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Week Ending: February 6, 2010
Alan Franciscus
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January 30, 2010
Physicians Must Treat 'Transplant Tourists'
http://abcnews.go.com
By KRISTINA FIORE
MedPage Today
Cases Reveal Hidden Risks of Substandard Transplant Procedures
Patients who travel to foreign countries for organ transplants may return with more problems than they left with -- and physicians here have a moral responsibility to treat them, researchers asserted in a transplant journal.
"Medical tourism" has been on the rise as demand for organs outpaces supply and health care costs in the United States skyrocket, Dr. Thomas Schiano and Rosamond Rhodes of Mount Sinai School of Medicine reported in Liver Transplantation.
"If there were enough organs to go around, no one would go abroad to get transplanted," Schiano said. "In our practice, it clearly has increased over the last three to five years."
Researchers have estimated that 300 medical tourism transplants occurred between 2004 and 2006, with more than 40 percent of transplant tourists residing in New York or California, which have only 18 percent of the total U.S. population.
Yet physicians have had little guidance on delivering care to these patients, and some transplant centers may turn them away based on their actions.
"One of the liver transplant centers in our region, their policy is not to take on care of these patients, even if they were known to them before the transplant," Schiano said.
His questions about treatment arose with a 46-year-old Chinese patient who had been put on a waiting list for a liver transplant here because of end-stage liver disease.
The patient waited on the list for a year as his disease progressed from 18 points to 21 points on a 40-point severity scale.
Rather than wait any longer, the patient flew to China and had a liver transplant there.
Many transplanted organs in China come from executed prisoners, raising concerns about disease. Also, foreign transplants may be compromised by poor organ matching, unhealthy donors, and post-transplant infections. And some transplant centers abroad may use substandard surgical techniques.
Foreign centers are also less likely to send patients home with adequate records and education than centers here, the researchers said.
Three months after his transplant in China, the patient came back to the clinic at Mount Sinai for follow-up care because he was about to run out of imunosuppressive medication.
Two months after that, he developed septic shock, requiring three additional hospitalizations for a serious complication known as biliary sepsis. At that point, re-transplantation was the only viable option, Schiano said.
However, members of the medical team had conflicting views about giving the patient another new liver.
"The concern was that ... by re-transplanting him we're going to take a liver away from another patient on the waiting list who may die because they didn't get the organ," Schiano said. "That was the main ethical issue."
The clinicians had few ethical guidelines to refer to in making their decision because many deal solely with moral issues related to donors and foreign medical standards.
For example, the International Society for Heart and Lung Transplantation issued a statement against accepting organs from prisoners in April 2007, and the American Association for the Study of Liver Diseases and the International Liver Transplant Society endorsed similar policies.
The American Medical Association's guidelines on medical tourism focus on best practices -- for example, the procedure must be voluntary, it can't limit the alternatives offered to patients, and patients should only be referred to accredited institutions.
While the United Network for Organ Sharing (UNOS)'s statement on medical tourism does maintain that the medical community has an obligation to provide care for these patients, it stops short of offering further direction to transplant programs.
Because of the dearth of guidance for dealing with specific problems that arise with transplant tourists, Schiano and Rhodes created some basic ethical principles.
They based their ideas on the understanding that physicians have a "professional obligation to promote the good of patients" as well as a "professional responsibility to adhere to medicine's commitment to nonjudgmental regard."
"We're supposed to take care of everybody, whatever their lot in life," Schiano said. "That has to be the overriding principle. We can't blame these people for trying to save their lives and getting transplanted."
Physicians shouldn't deny patients post-transplantation care, and they ought to provide emergent care at the very least. They may refer the patient to another transplant center for long-term follow up if they regard it as unethical to continue treatment.
"To turn your back on patients, especially if you know them before the transplant -- I don't agree with that," Schiano said. "It's the same thing in war. We treat the enemy soldier."
Patients should also be informed about the possibility of transplant tourism when they are not eligible for a transplant in the U.S. or when they are likely to die before reaching the top of the transplant list, Schiano and Rhodes wrote.
Schiano said that he'd rather have more information about centers abroad before referring patients there. He does, however, recommend that patients travel to other areas in the U.S. to get their transplant if they live in high-demand areas such as New York or California.
"There are geographic differences in terms of organ availability. For instance, you can go to Florida with the same [severity] score and blood type and be transplanted a lot sooner than you can in New York," Schiano said. "It's probably because more donors become available in certain areas of the country."
As for the 46-year-old patient who was transplanted in China, the Mount Sinai team decided a transplant program must treat all patients on the basis of their need, "regardless of what they might have done or how they secured their transplant organ."
"Although [the patient] had a long, complicated transplantation course," Schiano and Rosamond wrote, "he is currently doing well."
Mount Sinai has seen a total of nine patients who pursued transplants in China. Three of those had post-transplant problems but had been turned away elsewhere.
Seven of those nine patients have hepatitis B. Another three had had a renal transplant in India, and subsequently developed liver failure.
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Gates Foundation Pledges $10 Billion to Fund Vaccines
http://www.emaxhealth.com
Denise Reynolds
Microsoft cofounder Bill Gates and his wife Melinda have pledged $10 billion dollars to support research and access to immunizations worldwide over the next ten years. Mr. Gates, who made the announcement at the annual meeting of the World Economic Forum in Switzerland, predicts that the plan could potentially prevent nearly 8 million child deaths.
The complete story can be found at http://www.emaxhealth.com/1506/50/35311/gates-foundation-pledges-10-billion-fund-vaccines.html
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January 31, 2010
Phase 1 Clinical Trial Results Expected on January 31, 2010
http://www.favstocks.com
By John McCalister
On December 15, 2009, Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) disclosed some crucial information from the initial results of the second stage of the Phase 1 trial. This trial is being conducted by Achillion Pharma to measure the effectiveness and the safety of the ACH-1625, which is a drug that is being developed by the pharmaceutical company to treat patients who are suffering from Hepatitis C (HCV). The results showed that if a patient receives a monotherapy (that is, a therapy that includes only ACH-1625) for five days, then he or she can experience an average of “3.94 log10 reduction in HCV RNA”. This meant that a treatment with ACH-1625 can significantly improve the conditions of people diagnosed with Hepatitis C virus. It has also been found that patients can tolerate well the doses of ACH-1625. Moreover, the drug ACH-1625 is considered to be completely safe. Achillion Pharmaceuticals plans to disclose other detailed information on the second stage of the Phase 1 trial by January 31, 2010. The company is thinking of arranging a conference with investors. Apart from disclosing information on the second stage of the Phase 1 trial, the company also plans to talk about both stage A and stage B of the trial. Also, the company wants to do the same in the European Association for the Study of Liver Disease (EASL) meeting that will take place in Vienna in April 2010.
The Phase 1 trial was started by Achillion Pharmaceuticals on June 2009. The trial consists of two stages: stage A and stage B. Both these stages have been completed by the pharmaceutical company. The Phase 1 trial is a “randomized, double-blind, placebo-controlled phase” that measured how safe and tolerable the drug ACH-1625 is. Moreover, the trial wanted to find how effective the drug is in combating the fatal HCV. The trial was conducted in Europe. About 54 people participated in the trial. A few of the participants were healthy (that is, they were not infected with HCV) while the others were infected with HCV. These patients were administered double and single doses of ACH-1625 for 5 days.
In September 2009, Achillion Pharmaceuticals confirmed that it had received favorable results from Stage A of the Phase 1 trial. After the announcement, the company started the second stage, which also achieved encouraging results.
Dr. Elizabeth Olek, who is the Chief Medical Officer (CMO) of Achillion Pharmaceuticals, said:
“In addition to the dramatic reduction in viral load after 5 days of monotherapy, ACH-1625 demonstrates slow viral rebound, which is an important differentiating characteristic, as this continued suppression of viral load after discontinuation of the drug may translate into a more durable antiviral response. These positive proof-of-concept results corroborate our findings from pre-clinical studies with ACH-1625, which demonstrated high potency, unique pharmacokinetic properties, and an excellent safety profile.”
Michael Kishbauch, who is the Chief Executive Officer and also the President of Achillion Pharmaceuticals, credited the companies R&D department for favorable results. He said:
“These compelling interim results are very encouraging as we continue to advance the clinical development of this compound for the treatment of HCV. Not only are the results especially robust, but they give us proof-of-concept ahead of schedule. This is a credit to our top-notch research and development team, which deserves recognition for its scientific excellence and tireless efforts.”
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Canada's Olympics City Has Notorious Skid Row
http://bleacherreport.com
By Jeremy Hainsworth
Associated Press Writer
VANCOUVER, British Columbia (AP) -- Five blocks away from the venue for Vancouver's Winter Olympics opening ceremonies, four grizzled addicts huddle in the rain, injecting themselves with heroin behind a trash bin.
This is the Downtown Eastside, where life is volatile and the slightest misstep can invite brutal retaliation.
''It's a jungle,'' said Glen, a 49-year-old heroin addict who goes by the street name Trouble. ''You want to get out of here.''
As Vancouver prepares for the Olympics and the descent of the world's media, the Downtown Eastside remains a huge problem -- 15 square blocks of despair, squalid rooming houses and alleys populated by thousands of addicts, the homeless, the mentally ill and the drug dealers who prey on them.
This neighborhood is the most concentrated drug and poverty ghetto in North America, with high use of heroin, cocaine and methamphetamine, according to criminologist Benedikt Fischer of Simon Fraser University. It also is the only place in North America where drug addicts can shoot heroin into their veins at an officially sanctioned injection site.
At the center of the neighborhood is a neoclassical building endowed by philanthropist Andrew Carnegie in 1903. Behind it, dealers and pimps hawk drugs and women in a filthy alley. On the building's front steps is Vancouver's largest open-air drug market, at the intersection of Main and Hastings streets, called ''Pain and Wastings'' by locals.
Across the street is Vancouver's biggest police station. Police Const. Lindsey Houghton said officers often find themselves in the role of social workers while continuing to target the drug trade. About 49 percent of Downtown Eastside calls are related to mental health, according to the Vancouver Police Department.
''It's a tremendous challenge that goes beyond the traditional scope of policing,'' Houghton said.
The International Olympic Committee's bid evaluation team did not see the Downtown Eastside when it assessed Vancouver's bid in 2003. When it came time to tour Vancouver venues, the IOC's bus took a wide detour around the neighborhood.
The bid evaluation team did see the scenic but treacherous highway from Vancouver to Whistler, host of alpine and sliding events. While about US$500 million has been spent on the road, the Downtown Eastside remains much the same.
As they did in 2003, welfare recipients still line up once a month to receive their welfare checks. Welfare Wednesday is known as Mardi Gras in the area, a day the recipients become what they call ''two-day millionaires.'' Needle exchange staff work on the welfare lines.
The area gained international attention when pig farmer Robert Pickton was arrested in 2002 and charged with the deaths of 26 prostitutes and addicts from the Downtown Eastside, in what police say is Canada's worst serial murder case. He was convicted of killing and butchering six of them at his suburban farm. Some remains he fed to pigs. The rest went to a rendering plant.
Mona Wilson's head, hands and feet were found in a bucket at Pickton's farm. Her brother, Jason Fleury, called the Downtown Eastside a time bomb and accused officials of doing nothing to defuse it while spending millions on the Olympics.
''It's crazy. It's insane,'' said Fleury.
Prostitution rights activist Jamie Lee Hamilton said little has been done to curb violence against prostitutes since Pickton's arrest.
''There is this perception that all the violence ended when Pickton was arrested,'' Hamilton said. ''We know it's hunting grounds down there, and we're doing nothing about it. The women, the men and the transgendered are living prey.''
Due in part to rampant intravenous drug use, the area's HIV rate is the worst in the developed world, said International AIDS Society president Dr. Julio Montaner. The HIV rate qualifies the Downtown Eastside for World Health Organization epidemic status, he said.
Montaner said the combination of drug and health programs as well as housing initiatives are beginning to slow the crisis. But progress may be halted by the increasing violence of Vancouver's drug trade, as cocaine prices skyrocket in the aftermath of a Mexican crackdown on drug cartels.
Critics allege the Downtown Eastside will be sanitized during the Games under recently passed legislation that allows police to force the homeless into shelters in cold weather. That would violate bid assurances, they say.
''Nobody has a right to move those people simply to accommodate a better visual image for the Olympics,'' said provincial legislative housing critic Shane Simpson.
Vancouver Organizing Committee vice president of sustainability Linda Coady said the issue has nothing to do with the organizing committee, and that VANOC's interest is what goes on inside Games venues.
''Outside is the domain of the Vancouver Police Department,'' Coady said.
Meanwhile, the safe injection site in the Downtown Eastside is the busiest in the world, with about 500 supervised injections a day, according to Russ Maynard, supervisor of Insite, a provincial government-financed office for Downtown Eastside. Addicts shoot up at 12 booths with mirrors on the walls so that nurses on a raised platform can see them.
Maynard said by the time addicts get to the Downtown Eastside, they are totally dysfunctional. Even trying to get help is hard, he said, as pay phones are used constantly to make drug deals.
''You could get beat up for tying up a phone for five minutes,'' he said.
He said 90 percent of people using Insite have Hepatitis C. The national rate is less than 1 percent.
Insite has operated for six years under an exemption from Canada's health laws. The federal government's attempt to close Insite ended Jan. 15 when the British Columbia Court of Appeal ruled addicts had a constitutional right to health care. Whether the case eventually reaches the Supreme Court of Canada remains to be seen.
Above Insite is Onsite, a 12-bed operation offering detox and the start of a recovery program.
''Those who come in are stick and bone,'' said Onsite manager Liz Moss. ''They need to rest. They need to eat.''
Vancouver Mayor Gregor Robertson said the city and province have opened hundreds of shelter beds and housing units in the past year, but the provincial government needs to put more money into addiction treatment and housing.
''Every big city has these extremes now that are very uncomfortable and need to be remedied,'' he said.
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February 1, 2010
Sedative Manufacturer Might Share Liability in Hepatitis Cases
http://www.lasvegassun.com
By Steve Kanigher
Attorneys who represent former patients of the shuttered Endoscopy Center of Southern Nevada say that a sworn deposition from a drug company executive will help them prove that his company, which makes the sedative propofol used at the clinic, was partly responsible for the valley’s hepatitis C outbreak.
If proved in court, the drug’s role could expose its manufacturer to damages in connection with the outbreak, which unnerved the region when it was announced in February 2008.
In his deposition, Craig Lea, a marketing vice president of Teva Parenteral Medicines in Irvine, Calif., said that a version of the medication for dogs and cats, known by the brand name Rapinovet, has clearer instructions than the milky white propofol used in humans.
One major difference, he said: the Rapinovet label states that the entire contents of the vial should be drawn into sterile syringes, whereas the propofol label is not as specific.
That distinction may go to the issue of how the clinic’s staff used single-use vials for more than one patient, leading to the infection of others.
Lea’s deposition was taken in May but hadn’t been available until last week. Portions were deleted to protect certain company secrets and operations.
The Southern Nevada Health District found that as many as 63,000 patients could have been exposed to infection through reuse of propofol vials and syringes. Plaintiffs’ attorneys, who will begin trying Endoscopy Center cases in April, plan to argue that Teva failed to properly instruct medical professionals on propofol’s use, contributing to the spread of potentially deadly blood-borne pathogens.
Las Vegas attorney Will Kemp and fellow plaintiffs’ attorney Robert Cottle of Las Vegas said the clinic used 20-milliliter and 50-milliliter vials of propofol, with the larger vials more apt to be reused. With the average adult endoscopy requiring only 10 milliliters — give or take a few milliliters depending on the size of the patient — they said clinic personnel were encouraged to reuse the 50-milliliter vials for multiple patients to avoid having to discard unused propofol.
“Hospitals account for all the propofol that they use,” Cottle said. “In this case, no one was counting the milliliters that were used. No one was counting the waste because no one at the clinic wanted to waste any propofol.”
It was precisely to avoid the possible reuse of large vials that Teva at one time made a single-use, 10-milliliter vial intended for procedures such as endoscopies.
Lea confirmed as much when he said 50-milliliter vials are intended to be used only by one patient for medical procedures that can last many hours, as opposed to endoscopies, which can take less than a half-hour.
“I think a smaller vial size is more ... probably more appropriate for that, for a shorter duration case,” Lea said. A short time later, he said that the vials are labeled for single-dose use because “you’re trying to minimize the amount of product you’re throwing away.” He also answered affirmatively when Kemp asked whether the 10-milliliter vials would reduce the temptation and opportunity for dosing multiple patients from a single propofol container.
Kemp also read into the record a written statement from Lea indicating that the 10-milliliter vials would “enhance patient safety.”
Lea, though, said Teva discontinued the 10-milliliter vials, making the 20-milliliter propofol vials the smallest manufactured by that company and available for endoscopies. Kemp and Cottle are left to question why the clinics even needed or were sold 50-milliliter vials.
“It’s a shared responsibility,” Kemp said of the hepatitis outbreak. “If Teva hadn’t shared the 50-milliliter vials with the Endoscopy Center, the temptation wouldn’t have been there to reuse the vials.”
Teva is part of a massive company, Israeli-based Teva Pharmaceutical Industries, with deep pockets. Teva Pharmaceutical, one of the world’s largest manufacturers of generic drugs, trades on Nasdaq and has a market value exceeding $50 billion.
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Calif. Officials Step Up the Fight against Hepatitis
http://www.recordnet.com
By Joe Goldeen
Record Staff Writer
STOCKTON - With a new strategic plan in place, California public health officials hope to break the silence about hepatitis.
"It's important to recognize that viral hepatitis is a significant and costly public health problem. Most people who are infected have no symptoms and are completely unaware of their status. We have been silent too long about the problem," said Dr. Gail Bolan, chief of the Sexually Transmitted Diseases Control Branch of the state Department of Public Health.
Dr. Karen Furst, health officer with San Joaquin County's Public Health Services, said, "The ultimate control is prevention. We still have a lot of folks out there who don't know they are infected. So it's important to identify those people at high risk."
To learn more
- California Hepatitis Alliance: www.calhep.org
- California Department of Public Health: www.cdph.ca.gov/programs/Pages/ovhp.aspx
- Federal Centers for Disease Control and Prevention: www.cdc.gov/hepatitis
Hepatitis - inflammation of the liver caused by a viral infection - can lead to liver disease such as cirrhosis and liver cancer. The three most common viruses are hepatitis A, hepatitis B and hepatitis C.
According to the federal Centers for Disease Control and Prevention, viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplants. In the United States, an estimated 1.2 million Americans are living with chronic hepatitis B and 3.2 million are living with chronic hepatitis C.
Earlier this month, Bolan's agency released a comprehensive planning document. Among key findings:
- The need for awareness of what hepatitis is, how it is transmitted, the availability of simple screening tests and effective vaccination (except for hepatitis C, for which there is no vaccine).
- In 2007, state hospitalizations for hepatitis B and C cost $2 billion.
- The incidence of liver cancer over the next 20 years is expected to increase 59 percent and be highest among Latinos, Asian Americans and Pacific Islanders.
People with hepatitis A have symptoms ranging from a mild illness lasting a few weeks to severe health problems lasting months. It is usually spread when a person ingests fecal matter from contact with contaminated objects, food or drinks. It can be prevented through vaccination.
As a reportable disease, there were 10 cases of hepatitis A in San Joaquin County during 2008, the last year for available data. Statistics show the disease steadily in decline the past 10 years except for outbreaks in 2001 and 2005.
Hepatitis B, on the other hand, is usually spread when blood, semen or another body fluid from an infected person enters the body of someone who is not infected. This can happen through sexual contact, sharing drug needles or from an infected mother to her baby at birth.
Acute hepatitis B is a short-term illness that usually occurs within six months of exposure and can - but does not always - lead to chronic infection. Chronic hepatitis B remains in the body long term, leading to serious health problems and even death. An effective vaccine preventing hepatitis B has been available since 1982.
In 2008, there were eight new cases of acute hepatitis B reported in San Joaquin County. There was a high of 49 cases in 2002. There were 220 cases in the county of chronic hepatitis B in 2008, showing little change over the previous two years.
The county's efforts to break the cycle of transmission between infected mother and baby are working exceptionally well, according to Furst. Doctors are required to test pregnant women for hepatitis B.
"They have very good efficacy for preventing the baby from getting chronic hepatitis B," Furst said. In addition, "we evaluate the whole family. If there are no (hepatitis) infections, we vaccinate," Furst said.
Most people at risk today for hepatitis B are in their 30s or older, since most young people have been vaccinated.
Hepatitis C is the nation's most common chronic blood-borne infection. During 2008, there were 1,819 cases reported in the county. That's almost double the 931 cases reported in 2007, but the reporting pool grew when clinical laboratories were first required to report cases in addition to physicians.
Furst also noted that county numbers are skewed higher because of the presence of Deuel Vocational Institution near Tracy, a large state prison. According to the state report, approximately 55,000 of the more than 150,000 people incarcerated in California prisons have hepatitis C.
Hepatitis C is primarily transmitted through dirty syringes commonly shared among intravenous drug users.
Dr. Aziz Khambati, an internal medicine physician who has been with downtown Stockton's Channel Medical Center for 14 years, sees about 25 patients with hepatitis C. Most acquired the disease because they were sharing needles.
"I see a need for a clean needle-exchange program along with a strong educational element. I would advocate for education," Khambati said.
Stockton and San Joaquin County are among the largest jurisdictions in the state without an authorized needle-exchange program. Advocates say it is the simplest way to prevent the spread of hepatitis C.
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Support for Safe Injection Sites
http://mcgilldaily.com
By Tara Brosnan
Positive studies might not be enough to get Quebec on board
A public health organization has voiced support for supervised injection sites in Quebec in a recent publication drawing from studies that examined Insite Vancouver, North America’s first supervised injection site.
The 2009 report from the Institut national de santé publique du Quebec (INSPQ) pointed to positive benefits such as minimizing disease transmission and overdose-related deaths, as well as providing injection drug users with access to health care as reasons for the recommendation.
This is only the first step in implementing the still-controversial supervised injection sites in Quebec, but places like Insite, established less than seven years ago, have demonstrated that there are surprisingly few drawbacks compared to the benefits.
Clientele at safe injection sites are given clean syringes and other necessary equipment to decrease the transmission of HIV and Hepatitis C, which can be spread through sharing needles. According to a summary of findings published in the Canadian Medical Association Journal in 2006, there have been drug overdoses at Insite, but no overdose-related deaths, thanks to the medical care immediately available.
The benefits of supervised injection sites don’t stop after users walk out the facility’s doors. This was explained by Jean-François Mary, client representative of Cactus – a community organization in Montreal which provides a needle exchange program as well as social support for at-risk populations including intravenous drug users and sex-trade workers.
“[The sites] promote safer habits for injection…even if the person doesn’t do all of his [or her] injections in the safe injection site. There is a lot of education going on there on the practices of injection,” Mary said. “The nurses have the ability to teach people how to inject safely and properly.”
Sarina Isenberg, student director of the McGill Global AIDS Coalition, voices support for resources such as addiction treatment services and Insite’s social benefits.
“Not only do they train people on how to inject safely with the supervision of nurses and trained staff but they also have kind of a support group there, and there’s counselling available. It functions as a community centre of sorts,” Isenberg said.
Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, pointed out a cost-saving aspect of supervised injection sites.
“There is the benefit of saving public funds by actually getting health services to people in need of them in a preventive, expense-saving kind of way rather than high expenses of ambulance responses to overdoses, hospitalization costs associated with those, all of the costs of treating people for untreated infection, whether it is with HIV or [Hepatitis-C] or other kinds of sepsis from abscess sites that get infected,” said Elliott.
Despite the proven benefits of supervised injection sites, the federal government recently appealed to shut down Insite. With the appeal dismissed in January, Insite was allowed to remain open on both jurisdictional and constitutional grounds, meaning that the provincial, rather than the federal government, held precedence in the matter. More importantly, the site was determined to have a sound constitutional basis.
According to Elliott, this legal case is important. “There are some very significant implications for what might happen in other provinces,” he said. But what does this mean for supervised injection sites in Quebec?
“The ministry of health doesn’t have much to hide behind now…. It’s time…to take a position on this matter. Whether it is a positive or negative response, we need to be aware of what the position is,” said Mary.
“I think the time has well passed for continuing to wonder about whether or not these sites are a good idea. The evidence is certainly in,” said Elliott.
According to Elliott, the publication from the INSPQ should be “an encouragement for the Quebec government to actually get on with looking at where those sites might be needed and useful in Quebec and working with community organizations that work with the communities most affected.”
Mary commented on Cactus’s possible future in implementing supervised injection sites.
“We’ve been running a needle exchange program for more than 20 years so we know that we would be able to offer, in the premises of Cactus, a place for people to inject safely and I think this is the position of other exchange programs in Montreal,” he said.
Mary noted, however, that Insite runs on funding provided by the British Columbia Ministry of Health, and so far there has been no indication of the Quebec Ministry of Health’s opinion on the sites.
A supervised injection site in Quebec would also require a federal waiver of criminal liability, like Insite Vancouver obtained in 2003 during the Martin administration. Mark Wainberg, director of the McGill AIDS Centre, was not optimistic that such a waiver could be obtained from the current Harper administration.
“It’s one thing to challenge the existence of a site or to challenge the government for wanting to shut it down once it’s open already. It’s a much more difficult thing to start a new site from scratch,” said Wainberg. “I’m not aware of any serious efforts being made here to open such a site, although I think it’s fair to say that the vast majority of HIV researchers in Quebec would endorse the idea.”
While there may be a long way to go before opening a supervised injection site in Quebec, the dismissal of the appeal against Insite in Vancouver indicates that these types of health care centres could eventually take root in other Canadian cities.
While the public generally tends to look at the big picture of supervised injection sites, Elliott notes that we must remember these sites are helping individuals. “The potential for protecting individuals’ health is one of the benefits, particularly individuals who are some of the most marginalized and least connected to necessary health services.”
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Didanosine Associated with Noncirrhotic Portal Hypertension
www.medscape.com
Emma Hitt, PhD
January 29, 2010 — Didanosine (Videc, VidecEC, Bristol Myers-Squibb) is associated with noncirrhotic portal hypertension, and as a result the label is being updated to include this information, the US Food and Drug Administration (FDA) announced today.
"FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System," states an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. "Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug."
A total of 42 postmarketing cases of noncirrhotic portal hypertension have been reported; of those, 4 patients died. Deaths were associated with hemorrhage from esophageal varices in 2 patients; progressive liver failure in 1 patient; and multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis in 1 patient each. Only the 3 patients who received a liver transplant fully recovered. Duration of didanosine treatment ranged from months to years.
As a result of these findings, the FDA has revised the warning and precautions and the patient counseling information sections of the didanosine drug label to include a section on noncirrhotic portal hypertension.
The FDA recommends that healthcare providers discuss with patients the clinical benefits and potential risks of didanosine treatment, including the risk for noncirrhotic portal hypertension. They should also continue to monitor patients for the development of portal hypertension and esophageal varices.
The FDA maintains that the clinical benefits of didanosine "for certain patients with HIV continue to outweigh its potential risks." The agency recommends that clinicians and patients make the decision to use didanosine on a case-by-case basis.
Didanosine currently has a boxed warning for lactic acidosis and hepatomegaly with steatosis. In addition, didanosine has been associated with the development of liver toxicity when used in combination with other antiretroviral agents.
More information is available on the FDA's MedWatch Web site.
Adverse events related to didanosine should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Insurers Must Offer Equal Coverage for Those with Emotional, Addiction Problems
http://www.medicinenet.com
Robert Preidt
FRIDAY, Jan. 29 (HealthDay News) -- Group health insurance plans can no longer limit benefits and require higher patient costs for people with mental health or substance abuse disorders, according to new rules issued Friday by the U.S. government.
Any group health plan -- typically offered by employers -- that includes mental health and substance abuse disorder benefits must treat them equally with standard medical and surgical coverage in terms of out-of-pocket costs, benefit limits and practices such as prior authorization and utilization review, according to the new rules.
"These practices must be based on the same level of scientific evidence used by the insurer for medical and surgical benefits. For example, a plan may not apply separate deductibles for treatment related to mental health or substance abuse disorders and medical and surgical benefits -- they must be calculated as one limit," said a news release from the U.S. Health and Human Services Department.
The new rules, effective for plan years beginning on or after July 1, 2010, implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), which expands on the earlier Mental Health Parity Act of 1996. The new act is named for two federal lawmakers who pushed for equal treatment of mental health and substance abuse disorder benefits.
MHPAEA applies to businesses with 50 or more employees whose group health plan offers mental health and substance abuse disorder benefits.
The Departments of Health and Human Services, Labor and the Treasury jointly issued the new parity rules, which were developed based on the departments' review of more than 400 public comments on the issue.
"Workers covered by group health plans who need mental health and substance abuse care deserve fair treatment. These rules expand on existing protection to ensure that people don't face unnecessary barriers to the treatment they need," Deputy Treasury Secretary Neil Wolin said in the news release.
"Today's rules will bring needed relief to families faced with meeting the cost of obtaining mental health and substance abuse services," added Secretary of Labor Hilda L. Solis. "The benefits will give these Americans access to greatly needed medical treatment, which will better allow them to participate fully in society."
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President’s Budget Falls Short of Funds Needed to Fight HIV/AIDS and Viral Hepatitis Epidemics
http://www.projectinform.org/
Ryan Clary
SAN FRANCISCO, CA — Project Inform today thanked President Obama for providing increases to domestic HIV/AIDS and chronic viral hepatitis programs in a challenging economic environment. However, the organization expressed overall disappointment in his Fiscal Year 2011 budget. While the budget does call for minor increases to HIV care, treatment, prevention, housing, and other vital services, it does not match the President’s goal of reinvigorating the fight against the domestic HIV epidemic. The budget also would make the President’s goal of implementing a National AIDS Strategy more difficult, as it would not provide the resources necessary to achieve the objectives of reducing HIV incidence, increasing the number of HIV positive people who are accessing care, and reducing health disparities.
“We appreciate that President Obama has prioritized domestic HIV/AIDS programs in his budget,” said Ryan Clary, Project Inform’s Director of Public Policy. “However, this proposal falls far short of building a serious effort to help people learn their HIV status and enter care, while reducing new HIV infections. It would also fail to assist many states that are struggling to provide basic care and treatment services to low-income and uninsured people living with HIV. Congress must improve these funding levels as it develops the final spending bill.”
The President also proposed a $1.8 million increase for viral hepatitis programs at the Centers for Disease Control and Prevention (CDC), which currently receive only $19.3 million per year. While this is significantly higher than the President’s request last year, it also falls far short of funding needed to improve the nation’s hepatitis screening, testing, surveillance, and education programs. Nearly 5 million Americans have chronic hepatitis B and/or hepatitis C, with 75% not knowing their status. Many of them are co-infected with HIV.
“Two weeks ago, the Institutes of Medicine released a scathing report highlighting the federal government’s failure to address the chronic hepatitis B and hepatitis C epidemics, which result in 15,000 deaths per year,” continued Clary. “Congress must increase the President’ funding request for viral hepatitis programs to demonstrate it is ready to lead a strong effort to fight these epidemics.”
Project Inform will work with its national HIV and hepatitis advocacy partners to encourage Congress to provide adequate funding for these epidemics.
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February 2, 2010
Achillion Shares Rise on Drug Development Deal in China
www.reuters.com
Feb 2 (Reuters) - Shares of Achillion Pharmaceuticals Inc (ACHN.O) were up about 5 percent before the bell Tuesday, a day after the company said it signed a license deal for the development of its hepatitis B drug, elvucitabine, in China.
Under the agreement, GCA Therapeutics Ltd, through its Chinese joint venture with Tianjing Institute of Pharmaceutical Research, will develop and commercialize elvucitabine in mainland China, Hong Kong, and Taiwan as a treatment for both hepatitis B virus and HIV infection.
The drug is in mid-stage trials for both indications.
Shares of the company closed at $2.42 Monday on Nasdaq. They were trading at $2.53 before the bell. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Aradhana Aravindan)
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Prison Report Urges Needle Exchange Programs
www.cbc.ca
Prison needle and syringe programs have been introduced in more than 60 prisons in at least 10 countries in Europe and Asia, producing positive results and few problems, according to a report by the Canadian HIV/AIDS Legal Network.
A report on drug use in prisons urges the federal government to set up needle exchange programs for inmates.
Rates of HIV and hepatitis C infections in prison are 10 to 20 times higher than in the general population, says the report to be released Tuesday by the Canadian HIV/AIDS Legal Network.
"Because of the scarcity of needles and syringes in prison, people who inject drugs are more likely to share injecting equipment than people in the community," the report said. "This significantly increases their risk of contracting HIV and HCV."
The report noted that as of 2009, prison needle and syringe programs have been introduced in more than 60 prisons of varying sizes in at least 10 countries in Europe and Asia, producing positive results and few problems.
"In spite of the overwhelming evidence of the benefits of (the programs), at this time no Canadian prison permits the distribution of clean needles," the report said. "This harms the health of people in prison, given the increasing presence of HIV and (hepatitis C) behind bars.
"This also creates a further risk to public health more broadly [because] the vast majority of people who spend time in prison return to their families and communities."
The network's purpose is to promote the human rights of people living with, or vulnerable to, HIV/AIDs.
"We’re not evil people, we’re people’s daughters, we’re people’s mothers, we’re just people wanting help," Karen Dooks, who contracted both HIV and hepatitis C in prison, told CBC News. "If they had a needle exchange, there'd be a lot less sickness — it would work, that's all I know, it would work."
To bolster its case for needle exchange programs, the HIV/AIDS Legal Network spent 2008 and 2009 interviewing and gathering testimonials from 50 people who had spent time in jail to find out "what do people in prison have to say about the Canadian government's unwillingness to address the problem?"
Testimonials strengthen message
The group said it hopes the testimonials, which form the bulk of the report, will help bring about a change in government policy.
"They describe first hand how the denial of clean needles in prison has contributed to the harm they have experienced, why (needle programs) are critical to protect their health and what they think a prison system can and should do if truly committed to people's health," the report said.
"The hope is that their stories will strengthen the case for change, which governments continue to ignore even as a growing body of evidence highlights the need."
Greg Simmons, who sold and used drugs during his 20 years in prison, told CBC News his supply came from visitors, guards, volunteers and staff. Now clean and working in a Toronto youth centre, Simmons said the prison environment pushes many people into using drugs.
"It’s a breeding ground for addiction … the loneliness," he said. "I’ve seen people literally cut themselves and get their vein open and pour it in there without a syringe, that’s how desperate, wanting to kill the pain."
Dooks spent four years in prison for more than 500 break-ins, all to support her habit.
"I remember using a needle that was so bent and dirty, but you don’t care," she said.
Both Simmons and Dooks said the millions being spent by the federal government to try to keep drugs out of prisons would be better spent helping inmates who are addicted.
Sandra Chu, senior policy analyst for the HIV/AIDS Legal Network, said previous reports on the problem have concentrated on laws, policies and public health issues, but the organization felt a different approach was needed.
"What we thought was really missing was the voices of the people directly affected, the formerly or currently incarcerated people," she said. "So we thought this report would really humanize them."
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County Receives Grant for HIV, Hepatitis C Prevention
http://www.globegazette.com
By Laura Bird
MASON CITY — The Cerro Gordo County Department of Public Health was awarded a $13,160 grant for HIV and hepatitis C prevention on Monday.
The Iowa Department of Public Health (IDPH) awarded $682,000 in funding across the state.
In Cerro Gordo County the funds will be used for HIV testing, hepatitis C testing and hepatitis A and B vaccinations for select populations.
“We have the risk population,” said Betty Krones, disease prevention specialist with Cerro Gordo County Department of Public Health. “I think it’s a good service because people who tend to be most at risk don’t have the funding for the test.”
Last year the Cerro Gordo Department of Public Health tested 202 people for HIV, 44 for hepatitis C and 133 people were eligible for the hepatitis A and B vaccines but not all of them opted for it, Krones said.
Statewide, according to IDPH, 123 Iowans were diagnosed with HIV in 2009. As many as 53,000 Iowans are infected with hepatitis C, but fewer than 20 percent have been diagnosed.
“Clearly, the need for primary prevention programs in Iowa is great,” said Randy Mayer, IDPH HIV, STD, and Hepatitis Bureau Chief. “We are pleased with the range of programs offered and populations served by agencies across Iowa.”
Those eligible for the free HIV testing in Cerro Gordo County include anybody who has had unprotected sex with someone HIV positive; someone diagnosed with a sexually transmitted disease within the last year; a man who has had unprotected sex with another man; someone who has had unprotected sex with a bisexual man; someone sharing IV drug use equipment; someone who trades sex for drugs, money, etc.; a person who has unprotected sex with someone who trades sex for other things; someone who’s had unprotected sex with an IV drug user and anyone black or Hispanic who has concerns about HIV.
Eligibility for the free hepatitis C test includes anyone who is an IV drug user; had a blood transfusion or organ transplant before 1992 or has ever been on long-term dialysis.
Those eligible for the free hepatitis A and B vaccine include anybody with a history of drug use; a man who has had sex with another man; someone diagnosed with an STD within the last year; someone who has HIV or hepatitis C or someone who’s sex partner has HIV or hepatitis A or B.
For more information or to make an appointment contact the Cerro Gordo County Department of Public Health at 641-421-9300 or 1-888-264-2581.
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Experts Say 40 Percent of Cancers Could Be Prevented
www.reuters.com
Kate Kelland
LONDON (Reuters) - Forty percent of the 12 million people diagnosed with cancer worldwide each year could avert the killer disease by protecting themselves against infections and changing their lifestyles, experts said Tuesday.
A report by the Geneva-based International Union Against Cancer (UICC) highlighted nine infections that can lead to cancer and urged health officials to drive home the importance of vaccines and lifestyle changes in fighting the disease.
"If there was an announcement that somebody had discovered a cure for 40 percent of the world's cancers, there would quite justifiably be huge jubilation," UICC president David Hill told Reuters in a telephone interview.
"But the fact is that we have, now, the knowledge to prevent 40 percent of cancers. The tragedy is, we're not using it."
Cervical and liver cancer, both caused by infections which can be prevented with vaccines, should be top priorities, the report said, not only in rich nations, but also in developing countries where 80 percent of global cervical cancer occur.
Cancer is a leading cause of death worldwide and the total number of cases globally is increasing, according to the World Health Organization (WHO).
The number of global cancer deaths is projected to rise by 45 percent from 2007 to 2030 from 7.9 million to 11.5 million deaths, driven partly by a growing and aging global population.
The UICC said it wanted to focus policymakers' attention on cancer-preventing vaccines -- like ones made by GlaxoSmithKline and Merck & Co against the human papillomavirus (HPV) which causes cervical cancer, and others against hepatitis B, which causes liver disease and cancer.
"Policymakers around the world have the opportunity and obligation to use these vaccines to save people's lives and educate their communities toward lifestyle choices and control measures that reduce their risk of cancer," Cary Adams, UICC's chief executive, said in a commentary on the report.
Other cancer-causing infections include hepatitis C, human immunodeficiency virus (HIV) and Epstein Barr, a herpes-type virus transmitted by saliva.
The experts said the risk of developing cancer could potentially be reduced by up to 40 percent if full immunization and prevention measures were deployed and combined with simple lifestyle changes like quitting smoking, eating healthily, limiting alcohol intake and reducing sun exposure.
Hill said national health authorities should also work to dispel widespread myths about cancer, in particular a sense of fatalism felt by many people in the face of the disease.
As part of this, the UICC is launching a campaign called "Cancer can be prevented too" on World Cancer Day on February 4 to encourage people to face up to the fact that smoking, poor diet and some infections carry high cancer risks.
European cancer experts issued a report last year warning that a wave of cancer now threatens developing countries, estimating that around half of the 12.4 million new cases in 2008 occurred in low and middle income countries.
Despite the availability of so much scientific knowledge about the disease's causes, Hill said there was great concern among health experts that "the opportunity to prevent this huge escalation of cancer may be missed."
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NVHR: Administration's 2011 Budget Proposal Shortchanges Five Million Americans Afflicted with Chronic Viral Hepatitis
Press Release
– Administration Continues Pattern of Underfunding CDC's Division of Viral Hepatitis
– NVHR Urges Action on Bipartisan Honda-Dent Legislation to Fund State-based Viral Hepatitis Education, Detection, & Surveillance Programs
Washington, DC-Just weeks after the Institute of Medicine (IOM) blasted the federal government for its failure to respond to the nation's viral hepatitis epidemic, the Administration has continued a pattern of neglect with its 2011 budget proposal. In calling for an inadequate funding increase of $1.8 million for the Centers for Disease Control and Prevention's (CDC) Division of Viral Hepatitis, the Administration has shortchanged five million Americans afflicted with chronic viral hepatitis and has failed to translate the IOM's recommendations into decisive action, the National Viral Hepatitis Roundtable (NVHR) said today.
NVHR is a coalition of more than 150 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org
"While the Administration's proposed $1.8 million increase for the Division of Viral Hepatitis is better than we have seen in years, its budget proposal ultimately shortchanges more than five million Americans afflicted with chronic viral hepatitis," said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. "Members of Congress from both sides of the aisle have mobilized to address the chronic viral hepatitis crisis and we need a commensurate response from the Administration. We are hopeful that the bipartisan Honda-Dent legislation (HR 3974) will provide a rational starting point for how best to fund the needs of five million Americans afflicted with chronic viral hepatitis."
The CDC's National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Prevention (NCHHSTP) is the umbrella federal agency overseeing the Division of Viral Hepatitis (DVH). While still inadequate, the Administration's FY 2011 budget proposal released yesterday is a marked improvement from last year's meager $51,000 increase the Administration proposed for the DVH's viral hepatitis, prevention, treatment, and surveillance programs. Perhaps most tellingly, the Administration's total 2011 budget proposal for DVH of $21 million is still less than the $25 million in annual funding that was allocated ten years ago. Meanwhile, the depth and breadth of this crisis has only worsened.
With roughly 1 in 50 Americans afflicted with chronic viral hepatitis B or C - and an overwhelming majority unaware they are infected - millions of Americans are at risk, especially African Americans and Asian Americans. Without detection and treatment, chronic viral hepatitis leads to liver cancer, cirrhosis, or liver failure. In the absence of federal leadership, the research firm Milliman estimates that public and private payers' cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion. Medicare and Medicaid would absorb a disproportionate share of these added costs.
Last month, the Institute of Medicine (IOM) issued a landmark report finding that the federal government has failed to provide adequate resources for national and local prevention, control, and surveillance programs for chronic viral hepatitis. As a result, the IoM made nearly two-dozen recommendations for improving our nation's public health infrastructure. Regrettably, the Administration's budget all but ignores these expert recommendations.
In contrast to the Administration's indifference, bipartisan legislation, "The Viral Hepatitis and Liver Cancer Control and Prevention Act," sponsored by Representatives Mike Honda (D-Calif.), Charles Dent (R-Pa.) and 21 other House Members would provide $90 million in funding in 2011 and beyond. The Honda-Dent legislation would increase the ability of the CDC to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with the IoM's recommendations.
"The Administration's budget proposal is only the first step in a long process," added Ms. Sandt. "We urge Congress to close the funding gap through the appropriations process. Until the Administration and Congress come together to take decisive, bipartisan action to address the chronic viral hepatitis crisis, NVHR and the entire viral hepatitis community will continue to sound the alarm from coast to coast. We are not going away and we will not be ignored."
Contact:
Phil Blando, pblando@abmpartnersllc.com, 202-534-1772
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Free Needle Exchange Kicks Off
http://www.troyrecord.com
By Jessica M. Pasko
The Record
ALBANY - A free needle exchange program for drug users began Monday in Albany, a joint effort of Catholic Charities and the AIDS Council of Northeastern New York.
Through Project Safe Point, drug users can turn in used, dirty syringes in exchange clean ones. The program’s unmarked white van will make scheduled weekly visits to two city neighborhoods to exchange needles, conduct street outreach and offer prevention education. Testing and exchanges will be done anonymously and no information will be taken or shared with police, according to organizers.
Needle exchange programs have "been proven to significantly reduce HIV and Hepatitis C transmission between people who use drugs," said Michele McClave, executive director of the AIDS Council.
Similar programs are run around the state, in cities including New York City, Buffalo, Rochester, Binghamton, and Ithaca.
"About five years ago, we began exploring the idea of a syringe exchange in this area," based on the other programs in the state, said Angela Keller of Catholic Charities. Funding for Albany’s program comes from a state Department of Health grant.
Keller said the agency narrowed it down to the two neighborhoods - Albany’s South End and Arbor Hill - where they felt they could make the most difference. The decision came after talking to city police, holding focus groups, and looking at drug arrest records, among other research.
"We had our first customer today," Keller said Monday. "It went really well."
The AIDS Council will also provide HIV and Hepatitis C testing on the van.
Albany County District Attorney David Soares said he believes the mobile outreach program will help improve the quality of life for area residents.
The Project Safe Point van will be at the corner of Dongan Avenue and Bassett Street from 10 a.m. to 1 p.m. Monday, Wednesday and Friday, and at the corner of North Swan Street and Ten Broeck Place from noon to 3 p.m. Tuesday and Thursday.
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February 3, 2010
Anadys Pharmaceuticals to Present at the BIO CEO & Investor Conference
www.prnewswire.com
SAN DIEGO, Feb. 2 /PRNewswire-FirstCall/ — Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that it will present at the 12th Annual BIO CEO & Investor Conference on Tuesday, February 9, 2010 at 10:00 a.m. EST (7:00 a.m. PST). The conference is being held at the Waldorf-Astoria Hotel in New York. Steve Worland, Ph.D., President and Chief Executive Officer of Anadys, will provide an overview of Anadys and its clinical development programs, ANA598 and ANA773.
Additionally, Dr. Worland will participate as a panelist on the BIO CEO & Investor Conference HCV Panel on Tuesday, February 9, 2010 at 12:00 p.m. EST (9:00 a.m. PST).
The corporate presentation will be simultaneously webcast and can be accessed on the Investor Relations page of the Company's website at www.anadyspharma.com. Listeners are encouraged to visit the website approximately five minutes prior to the corporate presentation to download or install any necessary software. A replay of the presentation will be available approximately one hour after the live webcast concludes and will be available through February 23, 2010.
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Nearly 2,000 Scots Unaware They Suffer from Hepatitis C
http://news.scotsman.com
By Lyndsay Moss
HALF of all hepatitis C cases in Scotland go undiagnosed each year, campaigners warned.
For every person diagnosed with hepatitis C in Scotland, there is another one unaware they have the virus, according to the Hepatitis C Trust.
Charles Gore, chief executive of the trust, issued the warning at the launch of their first Scottish office yesterday.
Speaking at the event in the Scottish Parliament he said: "With diagnostic rates now sitting at more than 1,700 new patients each year, the hepatitis C figures in Scotland are giving concern.
"However, what is more alarming is that we also know there are another 1,700 people each year unaware they have the condition.
"Current treatment for chronic hepatitis C continues to improve and can clear the virus in more than half those treated.
"But that statistic is greatly diluted if we have not identified half of the known patients."
Mr Gore said in the longer term this meant that patients were not known in the NHS system and they are not getting access to support or treatment to help cure the virus.
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Minimally Invasive Adult Liver Donation for Pediatric Transplantation Available Exclusively at NewYork-Presbyterian Morgan Stanley Children's Hospital
www.medicalnewstoday.com
NewYork-Presbyterian Morgan Stanley Children's Hospital is the only medical center in the United States to offer minimally invasive liver donation for pediatric transplantation. Surgeons use a laparoscopic technique to remove a section of liver from a living donor for implantation in a pediatric patient -- typically a parent donating to their child. The innovative approach promises dramatically improved recovery for the donor.
The laparoscopic liver retrieval is offered by Dr. Benjamin Samstein, a transplant surgeon at NewYork-Presbyterian Morgan Stanley Children's Hospital and NewYork-Presbyterian Hospital/Columbia University Medical Center, and assistant professor of surgery at Columbia University College of Physicians and Surgeons. Standard pediatric liver implantation is led by Dr. Tomoaki Kato, surgical director of liver and intestinal transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and professor of surgery at Columbia University College of Physicians and Surgeons.
"Despite its many advantages and superb track record, living donor transplantation involving a child and their parent can have a debilitating effect on the family. Since the standard adult organ donor surgery involves a long recovery, it can impede a parent's ability to care for their recently transplanted child," says Dr. Kato. "Laparoscopy promises to significantly shorten recovery. If the approach catches on, it could potentially revolutionize living donor transplantation for children by encouraging more donors, increasing the availability of organs and improving outcomes."
"Standard open organ retrieval requires a foot-long incision from the breast bone to the belly button. Recovery is two to three months. By contrast, in laparoscopy, we make five small incisions, the largest of which is three inches. The donor is typically completely back to normal only a month after surgery," says Dr. Samstein.
The minimally invasive liver retrieval technique was first introduced to Dr. Samstein by Dr. Daniel Cherqui of Hôpital Henri Mondor, Paris. "I am grateful to Dr. Cherqui for generously assisting us with these procedures," Dr. Samstein says.
Leaders in Living Organ Transplantation
The new surgical advance represents the latest chapter in a history of innovations in living organ donation by NewYork-Presbyterian/Columbia surgeons. Dr. Jean Emond, chief of transplantation, was a key member of the team that performed the first pediatric living donor liver transplantation in North America in 1989 while at the University of Chicago Medical Center. Dr. Lloyd Ratner, director of renal and pancreatic transplantation, performed the nation's first adult-to-adult laparoscopic living donor kidney transplant in 1995 while at Johns Hopkins Medical Center. Today more than half of kidney transplants are done with a living donor, and 80 percent of these are retrieved laparoscopically.
Living organ donation is currently done in 3 percent of all liver transplant cases, and laparoscopic liver retrieval is only now becoming possible for pediatric cases.
"Laparoscopy for kidney retrieval is fairly straight-forward. The surgeon only needs to cut around the organ to remove it. For the liver, we must cut through the organ, while preserving its blood supply," explains Dr. Samstein. "This new surgery keeps the piece of extracted liver connected to the donor's blood vessels until the moment when it's removed, helping ensure its fitness for transplant."
Laparoscopic living donor liver retrieval for pediatric transplant was developed by Dr. Daniel Cherqui, who reported the first case in 2002; since then he has performed the procedure approximately 20 times. Dr. Cherqui trained under NewYork-Presbyterian/Columbia's Dr. Jean Emond in the late 1980s. Today, Dr. Cherqui has a reputation as one of the most experienced laparoscopic liver surgeons in the world.
Organ Transplantation at NewYork-Presbyterian Hospital
The Center for Liver Disease and Transplantation (CLDT) at NewYork-Presbyterian Hospital/Columbia University Medical Center and NewYork-Presbyterian Morgan Stanley Children's Hospital is among the top 10 centers in the country for number of transplants performed annually, and has completed more than 1,000 successful transplants since its inception in 1998.
The larger organ transplantation program at NewYork-Presbyterian Hospital -- which includes NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center and The Rogosin Institute -- is the most active program of its kind in the nation, and offers comprehensive and personalized care for the heart, liver, pancreas, kidney and lung. With outcomes ranked among the nation's best, the Hospital is dedicated to improving quality of life for its patients. NewYork-Presbyterian's dedicated teams of surgeons and physicians are responsible for many significant advances made over the past several decades in transplant surgery and the maintenance of healthy organs. The Hospital has been on the forefront of developing and improving anti-rejection medications (immunosuppressants), minimally invasive surgery for living donors, genetic methods to detect transplant rejection, strategies to increase opportunities for donor matching, islet cell transplantation, and the FDA-approved Left Ventricle Assist Device (LVAD) that functions as a bridge to transplantation for those waiting for a new heart.
Source: NewYork-Presbyterian Morgan Stanley Children's Hospital, Columbia University Medical Center
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Cell-Culture and Animal Tests Show Antiviral Could Provide Protection against HIV, Ebola, Hepatitis C, Herpes and More
www.medicalnewstoday.com
The development of antibiotics gave physicians seemingly miraculous weapons against infectious disease. Effective cures for terrible afflictions like pneumonia, syphilis and tuberculosis were suddenly at hand. Moreover, many of the drugs that made them possible were versatile enough to knock out a wide range of deadly bacterial threats.
Unfortunately, antibiotics have a fundamental limitation: They're useless against viruses, which cause most infectious diseases. Antiviral drugs have proven far more difficult to create, and almost all are specifically directed at a few particular pathogens - namely HIV, herpes viruses and influenza viruses. The two "broad-spectrum" antivirals in use, ribavirin and interferon-alpha, both cause debilitating side effects.
Now, researchers from the University of Texas Medical Branch at Galveston, UCLA, Harvard University, the U.S. Army Medical Research Institute of Infectious Diseases and Cornell University have teamed up to develop and test a broad-spectrum antiviral compound capable of stopping a wide range of highly dangerous viruses, including Ebola, HIV, hepatitis C virus, West Nile virus, Rift Valley fever virus and yellow fever virus, among others.
UCLA researchers led by Dr. Benhur Lee - corresponding author on a paper on the work appearing this week on the Proceedings of the National Academy of Science Web site - identified the compound (which they call LJ001), after screening a "library" of about 30,000 molecules to find a one that blocked the host cell entry of deadly Nipah virus. Subsequent experiments revealed that LJ001 blocked other viruses that, like Nipah, were surrounded by fatty capsules known as lipid envelopes. It had no effect on nonenveloped viruses.
"Once we started testing more and more, we realized that it was only targeting enveloped viruses," said Alexander Freiberg, director of UTMB's Robert E. Shope, M.D. Laboratory, the Biosafety Level 4 lab where much of the cell-culture work was done, as well as mouse studies with Ebola and Rift Valley fever viruses. "We followed up and determined that it was somehow changing the lipid envelope to prevent the fusion of the virus particle with the host cell."
Additional experiments indicated that while LJ001 also interacted with cell membranes, whose composition is nearly identical with that of virus envelopes, it caused them no ill effects. The reason, according to the researchers: Cells can rapidly repair their membranes, but viruses can't fix their envelopes.
"At antiviral concentrations, any damage it does to the cell's membrane can be repaired, while damage done to static viral envelopes, which have no inherent regenerative capacity, is permanent and irreversible," said Lee.
UTMB authors of the PNAS paper include graduate student Sara Woodson and adjunct associate professor Michael Holbrook, former director of the Shope BSL4 lab and principal investigator on the UTMB portion of the project. UCLA contributors are Mike Wolf, Tinghu Zhang, Zeynep Akyol-Ataman, Andrew Grock, Patrick Hong, Natalya Watson, Angela Fang, Hector Aguilar, Robert Damaoiseaux, John Miller, Steven Chantasirivisal, Vanessa Fontanes, Oscar Negrete, Paul Krogstad, Asim Dasgupta, Kym Faull and Michael Jung. Other authors are Jianrong Li and Sean Whelan of Harvard; Matteo Porotto and Anne Moscona of Cornell; and Anna Honko and Lisa Hensley of USAMRIID.
The National Institutes of Health, the UCLA Center for AIDS Research, the Burroughs Wellcome fund, the March of Dimes, the California Nanosystems Institute and the Warsaw Fellowship Endowment supported this research.
Source: Jim Kelly, University of Texas Medical Branch at Galveston
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OTC Analgesics Not Associated with Acute Decompensation in Cirrhotic Patients
http://www.the-hospitalist.org
Clinical question: Do over-the-counter (OTC) analgesics lead to acute hepatic decompensation among patients with cirrhosis?
Background: In theory, intake of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs) can worsen hepatic function and lead to complications among cirrhotic patients. The role of OTC analgesics in potentially triggering acute hepatic decompensation among cirrhotic patients has not been studied.
Study design: Prospective case-control study.
Setting: Two tertiary-care hospitals.
Synopsis: Cirrhotic patients hospitalized for acute liver decompensation were compared with compensated cirrhotic patients in the liver clinic (cirrhotic controls) and with randomly selected, noncirrhotic patients who were simultaneously hospitalized (noncirrhotic controls). Data collected through questionnaires included quantity and dose of OTC analgesics used and alcohol consumption in the past 30 days.
Thirty-five percent of the hospitalized cirrhotic patients, 52% of the cirrhotic controls, and 70% of the noncirrhotic controls used OTC analgesics. At doses lower than those recommended, acetaminophen is not associated with acute liver decompensation among cirrhotic patients, even with recent alcohol use. However, NSAIDs taken by the cirrhotic patients, when compared to control subjects, were in larger doses and used for a longer duration, suggesting NSAIDs may have contributed to the acute decompensation.
Study limitations include the nature of the study design, reliance on the patient’s recall of OTC analgesic use, and obtaining other possible causes of decompensation, such as herbal supplement intake or compliance with diuretics or dietary indiscretion.
Bottom line: Acetaminophen at doses lower than recommended is not associated with adverse complications in cirrhotic patients, but NSAIDs are possibly associated with acute decompensation.
Citation: Khalid SK, Lane J, Navarro V, Garcia-Tsao G. Use of over-the-counter analgesics is not associated with acute decompensation in patients with cirrhosis. Clin Gastroenterol Hepatol. 2009;7(9):994-999.
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February 4, 2010
'Prewashed' Salads May Need Another Rinse
http://www.medicinenet.com
By Salynn Boyles
WebMD Health News
Reviewed by Louise Chang, MD
Feb. 3, 2010 -- Those "prewashed" and "triple-washed" bagged salad greens in the produce section of the supermarket may not be as clean as you think.
In a new investigation from the Consumers Union, which publishes Consumer Reports, high levels of bacteria commonly linked to poor sanitation and fecal contamination were found in many of the sampled packaged salads.
The bacteria did not pose a health risk to the public, but their presence indicated a higher likelihood of contamination with rare but potentially deadly pathogens like E. coli and salmonella, Consumers Union senior scientist Michael Hansen, PhD, tells WebMD.
An E. coli outbreak in the fall of 2006 traced to packaged fresh spinach killed three people and hospitalized more than 100.
The cause of the contamination was never confirmed, but the E. coli is widely believed to have reached the spinach through groundwater that contained the feces of cattle and pigs.
Oldest Produce Had Most Bacteria
Consumer Reports investigators sampled 208 packaged salads, representing 16 brands purchased last summer in Connecticut, New Jersey, and New York. The salads were sold in either bags or plastic clamshell containers.
They found that 39% of the samples contained more than 10,000 "most probable number" per gram -- a measure of total coliforms, which are bacteria associated with fecal contamination. And 23% had more than 10,000 colony forming units (CFU) per gram of the bacterium enterococcus.
According to the report, experts contacted by Consumer Reports considered these levels unacceptable.
Bacteria levels varied widely, with some samples containing undetectable levels and others containing more than 1 million CFUs per gram, Hansen says.
Among the other findings:
- Packaged produce tested at least six days from their use-by date tended to have lower levels of the bacteria than produce tested within five days of the use-by date.
- Salad mixes that included spinach tended to have higher bacteria levels than those without spinach.
- Contamination levels were similar whether the produce was packaged in a bag or clamshell container. And samples labeled "organic" were just as likely to have high levels of the bacteria as other samples.
- Little difference was seen in bacteria levels between larger, nationally distributed brands and smaller, regional brands. All brands with more than four samples had at least one package with relatively high levels of total coliforms or enterococcus.
Hansen says consumers should look for products that are at least six days from their use-by date when buying packaged salad products.
And products labeled "prewashed" or "triple-washed" should be washed again, even though this probably won't remove all bacteria, he says.
The report was made public online this week and it appears in the March issue of Consumer Reports.
Produce Industry Responds
Packaged salad products exploded onto the market in the early 1990s and in less than two decades sales have climbed to almost $3 billion a year.
The produce industry responded to the article in Consumer Reports by stressing that the bacteria found by the investigators posed no risk to the public.
"Consumer Union found only harmless, naturally occurring bacteria, for which no detection standards have been established by the federal government," reads a joint written statement from the Produce Marketing Association and the United Fresh Produce Association.
The trade groups also called on Congress to pass comprehensive food safety reform and adequately fund the FDA to ensure the agency can "fulfill its mission to safeguard consumers."
"The produce industry is committed to providing safe and healthy foods, every bite, every time," the statement reads. "Our growers are often the first to eat the foods we sell, and they understand the importance of maintaining consumer confidence. The industry has already invested tens of millions of dollars in food safety programs, and related research."
A spokesman for Chiquita Brands, which markets the Fresh Express line of packaged salads, also emphasizes that the bacteria found in the investigation are considered harmless to humans.
"Experts, such as the National Advisory Committee on Microbiological Criteria for Foods, do not consider the presence of coliforms as an accurate indicator of a health concern in fresh produce," Chiquita Director of Investor Relations and Corporate Communications Ed Loyd tells WebMD in a written statement. "Specifically, the publication fully acknowledged that no pathogens were present in any of the salad samples."
Loyd writes that Chiquita's food safety practices exceed industry standards and government guidelines.
The Senate is considering a food safety reform bill that would require the FDA to develop safety standards for the growing and processing of fresh produce. The reform would also require the agency to declare acceptable levels of specific bacteria in packaged products.
SOURCES:
- Consumer Reports, March 2010.
- News release, Consumers Union.
- News release, Produce Marketing Association and United Fresh Produce Association.
- Michael Hansen, PhD, senior scientist, Consumers Union.
- CDC: "Update on Multi-State Outbreak of E. coli 0157:H7 Infections from Fresh Spinach," Oct. 6, 2006.
- Ed Loyd, director of investor relations and corporate communications, Chiquita Brands.
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Team Identifies Novel Hepatitis C Inhibitors
http://www.scripps.edu
By Eric Sauter
Scientists from the Scripps Florida campus of The Scripps Research Institute and their colleagues at Boston University have described their discovery of several novel drug-like inhibitors of the hepatitis C virus (HCV). These new inhibitors have the potential to substantially widen the current options to treat HCV infection.
The research, from the laboratory of Professor Donny Strosberg of Scripps Florida, supported by members of the Scripps Florida Lead Discovery Division directed by Peter Hodder, and colleagues from Boston University, will be published in an upcoming print edition of the journal ASSAY and Drug Development Technologies and appeared in the December 15, 2009 print edition of the journal Bioorganic & Medicinal Chemistry Letters.
With more than 130 million people infected worldwide by HCV, new therapeutic strategies are urgently needed for this blood-borne disease, which is the main cause, with hepatitis B, of liver cancer, according to the National Cancer Institute.
Using a new fluorescence-based assay, the scientists were able to identify four small-molecule inhibitors of dimerization of the viral core protein. In this process, which is essential to the survival of the virus, the core protein binds to itself and related proteins to form the viral capsid, the outer lipid-encapsulated protein shell that protects the virus's genetic material like an eggshell protects its yolk sack.
"The fact that is so exciting is that no one has really considered the core protein as a viable target in HCV—in HIV, yes, but not HCV," said Strosberg. "With this study, there is now no good reason why researchers shouldn't go after the HCV core protein."
One of the problems in developing drugs for HCV is that it mutates at such prodigious rates; mutations in viral enzymes tend to lead to increased drug resistance.
By targeting the interactions of the core protein with itself and with other proteins, Strosberg and his colleagues have sought to reduce the problem of rapid mutation—because the core protein mutates much less than the other HCV proteins, and because mutations that affect the interface between core and itself or other proteins would be more likely to deactivate the virus anyway. Core proteins orchestrate the assembly and release of the infectious virus, as well as the disassembly of viral particles upon entering host cells.
Significantly, the new compounds not only inhibited dimerization of the core but also inhibited propagation of HCV in isolated hepatoma cells.
The New Assay
In a study that appeared in the Journal of General Virology earlier this year, Strosberg and his colleague described how peptides (molecules of two or more amino acids that are the building blocks of proteins) derived from the HCV core protein also inhibited its dimerization. Peptides however, are difficult to administer orally, unstable in the blood circulation, and are therefore difficult to use therapeutically.
The new assay goes one step further, allowing Strosberg and his colleagues to identify the three times smaller molecules with potential to interfere with the core protein function in the virus.
"While there is no similarity structurally between these new small molecule inhibitors and the peptides, functionally they behave precisely the same way," Strosberg said. "We developed an assay to screen small molecules that is robust and capable of revealing useful compounds that block protein-protein interactions and production of the virus."
Protein-protein interactions, which involve such key physiological actions as signal transduction and protein assembly, are highly desirable drug discovery targets, not only for HCV, but also for other viral infections because inhibitors of these protein associations have been shown to lack many clinical complications, such as the adverse side effects of recombinant therapeutic proteins. However, designing small molecules that inhibit protein-protein interaction remains problematic for a number of reasons, primarily because proteins are so large—interactions are thought to often take place over a wide area and conformation/site-selectivity is difficult to engineer.
"We always look for the simplest solution," Strosberg said. "We knew from our peptide study that we could split the core protein and use only one part that we knew still allowed the dimerization process. That simplified the process because the core protein is sometimes difficult to work with."
Next, Strosberg and his team uncovered a domain on the core protein—what they call "a hot spot"—that was essential for the interaction that creates the capsid and allows the virus to function.
"Since we had already established a proof-of-concept that certain peptides could disrupt capsid formation, we left the peptide world and moved into the small-molecule world," he said. "We developed the high-throughput version of the assay. That's what the industry always wants to know first—can you move from a peptide to a small-molecule and can you find inhibitors among screen large collections?"
From there, the team screened small-molecule compounds that could potentially disrupt the protein-protein gears that create the viral capsid, using the protein library and high-throughput screening technology available at Scripps Florida. For initial screening, Strosberg and his colleagues used a relatively small library containing nearly 2,250 indoline alkaloid-type compounds, produced by their colleagues at Boston University.
These studies revealed the four promising compounds described in the study. "These new compounds definitely put us closer to the 'El Dorado' of finding viable protein-protein inhibitors for HCV," said Strosberg.
The small molecule inhibitor study made clear that three of the newly discovered inhibitors are relatively non-toxic compounds that could be the basis for the development of new anti-HCV drugs or could be used in combination with other compounds such as interferon on HCV targets other than the virus's core protein.
"These small-molecule candidates are quite promising," Strosberg said. "We continue to study the binding of these compounds with the HCV core protein and hope to design even more potent inhibitors based on their structures."
The first author of the ASSAY and Drug Development Technologies study, "A Time-Resolved Fluorescence-Resonance Energy Transfer Assay for Identifying Inhibitors of Hepatitis C Virus Core Dimerization," is Smitha Kota of The Scripps Research Institute. In addition to Strosberg, others authors include, Louis Scampavia, Timothy Spicer, Virginia Takahashi, and Peter Hodder of The Scripps Research Institute, and Aaron Beeler, John Snyder and John Porco of The Center for Chemical Methodology and Library Development, Boston University. See http://www.liebertonline.com/doi/full/10.1089
/adt.2009.0217?cookieSet=1.
The first author of the Bioorganic & Medicinal Chemistry Letters study, "New Small Molecule Inhibitors of Hepatitis C Virus," is Wanguo Wei of The Center for Chemical Methodology and Library Development, Boston University; the corresponding author is John K. Snyder, also of Boston University. In addition to Strosberg, other authors include Smitha Kota and Virginia Takahashi of The Scripps Research Institute; and Cuifang Cai of Boston University. For more information, see Pub Med.
Both studies were supported by The Scripps Research Institute, the Factor Foundation of America, the National Institute of General Medical Sciences, and other funding from the National Institutes of Health.
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Viral Hepatitis Training Center Announces New Webinars
The Division of Viral Hepatitis-funded Training Center at the University of Alabama at Birmingham (UAB) is pleased to launch a new training and resource website, www.KnowHepatitis.org.
One of the Center’s first webinars features DVH Director, Dr. John Ward discussing the recently released Institute of Medicine report, “Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C.
The Training Center has also created a Viral Hepatitis 101, which features Dr. Laura Bachman presenting a basic overview of viral hepatitis and how it can be prevented among adults at risk. Both of these webinars were designed for public health professionals unfamiliar with viral hepatitis and its relevance to HIV and STD prevention.
We hope these resources will be useful in your work. Please visit the training section of the website to view these webinars, www.KnowHepatitis.org/training/center/.
We also encourage you to sign up for emails at KnowHepatitis.org/mailing list to stay informed of new trainings and resources. If you have any questions or suggestions on these or other needed trainings and webinars, please feel free to contact the PI, Melissa Mauser Galvin, PhD (mgalvin@uab.edu) or the CDC Project Officer, Alycia Downs (ADowns@cdc.gov).
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NVHR: Stop Liver Cancer ‘Dead in Its Tracks’ by Closing Funding Gap for Viral Hepatitis Education, Screening Programs
NVHR Press Release
- Most Liver Cancers Caused by Undetected & Untreated Viral Hepatitis B & C
- Bipartisan Honda-Dent Legislation Would Help Reduce Incidence of Liver Cancer, Lessen Transplant Waiting Times
Washington, DC—With most liver cancer caused by undetected or untreated hepatitis B or C viral infection, the 22,000 new cases of liver cancer that are diagnosed each year could be dramatically reduced if Congress took decisive action to close the funding gap for federal viral hepatitis education, screening, and surveillance programs, the National Viral Hepatitis Roundtable (NVHR) said today. NVHR made the comments in conjunction with World Cancer Day 2010, which is being observed today and led by the International Union Against Cancer.
NVHR is a coalition of more than 150 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org
“If policymakers are serious about reducing US cancer rates, including liver cancer, they should act immediately on the bipartisan Honda-Dent legislation to fully fund viral hepatitis education, screening, and surveillance programs for five million Americans,” said Ms. Lorren Sandt, Chair of the National Viral Hepatitis Roundtable (NVHR) and Executive Director of Caring Ambassadors Program, based in Portland, OR. “Liver cancer is one of the three fastest growing cancer diagnoses in the US. Early detection and treatment of chronic viral hepatitis will stop the spread of liver cancer dead in its tracks and reduce transplant waiting times. This approach will dramatically reduce avoidable health care costs, improve quality, and allow millions of Americans to enjoy more productive lives. It’s a no brainer.”
Liver cancer is the fifth most common cancer worldwide and is one of the top ten occurring cancers in the US, annually striking an estimated 22,000 Americans. An overwhelming majority of liver cancers result from chronic viral hepatitis B or C infection. Because chronic viral hepatitis infection can be asymptomatic for decades, most Americans do not get tested and, consequently, do not know they are infected until their condition deteriorates to liver cancer, cirrhosis or liver failure. More than five million Americans – as many as 1 in 50 Americans – are afflicted with viral hepatitis and most are unaware they are infected. While chronic viral hepatitis strikes individuals from all walks of life, African Americans and Asian Americans are most at risk. In the US, liver cancer is the third-highest cause of cancer deaths among Asian Americans.
Bipartisan legislation pending on Capitol Hill, “The Viral Hepatitis and Liver Cancer Control and Prevention Act” sponsored by Representatives Mike Honda (D-Calif.) and Charles Dent (R-Pa.), would close the viral hepatitis funding gap by providing $90 million in funding in 2011 and more thereafter. The Honda-Dent legislation would increase the ability of the Centers for Disease Control and Prevention (CDC) to support state health departments in their prevention, immunization and surveillance, and referral to care efforts. Much of the Honda-Dent legislation tracks with recent recommendations made by the Institute of Medicine (IOM) in a landmark report addressing this public health crisis.
“As a practicing primary care physician of 28 years, I have seen first-hand how hepatitis infections can ravage patients and lead to liver cancer, cirrhosis, and even death. That’s why education, screening, and detection programs are so critically important,” said Dr. Mark Li, President of the Chinese American Medical Society, Mid-Atlantic Chapter, based in Washington, D.C. “As a silent disease, hepatitis is often ignored and it’s danger as a public health threat greatly underestimated. If we want to get serious about reducing US cancer rates, we need to address chronic viral hepatitis. The two go hand in hand.”
Earlier this week, the Administration released its 2011 budget proposal that continues to underfund the CDC’s Division of Viral Hepatitis by providing just $21 million in 2011, compared with $25 million allocated annually a decade ago. In the absence of national leadership, the research firm Milliman estimates that public and private payers’ cost of treating chronic viral hepatitis C alone will more than triple by 2024 to $85 billion annually. Medicare and Medicaid would absorb a disproportionate share of these added costs, thereby worsening an already bleak fiscal outlook for our nation and the 50 states.
Contact: Phil Blando, pblando@abmpartnersllc.com, 202-534-1772
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February 5, 2010
House Panel Kills Bill Backed by Smithfield Lt. Kurt Beach
http://www.dailypress.com
By Kimball Payne 247-4765
RICHMOND — Smithfield police Lt. Kurt Beach was desperately searching for a liver donor a year ago. On Thursday he went to Richmond to ask state lawmakers to protect police officers, paramedics and firefighters from sharing his fate.
Beach is on the mend these days, but after 15 years fighting hepatitis C and battling bureaucratic hurdles, he wants to make sure that Virginia gives workers more time to file compensation claims. Under a bill proposed by Del. Bill Barlow, D- Isle of Wight, Virginia's first responders would have two years after a hepatitis diagnosis to make a claim.
Beach was a rookie on the force in 1988 when he gave mouth-to-mouth resuscitation to a dying infant. He had no idea he had the disease until 1995 when he went to donate blood. State law says workers must file compensation claims within five years of contracting a disease.
"I'm living proof. I'm the example," Beach told the committee. "Give the people a voice — a full vote in the House."
Lawmakers on a House Commerce and Labor subcommittee greeted Beach with a round of applause, but after a short amount of testimony, they opted to put down Barlow's proposal on a straight party-line vote, with six Republicans opposing the expansion and four Democrats supporting it.
"It's very disheartening," Beach said afterward. "I would stand beside any delegate or senator who wanted to revive this bill."
Chris LaGow, a lobbyist representing the Virginia Municipal League, spoke against the bill, warning that the expansion could force cash-strapped cities and counties to shell out money to pay for a disease that infects as much as 3 percent of the population. LaGow said localities could be held responsible for claims nearly impossible to dispute.
"In many cases, it's 20 or 30 years before symptoms arise," LaGow said.
Last year, Beach's personal story captivated lawmakers in the General Assembly, who despite intense pressure to limit state spending managed to find $250,000 to help him pay medical bills and for the ongoing medications and treatments to survive.
During the 2009 session, House lawmakers balked at changing the law that forced Beach into medical limbo. Barlow's bill to change the time limit on claims died in a subcommittee of the House Commerce and Labor panel.
Barlow vowed last year to bring the bill back again, and once again he faced the same committee. With concerns over cash running rampant in Richmond, Barlow crafted a narrow bill that would specifically give workers more time if they were exposed to hepatitis.
Barlow said he understands Virginia lawmakers' desire to keep the state as business-friendly as possible but said covering hepatitis — in the same way the state covers AIDS and asbestosis — would amount to giving first responders backup.
"In the last session, we didn't know if he was going to make it or not, but now he's back on duty and doing well," Barlow said.
"I knew it was going to be tough. It's very, very frustrating."
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Liver Lines - February 5, 2010
http://www.antonnews.com
Written by David Bernstein
At the start of this new decade, liver disease continues to be major source of morbidity and mortality both at home and around the world. We expect a significant rise in the incidence of viral hepatitis and other infectious diseases following the devastating earthquake in Haiti.
Hepatitis B is one of those conditions. During the last decade, our ability to recognize, understand and treat hepatitis B has improved exponentially. From the first approved therapies in the mid-1990s through today, we have seen several new potent agents become available to treat this potentially serious infection.
Chronic hepatitis B affects an estimated 300 million to 400 million people worldwide and about 1 million to 2 million people Americans. It is more common in Asian-Americans and Native Americans than Caucasians and African-Americans. Chronic hepatitis B is characterized in the blood by a positive hepatitis B surface antigen and the presence of hepatitis B virus in the blood and it is usually asymptomatic.
People suffering from this virus have an increased chance of developing cirrhosis, liver cancer and needing a liver transplantation due to liver failure. In the United States, sexual contact is the most common means of disease transmission, although this condition may be passed along via contact from any bodily fluid.
It is for this reason that all close contacts of chronic hepatitis B patients need to be vaccinated against hepatitis B to prevent its spread.
Therapy is available for people chronically infected with hepatitis B. Luckily, therapy is not indicated for all patients as the majority of patients will not develop significant progressive disease. A medical professional must determine who is an appropriate candidate for treatment as treatments may be costly and in many cases, are indefinite.
Hepatitis B is not a curable disease at this point and therefore the goal of therapy is to slow or prevent the progression of disease. Many of the current therapies have been shown to improve underlying liver histology but not necessarily lessen the risk of developing liver cancer.
Hopefully newer therapies which are in the pipeline will be able to meet these objectives. The treatments of hepatitis B are for the most part oral agents without side effects. These treatments, however, require absolute compliance as starting and then stopping medications can lead to life-threatening recurrence of disease.
Currently, the two most commonly used oral agents are entecavir and tenofovir. Both of these agents are well tolerated and have minimal side effects. The main concern when using these agents is that they may induce the development of mutations and thus allow for the development of resistant strains of hepatitis B.
So far, the risk of resistance with these medications has been low. While we currently apply single-drug therapy for the treatment of chronic hepatitis B, most hepatologists believe that future treatment regimens will consist of multiple combinations of medications similar to the way the human immunodeficiency virus is treated as this should further decrease the incidence of mutations. I think that the upcoming decade will be very exciting in our ability to better understand and control the hepatitis B virus.
While these therapies all offer promise that we can control this common and deadly disease, the best mode of prevention is avoiding risk factors and ensuring that all people who are not previously exposed to hepatitis B receive appropriate vaccination.
Dr. Bernstein is the director of Hepatology for the North Shore-Long Island Jewish Health System. You may write to Dr. Bernstein, c/o Anton Community Newspapers, 132 E. Second Street, Mineola, NY 11501 or email dbernste@nshs.edu.
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