acquisition business practices, Merck declined to comment beyond the statement contained within its 10-Q filing.
If prosecutors are not singling out Merck, and the letters they sent were just standard forms, then the matter could end with a simple reply to the feds’ letters. On the other hand, companies found guilty of FCPA violations have been forced to disgorge the profits made from any corrupt scheme.
Either way there’s a lesson in this experience for any company that seeks growth through acquisitions: You may get more than you paid for, and that’s not always a welcome thing.
Related:
EDITOR’S NOTE: This is a revised version of an earlier BNET column. Merck objected to our characterizations of a Department of Justice and the SEC investigation in that article, and BNET regrets any errors or false implications.
Merck (MRK) disclosed in its quarterly 10-Q filing that it is the subject of an investigation by the Department of Justice and the SEC for possible violations of the Foreign Corrupt Practices Act (which prohibits paying bribes to do business in foreign countries). The investigation comes with a bit of unspoken history — and some potential risk created by Merck’s recent acquisition of Schering-Plough.
Merck says “this inquiry is part of a broader review of pharmaceutical industry practice.” That’s true: at least 10 other companies are suspected of doing the same thing, and an 11th — SciClone (SCLN.O) popped up Tuesday.
However, the fuller context is that the letters are more serious than a “review.” A DOJ assistant attorney general warned an assemblage of pharma industry lawyers last year that DOJ “will be intensely focused on rooting out foreign bribery in your industry.” A similar criminal investigation has already led to the imprisonment of one executive at Johnson & Johnson (JNJ) in the U.K., and J&J admitted in its most recent 10-Q that it had violated anti-corruption laws and that investigations are under way in several nations, including the United States.
The U.S. investigation is ongoing, and Merck told BNET it’s cooperating with authorities. While emphasizing that it has an FCPA compliance program in place, Merck’s 10-Q says that the company has not been charged with any FCPA violations:
The company has received letters from the DOJ and the SEC that seek information about activities in a number of countries and reference the Foreign Corrupt Practices Act. The company is cooperating with the agencies in their requests and believes that this inquiry is part of a broader review of pharmaceutical industry practices in foreign countries.
Despite its public assurances and FCPA compliance programs, Merck nevertheless may have significant exposure in the investigation. The biggest source of vulnerability may be Schering-Plough, which Merck acquired in 2009. One ominous sign is that Schering-Plough has already been named in connection with an alleged foreign kickback scheme to promote the Hepatitis C drug PegIntron in Vietnam.
Schering-Plough stands accused of offering Vietnamese doctors a kickback of 10 to 30 percent of the medicine’s price, according to Vietnam’s English-language press. Vietnam’s Health Ministry investigated those reports, and in March 2010, the prime minister demanded penalties be imposed on Schering for paying monthly commissions of $26,300 to doctors who prescribed PegIntron. One doctor at a medical school was rumored, according to the local press, to also be a marketing director at Schering.
As Schering’s new parent, Merck assumes responsibility for any missteps Schering made prior to its acquisition.
While there’s no evidence of wrongdoing at Merck, the company would not have needed to make the disclosure at all if it believed the probe would never become “material” to its financial statements. So what is the potential exposure? As the Vietnam incident suggests, the business practices of Schering-Plough prior to its acquisition by Merck stand out as a potential wildcard.
In response to BNET’s queries about potential liabilities resulting from Schering-Plough’s pre-acquisition business practices, Merck declined to comment beyond the statement contained within its 10-Q filing.
If prosecutors are not singling out Merck, and the letters they sent were just standard forms, then the matter could end with a simple reply to the feds’ letters. On the other hand, companies found guilty of FCPA violations have been forced to disgorge the profits made from any corrupt scheme.
Either way there’s a lesson in this experience for any company that seeks growth through acquisitions: You may get more than you paid for, and that’s not always a welcome thing.
Related:
- The Price of Admission: 10 Medical Companies Suspected of Paying Bribes in Foreign Countries
- J&J’s Other Headache: Foreign Bribery Probe Targets Shanghai Unit
- Did Pfizer Violate Foreign Corrupt Practices Act in Philippine “Bribe” Flap?
- J&J’s Rude Education: So There Is a Difference Between Doctor Bribery and “Professional Education”
Liver Cancer Kills Legendary Drummer Richie Hayward
Published August 13, 2010 by:
Sylvia Cochran
Famous Musician Succumbs to Deadly Disease
For Little Feat drummer Richie Hayward, cancer became a reality more than a year ago. Diagnosed with liver cancer, the influential musician lost his battle with the disease on Aug. 12, 2010. Would you know how to detect liver cancer symptoms?
Richie Hayward Dead from Liver Cancer
Drum! Magazine reports that Little Feat drummer Richie Hayward died from liver cancer at the age of 64. Even though he was a major powerhouse on the national and international music scene, Hayward did not have health insurance. A currently scheduled benefit concert designed to help defray the drummer's costs associated with healthcare will proceed. It is noteworthy that Hayward fought the illness since last year, when liver cancer symptoms first prompted a diagnosis.
Understanding Liver Cancer
According to the National Cancer Institute, each year liver cancer affects approximately 15,000 men and 6,000 women. The average age of diagnosis is over 64. There are a number of risk factors that heighten a person's susceptibility of contracting liver cancer. A prolonged infection with hepatitis B or C, long-term alcohol abuse, exposure to deadly mold toxins, excessive bodily iron storage and diabetes, as well as obesity, are well-known risk factors.
The fact that the early stages of the disease do not present many noticeable symptoms contributes to the frequently poor liver cancer prognosis. Once the tumor is sufficiently large, liver cancer symptoms include weight loss, upper abdominal pain, bloating, jaundice and fever. Physicians evaluate the stage of the disease by how extensively it is spread; it may reach the lungs, as well as the bones and lymph nodes. A cure is only possible if patient and doctor catch liver cancer before it spreads, and the sufferer is sufficiently well to be a candidate for surgery.
Richie Hayward Joins Long List of Famous Liver Cancer Victims
The Encyclopedia of Jazz Musicians reports that music legend Ray Charles died from liver cancer in 2004 at age 73. Blues celebrity John Jackson succumbed to the disease in 2002 at age 77, All Music reveals.
Liver cancer also claimed the life of Wendy's founder and noted philanthropist Dave Thomas. Back in 2002, CNN revealed that Thomas had battled liver cancer for 10 years before the disease finally won.
Sources
http://www.drummagazine.com/wiretap
http://www.cancer.gov/cancertopics/wyntk/liver
http://www.jazz.com/encyclopedia/charles-ray-ray-charles-robinson
http://www.allmusic.com/cg/amg.dll?p=amg&sql=11:gifixq95ldke~T1
http://money.cnn.com/2002/01/08/companies/wendys_obit/index.htm
Source
Sylvia Cochran
Famous Musician Succumbs to Deadly Disease
For Little Feat drummer Richie Hayward, cancer became a reality more than a year ago. Diagnosed with liver cancer, the influential musician lost his battle with the disease on Aug. 12, 2010. Would you know how to detect liver cancer symptoms?
Richie Hayward Dead from Liver Cancer
Drum! Magazine reports that Little Feat drummer Richie Hayward died from liver cancer at the age of 64. Even though he was a major powerhouse on the national and international music scene, Hayward did not have health insurance. A currently scheduled benefit concert designed to help defray the drummer's costs associated with healthcare will proceed. It is noteworthy that Hayward fought the illness since last year, when liver cancer symptoms first prompted a diagnosis.
Understanding Liver Cancer
According to the National Cancer Institute, each year liver cancer affects approximately 15,000 men and 6,000 women. The average age of diagnosis is over 64. There are a number of risk factors that heighten a person's susceptibility of contracting liver cancer. A prolonged infection with hepatitis B or C, long-term alcohol abuse, exposure to deadly mold toxins, excessive bodily iron storage and diabetes, as well as obesity, are well-known risk factors.
The fact that the early stages of the disease do not present many noticeable symptoms contributes to the frequently poor liver cancer prognosis. Once the tumor is sufficiently large, liver cancer symptoms include weight loss, upper abdominal pain, bloating, jaundice and fever. Physicians evaluate the stage of the disease by how extensively it is spread; it may reach the lungs, as well as the bones and lymph nodes. A cure is only possible if patient and doctor catch liver cancer before it spreads, and the sufferer is sufficiently well to be a candidate for surgery.
Richie Hayward Joins Long List of Famous Liver Cancer Victims
The Encyclopedia of Jazz Musicians reports that music legend Ray Charles died from liver cancer in 2004 at age 73. Blues celebrity John Jackson succumbed to the disease in 2002 at age 77, All Music reveals.
Liver cancer also claimed the life of Wendy's founder and noted philanthropist Dave Thomas. Back in 2002, CNN revealed that Thomas had battled liver cancer for 10 years before the disease finally won.
Sources
http://www.drummagazine.com/wiretap
http://www.cancer.gov/cancertopics/wyntk/liver
http://www.jazz.com/encyclopedia/charles-ray-ray-charles-robinson
http://www.allmusic.com/cg/amg.dll?p=amg&sql=11:gifixq95ldke~T1
http://money.cnn.com/2002/01/08/companies/wendys_obit/index.htm
Source
Boost for drugs against hepatitis C
Hepatitis virus particles: drugs targeting hepatitis C could make billions of dollars, say analysts.
AMI IMAGES / SCIENCE PHOTO LIBRARY
Published online 13 August 2010
Nature doi:10.1038/news.2010.408
Promising clinical trial results point to the pharmaceutical industry's next blockbuster.
Ewen Callaway
A new generation of drugs with the potential to cure hepatitis C is set to flood the market.
This month, Vertex Pharmaceuticals, based in Cambridge, Massachusetts, and drug behemoth Merck, headquartered in Whitehouse Station, New Jersey, both released promising results from late-stage clinical trials of their leading drugs against hepatitis C virus (HCV).
The two treatments belong to the first wave of what pharmaceutical analysts think will be a profusion of HCV-targeting drugs that could ring up billions of dollars in annual sales. "There certainly is blockbuster potential for new and efficacious drugs in hepatitis C," says Hedwig Kresse, a drug-market analyst at Datamonitor in London.
The virus infects liver cells and can cause cirrhosis and liver cancer. It affects about 3% of the world's population — and new treatments are urgently needed.
"There are a lot of people who don't respond to the current therapies or are unable to tolerate them," says Paul Klenerman, who works on hepatitis C therapies at the University of Oxford, UK. "There's no doubt there's a big unmet need there."
Currently, patients spend about a year taking a combination of interferon-α, a protein that boosts the immune system, and ribavirin, an antiviral drug that does not specifically target HCV. Roughly half of all patients with hepatitis C are cured by this course, but it can also cause serious side effects, such as depression, anaemia, and flu-like illness.
Protease punch
Enter Vertex's drug telaprevir and Merck's boceprevir. Both block HCV's protease enzyme so that it cannot carry out one of its key tasks. All of HCV's proteins are initially produced as one long polyprotein, which needs to be cleaved into its component proteins by the protease. Blocking the protease prevents the virus from producing functional proteins.
The companies will submit their medicines to the US Food and Drug Administration by the end of this year, with an eye towards approval in mid-2011.
Data released this month fulfil the pharmaceutical industry's high expectations for the effectiveness of these drugs. Boceprevir, combined with interferon-α and ribavirin, cured the infections of about two-thirds of the patients who followed a 48-week course, Merck announced on 4 August. Some patients were able to finish the course even sooner, at 28 or 36 weeks.
Telaprevir, also combined with the standard drugs, cured 72% of patients after just 24 weeks of treatment, Vertex said on 10 August. Patients who responded quickly to the drug, within 4 to 12 weeks, were the most likely to be cured by it. Another phase III trial of telaprevir, the results for which Vertex released in May, had already demonstrated the benefits of the 24-week course, but the latest study confirmed that it was just as effective as a 48-week regimen for most patients.
"This is such a huge step forward. You can't call it one step — it's multiple steps with one drug," says Stefan Zeuzem, a professor of medicine who studies hepatitis C at Johann Wolfgang Goethe University Hospital in Frankfurt, Germany.
Analysts are already giving telaprevir the edge, largely because of the shorter course of treatment. Peter Chang, a scientific analyst at Sagient Research Systems in San Diego, California, estimates that sales of telaprevir could reach US$6 billion a year across the United States and Europe by 2014. Vertex is developing the drug in collaboration with the pharmaceutical companies Tibotec Pharmaceuticals, based in Ireland, and Mitsubishi Tanabe Pharma, based in Japan.
Cocktail approach
If approved, telaprevir and boceprevir will take the early lead in an HCV drug field that could grow to be worth $15 billion by 2017, according to Irena Melnikova, a life-sciences analyst at TVM Capital in Boston, Massachusetts. The field is poised to become even more crowded in the coming years. "There are still going to be a number of patients who fail [to be cured by] telaprevir or boceprevir," says Chang. "There's plenty of market to still go after."
Other companies are also developing protease inhibitors, as well as drugs that target other parts of the virus. The main targets apart from the protease are HCV's polymerase enzyme, which copies its RNA genome, and its NS5A protein, which is involved in replication and viral assembly but is not an enzyme. Drugs targeting these proteins are now in phase I and II trials.
Experimental drugs targeting different parts of the virus should also stymie the development of drug-resistant strains of HCV. The approach would be similar to the one taken against HIV, for which patients take a cocktail of drugs.
With vaccines that would prevent HCV infection still in early stages of development, the next-generation drugs will be vital for curing those who are affected. For now, the protease inhibitors being developed will be combined with interferon-α and ribavirin. But Klenerman says that "once we have more agents we will have room to design some interesting therapies".
Pharmaceutical firms are already testing different combinations of drug candidates to see what works best for different patients. "Ultimately, we should have a cocktail allowing viral eradication for every patient," says Zeuzem.
Source
August 12, 2010
Caregiver Relationship Predicts Post-Transplant Anxiety
Depression, anxiety reduced after liver transplant, but improvement is attenuated by emotional distance
Publish date: Aug 12, 2010
THURSDAY, Aug. 12 (HealthDay News) -- Many patients with end-stage liver disease (ESLD) have less depression and anxiety after receiving a liver transplant, but this improvement is attenuated in individuals with emotionally distant caregiving relationships, according to research presented at the International Congress of Behavioral Medicine, held from Aug. 4 to 7 in Washington, D.C.
Anne Eshelman, Ph.D., of the Henry Ford Hospital in Detroit, and colleagues surveyed 74 patients with ESLD before liver transplant and six months' post-op, and asked their primary caregivers what degree of closeness they felt in their relationship.
The researchers found that caregivers reporting maximum closeness were in the majority (44 versus 30). Depression and anxiety decreased after transplant, but more so in the patients whose caregivers reported emotionally close relationships. Gender was a confounding variable, and further analysis suggested emotional closeness was more important for improvement in men than in women.
"For patients with ESLD, depression and anxiety decline sharply after liver transplant, but declines are attenuated for individuals with emotionally distant caregiving relationships. These findings suggest caregiving relationships as a target for psychotherapeutic intervention among patients with ESLD," the authors write.
Source
Publish date: Aug 12, 2010
THURSDAY, Aug. 12 (HealthDay News) -- Many patients with end-stage liver disease (ESLD) have less depression and anxiety after receiving a liver transplant, but this improvement is attenuated in individuals with emotionally distant caregiving relationships, according to research presented at the International Congress of Behavioral Medicine, held from Aug. 4 to 7 in Washington, D.C.
Anne Eshelman, Ph.D., of the Henry Ford Hospital in Detroit, and colleagues surveyed 74 patients with ESLD before liver transplant and six months' post-op, and asked their primary caregivers what degree of closeness they felt in their relationship.
The researchers found that caregivers reporting maximum closeness were in the majority (44 versus 30). Depression and anxiety decreased after transplant, but more so in the patients whose caregivers reported emotionally close relationships. Gender was a confounding variable, and further analysis suggested emotional closeness was more important for improvement in men than in women.
"For patients with ESLD, depression and anxiety decline sharply after liver transplant, but declines are attenuated for individuals with emotionally distant caregiving relationships. These findings suggest caregiving relationships as a target for psychotherapeutic intervention among patients with ESLD," the authors write.
Source
Studies Find High Risk Of Heart Problems In HIV-Positive Adults (AIDS 2010)
By Caitlin McHugh and Courtney McQueen
Published: Aug 11, 2010 6:21 pm
Researchers presented several studies at the 2010 International AIDS Conference in Vienna, Austria that evaluated heart function and heart disease in HIV-positive adults. Two studies found that even young, healthy people with HIV may show signs of heart problems; two additional studies showed that kidney disease and heart disease in people with HIV may be linked.
People with HIV can be particularly prone to heart disease and heart problems, with some studies estimating that heart disease causes a fifth of all deaths in people with HIV.
As a result, researchers are conducting studies to identify risk factors and how heart disease develops in HIV-positive adults.
Adults With HIV May Have High Rates Of Coronary Artery Narrowing
This pilot study examined 52 HIV-positive adults with a low risk for heart disease to determine the rate of coronary artery stenosis – narrowing of the arteries that bring blood to the heart muscle. Results showed that even in this low-risk group half of study participants had coronary artery narrowing.
Narrowing of the arteries restricts blood flow to the heart, which increases the risk for a heart attack. Since people with HIV are already at higher risk of heart problems, the researchers wanted to determine the rate of coronary artery narrowing in otherwise healthy people with HIV.
All the study participants were classified as low risk for heart disease based on their age, cholesterol levels, weight, and other factors. None had previously shown any signs or symptoms of heart problems.
In addition, the majority of participants (73 percent) had a low viral load (amount of virus in the blood) of 50 copies per milliliter or less.
Testing revealed that half of the participants in the study had coronary artery narrowing. Of these, half were mild cases and the rest were moderate or severe. A total of five study participants (10 percent) were diagnosed with severe artery stenosis.
The researchers could find no differences between participants in immune system functioning, or other medical tests, to explain who developed artery narrowing and who did not.
They concluded that all HIV-positive adults should be screened for heart disease regardless of risk factors or symptoms.
Fatty Liver Disease Is Associated With Heart Disease In People With HIV
This study was aimed at discovering whether fatty liver disease indicates heart disease in people with HIV.
Fatty liver disease is reversible and results from abnormal fat accumulation in liver cells. It can be caused by excessive drinking or obesity, but can also be caused by lipodystrophy, an abnormal change in the body’s fat distribution that is a common side effect of some antiretroviral medications.
Most of the 204 HIV-positive adults, with an average age of 44 years, did not have other HIV-related diseases.
Despite the age and relative health of the participants in the study, researchers found that over a third (36 percent) had heart disease. They also found that fatty liver disease was associated with heart disease.
Older age, high blood pressure, and possibly Ziagen (abacavir) use were also linked to heart disease.
The researchers concluded that fatty liver disease may indicate heart disease in people with HIV. They recommend that HIV-positive adults with fatty liver disease be tested for heart disease and consider discontinuing the use of Ziagen to prevent further heart problems.
Abnormal Heart Blood Flow Linked To Poor Kidney Function And Low CD4 Count
Another study examined patients in the HIV Clinic Database who had undergone a stress test, which determines the amount of blood flowing to the heart, between 2004 and 2009. Results showed that abnormal heart blood flow is linked to poor kidney function and low CD4 counts.
When heart blood flow is abnormal not enough oxygen reaches the heart, which increases a person’s risk of heart disease and heart attack. Abnormal heart blood flow often manifests as chest pain.
For the study, researchers compared 20 HIV-positive patients who had stress tests revealing abnormal blood flow to 20 HIV-positive patients of the same age and sex with normal tests.
The comparison showed that there were no significant differences in age, sex, body mass, heart disease risk factors, or antiretroviral therapy between the two groups.
However, the results did show that patients with poor kidney function and low CD4 counts (350 cells per microliter or less) were more likely to have abnormal blood flow as measured in the stress tests.
As a result of their findings, the researchers advise people with HIV who have kidney disease and a low CD4 count to work to reduce their risk of heart disease.
This includes avoiding cigarettes and alcohol, reducing blood pressure and cholesterol, exercising, and losing excess body fat.
Kidney Disease Linked To Recurrent Hospitalization In HIV-Positive Patients With Heart Failure
A study at St. Luke’s-Roosevelt Hospital Center in New York examined factors contributing to frequent hospitalization in HIV-positive patients with heart failure.
A total of 77 patients were followed over the course of one year. Researchers recorded factors such as viral load, CD4 count, heart and kidney function, blood pressure, and number of hospitalizations.
The results revealed that chronic kidney disease was the only factor that was significantly associated with frequent hospitalization.
Researchers determined that 61 percent of the patients had chronic kidney disease and that kidney disease nearly doubled the number of yearly hospital visits necessary.
They concluded that kidney disease is the primary factor responsible for recurrent hospitalizations in HIV-positive adults with heart failure.
For more information, please see the AIDS 2010 conference website.
Source
Over 1000 Clinical Cases Evaluated Using IQQA®-Liver in Supporting Multidisciplinary Liver Imaging Evaluations
PRINCETON, N.J., Aug. 12 /PRNewswire/ -- EDDA Technology announced today that the number of clinical cases evaluated for pre- and post- operative assessment using IQQA®-Liver in hospitals has exceeded 1000 examinations, since the first commercial system installation in Q2 2009. EDDA's IQQA®-Liver, now marketed worldwide, is a comprehensive workflow solution supporting modern multidisciplinary liver imaging evaluation and management.
Primary liver cancer represents one of the most common malignancies in the world and accounts for almost 1.25 million deaths annually. In the US, liver disease is among the ten major causes of death. The management of hepatic tumors presents a challenging problem. Advanced preoperative imaging assessment is paramount in determining appropriate treatment, and requires the participation of a multidisciplinary team of surgeons, oncologists, hepatologists, and interventional radiologists specializing in liver malignancy.
IQQA®-Liver is designed to cope with such a challenge. It provides an innovative toolset for real-time interactive assessment and volumetric quantification of liver, liver lobes, hepatics lesions and vessels. With the intuitive and easy-to-use tools, physicians may in real-time perform virtual simulation of resection, lobular/segmental/vascular manipulation and quantification to achieve desired planning result typically within minutes.
EDDA's proprietary IT technology allows enterprise-wide deployment of IQQA®-Liver via web so as to quick share data and results anywhere anytime among the multidisciplinary liver team.
IQQA®-Liver has clearance by the FDA, China SFDA, Taiwan DOH, and carries the CE mark. It is currently in use at numerous prestigious liver transplantation/surgery/interventional centers worldwide, including University of Colorado Hospitals Denver, Shanghai Zhongshan Hospital, Shanghai Ruijin Hospital, Tianjin First Center Hospital, Beijing You'an Hospital, Nanjing Gulou Hospital and etc.
In one study, University of Colorado Hospital Denver used IQQA®-Liver to retrospectively evaluate the entire living liver donor (LLD) candidate studies rejected in a 2 year period, and found that about 48% that were previously rejected due to anatomic abnormalities by conventional CT visualization could have favorable anatomy for LLD. According to Dr. Igal Kam, Chief of Transplantation, and Dr. Paul Russ, Professor of Radiology, "IQQA®-Liver allows for better understanding of surgical anatomy and surgical planning in the preoperative evaluation. This will have positive outcome on available livers and LLD selection." Results will be presented at the XXIII International Congress of the Transplantation Society in Vancouver. EDDA will exhibit IQQA®-Liver at this congress (booth #38).
About EDDA Technology
EDDA Technology, Inc. is an innovative clinical computer solution provider in healthcare imaging and analysis. EDDA offers a series of next generation computer assistance solutions to the entire patient care management cycle, including enabling early detection and diagnosis of diseases, as well as enhancing efficiency and precision in treatment planning, management and follow-up. EDDA's goal is to deliver, with broad accessibility, advanced information analysis technologies that improve clinical workflow and accuracy. A privately held Delaware corporation, EDDA is headquartered in Princeton, New Jersey, and has a subsidiary in Shanghai, China. IQQA® is a registered trademark of EDDA Technology. http://www.eddatech.com/
SOURCE EDDA Technology, Inc.
RELATED LINKS
http://www.eddatech.com/
Source
Primary liver cancer represents one of the most common malignancies in the world and accounts for almost 1.25 million deaths annually. In the US, liver disease is among the ten major causes of death. The management of hepatic tumors presents a challenging problem. Advanced preoperative imaging assessment is paramount in determining appropriate treatment, and requires the participation of a multidisciplinary team of surgeons, oncologists, hepatologists, and interventional radiologists specializing in liver malignancy.
IQQA®-Liver is designed to cope with such a challenge. It provides an innovative toolset for real-time interactive assessment and volumetric quantification of liver, liver lobes, hepatics lesions and vessels. With the intuitive and easy-to-use tools, physicians may in real-time perform virtual simulation of resection, lobular/segmental/vascular manipulation and quantification to achieve desired planning result typically within minutes.
EDDA's proprietary IT technology allows enterprise-wide deployment of IQQA®-Liver via web so as to quick share data and results anywhere anytime among the multidisciplinary liver team.
IQQA®-Liver has clearance by the FDA, China SFDA, Taiwan DOH, and carries the CE mark. It is currently in use at numerous prestigious liver transplantation/surgery/interventional centers worldwide, including University of Colorado Hospitals Denver, Shanghai Zhongshan Hospital, Shanghai Ruijin Hospital, Tianjin First Center Hospital, Beijing You'an Hospital, Nanjing Gulou Hospital and etc.
In one study, University of Colorado Hospital Denver used IQQA®-Liver to retrospectively evaluate the entire living liver donor (LLD) candidate studies rejected in a 2 year period, and found that about 48% that were previously rejected due to anatomic abnormalities by conventional CT visualization could have favorable anatomy for LLD. According to Dr. Igal Kam, Chief of Transplantation, and Dr. Paul Russ, Professor of Radiology, "IQQA®-Liver allows for better understanding of surgical anatomy and surgical planning in the preoperative evaluation. This will have positive outcome on available livers and LLD selection." Results will be presented at the XXIII International Congress of the Transplantation Society in Vancouver. EDDA will exhibit IQQA®-Liver at this congress (booth #38).
About EDDA Technology
EDDA Technology, Inc. is an innovative clinical computer solution provider in healthcare imaging and analysis. EDDA offers a series of next generation computer assistance solutions to the entire patient care management cycle, including enabling early detection and diagnosis of diseases, as well as enhancing efficiency and precision in treatment planning, management and follow-up. EDDA's goal is to deliver, with broad accessibility, advanced information analysis technologies that improve clinical workflow and accuracy. A privately held Delaware corporation, EDDA is headquartered in Princeton, New Jersey, and has a subsidiary in Shanghai, China. IQQA® is a registered trademark of EDDA Technology. http://www.eddatech.com/
SOURCE EDDA Technology, Inc.
RELATED LINKS
http://www.eddatech.com/
Source
HFCS - the poison that promotes obesity and liver damage
Posted: 2010/08/12
From: Mathaba
(NaturalNews) Two new studies have added more reason for concern that high-fructose corn syrup causes significantly more harm to the body than its mere sugar content would suggest.
High-fructose corn syrup contains 55 percent fructose and 45 percent glucose. In contrast, table sugar (also known as sucrose) contains a 50-50 split.
In the first study, published in the journal Pharmacology, Biochemistry and Behavior, researchers from Princeton University found that rats consuming high fructose corn syrup gained more weight and developed more cardiovascular risk factors than rats consuming equivalent amounts of sucrose.
"Some people have claimed that high-fructose corn syrup is no different than other sweeteners when it comes to weight gain and obesity, but our results make it clear that this just isn't true, " researcher Bart Hoebel said.
Hoebel and colleagues fed two groups of rats an identical diet, supplemented with one of two sweetened beverages. One beverage consisted of a sucrose solution in concentrations similar to those found in many sweetened beverages. The other consisted of a high-fructose corn syrup solution at roughly half the concentration of a typical soda. The researchers found that the rats consuming the corn syrup solution gained significantly more weight than the rats consuming the sucrose solution.
In a followup experiment, the researchers compared metabolic changes in rats fed only rat chow with rats fed chow plus a high-fructose corn syrup solution. All the rats consumed the same amount of calories.
After six months, the rats in the corn syrup group had gained 48 percent more weight. They also underwent an increase in fat deposition (especially in the abdomen) and a drop in circulating triglycerides. These changes are consistent with metabolic syndrome, a cluster of symptoms that predispose humans to cardiovascular disease and diabetes.
Every rat consuming high-fructose corn syrup became obese. In contrast, rats fed a high-fat diet did not become obese in all cases.
Another study, conducted by Duke University researchers, once again implicates high-fructose corn syrup in a heightened risk of liver damage.
Previous research has suggested that large amounts of fructose liver in the same way as excessive alcohol consumption. Another study linked high-fructose corn syrup specifically with a form of liver scarring known as non-alcoholic fatty liver disease (NAFLD).
The new study, published in the Journal of Hepatology, found that high-fructose corn syrup worsened the effects of NAFLD.
"We found that increased consumption of high fructose corn syrup was associated with scarring in the liver ... among patients with NAFLD," researcher Manal Abdelmalek said.
The researchers analyzed the diets and livers of 427 adults with NAFLD, and found that only 19 percent of them never consumed fructose-containing beverages. In contrast, 52 percent of participants had between one and six servings of a fructose-containing beverage per week, while another 29 percent had at least one serving per day. The higher patients' fructose intake, the worse the scarring of their livers.
"We have identified an environmental risk factor that may contribute to the metabolic syndrome of insulin resistance and the complications of the metabolic syndrome, including liver injury," Abdelmalek said.
Abdelmalek noted that NAFLD is a severe problem that cannot be treated and may lead in some cases to liver cancer, liver failure and a need for liver transplant.
Researchers are still unsure why high-fructose corn syrup appears to damage the body more than its extra 5 percent fructose content would suggest. Some have hypothesized that the negative effects come from the massive quantities in which it is consumed -- high-fructose corn syrup is found in nearly all processed foods.
Other researchers have observed that beverages made with high-fructose corn syrup contain high levels of reactive carbonyls, which can damage cells. Still others have noted that the fructose in high-fructose corn syrup is chemically unbonded and thus spreads through the body more freely than the fructose in table sugar.
Sources for this story include:
http://www.aolnews.com/health/artic...
http://www.nytimes.com/2009/03/21/d...
http://www.sciencedaily.com/release...
http://www.foodconsumer.org/newsite....
Source
From: Mathaba
(NaturalNews) Two new studies have added more reason for concern that high-fructose corn syrup causes significantly more harm to the body than its mere sugar content would suggest.
High-fructose corn syrup contains 55 percent fructose and 45 percent glucose. In contrast, table sugar (also known as sucrose) contains a 50-50 split.
In the first study, published in the journal Pharmacology, Biochemistry and Behavior, researchers from Princeton University found that rats consuming high fructose corn syrup gained more weight and developed more cardiovascular risk factors than rats consuming equivalent amounts of sucrose.
"Some people have claimed that high-fructose corn syrup is no different than other sweeteners when it comes to weight gain and obesity, but our results make it clear that this just isn't true, " researcher Bart Hoebel said.
Hoebel and colleagues fed two groups of rats an identical diet, supplemented with one of two sweetened beverages. One beverage consisted of a sucrose solution in concentrations similar to those found in many sweetened beverages. The other consisted of a high-fructose corn syrup solution at roughly half the concentration of a typical soda. The researchers found that the rats consuming the corn syrup solution gained significantly more weight than the rats consuming the sucrose solution.
In a followup experiment, the researchers compared metabolic changes in rats fed only rat chow with rats fed chow plus a high-fructose corn syrup solution. All the rats consumed the same amount of calories.
After six months, the rats in the corn syrup group had gained 48 percent more weight. They also underwent an increase in fat deposition (especially in the abdomen) and a drop in circulating triglycerides. These changes are consistent with metabolic syndrome, a cluster of symptoms that predispose humans to cardiovascular disease and diabetes.
Every rat consuming high-fructose corn syrup became obese. In contrast, rats fed a high-fat diet did not become obese in all cases.
Another study, conducted by Duke University researchers, once again implicates high-fructose corn syrup in a heightened risk of liver damage.
Previous research has suggested that large amounts of fructose liver in the same way as excessive alcohol consumption. Another study linked high-fructose corn syrup specifically with a form of liver scarring known as non-alcoholic fatty liver disease (NAFLD).
The new study, published in the Journal of Hepatology, found that high-fructose corn syrup worsened the effects of NAFLD.
"We found that increased consumption of high fructose corn syrup was associated with scarring in the liver ... among patients with NAFLD," researcher Manal Abdelmalek said.
The researchers analyzed the diets and livers of 427 adults with NAFLD, and found that only 19 percent of them never consumed fructose-containing beverages. In contrast, 52 percent of participants had between one and six servings of a fructose-containing beverage per week, while another 29 percent had at least one serving per day. The higher patients' fructose intake, the worse the scarring of their livers.
"We have identified an environmental risk factor that may contribute to the metabolic syndrome of insulin resistance and the complications of the metabolic syndrome, including liver injury," Abdelmalek said.
Abdelmalek noted that NAFLD is a severe problem that cannot be treated and may lead in some cases to liver cancer, liver failure and a need for liver transplant.
Researchers are still unsure why high-fructose corn syrup appears to damage the body more than its extra 5 percent fructose content would suggest. Some have hypothesized that the negative effects come from the massive quantities in which it is consumed -- high-fructose corn syrup is found in nearly all processed foods.
Other researchers have observed that beverages made with high-fructose corn syrup contain high levels of reactive carbonyls, which can damage cells. Still others have noted that the fructose in high-fructose corn syrup is chemically unbonded and thus spreads through the body more freely than the fructose in table sugar.
Sources for this story include:
http://www.aolnews.com/health/artic...
http://www.nytimes.com/2009/03/21/d...
http://www.sciencedaily.com/release...
http://www.foodconsumer.org/newsite....
Source
Merlin protein found to control liver stem cells, prevent tumor development
Public release date: 12-Aug-2010
Contact: Katie Marquedant
kmarquedant@partners.org
617-726-0337
Massachusetts General Hospital
A protein known to be involved in a rare hereditary cancer syndrome may have a role in the regulation of liver stem cells and the development of liver cancer. In the August 15 issue of Genes & Development, a Massachusetts General Hospital (MGH) research team describes finding that the protein called merlin, encoded by the NF2 (neurofibromatosis type 2) gene, controls the activity of adult stem cells that give rise to the two major types of liver cells.
"We found that mutation of the NF2 tumor suppressor gene in the mouse liver led to a dramatic overproliferation of liver stem cells – the cells that contribute to the liver's remarkable ability to regenerate," says Andrea McClatchey, PhD, of the MGH Center for Cancer Research, who led the study. "These mice go on to develop the two forms of liver cancer that are most common in humans, suggesting that liver stem cells may be the cells of origin of these tumors."
The liver has a rare ability to regenerate and replace damaged or missing tissue. If one lobe is removed for transplantation, the rest of the donor's organ will return to its previous size and the transplanted lobe will grow to match the needs of the recipient. This regeneration usually involves proliferation of the most characteristic liver cells, called hepatocytes, and of bile duct cells; but if that growth is blocked or those cells are damaged, a population of less-differentiated progenitor cells will start to expand. These liver stem cells have been identified in rodents, and potential equivalents found but not confirmed in humans.
Previous research also indicated that liver stem cells may be the source of some tumors in animals, and suggested that the tumor suppressor gene NF2 may help prevent tumor development. Originally discovered through its involvement in the rare genetic disorder neurofibromatosis type 2, the NF2 gene codes for merlin, a protein known to suppress the activity of a number of cellular receptors. One of these is the epidermal growth factor receptor (EGFR), and oversignaling by that protein is known to lead to several types of cancer. The current study was designed to investigate the role of NF2 and merlin in the fetal and adult mouse liver, including possible involvement with tumor development.
The researchers found that infant mice lacking functioning NF2 in their livers developed dramatic overgrowth of liver stem cells, to the point of crowding out hepatocytes. Mice that did not die from a lack of functioning liver cells soon developed the two major types of liver cancer, and the fact that stem cell overgrowth preceded tumor development strongly suggested that the undifferentiated progenitors were the source of the tumors. Blocking the expression of NF2 in the livers of adult mice had minimal effect on the animals unless a portion of the liver was surgically removed, setting off the regeneration process and leading to the same stem cell overproliferation and tumor development.
McClatchey explains that the study's findings provide new information about liver stem cells and how their proliferation is controlled; identifies a new animal model for liver cancer, the lack of which has seriously impeded understanding the disease; and suggests that liver tumors may originate from liver stem cells and that excess EGFR signaling leads to liver tumor development. "These results are consistent with our previous studies showing that merlin helps to regulate EGFR activity at the cell membrance," she says. "We also showed that merlin's role in cell-to-cell communication is essential for cells to stop growing when they fill the appropriate space. Since liver progenitors need to be poised to regenerate in case of injury, they may be particularly sensitive to the loss of merlin's regulatory function." McClatchey is an associate professor of Pathology at Harvard Medical School.
###
Co-lead authors of the Genes and Development report are Samira Benhamouche, PhD, and Marcello Curto, MD, PhD, MGH Center for Cancer Research. Additional co-authors are Ichiko Saotome, Andrew Gladden, PhD, and Ching-Hui Liu, MGH Center for Cancer Research; and Marco Giovannini, MD, PhD, House Ear Institute, Los Angeles. The study was supported by grants from the Tucker-Gosnell Foundation, the U.S. Department of Defense and National Institutes of Health, and the Children's Tumor Foundation.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $600 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
Source
Contact: Katie Marquedant
kmarquedant@partners.org
617-726-0337
Massachusetts General Hospital
A protein known to be involved in a rare hereditary cancer syndrome may have a role in the regulation of liver stem cells and the development of liver cancer. In the August 15 issue of Genes & Development, a Massachusetts General Hospital (MGH) research team describes finding that the protein called merlin, encoded by the NF2 (neurofibromatosis type 2) gene, controls the activity of adult stem cells that give rise to the two major types of liver cells.
"We found that mutation of the NF2 tumor suppressor gene in the mouse liver led to a dramatic overproliferation of liver stem cells – the cells that contribute to the liver's remarkable ability to regenerate," says Andrea McClatchey, PhD, of the MGH Center for Cancer Research, who led the study. "These mice go on to develop the two forms of liver cancer that are most common in humans, suggesting that liver stem cells may be the cells of origin of these tumors."
The liver has a rare ability to regenerate and replace damaged or missing tissue. If one lobe is removed for transplantation, the rest of the donor's organ will return to its previous size and the transplanted lobe will grow to match the needs of the recipient. This regeneration usually involves proliferation of the most characteristic liver cells, called hepatocytes, and of bile duct cells; but if that growth is blocked or those cells are damaged, a population of less-differentiated progenitor cells will start to expand. These liver stem cells have been identified in rodents, and potential equivalents found but not confirmed in humans.
Previous research also indicated that liver stem cells may be the source of some tumors in animals, and suggested that the tumor suppressor gene NF2 may help prevent tumor development. Originally discovered through its involvement in the rare genetic disorder neurofibromatosis type 2, the NF2 gene codes for merlin, a protein known to suppress the activity of a number of cellular receptors. One of these is the epidermal growth factor receptor (EGFR), and oversignaling by that protein is known to lead to several types of cancer. The current study was designed to investigate the role of NF2 and merlin in the fetal and adult mouse liver, including possible involvement with tumor development.
The researchers found that infant mice lacking functioning NF2 in their livers developed dramatic overgrowth of liver stem cells, to the point of crowding out hepatocytes. Mice that did not die from a lack of functioning liver cells soon developed the two major types of liver cancer, and the fact that stem cell overgrowth preceded tumor development strongly suggested that the undifferentiated progenitors were the source of the tumors. Blocking the expression of NF2 in the livers of adult mice had minimal effect on the animals unless a portion of the liver was surgically removed, setting off the regeneration process and leading to the same stem cell overproliferation and tumor development.
McClatchey explains that the study's findings provide new information about liver stem cells and how their proliferation is controlled; identifies a new animal model for liver cancer, the lack of which has seriously impeded understanding the disease; and suggests that liver tumors may originate from liver stem cells and that excess EGFR signaling leads to liver tumor development. "These results are consistent with our previous studies showing that merlin helps to regulate EGFR activity at the cell membrance," she says. "We also showed that merlin's role in cell-to-cell communication is essential for cells to stop growing when they fill the appropriate space. Since liver progenitors need to be poised to regenerate in case of injury, they may be particularly sensitive to the loss of merlin's regulatory function." McClatchey is an associate professor of Pathology at Harvard Medical School.
###
Co-lead authors of the Genes and Development report are Samira Benhamouche, PhD, and Marcello Curto, MD, PhD, MGH Center for Cancer Research. Additional co-authors are Ichiko Saotome, Andrew Gladden, PhD, and Ching-Hui Liu, MGH Center for Cancer Research; and Marco Giovannini, MD, PhD, House Ear Institute, Los Angeles. The study was supported by grants from the Tucker-Gosnell Foundation, the U.S. Department of Defense and National Institutes of Health, and the Children's Tumor Foundation.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $600 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
Source
Poor kidney function common among HIV-infected injection drug users
Public release date: 12-Aug-2010
Contact: Shari Leventhal
sleventhal@asn-online.org
202-416-0658
American Society of Nephrology
Careful monitoring of kidney health may be warranted in this population
Poor kidney function is common among injection drug users, particularly those with HIV, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN). The results suggest that clinicians should monitor the kidney function of HIV-infected injection drug users and consider them candidates for medical treatments to protect their kidneys when appropriate.
HIV-infected individuals are more likely to have kidney disease compared with the general population. This may be due to a direct effect of HIV infection as well as indirect effects related to known risk factors for kidney disease that are commonly present among HIV-infected populations—for example, the presence of other illnesses, toxic effects of antiretroviral medications, low socioeconomic status, and African American race. Research also indicates that injection drug users exhibit increased risk of becoming infected with HIV. While little information is available about the burden of kidney disease in injection drug users, this population's drug use, higher prevalence of viral hepatitis, and poor access to medical care may increase the risk of kidney disease.
To investigate the issue, Shruti H Mehta, PhD (Johns Hopkins Bloomberg School of Public Health) and her colleagues analyzed the presence of proteinuria, or excess excretion of protein in the urine, in HIV-positive and HIV-negative injection drug users. Individuals with proteinuria often develop kidney disease; therefore, screening for proteinuria may help physicians prevent or slow damage to the kidneys.
Researchers analyzed information from 902 injection drug users who were predominantly African American, 273 of whom were infected with HIV. 24.8% had proteinuria and prevalence was 2.9 times higher among HIV-infected (45%) compared with uninfected individuals (16%). HIV infection, unemployment, increased age, diabetes, hepatitis C infection, and high blood pressure were linked to a higher prevalence of proteinuria.
Because proteinuria can lead to kidney failure and increases one's risk of developing cardiovascular disease, clinicians should aggressively screen HIV-infected injection drug users for proteinuria and consider them candidates for medical treatments that protect the heart and kidneys.
###
Study co-authors include Elizabeth Yanik (University of North Carolina-Chapel Hill School of Public Health); Gregory Lucas, MD, PhD (Johns Hopkins School of Medicine); David Vlahov, PhD (New York Academy of Medicine); and Gregory Kirk, MD, PhD (Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine).
Disclosures: The authors reported no financial disclosures.
The article, entitled "HIV and Proteinuria in an Injection Drug User Population," will appear online at http://cjasn.asnjournals.org/ on August 12, 2010, doi 10.2215/CJN.01030210.
The content of this article does not reflect the views or opinions of The American Society of Nephrology (ASN). Responsibility for the information and views expressed therein lies entirely with the author(s). ASN does not offer medical advice. All content in ASN publications is for informational purposes only, and is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This content should not be used during a medical emergency or for the diagnosis or treatment of any medical condition. Please consult your doctor or other qualified health care provider if you have any questions about a medical condition, or before taking any drug, changing your diet or commencing or discontinuing any course of treatment. Do not ignore or delay obtaining professional medical advice because of information accessed through ASN. Call 911 or your doctor for all medical emergencies.
Founded in 1966, the American Society of Nephrology (ASN) is the world's largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its world-renowned meetings and first-class publications, disseminates information and educational tools that empower physicians.
Source
Contact: Shari Leventhal
sleventhal@asn-online.org
202-416-0658
American Society of Nephrology
Careful monitoring of kidney health may be warranted in this population
Poor kidney function is common among injection drug users, particularly those with HIV, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN). The results suggest that clinicians should monitor the kidney function of HIV-infected injection drug users and consider them candidates for medical treatments to protect their kidneys when appropriate.
HIV-infected individuals are more likely to have kidney disease compared with the general population. This may be due to a direct effect of HIV infection as well as indirect effects related to known risk factors for kidney disease that are commonly present among HIV-infected populations—for example, the presence of other illnesses, toxic effects of antiretroviral medications, low socioeconomic status, and African American race. Research also indicates that injection drug users exhibit increased risk of becoming infected with HIV. While little information is available about the burden of kidney disease in injection drug users, this population's drug use, higher prevalence of viral hepatitis, and poor access to medical care may increase the risk of kidney disease.
To investigate the issue, Shruti H Mehta, PhD (Johns Hopkins Bloomberg School of Public Health) and her colleagues analyzed the presence of proteinuria, or excess excretion of protein in the urine, in HIV-positive and HIV-negative injection drug users. Individuals with proteinuria often develop kidney disease; therefore, screening for proteinuria may help physicians prevent or slow damage to the kidneys.
Researchers analyzed information from 902 injection drug users who were predominantly African American, 273 of whom were infected with HIV. 24.8% had proteinuria and prevalence was 2.9 times higher among HIV-infected (45%) compared with uninfected individuals (16%). HIV infection, unemployment, increased age, diabetes, hepatitis C infection, and high blood pressure were linked to a higher prevalence of proteinuria.
Because proteinuria can lead to kidney failure and increases one's risk of developing cardiovascular disease, clinicians should aggressively screen HIV-infected injection drug users for proteinuria and consider them candidates for medical treatments that protect the heart and kidneys.
###
Study co-authors include Elizabeth Yanik (University of North Carolina-Chapel Hill School of Public Health); Gregory Lucas, MD, PhD (Johns Hopkins School of Medicine); David Vlahov, PhD (New York Academy of Medicine); and Gregory Kirk, MD, PhD (Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine).
Disclosures: The authors reported no financial disclosures.
The article, entitled "HIV and Proteinuria in an Injection Drug User Population," will appear online at http://cjasn.asnjournals.org/ on August 12, 2010, doi 10.2215/CJN.01030210.
The content of this article does not reflect the views or opinions of The American Society of Nephrology (ASN). Responsibility for the information and views expressed therein lies entirely with the author(s). ASN does not offer medical advice. All content in ASN publications is for informational purposes only, and is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This content should not be used during a medical emergency or for the diagnosis or treatment of any medical condition. Please consult your doctor or other qualified health care provider if you have any questions about a medical condition, or before taking any drug, changing your diet or commencing or discontinuing any course of treatment. Do not ignore or delay obtaining professional medical advice because of information accessed through ASN. Call 911 or your doctor for all medical emergencies.
Founded in 1966, the American Society of Nephrology (ASN) is the world's largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its world-renowned meetings and first-class publications, disseminates information and educational tools that empower physicians.
Source
New Potential Asthma Treatment Discovered By Researchers
Posted by trump44 on Aug 12th, 2010
Researchers believe they may have discovered evidence that a current protein used to treat cancer and other diseases may also be an effective asthma treatment. Interferon is a protein currently used to treat cancer, MS and hepatitis C. Researchers believe the protein will work by blocking the creation of the cells that cause allergic reactions, which is the basic cause of chronic asthma. These cells are created after the body has come in contact with certain animal hair and pollens.
Researchers believe this could be an exciting breakthrough as interferon is already approved and available for use so the usual delays in bringing a medication to market will not be an issue in this case. Another reason researchers are excited about their discovery is that the only asthma treatment available are medications that provide temporary relief and it is possible that interferon could be more of a long term asthma treatment.
Asthma sufferers currently number around 20 million in the United States, many of which are children.
Researchers believe the evidence they have discovered should warrant a clinical trial to see if interferon could become a new asthma treatment therapy.
Julie Peters
Worlds Breaking News
Source
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