Home / August 28th, 2010; Vol.178 #5 / Feature
Tiny pieces of RNA may turn cells to the dark side
By Tina Hesman Saey
August 28th, 2010; Vol.178 #5 (p. 18)
When tiny hairpin-shaped molecules act up, they don’t rebel loner-style like James Dean. Instead they take on the persona of Darth Vader, crushing proteins under their command and turning acquaintances to the dark side as well. In this case, though, the fight is for control not of the universe, but of the body. And a dark-side victory could end in cancer.
No one would have predicted a decade ago that these microRNAs, as the hairpins are called, were involved in cancer, because no one even knew that they existed in people. Mere snippets of RNA — DNA’s underappreciated cousin — these micromolecules are about 22 chemical letters long. But their size belies their power.
When on their best behavior, the molecules are competent and capable managers of the protein-building process that keeps a cell humming in perfect harmony. But when microRNAs go rogue, the results can be disastrous.
New research is revealing just how important these newly discovered molecules are. An imbalance of microRNAs can cause cancer by encouraging runaway cell growth or by dampening a cell’s defenses, and can also make the disease more stubborn. But just as Darth Vader never completely lost the young Jedi Anakin Skywalker within him, even bad microRNAs may have good in them yet. Some scientists think that therapies aimed at soothing riled-up microRNAs may help cure the very cancers that the molecules help cause.
Most of the discoveries linking microRNAs and cancer have come in the past five years. “This is extremely rapid progression,” says Curtis Harris, chief of the human carcinogenesis lab at the National Cancer Institute, based in Bethesda, Md.
Micro middle managers
The realization that such small molecules could play a big role in disease was late in coming, says Carlo Croce of Ohio State University in Columbus. “In the beginning there was no interest in microRNAs at all,” he says.
The first microRNA was discovered in 1993 in roundworms. It took another seven years before the next microRNA was found in the same organism. Though both of those microRNAs help control worm development, most scientists regarded them as biological curiosities.
But then researchers found microRNAs at work in fruit flies, people and other organisms. Those discoveries suggested that microRNAs might be important regulatory molecules for all animals, not just flukes of worm biology.
MicroRNAs work in middle management in most plant and animal cells, scientists now know. The molecules help regulate the protein-manufacturing process by essentially issuing permits decreeing when and where proteins may be built. By riding piggyback on messenger RNAs, which are copies of the protein-building blueprints contained within DNA, microRNAs prevent the instructions from reaching protein-building machinery inside cells.
While it may sound nefarious, microRNAs’ interference with protein production helps a cell maintain balance. MicroRNAs ensure that cells save energy by not making unnecessary proteins and help prevent levels of potentially harmful proteins, such as those that initiate the self-destruct program known as apoptosis, from reaching critical mass.
Each type of microRNA in a cell may potentially pair with hundreds of different types of messenger RNA, says Isidore Rigoutsos, a computational and molecular biologist at Thomas Jefferson University in Philadelphia. And each messenger RNA may have many different microRNAs piling on its back.
“It’s safe to say that microRNAs are important,” Rigoutsos says. “The difficulty is saying what are the limits of importance, and they keep being expanded more and more and more.”
Cancer connection
Croce’s lab was among the first to illustrate just how big a role the little molecules could play in people. His group showed that genes encoding microRNAs frequently go missing in tumor cells. In particular, two microRNAs, miR-15 and miR-16, are missing or found at lower than normal levels in 68 percent of chronic lymphocytic leukemia cases.
Cancer biologists usually lump microRNAs into two groups: those that protect against cancer and those that promote it (though the distinction isn’t perfect). Cancer cells tend to have lower levels of most microRNAs but have an oversupply of a few others.
In the protective corner are microRNAs such as miR-15 and miR-16. One of the many proteins regulated by those two microRNAs is BCL2, which keeps cells from pushing the self-destruct button. Cells commit suicide when they become too damaged to operate properly — an important self-defense mechanism for an organism that doesn’t want to walk around with malfunctioning cells. So cells need just the right amount of BCL2 to keep from killing themselves unnecessarily, but not so much of it that they can never die.
The microRNAs pair with messenger RNA to strike the right balance of BCL2. But when miR-15 and miR-16 levels are knocked down — which can happen if a copy of a gene is lost or if something goes wrong during microRNA manufacturing — cells make far too much BCL2, essentially disabling the self-destruct mechanism and making cells immortal. Immortality is one hallmark of cancer.
At the opposite end of the spectrum is one of the baddest microRNA bad boys, miR-21. Elevated levels cause cancer in mice, researchers from Yale University reported online August 8 in Nature. And higher than normal levels have been linked to at least 13 major types of cancer in people and to poor prognoses for people with colon, lung, breast, pancreatic or head and neck cancers, Harris says (SN: 2/2/08, p. 70).
High levels of miR-21 can slow an important cellular security system involving a protein named p53, researchers from the University of California, Santa Barbara have found. This protein performs multiple protective services, including spurring repair of damaged DNA, halting growth until damage is repaired or ending it all if repair isn’t possible (SN: 12/6/08, p. 22). Last year researchers reported in Nature that p53 helps slice microRNAs into their mature form. Too much miR-21 can strip cells of their p53 defenses, leading to cancer.
Though miR-21 has stood out among the troublemakers, Croce’s team has shown that this microRNA and others don’t work alone. The molecular managers are master networkers. In 50 different normal human tissues, microRNAs collaborate to direct cellular activities, Croce and colleagues reported online May 3 in Genome Research. The networks consist of microRNAs that help direct production of proteins, some of which, in turn, control production of other microRNAs, and so on.
But time and again, in 51 different types of cancer, Croce’s team found that the microRNAs’ teamwork had broken down. The cohesive networks disintegrated into rogue hubs of activity. These anarchist factions throw a wrench into the well-oiled machinery that usually keeps a cell healthy.
It’s a rather small wrench, though. MicroRNAs wield their power subtly, tweaking and massaging protein levels up or down a wee bit here and there instead of stopping production altogether.
“A microRNA doesn’t function like an ‘off’ switch,” says cancer biologist Dihua Yu of the University of Texas MD Anderson Cancer Center in Houston.
Even a little bump or dip in protein levels, maybe by just 5 to 10 percent, is enough to send a cell careening down the path to cancer, Croce says.
One of the most delicately balanced cancer-associated proteins is PTEN. It reins in cell growth to prevent wild replication, as seen in cancer. In the parlance of cancer research, PTEN is known as a tumor suppressor, and it works best when there is just the right amount of it.
Losing one copy of the gene for PTEN — essentially cutting protein levels in half — is enough to turn a cell cancerous, previous studies have shown. Other research has demonstrated that microRNAs, including miR-21, help govern production of PTEN. And a study reported June 24 in Nature found that a messenger RNA doppelgänger of PTEN found in healthy cells distracts PTEN-stifling microRNAs, allowing more of the protein to be made. If the twin is missing, the weight of microRNAs on messenger RNA’s back can crush protein production.
New research from Yu’s lab also suggests that reducing the amount of PTEN protein in a tumor cell even slightly is not a good idea. Higher levels of miR-21 slow down PTEN production and make breast cancer cells resistant to an anticancer agent called Herceptin, Yu and colleague Sumaiyah Rehman reported in April in Washington, D.C., at the annual meeting of the American Association for Cancer Research.
Dicer danger
PTEN isn’t the only protein that can make cancer worse. A new study shows that small changes in the amount of a protein involved in producing microRNAs can determine whether tumors stay put or spread to the rest of the body.
That discovery grew from efforts to figure out why most microRNAs are at lower levels in cancer cells but some microRNAs are overproduced. “We were intrigued by this paradox,” says Stefano Piccolo, a cellular and molecular biologist at the University of Padua in Italy.
The resolution came from an unexpected source, a protein that helps slice larger RNAs into microRNAs. This protein, Dicer, is a key component of the microRNA manufacturing machinery. Cutting levels of Dicer in half spurs on cancer because less of it leads to less microRNA, which can mean increased production of proteins that drive rapid growth. Still, cancer cells need some Dicer to survive and reproduce, since Dicer helps make microRNAs that regulate production of proteins.
So cancer cells need to control Dicer levels the way a student sets the volume on an iPod to provide background study music. The volume shouldn’t be too quiet or too loud. “You need to find that perfect middle,” Piccolo says.
Cells dial in just the right amount of Dicer by using a family of microRNAs, miR-103.1, miR-103.2 and miR-107, Piccolo and his colleagues reported in the June 25 Cell. Those three microRNAs, which occur at high levels in some cancer cells, latch on to messenger RNAs encoding Dicer and ratchet down its production, meaning less of other microRNAs get made. But Dicer levels never drop to nothing, because the same microRNAs rely on the protein to snip them free from larger pieces of RNA.
Piccolo’s finding neatly solves the paradox of why most microRNA levels can be low in cancer cells while some are high, but his study didn’t stop there. The research also provides further evidence that low Dicer levels make cancer more dangerous.
In the study, Piccolo’s team discovered that some aggressive tumors had higher than normal levels of the microRNAs that regulate Dicer, and thus less of the protein. More of these microRNAs were also associated with breast cancer’s spread and poor prognosis in patients.
Additional experiments with tumor cells growing in lab dishes showed that the cells usually tend to cluster. But when Dicer levels are lowered to about 50 to 60 percent of normal, or levels of miR-107 are increased, cells begin migrating across the dish. Dips in Dicer levels make cells mobile, the team suggests. Less Dicer may mean less of other microRNAs that hold back production of proteins that are responsible for getting cells in gear. With fewer inhibitory microRNAs around, go-proteins can be made and cells get a move on.
Tumor cells may be taking advantage of one of Dicer’s jobs in normal cells — helping cells move around. “Cancer doesn’t invent anything,” Piccolo says.
Tiny treatment options
Getting a clue that a microRNA is involved in a problem also gives researchers a potential solution. In experiments with mice, inhibiting miR-21 made resistant tumor cells more susceptible to Herceptin, Rehman reported at the cancer research meeting.
Increasing susceptibility to anticancer drugs is just one way that microRNAs could be useful in the clinic, says oncologist Muller Fabbri of Ohio State.
Specific microRNA levels rise or fall in different tumor types, creating a signature for that type of cancer, studies have shown. Such signatures could help correctly diagnose cancer in people whose tumors have migrated. Often pathologists can examine a brain tumor and determine that it arose from breast cancer cells, but sometimes cancer cells conceal their real birthplace. Characteristic patterns of microRNA could help identify where tumor cells originated in the 8 to 10 percent of cases when “even the pathologist doesn’t have a clue,” Fabbri says. Examining the pattern of microRNA levels in a patient’s tumor may also help doctors identify aggressive forms (SN: 2/2/08, p. 70).
In diseases such as liver cancer, researchers may be able to replace missing microRNAs or boost levels to stop the cancer, a team reported last year in Cell. And in cancers in which levels of certain microRNAs are too high, researchers can deploy decoy molecules to pull microRNAs from their targets. A team reported in January in Science that the strategy appears to work for treating hepatitis C infection in monkeys (SN: 1/2/10, p. 14).
Croce thinks that targeting several microRNAs in anarchist networks may help treat cancer with little chance of resistance developing. But such therapies are still years away. “We have to show that it is really true,” he says, “not just in experiments with mice, but in clinical trials.”
For now, no microRNA therapies are available for cancer, but researchers are watching trials of the anti-microRNA therapy against hepatitis C in people.
“The rapidity of what’s going on is what gives some of us optimism that this could have value,” Harris says. “Relatively shortly, we’re going to know the degree of importance of microRNAs.”
Source
August 15, 2010
Alpha-fetoprotein above normal levels as a risk factor for the development of hepatocellular carcinoma in patients infected with hepatitis C virus
Journal of Gastroenterology
DOI: 10.1007/s00535-010-0293-6
Masakuni Tateyama, Hiroshi Yatsuhashi, Naota Taura, Yasuhide Motoyoshi, Shinya Nagaoka, Kenji Yanagi, Seigo Abiru, Koji Yano, Atsumasa Komori and Kiyoshi Migita, et al.
Abstract
Background
Noninvasive risk factors are required for predicting the development of hepatocellular carcinoma (HCC) not only in patients with cirrhosis but also in those with chronic hepatitis who are infected with hepatitis C virus (HCV).
Methods
A total of 707 patients with chronic HCV infection without other risks were evaluated for the predictive value of noninvasive risk factors for HCC, including age, sex, viral load, genotype, fibrosis stage, aspartate and alanine aminotransferase levels, bilirubin, albumin, platelet count, and alpha-fetoprotein (AFP) at entry to the study, as well as interferon (IFN) therapy they received.
Results
The ten-year cumulative incidence rates of HCC for patients with fibrosis stages F0/F1, F2, F3, and F4 were 2.5, 12.8, 19.3, and 55.9%, respectively. Multivariate analysis identified age ≥57 years [hazard ratio (HR) 2.026, P = 0.004], fibrosis stage F4 (HR 3.957, P < 0.001), and AFP 6–20 ng/mL (HR 1.942, P = 0.030) and ≥20 ng/mL (HR 3.884, P < 0.001), as well as the response to IFN [relative risk (RR) 0.099, P < 0.001], as independent risk factors for the development of HCC. The ten-year cumulative incidence rates of HCC in the patients with AFP levels of <6, 6–20, and ≥20 ng/mL at entry were 6.0, 24.6, and 47.3%, respectively.
Conclusions
Not only high (>20 ng/mL), but also even slightly elevated (6–20 ng/mL) AFP levels, could serve as a risk factor for HCC to complement the fibrosis stage. In contrast, AFP levels <6 ng/mL indicate a low risk of HCC development in patients infected with HCV, irrespective of the fibrosis stage.
Keywords Alpha-fetoprotein - Hepatitis C virus - Hepatocellular carcinoma
Source
DOI: 10.1007/s00535-010-0293-6
Masakuni Tateyama, Hiroshi Yatsuhashi, Naota Taura, Yasuhide Motoyoshi, Shinya Nagaoka, Kenji Yanagi, Seigo Abiru, Koji Yano, Atsumasa Komori and Kiyoshi Migita, et al.
Abstract
Background
Noninvasive risk factors are required for predicting the development of hepatocellular carcinoma (HCC) not only in patients with cirrhosis but also in those with chronic hepatitis who are infected with hepatitis C virus (HCV).
Methods
A total of 707 patients with chronic HCV infection without other risks were evaluated for the predictive value of noninvasive risk factors for HCC, including age, sex, viral load, genotype, fibrosis stage, aspartate and alanine aminotransferase levels, bilirubin, albumin, platelet count, and alpha-fetoprotein (AFP) at entry to the study, as well as interferon (IFN) therapy they received.
Results
The ten-year cumulative incidence rates of HCC for patients with fibrosis stages F0/F1, F2, F3, and F4 were 2.5, 12.8, 19.3, and 55.9%, respectively. Multivariate analysis identified age ≥57 years [hazard ratio (HR) 2.026, P = 0.004], fibrosis stage F4 (HR 3.957, P < 0.001), and AFP 6–20 ng/mL (HR 1.942, P = 0.030) and ≥20 ng/mL (HR 3.884, P < 0.001), as well as the response to IFN [relative risk (RR) 0.099, P < 0.001], as independent risk factors for the development of HCC. The ten-year cumulative incidence rates of HCC in the patients with AFP levels of <6, 6–20, and ≥20 ng/mL at entry were 6.0, 24.6, and 47.3%, respectively.
Conclusions
Not only high (>20 ng/mL), but also even slightly elevated (6–20 ng/mL) AFP levels, could serve as a risk factor for HCC to complement the fibrosis stage. In contrast, AFP levels <6 ng/mL indicate a low risk of HCC development in patients infected with HCV, irrespective of the fibrosis stage.
Keywords Alpha-fetoprotein - Hepatitis C virus - Hepatocellular carcinoma
Source
Hep C lawsuit asserts 1991 incident at Texas hospital should have increased caution
By Felisa Cardona
The Denver Post
Posted: 08/15/2010 01:00:00 AM MDT
Eighteen years before surgery scrub technician Kristen Parker infected 18 patients at Rose Medical Center with hepatitis C, another employee infected patients the same way at a Texas hospital later owned by one of the owners of Rose.
A lawsuit filed in Denver District Court states that Hospital Corporation of America, which partly owns Rose Medical Center, should have been more careful with the way drugs were stored and secured after its earlier lawsuit.
Parker, 27, is serving 30 years in federal prison after she injected herself with the painkiller fentanyl that was meant for surgery patients. She then filled the syringes with saline and placed them back on carts, resulting in the patients being injected with the infected needles during surgery.
The latest lawsuit, filed Aug. 3, claims anesthesiologists left the drugs in unlocked surgery rooms — in violation of hospital policy and state and federal statutes.
"Every single surgery room at Rose had controlled substances that were intended for vulnerable surgery patients lying around for drug addicts like Parker to divert, use and fill with saline," said patients' attorney Hollynd Hoskins.
Five lawsuits are pending against Rose Medical Center, and one has been settled, said Cara Harshberger, spokeswoman for the hospital.
The first case set for trial is in June before Denver District Judge Herbert Stern.
The latest suit was filed by Hoskins on behalf of a Denver mother of three who is using the initials L.K. because she does not want her medical condition made public.
For six minutes, a syringe filled with the painkiller fentanyl sat unsecured in a surgery room before L.K.'s procedure on Feb. 13, 2009. The lawsuit says that is when Parker stole the drug and left the infected needle behind.
The anesthesiologist, Dr. Herbert N. Chado, named as a defendant in the lawsuit, unknowingly injected L.K. with the contaminated needle, and months later, the woman learned that she was infected with hepatitis C.
L.K. underwent interferon treatment and, at first, responded to the medication, but the virus has since come back.
In 1994, the Colorado Board of Medical Examiners placed Chado on five years of probation for abusing the drug Sufenta, an opiate. Chado, who pursued treatment, did not practice medicine from 1993 to 2001, state records show.
Chado did not return a call seeking comment about the lawsuit.
Minutes before L.K. was infected, Chado failed to lock the surgery room and didn't have the fentanyl in his sight, the suit says.
"We have had and continue to have rigorous controls in place to ensure medication security," Harshberger said. "This includes having pass- code-protected computerized medication systems in each operating room, with methodical auditing of the usage of that equipment, providing ongoing education for staff and physicians regarding medication security, and exploring options for packaging of medication."
In 1991, scrub tech David Wayne Thomas stole fentanyl from the now-defunct Mid-Cities Surgi-Center in Bedford, Texas.
The hospital was owned by Medical Care America at the time of the incident but was acquired by Hospital Corporation of America in 1994, Harshberger said.
Thomas, who was infected with hepatitis C, pleaded guilty to stealing the drugs and served three years of an eight-year sentence, according to a 1995 Fort Worth Star-Telegram article. It is not clear whether Thomas knew he was infected with the virus, as Parker did, when he was contaminating the needles.
Civil lawsuits were brought by 48 patients against Hospital Corporation of America and the anesthesiologists who were responsible for securing the medication. The cases were settled.
Legal experts told the newspaper the settlements could have surpassed $100 million.
Harshberger said Rose remains committed to helping patients, including paying for the testing and treatment of those affected by Parker's actions.
"The criminal actions of this former employee put our patients at risk, and for that we were truly saddened and angered," she said.
Felisa Cardona: 303-954-1219 or fcardona@denverpost.com
Source
The Denver Post
Posted: 08/15/2010 01:00:00 AM MDT
Eighteen years before surgery scrub technician Kristen Parker infected 18 patients at Rose Medical Center with hepatitis C, another employee infected patients the same way at a Texas hospital later owned by one of the owners of Rose.
A lawsuit filed in Denver District Court states that Hospital Corporation of America, which partly owns Rose Medical Center, should have been more careful with the way drugs were stored and secured after its earlier lawsuit.
Parker, 27, is serving 30 years in federal prison after she injected herself with the painkiller fentanyl that was meant for surgery patients. She then filled the syringes with saline and placed them back on carts, resulting in the patients being injected with the infected needles during surgery.
The latest lawsuit, filed Aug. 3, claims anesthesiologists left the drugs in unlocked surgery rooms — in violation of hospital policy and state and federal statutes.
"Every single surgery room at Rose had controlled substances that were intended for vulnerable surgery patients lying around for drug addicts like Parker to divert, use and fill with saline," said patients' attorney Hollynd Hoskins.
Five lawsuits are pending against Rose Medical Center, and one has been settled, said Cara Harshberger, spokeswoman for the hospital.
The first case set for trial is in June before Denver District Judge Herbert Stern.
The latest suit was filed by Hoskins on behalf of a Denver mother of three who is using the initials L.K. because she does not want her medical condition made public.
For six minutes, a syringe filled with the painkiller fentanyl sat unsecured in a surgery room before L.K.'s procedure on Feb. 13, 2009. The lawsuit says that is when Parker stole the drug and left the infected needle behind.
The anesthesiologist, Dr. Herbert N. Chado, named as a defendant in the lawsuit, unknowingly injected L.K. with the contaminated needle, and months later, the woman learned that she was infected with hepatitis C.
L.K. underwent interferon treatment and, at first, responded to the medication, but the virus has since come back.
In 1994, the Colorado Board of Medical Examiners placed Chado on five years of probation for abusing the drug Sufenta, an opiate. Chado, who pursued treatment, did not practice medicine from 1993 to 2001, state records show.
Chado did not return a call seeking comment about the lawsuit.
Minutes before L.K. was infected, Chado failed to lock the surgery room and didn't have the fentanyl in his sight, the suit says.
"We have had and continue to have rigorous controls in place to ensure medication security," Harshberger said. "This includes having pass- code-protected computerized medication systems in each operating room, with methodical auditing of the usage of that equipment, providing ongoing education for staff and physicians regarding medication security, and exploring options for packaging of medication."
In 1991, scrub tech David Wayne Thomas stole fentanyl from the now-defunct Mid-Cities Surgi-Center in Bedford, Texas.
The hospital was owned by Medical Care America at the time of the incident but was acquired by Hospital Corporation of America in 1994, Harshberger said.
Thomas, who was infected with hepatitis C, pleaded guilty to stealing the drugs and served three years of an eight-year sentence, according to a 1995 Fort Worth Star-Telegram article. It is not clear whether Thomas knew he was infected with the virus, as Parker did, when he was contaminating the needles.
Civil lawsuits were brought by 48 patients against Hospital Corporation of America and the anesthesiologists who were responsible for securing the medication. The cases were settled.
Legal experts told the newspaper the settlements could have surpassed $100 million.
Harshberger said Rose remains committed to helping patients, including paying for the testing and treatment of those affected by Parker's actions.
"The criminal actions of this former employee put our patients at risk, and for that we were truly saddened and angered," she said.
Felisa Cardona: 303-954-1219 or fcardona@denverpost.com
Source
Death at his back
As his body succumbs to hepatitis C, inmate spends last days trying to warn others
11:33 PM CDT on Saturday, August 14, 2010
By Donna Fielder / Staff Writer
This is a cautionary tale from a dead man walking.
Michael Mabry doesn’t have a lot to be proud of.
He’s been in and out of prison all his adult life. He’s been a speed fiend and a cokehead most of that time. He’s been busted for drugs and burglarizing buildings and tried two jailbreaks, and he has a criminal record in three states. He has eight children “scattered around,” he says, but he’s mostly alone now.
He’s a dead man, he says.
He won’t leave the infirmary at the Denton County Jail alive. Hepatitis C attacked his liver before he knew anything was wrong. By the time it was diagnosed, he was in the final stages of cirrhosis of the liver, and there’s nothing anyone can do for him, in jail or not.
So the 49-year-old Denton man sits on his cot in a medical cell, with a commode in the open a couple of feet away and the only decoration a roll of toilet paper and some graffiti scratched on the wall, and he thinks about his life and what he’s done wrong. He wonders what he could do to maybe get one small mark on the right side of his sheet.
“I don’t think I’ve done anything to warrant going to hell,” he says. “But you never know. It sure wouldn’t hurt to get a few points in with the Man up there.”
He doesn’t have much time. He’s a con man, he admits. But he can’t con his way out of the trouble he’s in.
The only thing Mabry can offer is his life experience and its consequences as a warning to others. He got hepatitis C from jailhouse tattoos, he says. Everybody in prison gets tats; many contract hepatitis C from the methods they use.
But it’s the youngsters he’d like to help now, he said. Tattoos also are popular with the general population. Most adults go to tattoo parlors that are licensed by the state and have strict guidelines to hold down the chance of contracting a disease from infected implements. But those younger than 18 must have parental permission to legally obtain a tattoo. Many young people turn to more informal — and more dangerous — methods of inking up.
Gang wannabes use homemade devices to ink in their gang affiliations. Other kids get a friend to help them render forever their girlfriends’ names or symbols that have meaning to them. If they knew, Mabry says, if they understood that dirty needles, shared tattoo devices made of paper clips, safety pins — the myriad other unhealthy, sharp things — can kill them, maybe they wouldn’t get started down that road.
According to medical information provided by a website devoted to hepatitis, 4 million Americans now have hepatitis C.
It is more prevalent in Europe, but it emerged in the U.S. in the 1960s, related to blood transfusions and intravenous drug use. A reliable test for it was developed in the 1990s, and it was revealed to be a much larger problem than anyone knew. It causes cirrhosis of the liver and liver cancer.
When casual users share a needle to inject drugs or an instrument to inject ink under the skin, blood can be transmitted from one person to another. Hepatitis C is one of the diseases that can be transmitted in blood. It attacks the liver — and left untreated, destroys it.
The liver has many functions, including filtering harmful substances from the blood, breaking down fats, storing vitamins and producing urea. The body cannot survive without it. Cirrhosis inflames the liver and ultimately causes it to fail. Caught early, the symptoms can be treated. But it is incurable.
Jailhouse prevalence of hepatitis C
Doug Sanders supervises the medical staff at the jail. He believes that Mabry is within weeks of death. Since Mabry’s disease is only communicable by bodily fluid exchange, there’s no reason to isolate him, he said. The staff manages his medication to try to keep him comfortable.
Since Mabry also injected drugs, he could have contracted hepatitis from a dirty needle. But he is convinced it was a tattoo needle, and since he has so many tattoos, it is reasonable to think that he is right, Sanders said.
“It’s alarming. It’s extremely prevalent in jail populations. You might think the HIV virus would be more prevalent, but the greatest risk exposure in jails and prisons nationwide is hepatitis C.”
Jail administrators try hard to keep inmates from finding ways to make jailhouse tattoos, Sanders said. Guards seize anything that could be used to make them.
“We are absolutely discouraging it. We confiscate it. But they have so many ways of engineering a machine. They find ways around it,” he said.
Mabry’s isn’t the first advanced case that the jail medical staff have treated. They are preparing him as best they can for the suffering he’s about to endure, Sanders said. “He has some very difficult days ahead.”
A dim future
Death is becoming real for Mabry. He spends a lot of time talking to chaplain Bobby Ayers. He’s working on a bill he’d like to become a law. He knows he’s not going to finish it, so he offers advice.
“Kids are knuckleheaded, you know,” Mabry says. “If I could save one kid ...”
Perched on his cot, his longish black hair slicked down, his orange jumpsuit covering the numerous tats on his back, chest and legs, he thinks about that for a minute.
“It ain’t just the needle you get it from. It’s the ink they reuse,” he said. “You know, I studied the law and I beat it one time. I slicked out of a charge I did on a technicality. They wrote on my paperwork that I’m a master manipulator of the law. I studied this disease. I’m not stupid. I studied to find a way to beat it, but you can’t.”
He pulls up his shirt to display drug- and gang-related tattoos. He has a bandito tat on his chest, a large dagger with a snake wrapped around it — he says it’s related to Rex Cauble and the Cowboy Mafia — on one leg, and a fairly good rendering of the Grim Reaper on his back.
“He’s coming for me, by God,” he said. “It’s day by day now.”
Mabry demonstrates how a tattoo machine can be made with things not considered contraband in the jail and some that are. A decent jailhouse tattoo machine can be constructed with a ballpoint pen, a paper clip, some string and the tiny motor from a Walkman, he says. Ashes and shampoo can be combined to make ink.
Walkman tape players are no longer available at the county jail. Mabry said an inmate can always figure out another way.
“We say you can put one prisoner on one roof with a match and another one on another roof a mile away with a cigarette, and before you know it both of them have half a match and half a cigarette and they’re both smoking,” he said.
Mabry says his liver no longer functions. It swelled, he said, until it broke his ribs. He said he’s had eight heart attacks since he was diagnosed less than a year ago, and his aorta burst because his veins and arteries thinned out. He also has diabetes. He’s in pain, which the medical personnel in the infirmary try to lessen with drugs. He’s a poster boy for staying away from casual tattoos. If you have to get them, go to a licensed tattoo shop, he says. They have rules to keep things clean.
Mabry often loses his train of thought. He rambles and forgets.
“The worst part of this disease is your brain goes,” he said. “They tell me that when it gets that far, it’s the best thing for me. But I don’t want my brain to go and just be lying here.”
He thinks a minute and then laughs.
“I have a million dollars worth of medical bills right now. But they ain’t never gonna get it. Maybe somebody will read this story and it will save them. It’d be good if I could at least do that.”
DONNA FIELDER can be reached at 940-566-6885. Her e-mail address is dfielder@dentonrc.com.
Source
11:33 PM CDT on Saturday, August 14, 2010
By Donna Fielder / Staff Writer
This is a cautionary tale from a dead man walking.
Michael Mabry doesn’t have a lot to be proud of.
He’s been in and out of prison all his adult life. He’s been a speed fiend and a cokehead most of that time. He’s been busted for drugs and burglarizing buildings and tried two jailbreaks, and he has a criminal record in three states. He has eight children “scattered around,” he says, but he’s mostly alone now.
He’s a dead man, he says.
He won’t leave the infirmary at the Denton County Jail alive. Hepatitis C attacked his liver before he knew anything was wrong. By the time it was diagnosed, he was in the final stages of cirrhosis of the liver, and there’s nothing anyone can do for him, in jail or not.
So the 49-year-old Denton man sits on his cot in a medical cell, with a commode in the open a couple of feet away and the only decoration a roll of toilet paper and some graffiti scratched on the wall, and he thinks about his life and what he’s done wrong. He wonders what he could do to maybe get one small mark on the right side of his sheet.
“I don’t think I’ve done anything to warrant going to hell,” he says. “But you never know. It sure wouldn’t hurt to get a few points in with the Man up there.”
He doesn’t have much time. He’s a con man, he admits. But he can’t con his way out of the trouble he’s in.
The only thing Mabry can offer is his life experience and its consequences as a warning to others. He got hepatitis C from jailhouse tattoos, he says. Everybody in prison gets tats; many contract hepatitis C from the methods they use.
But it’s the youngsters he’d like to help now, he said. Tattoos also are popular with the general population. Most adults go to tattoo parlors that are licensed by the state and have strict guidelines to hold down the chance of contracting a disease from infected implements. But those younger than 18 must have parental permission to legally obtain a tattoo. Many young people turn to more informal — and more dangerous — methods of inking up.
Gang wannabes use homemade devices to ink in their gang affiliations. Other kids get a friend to help them render forever their girlfriends’ names or symbols that have meaning to them. If they knew, Mabry says, if they understood that dirty needles, shared tattoo devices made of paper clips, safety pins — the myriad other unhealthy, sharp things — can kill them, maybe they wouldn’t get started down that road.
According to medical information provided by a website devoted to hepatitis, 4 million Americans now have hepatitis C.
It is more prevalent in Europe, but it emerged in the U.S. in the 1960s, related to blood transfusions and intravenous drug use. A reliable test for it was developed in the 1990s, and it was revealed to be a much larger problem than anyone knew. It causes cirrhosis of the liver and liver cancer.
When casual users share a needle to inject drugs or an instrument to inject ink under the skin, blood can be transmitted from one person to another. Hepatitis C is one of the diseases that can be transmitted in blood. It attacks the liver — and left untreated, destroys it.
The liver has many functions, including filtering harmful substances from the blood, breaking down fats, storing vitamins and producing urea. The body cannot survive without it. Cirrhosis inflames the liver and ultimately causes it to fail. Caught early, the symptoms can be treated. But it is incurable.
Jailhouse prevalence of hepatitis C
Doug Sanders supervises the medical staff at the jail. He believes that Mabry is within weeks of death. Since Mabry’s disease is only communicable by bodily fluid exchange, there’s no reason to isolate him, he said. The staff manages his medication to try to keep him comfortable.
Since Mabry also injected drugs, he could have contracted hepatitis from a dirty needle. But he is convinced it was a tattoo needle, and since he has so many tattoos, it is reasonable to think that he is right, Sanders said.
“It’s alarming. It’s extremely prevalent in jail populations. You might think the HIV virus would be more prevalent, but the greatest risk exposure in jails and prisons nationwide is hepatitis C.”
Jail administrators try hard to keep inmates from finding ways to make jailhouse tattoos, Sanders said. Guards seize anything that could be used to make them.
“We are absolutely discouraging it. We confiscate it. But they have so many ways of engineering a machine. They find ways around it,” he said.
Mabry’s isn’t the first advanced case that the jail medical staff have treated. They are preparing him as best they can for the suffering he’s about to endure, Sanders said. “He has some very difficult days ahead.”
A dim future
Death is becoming real for Mabry. He spends a lot of time talking to chaplain Bobby Ayers. He’s working on a bill he’d like to become a law. He knows he’s not going to finish it, so he offers advice.
“Kids are knuckleheaded, you know,” Mabry says. “If I could save one kid ...”
Perched on his cot, his longish black hair slicked down, his orange jumpsuit covering the numerous tats on his back, chest and legs, he thinks about that for a minute.
“It ain’t just the needle you get it from. It’s the ink they reuse,” he said. “You know, I studied the law and I beat it one time. I slicked out of a charge I did on a technicality. They wrote on my paperwork that I’m a master manipulator of the law. I studied this disease. I’m not stupid. I studied to find a way to beat it, but you can’t.”
He pulls up his shirt to display drug- and gang-related tattoos. He has a bandito tat on his chest, a large dagger with a snake wrapped around it — he says it’s related to Rex Cauble and the Cowboy Mafia — on one leg, and a fairly good rendering of the Grim Reaper on his back.
“He’s coming for me, by God,” he said. “It’s day by day now.”
Mabry demonstrates how a tattoo machine can be made with things not considered contraband in the jail and some that are. A decent jailhouse tattoo machine can be constructed with a ballpoint pen, a paper clip, some string and the tiny motor from a Walkman, he says. Ashes and shampoo can be combined to make ink.
Walkman tape players are no longer available at the county jail. Mabry said an inmate can always figure out another way.
“We say you can put one prisoner on one roof with a match and another one on another roof a mile away with a cigarette, and before you know it both of them have half a match and half a cigarette and they’re both smoking,” he said.
Mabry says his liver no longer functions. It swelled, he said, until it broke his ribs. He said he’s had eight heart attacks since he was diagnosed less than a year ago, and his aorta burst because his veins and arteries thinned out. He also has diabetes. He’s in pain, which the medical personnel in the infirmary try to lessen with drugs. He’s a poster boy for staying away from casual tattoos. If you have to get them, go to a licensed tattoo shop, he says. They have rules to keep things clean.
Mabry often loses his train of thought. He rambles and forgets.
“The worst part of this disease is your brain goes,” he said. “They tell me that when it gets that far, it’s the best thing for me. But I don’t want my brain to go and just be lying here.”
He thinks a minute and then laughs.
“I have a million dollars worth of medical bills right now. But they ain’t never gonna get it. Maybe somebody will read this story and it will save them. It’d be good if I could at least do that.”
DONNA FIELDER can be reached at 940-566-6885. Her e-mail address is dfielder@dentonrc.com.
Source
Physicians Concerned About Nationwide Drug Shortages
Reported by: Kevin Reece - KHOU TV
HOUSTON - A watchdog group calls the current state of drug shortages in this country “alarming” and doctors in the Texas Medical Center agree the problem is more severe this summer than in years past.
Jonathan O’Malley, 18, is a leukemia patient at MD Anderson. Earlier this year he received a cord blood transplant and doctors are managing his recovery and the variety of health issues his fight includes. Among the litany of problems chemotherapy has already brought him, he's developed an infection. It’s called cytomegalovirus or CMV. The recommended treatment and final line of defense for Jonathan is an anti-viral drug called Foscarnet.
But on the blog kept by Jonathan's parents, we noticed this disturbing sentence from his mom: "There is a nationwide shortage of this drug and they have absolutely none available...this could be life or death for so many cancer patients," Melanie O’Malley wrote.
At Texas Children's Hospital we found a doctor who agreed.
“For these patients these drugs are life-saving and absolutely vital,” said Dr. Robert Krance, a stem cell and gene therapy expert. Two of his stem cell transplant patients also rely on Foscarnet to keep infections in check.
"And when you don't have suitable alternatives you really have patients at risk for having complications and even fatal complications if you can't work around that,” Krance said.
So why is Foscarnet suddenly in short supply? That's a difficult answer to get.
It was originally made by two companies: Astra Zeneca and Hospira. Astra Zeneca stopped making the drug last year. And now Hospira has temporarily halted production altogether.
The company, headquartered in Lake Forest, Illinois would only tell us by email that: “We expect to be back on the market in the fourth quarter (the quarter starting Oct. 1 and running through Dec. 31).” A report by the American Society of Health-Systems Pharmacists last month stated that “Hospira has Foscarnet presentations on hold due to product testing out of specification.”
"We really don't get a very clear reason why it happens so you're always left somewhat in the dark,” said Krance.
And it's not the only drug in short supply. The American Society of Health System Pharmacists currently lists shortages for more than 140 drugs and drug products including the likes of Hepatitis A Vaccine, morphine injections, and measles, mumps, and rubella vaccine.
The institute for Safe Medication Practices called the shortages "alarming," "unprecedented" and "grim."
"I think a lot of that is financial pressure,” said Wendy Smith RPH, PharmD, a pharmacist at MD Anderson. “There's not a lot of excess drugs sitting on the shelf at any one place."
Smith agrees the shortages are more severe this summer. But said managing sparse drug supplies are a daily part of doing business.
The Food and Drug Administration blames shortages on the business decisions of drug companies, occasional problems with manufacturing, or, in the case of Foscarnet, only one company finds it profitable to produce.
“We may not ever know why a particular product was shorted out,” added Smith.”So it's frustrating for a lot of people."
"We try to preserve product for patients who need it the most and try to withstand and wait until things on the production is able to be picked up,” said Smith.
As for Jonathan, we are told he has enough of the drugs he needs at least for now. Although Krance says he wishes it wasn’t an issue at all.
“When drugs are no longer available to a patient who needs it desperately, it's often too late,” said Krance
Source
The Race Is On For Hepatitis C Treatment
On Friday August 13, 2010, 6:57 pm EDT
How's this for a biopharmaceutical market opportunity? Prospective patients in need: 170 million. That's 3% of the world's population.
The disease is hepatitis C, a contagious, slow-developing, blood-borne disease that can make 80% of those infected vulnerable to severe liver problems, including cirrhosis and cancer.
Hepatitis C wasn't even identified until 1987. A blood test for it became available in 1992.
Now a score of companies are racing to bring new treatments on stream. Out front are Merck (NYSE:MRK - News) with boceprevir, and a partnership of Vertex Pharmaceuticals (NMS:VRTX) and Johnson & Johnson (NYSE:JNJ - News) with telaprevir.
The market will be pretty much evenly split between the two, says Damien Conover, a strategist and senior pharmaceutical analyst at rating firm Morningstar. Telaprevir may have a slight edge, he says.
Both drugs are protease inhibitors, which prevent a virus from replicating itself. While they treat the same disease, they are different in both results and side effects.
Used on patients who have had no previous treatment, boceprevir and telaprevir beat down the hepatitis C virus to undetectable levels in 66% and 75% of patients respectively, Conover says.
Both drugs are likely to go to the Food and Drug Administration for a verdict by the end of the year. That means both could reach the market next year.
"Right now it's hard to tell who's in the lead," Conover said.
Meanwhile, Merck and Vertex-J&J appear to be competing for headlines.
A week ago, the British-based Lancet medical journal carried a Merck-funded study showing that boceprevir brought the virus down to undetectable levels in 66% of patients over 48 weeks of treatment in combination with drugs in use now.
The next day, Aug. 10, Vertex reported study results showing that some patients did so well after a 24-week course of telaprevir (plus the current drugs in use) that they got no added benefit from a 48-week course of treatment. The message: Telaprevir does the job in half the time.
Merck acquired boceprevir with its $41 billion purchase of Schering-Plough in 2009. Vertex developed telaprevir with money from J&J in return for marketing rights.
Whether one or both of the drugs get FDA approval, the hepatitis market is about to undergo a "major paradigm shift," said Steven Silver, an analyst at Standard & Poor's.
"We've gone many years without a new drug on the landscape," he said.
It's hard to know which drug will do better in real life and in the market because they have not been tested head-to-head.
That's a long-standing problem in the drug-development industry. Prospective new products are tested either against a placebo (sugar pills) or, as in the cases of boceprevir and telaprevir, against the current standard of care.
For hepatitis C, that standard is a combination of interferon and ribavirin. It's a hit-or-miss treatment.
In simple terms, ribavirin is an antiviral medication that stops the virus that causes hepatitis C from spreading. Interferon prevents viral replication in surrounding cells.
According to the National Center for Biotechnology Information, it's not known if treatment with ribavirin and interferon actually cures hepatitis C infection, prevents liver damage caused by hepatitis C or keeps hepatitis C from spreading to other people.
The standard hepatitis C treatment results in a reduction of the virus to undetectable levels in fewer than half of cases, according to WebMD (NMS:WBMD).
Boceprevir and telaprevir are protease inhibitors. In brief, they attack the hepatitis C virus itself, WebMD says.
Without head-to-head tests, with the same dosing regimen and with the same kind of patient population, it's hard for investors to figure out whether boceprevir or telaprevir will be the greater success, assuming both get FDA approval, Conover says.
But head-to-head studies "are often not in the best interest of the company," he said.
They can show one drug so superior as to make the other unmarketable. "Head-to-head studies can backfire," Conover said.
According to Silver, the investment community "is trying to ballpark the information released to date."
He sees Vertex prevailing with telaprevir: "It's poised to be the market leader."
Data collected on real world use of these drugs are still some years off.
The market will be watching boceprevir and telaprevir for the next three or four years, Silver says.
An important factor will be the success rate of the drugs on people who have previously failed to respond to the standard of care.
That's not how clinical trials are run. They are usually conducted with patients who have not had therapy, the so-called treatment-naive. Using treatment-naive patients creates a baseline but does not approximate real-life conditions.
Most people with a disease have tried one or more drugs, ratcheting up from least to most powerful and expensive.
Another real-life issue will be the side effects. Newly diagnosed patients may find the side effects of either drug, plus interferon and ribavirin, intolerable.
The most common telaprevir side effect is a rash, Stevens says.
Boceprevir's predominant side effect is anemia. That raises the prospect that another drug will need to be added to the regimen, perhaps Epogen, the anemia-fighting biologic from Amgen (NMS:AMGN).
It's available as a generic in Europe, but remains branded in the U.S.
Another reason to think telaprevir has the inside track is the likelihood that it will require a shorter period of treatment, Silver says.
"At the end of the day, this race will be data-driven," he said.
While there's been no head-to-head trial, the existing data should become available for close comparison at a meeting of the American Association for the Study of Liver Diseases in Boston starting Oct. 28.
By most counts, the global market for hepatitis C products is now $4 billion a year. According to a report from the commercial analysis firm Research & Markets, that should rise to $8.5 billion by 2016.
The reasons for the growth: the increasing number of cases and the new drugs in the pipeline that will make treatment more accessible and tolerable.
Source
How's this for a biopharmaceutical market opportunity? Prospective patients in need: 170 million. That's 3% of the world's population.
The disease is hepatitis C, a contagious, slow-developing, blood-borne disease that can make 80% of those infected vulnerable to severe liver problems, including cirrhosis and cancer.
Hepatitis C wasn't even identified until 1987. A blood test for it became available in 1992.
Now a score of companies are racing to bring new treatments on stream. Out front are Merck (NYSE:MRK - News) with boceprevir, and a partnership of Vertex Pharmaceuticals (NMS:VRTX) and Johnson & Johnson (NYSE:JNJ - News) with telaprevir.
The market will be pretty much evenly split between the two, says Damien Conover, a strategist and senior pharmaceutical analyst at rating firm Morningstar. Telaprevir may have a slight edge, he says.
Both drugs are protease inhibitors, which prevent a virus from replicating itself. While they treat the same disease, they are different in both results and side effects.
Used on patients who have had no previous treatment, boceprevir and telaprevir beat down the hepatitis C virus to undetectable levels in 66% and 75% of patients respectively, Conover says.
Both drugs are likely to go to the Food and Drug Administration for a verdict by the end of the year. That means both could reach the market next year.
"Right now it's hard to tell who's in the lead," Conover said.
Meanwhile, Merck and Vertex-J&J appear to be competing for headlines.
A week ago, the British-based Lancet medical journal carried a Merck-funded study showing that boceprevir brought the virus down to undetectable levels in 66% of patients over 48 weeks of treatment in combination with drugs in use now.
The next day, Aug. 10, Vertex reported study results showing that some patients did so well after a 24-week course of telaprevir (plus the current drugs in use) that they got no added benefit from a 48-week course of treatment. The message: Telaprevir does the job in half the time.
Merck acquired boceprevir with its $41 billion purchase of Schering-Plough in 2009. Vertex developed telaprevir with money from J&J in return for marketing rights.
Whether one or both of the drugs get FDA approval, the hepatitis market is about to undergo a "major paradigm shift," said Steven Silver, an analyst at Standard & Poor's.
"We've gone many years without a new drug on the landscape," he said.
It's hard to know which drug will do better in real life and in the market because they have not been tested head-to-head.
That's a long-standing problem in the drug-development industry. Prospective new products are tested either against a placebo (sugar pills) or, as in the cases of boceprevir and telaprevir, against the current standard of care.
For hepatitis C, that standard is a combination of interferon and ribavirin. It's a hit-or-miss treatment.
In simple terms, ribavirin is an antiviral medication that stops the virus that causes hepatitis C from spreading. Interferon prevents viral replication in surrounding cells.
According to the National Center for Biotechnology Information, it's not known if treatment with ribavirin and interferon actually cures hepatitis C infection, prevents liver damage caused by hepatitis C or keeps hepatitis C from spreading to other people.
The standard hepatitis C treatment results in a reduction of the virus to undetectable levels in fewer than half of cases, according to WebMD (NMS:WBMD).
Boceprevir and telaprevir are protease inhibitors. In brief, they attack the hepatitis C virus itself, WebMD says.
Without head-to-head tests, with the same dosing regimen and with the same kind of patient population, it's hard for investors to figure out whether boceprevir or telaprevir will be the greater success, assuming both get FDA approval, Conover says.
But head-to-head studies "are often not in the best interest of the company," he said.
They can show one drug so superior as to make the other unmarketable. "Head-to-head studies can backfire," Conover said.
According to Silver, the investment community "is trying to ballpark the information released to date."
He sees Vertex prevailing with telaprevir: "It's poised to be the market leader."
Data collected on real world use of these drugs are still some years off.
The market will be watching boceprevir and telaprevir for the next three or four years, Silver says.
An important factor will be the success rate of the drugs on people who have previously failed to respond to the standard of care.
That's not how clinical trials are run. They are usually conducted with patients who have not had therapy, the so-called treatment-naive. Using treatment-naive patients creates a baseline but does not approximate real-life conditions.
Most people with a disease have tried one or more drugs, ratcheting up from least to most powerful and expensive.
Another real-life issue will be the side effects. Newly diagnosed patients may find the side effects of either drug, plus interferon and ribavirin, intolerable.
The most common telaprevir side effect is a rash, Stevens says.
Boceprevir's predominant side effect is anemia. That raises the prospect that another drug will need to be added to the regimen, perhaps Epogen, the anemia-fighting biologic from Amgen (NMS:AMGN).
It's available as a generic in Europe, but remains branded in the U.S.
Another reason to think telaprevir has the inside track is the likelihood that it will require a shorter period of treatment, Silver says.
"At the end of the day, this race will be data-driven," he said.
While there's been no head-to-head trial, the existing data should become available for close comparison at a meeting of the American Association for the Study of Liver Diseases in Boston starting Oct. 28.
By most counts, the global market for hepatitis C products is now $4 billion a year. According to a report from the commercial analysis firm Research & Markets, that should rise to $8.5 billion by 2016.
The reasons for the growth: the increasing number of cases and the new drugs in the pipeline that will make treatment more accessible and tolerable.
Source
August 14, 2010
Less-Invasive Biopsies More Common
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
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
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-CĂ©ron, 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
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