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Week Ending: December 5, 2009
Alan Franciscus
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November 30, 2009
What Happens When Doctors Give Patients More Power?
www.reuters.com
By Amy Norton
NEW YORK (Reuters Health) - When patients are given the responsibility for medical decisions, they may be less willing to try a potentially risky treatment, a study published Monday suggests.
The study, of 216 patients with arthritis and other similar diseases, tested patients' willingness to take a hypothetical "new" drug that carried important benefits but also a small risk of serious side effects.
It turned out that patients were less willing to try the drug when they were given complete power over the decision than when a doctor advised them to take the medication.
When given a choice rather than a doctor's order, the study found, patients appeared to give greater thought to the potential side effects of the drug.
The findings, published in the journal Arthritis Care & Research, have implications for the trend toward greater patient involvement in healthcare. Studies have shown that patients who are more active in their care tend to fare better. However, there has been less research into what happens when actual decision-making is shifted over to patients.
The current results "suggest that asking some patients to assume more responsibility for decisions involving their healthcare may have unanticipated consequences," lead researcher Dr. Liana Fraenkel, of the Yale University School of Medicine, told Reuters Health in an email.
For the study, Fraenkel and colleague Dr. Ellen Peters had patients view one of two videos. Each featured a doctor describing a hypothetical new medication for which the patients were candidates -- a pain drug or a drug designed to lower heart disease risk.
Each drug was described as "very effective" and generally safe, but with a small risk of a serious side effect: either a breakdown of tissue in the jaw, or a rare but often fatal infection that causes brain inflammation. (Both of those are side effects of drugs currently on the market.)
After seeing the video, patients rated their willingness to take the drug under two circumstances: in one, their doctor said they should take the drug and wrote a prescription; in the other, the decision was left completely to the patient.
Overall, the researchers found, patients were less open to taking the drug when the decision was theirs alone. They also expressed greater worries over side effects.
"The shift of responsibility from M.D. to patient may cause some patients to pay more attention to risks," Fraenkel explained.
She and Peters note that studies in other areas have suggested that when people have a choice about whether to take a potentially risky action, they consider those risks more carefully. For example, city dwellers who can opt to drive or take the bus are more likely to see driving as a risky endeavor than do rural residents -- who have no choice but to drive.
According to Fraenkel, the current findings suggest that to make the most informed decisions about medical treatments, patients need help in weighing the potential benefits against the risks.
"I would argue that these results highlight the need to ensure that patients have the proper support to be able to participate in decision making," she said.
SOURCE: Arthritis Care & Research, online November 30, 2009.
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The ABCs of Hepatitis
http://www.bookofodds.com
Stephanie Dutchen
It's no fun having hepatitis. Your liver—the largest organ in your body besides your skin—swells up, perhaps until your abdomen is tender to the touch. In addition to feeling generally sick and feverish, you might lose your appetite or throw up. Your skin might turn yellow with jaundice. Your joints might ache. If it lasts long enough, hepatitis can permanently damage your liver.
The cause of your misery could be a virus, bacteria, toxins, various drugs, long-term alcohol use, or certain diseases. If you have an acute case, you could be feeling better in a few weeks or months. If you're one of the unlucky ones to develop chronic hepatitis, though, you'll be sick for at least six months—possibly for the rest of your life.
Three types of viral hepatitis are common in the United States: A, B, and C. And viral hepatitis is one of the four deadliest communicable diseases in the country.
If you had to pick one, hepatitis A (HAV) might be the way to go. Typically spread by contact with food or other objects contaminated with infected fecal matter, this is the one you hear about in the news when a restaurant is implicated in an outbreak. It can be mild or severe, but it doesn't become chronic, and most people recover on their own.
Since a vaccine became available in 1995, the infection and death rates of hepatitis A have dropped to a 40-year low. Now, the odds of being diagnosed with hepatitis A in a year are 1 in 83,330. If you have it, the odds you'll die of it in a year are 1 in 322.4.
Hepatitis B (HBV) is the most common of the three, with the odds of being diagnosed in a year at 1 in 62,500, which is nearly the same as the odds a person in Lincoln, Nebraska will be murdered in a year (1 in 62,890). Even though deaths have dropped 82% since a vaccine became available in 1990, hepatitis B is still the most likely to kill you if you have it; once infected, your odds of dying from it in a year are 1 in 117.6. Unlike hepatitis A, it can morph into a chronic condition, raising your risk of liver damage, cancer, and death. Hepatitis B is spread through contact with infected bodily fluid during activities such as birth, sex, and needle sticks.
Judging by the numbers, hepatitis C (HCV) doesn't sound as bad. The odds of being diagnosed in a year are just 1 in 333,300, and the odds of dying from it in a year once you have it are 1 in 450. But most people who have it develop chronic liver disease, and it's the most common reason people need new livers. There is no vaccine. Treatment takes almost a year, although an April 2009 study suggests that adding the drug telaprevir to the cocktail could cut the time in half.
The biggest risk of contracting hepatitis C comes from sharing needles. People who had blood transfusions before hepatitis screening started in the early 1990s are also at risk for B and C.
Since it's possible to have hepatitis without experiencing symptoms, many people become infected or infect others without even knowing it.
Altogether, the odds a death in the US will be due to viral hepatitis in a year are 1 in 442.8. The odds are actually worst for the 45-54 age range, at 1 in 79.31, rather than for the elderly or very young. In fact, the odds the death of a child aged 5-14 will be from viral hepatitis are just 1 in 6,602, thanks in large part to vaccines.
Vaccination, better hygiene, blood-product screening, education, and clean-needle programs have already reduced hepatitis deaths in this country to record lows. Hopefully, research into new treatments and prevention programs as well as the genetics of susceptibility and drug response will bring us further still.
Referenced Odds
- 1 in 83,330
The odds a person will be diagnosed with hepatitis A in a year are 1 in 83,330 (US, 2006).
- 1 in 322.4
The odds a person with hepatitis A will die as a result in a year are 1 in 322.4 (US, 2006).
- 1 in 62,500
The odds a person will be diagnosed with hepatitis B in a year are 1 in 62,500 (US, 2006).
- 1 in 62,890
The odds a person in Lincoln, Nebraska will be murdered in a year are 1 in 62,890 (Lincoln, NE, US, 2008).
- 1 in 117.6
The odds a person with hepatitis B will die as a result in a year are 1 in 117.6 (US, 2006).
- 1 in 333,300
The odds a person will be diagnosed with hepatitis C in a year are 1 in 333,300 (US, 2006).
- 1 in 450
The odds a person with hepatitis C will die as a result in a year are 1 in 450 (US, 2006).
- 1 in 442.8
The odds a death will be due to viral hepatitis are 1 in 442.8 (US, 2005).
- 1 in 79.31
The odds a death of a person 45 - 54 will be due to viral hepatitis are 1 in 79.31 (US, 2005).
- 1 in 6,602
The odds a death of a child 5 - 14 will be due to viral hepatitis are 1 in 6,602 (US, 2005).
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Law to Offer Comprehensive Relief to Hepatitis Patients Enacted
http://www.istockanalyst.com
TOKYO, Nov. 30, 2009 (Kyodo News International) -- A law to offer financial support and other comprehensive relief to hepatitis patients was enacted by parliament Monday, acknowledging the state's responsibility for the spread of hepatitis B and C in Japan.
The law, which will take effect in January, makes it clear that the central and local governments will take necessary steps so that hepatitis patients can undergo appropriate treatment.
The law passed the House of Councillors at its plenary session by a unanimous vote Monday morning, following approval by the House of Representatives on Thursday.
The main opposition Liberal Democratic Party abstained from voting in the upper house.
The law stipulates that the state is responsible for hepatitis C sufferers who contracted the disease through tainted blood products and hepatitis B patients who were infected via syringes repeatedly used in vaccination drives.
It is to extend the scope of relief for hepatitis patients compared with a similar law enacted in January 2008.
Under the law, the health, labor and welfare minister will lay out a basic policy on relief measures in such areas as prevention, examination, and medical support systems as well as research and development.
The measures will also have to include opinions from representatives of patients.
There are an estimated 3.5 million hepatitis patients in Japan and medical expenses have become a heavy financial burden for them.
After observing the upper house voting, Eriko Fukuda, a lower house lawmaker of the ruling Democratic Party of Japan who actively pushed for the legislation, said, ''The enactment is a little bit like a dream. To win budget allocations, I strongly hoped to get the bill passed during this Diet session.''
The government is looking to formulate a state budget for fiscal 2010 from April by the end of this year.
Fukuda, who led a group of hepatitis C patients in a lawsuit against the government and won her Diet seat in the August election, had worked for the enactment of the law in consultation with senior DPJ members including party Secretary General Ichiro Ozawa and health minister Akira Nagatsuma.
In a meeting with representatives of hepatitis patients at the parliament building, Prime Minister Yukio Hatoyama told them that his government will make all-out efforts to secure enough allocations for relief measures.
''If the budget allocations are insufficient, it cannot be said that we fully understand your feelings,'' Hatoyama said. ''We will make every effort.''
The law will be the first sponsored by lawmakers instead of the Cabinet since the DPJ-led coalition took power in mid-September, dethroning the LDP.
(Source: iStockAnalyst )
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December 1, 2009
HCV Infection Tied to Increased Mortality in HIV+ Patients During HAART Era
www.medscape.com
NEW YORK (Reuters Health) Nov 27 - Since the introduction of highly active antiretroviral therapy (HAART) in the mid-1990s, hepatitis C virus (HCV) infection has become an important contributor to mortality in HIV-infected patients, new research shows.
The results show that during the HAART era, HCV infection increases the risk of death, but not the risk of an AIDS-defining illness.
"Before the introduction of HAART, mortality related to HIV overwhelmed that related to HCV," Dr. Ting-Yi Chen, from Wayne State University in Detroit, and associates note. Since then, studies on the reciprocal effects of the two viruses on disease progression have yielded conflicting results.
Dr. Chen's team conducted a meta-analysis to estimate the effect of HCV infection on HIV disease progression and overall mortality in the pre-HAART (before 1996) and HAART eras. Their findings appear in the November 15th issue of Clinical Infectious Diseases.
Their analysis included 10 studies in the pre-HAART era with 4413 HCV-HIV coinfected patients and 10,213 HIV-monoinfected patients. The HAART era was represented by 27 studies involving 25,319 coinfected patients and 61,697 HIV-monoinfected patients.
The pre-HAART analysis implied that HCV had a protective effect (risk ratio for mortality, 0.69). However, once a single study that recruited patients through hospitalization was excluded, the remaining studies no longer showed a protective effect, either individually or in aggregate, the report indicates.
By contrast, dual infection was associated with increased mortality during the HAART era (RR 1.35). But there was no significant evidence of increased risk for AIDS-defining events in coinfected patients during this latter period.
"Potential mechanisms by which HCV infection may accelerate progression to AIDS (e.g., a blunted immunologic response to HAART) may not have significant clinical impact," the authors maintain.
Thus, it is likely that the major contributor to mortality in these patients is likely to be liver disease.
These findings imply that "broader application of more effective anti-HCV therapies is needed to reduce this excess mortality," Dr. Chen and associates write.
Clin Infect Dis 2009;49:1605-1615.
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New Guidelines on Reporting Industry-Supported Clinical Trial Results
www.medscape.com
Laurie Barclay, MD
December 1, 2009 — New guidance on standards required for communicating industry-supported medical research has lead 2 experts to debate whether the resulting conflict of interest is acceptable. The updated guidelines, which apply to peer-reviewed journal articles and presentations at scientific congresses, and 2 accompanying comments were published online November 29 in the British Medical Journal.
"The good publication practice (GPP2) guidelines presented here make recommendations that will help individuals and organisations maintain ethical practices and comply with current requirements when they contribute to the communication of medical research sponsored by companies," write Chris Graf, from John Wiley & Sons, Wiley-Blackwell, Oxford, United Kingdom, and colleagues from the International Society for Medical Publication Professionals. "In response to changes in the environment in which authors, presenters, and other contributors work together to communicate medical research the International Society for Medical Publication Professionals has updated the [GPP2] guidelines.
"Some or all of the people who contribute to this collaboration may be employees of research sponsors, contract research organisations, or medical communications agencies that may be funded by pharmaceutical, medical device, or biotechnology companies," the guidelines authors write."The authors, collaborators, and organisations share responsibility for developing articles and presentations in a responsible and ethical manner."
Extensive Consultation Process
Preparation of the new guidelines involved an extensive consultation process among 193 invited experts. Compared with previous GPP2 guidelines, new elements in the GPP2 updates include authorship guidance — recommending assignment of a lead author and guarantor, contributorship guidance — recommending that the role of the sponsor be described, recommendations concerning reimbursement, recommendations regarding specific types of articles and presentations, and recommendations for publication planning and documentation.
In addition, updated elements in the GPP2 guidelines include recommendations regarding how the roles of authors, sponsors, and other contributors should be defined, and guidance on setting up a publication steering committee.
A GPP2 checklist for articles and presentations contains the following recommendations:
- To ensure integrity, writing should be accurate, objective, and balanced. Authors and contributors should have full access to data. Publications should not be duplicative, and authorship should be honestly attributed.
- To ensure completeness, research hypotheses should be clearly described, and sufficient detail should be reported so that the presentation is unbiased. Related work should be completely and honestly cited, and unique trial identifiers should be used. Limitations of the study design and findings should be acknowledged and discussed, and the results should be published or made public regardless of the outcome.
- To ensure transparency, sources of funding should be clearly stated and potential conflicts of interest disclosed. Individuals who have made significant contributions should be acknowledged and their contributions described, as well as the contributions of research sponsors.
- To ensure accountability, authors and presenters should be accountable for the work, take public responsibility for the work, and assign a guarantor.
- To ensure responsibility, results should be published or made public in a timely manner, and intellectual property should be respected. The responsibilities of contributing individuals and organizations for GPP2 should also be respected.
Conflict Results in "Bad Evidence"
In an accompanying comment, Ben Goldacre, MD, a physician and writer from Nuffield College in Oxford, United Kingdom, takes the position that the conflict of interest when drug companies conduct trials on their own drugs is unacceptable.
"There is no doubt that these companies have a conflict of interest when they conduct trials: they want to sell their products, and so naturally they want a positive result from the trials they sponsor," Dr. Goldacre writes. "But there is now good evidence from systematic reviews, meta-analyses, and case studies that this conflict of interest results in bad evidence, which distorts medical decision making and so harms patients."
He offers several possible explanations for systematic bias resulting in publications that put a drug company's product in a favorable light. These include questionable trial design, in which the competitor drug is given at too low or too high a dose; the industry selectively choosing which data to publish; and publication bias, in which negative results are less likely to be published. Conversely, positive results may be published repeatedly.
"Doctors who are making treatment decisions need access to good quality trial data, presented transparently, and all of it, not just the positive findings that drug companies choose to share," Dr. Goldacre writes. "The problems I have described are not new, and they have been described on many previous occasions. They could be fixed, without taking research out of the hands of industry altogether, but to do so would require that the drug companies recognised the scale of this scandal, and campaigned themselves for more effective regulation: demanding full mandatory publication of all trial data from themselves and their competitors, for example."
Opposing Stance
Vincent Lawton, healthcare consultant and nonexecutive director, Medicines and Healthcare products Regulatory Agency, London, United Kingdom, takes the opposing stance in his comment, arguing that it is unrealistic to expect the drug industry to surrender its intellectual property once it has invested considerable sums on developing new drugs.
He warns of delays, inefficiency, and a lack of innovation in drug development that could result from curtailing pharmaceutical company research. Provided these companies conduct rigorous clinical trials and make their data publicly accessible, he suggests that it is acceptable for the drug industry to make a profit and still perform research on their own products.
"The better way for patients, health care, and innovation is to continuously improve what we have, despite potential competing interests," Dr. Lawton writes. "Competition and investment drive innovation and are dependent on the right environment. Companies should continue to work closely with academia and regulators to identify weaknesses or shortcomings and find ways to address them. Appropriate safeguards of transparency, scientific integrity, and regulation should ensure that different interests do not become unacceptably conflicted."
The International Society for Medical Publication Professionals provided the guidelines contributors with meeting and teleconferencing facilities and Web conferencing technology. All guidelines authors are members of the International Society for Medical Publication Professionals, a not for profit organization with membership comprising pharmaceutical, biotechnology, and device industries; medical communications agencies; publishers; and independent medical writers. The society is funded by its membership. Some of the guidelines authors report various financial relationships with Johnson & Johnson, Novo Nordisk, Parexel, AstraZeneca, Wyeth, Cephalon, the Committee on Publication Ethics, and/or Wyeth. Dr. Goldberg has written newspaper articles and part of a book criticizing questionable activities in the drug industry, and he has a clinical research training fellowship from the Wellcome Trust. Dr. Lawton is a nonexecutive director of the Medical and Healthcare Products Regulatory Agency, is a nonexecutive director of Addex Pharmaceuticals, and for 26 years was an employee of Merck Pharmaceuticals.
BMJ. Published online November 29, 2009.
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December 2, 2009
Former Army Nurse Gets Prison in Hepatitis C Case
http://www.chron.com
By Alicia A. Caldwell, Associated Press Writer
EL PASO, Texas — A former Army nurse who admitted infecting patients at a military hospital with hepatitis C while stealing powerful painkillers from them during surgery was sentenced Tuesday to more than three years in federal prison.
Jon Dale Jones, a 47-year-old retired Army major, admitted in April that he repeatedly stole the intravenous painkiller fentanyl — often used in anesthesia — from surgery patients while working as a civilian nurse anesthetist at William Beaumont Army Medical Center in El Paso.
Assistant U.S. Attorney Bill Lewis said then that investigators believed Jones infected at least 16 patients after pulling fentanyl from a clean vial at the hospital and putting it in a contaminated container he brought from home. He would then give patients the remaining medicine from the hospital's newly infected vials, Lewis said.
During Tuesday's hearing, two of Jones' victims testified that the one-time soldier was remorseful and should be given leniency.
"I believe he deserves a second chance," Ivan Westrick told U.S. District Judge Frank Montalvo. "I ... believe he's taken a step forward."
A Florida psychologist, Karen Gold, testified that Jones has dealt with drug and alcohol addictions since his youth, and suffers from post traumatic stress disorder because of abuses suffered as a teenager. She said he has been forthcoming about both his addictions, which he has been in treatment for, and his guilt in this case.
In asking Montalvo for leniency Jones apologized for what he had done and said he was starting "to put my life back together."
"Today I know how to ask for help and I do so on a regular basis," Jones said. "It's all about service to others; I think that is my new calling in life."
Still, Lewis, the lead prosecutor in the case, argued Jones repeatedly lied about his involvement in the 2004 hepatitis outbreak at William Beaumont and only admitted his role after being charged with several felony counts. Lewis added that Jones didn't acknowledge his addiction to painkillers until he was later caught diverting drugs while working at a hospital in Washington, D.C.
Montalvo said he took seriously statements from victims who supported a shorter sentence for Jones, who faced up to 20 years in prison, and his own apologies Tuesday. But he said he sentenced Jones to 41 months in federal prison, followed by three years of supervised release, in part to ensure he was properly punished for abusing his position as a medical professional.
"The message needs to get out that there are serious consequences for people who are in your position who abuse drugs of their patients," Montalvo said.
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Fine Levied against Illegal Tattooist
http://www.wivb.com
Posted by: Eli George
MAYVILLE, N.Y. (RELEASE) - Kenneth Paul Fenti was fined $1,000 for running an unpermitted tattooing operation at a private residence in Jamestown. At its November 19, 2009 meeting, the Chautauqua County Board of Health levied the maximum fine of $1000 against Mr. Fenti after it was determined that his tattooing operation was in violation of Article XIII of the Sanitary Code of the Chautauqua County Health District. Article XIII requires both the tattoo artist and the place of business to be permitted by the Chautauqua County Health Department. Presented as evidence was the tattoo gun used by Fenti, which was crafted out of a motor, toothbrush, pen, and sewing needle.
"When getting a tattoo or piercing, individuals face risk of infection from blood borne pathogens, such as hepatitis B, hepatitis C, and HIV, which are serious life-threatening conditions," said Christine Schuyler, Public Health Director. "The use of unclean needles and unsanitary conditions can make the transmission of these pathogens possible. Those who desire a tattoo or piercing should be very mindful of this risk.and ensure proper procedures are followed," added Schuyler.
"During the permitting process, the Health Department ensures that tattoo artists and businesses are using proper infection control techniques to prevent the transmission of the blood borne diseases," said Mark Stow, Environmental Health Director for the County Health Department. "Under the permit, tattooists are required to wear gloves and use sterilized or single-use needles, and approved tattoo guns and ink supplies, as well as follow several other guidelines," added Stow.
The Health Department advises individuals who decide to get a tattoo to exercise caution and responsibility by taking the time to choose a safe venue. It is important to research both the tattoo artist and parlor of choice to ensure that they are licensed and are using proper infection control techniques. Once at the parlor, surroundings should be examined for any suspicious activity. Make sure that the equipment appears legitimate and safe. Take time to discuss the safety procedures with the artists working at the shop or tattoo parlor. The artist should explain the process and clarify what they do to keep everyone safe and healthy by using sterile needles and razors, washing hands, wearing gloves, and keeping surfaces clean.
The Health Department also strongly encourages individuals to avoid getting a tattoo when under the influence of drugs or alcohol. When inhibitions are lowered, you may not take the necessary precautions to ensure that the operation is safe.
For more information contact the Chautauqua County Health Department at 1-866-604-6789 or log onto their website .
For more information on tattoo health and safety, please visit the CDC's website.
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December 3, 2009
Metabolic Syndrome Prevalent after Liver Transplant
http://www.modernmedicine.com
But literature review finds evidence is inconclusive on syndrome's impact on long-term survival
THURSDAY, Dec. 3 (HealthDay News) -- Patients who receive liver transplants are at high risk for developing metabolic syndrome and resulting cardiovascular complications, but the impact on mortality and long-term survival are inconclusive, according to a review in the December Liver Transplantation.
Mangesh Pagadala, M.D., of the Cleveland Clinic Foundation, and colleagues conducted a literature review on the development of metabolic syndrome among transplant patients, including hypertension, dyslipidemia, diabetes mellitus and obesity, all of which can contribute to cardiovascular complications and mortality. The reviewers examined 21 studies and identified risk factors for metabolic syndrome and its constituent conditions, and assessed patient outcomes for those developing metabolic syndrome.
The researchers note that the prevalence of metabolic syndrome ranged from 43 to 58 percent among post-transplant patients. Among the risk factors for developing post-transplant metabolic syndrome were immunosuppression, older age at transplant, male sex, smoking history, higher pre-transplant body mass index, pre-transplant diabetes, the type of liver disease resulting in the transplant (hepatitis C, cryptogenic cirrhosis, or alcohol), and marital status. The reviewers further found that despite cardiovascular risk, potential organ rejection, and infection risk among transplant patients with metabolic syndrome, the effects on long-term survival and mortality were inconclusive.
"Strategies to reduce the development of metabolic syndrome after transplantation should include lifestyle modifications involving alterations in diet and increased physical activity. Additional measures that may be potentially beneficial include the use of lipid-lowering agents, the optimal control of blood glucose, and the use of tacrolimus instead of cyclosporine," the authors write.
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New Hepatitis C Treatment Shows Promise
http://health.usnews.com
By Jennifer Thomas
HealthDay Reporter
Drug prevented virus from replicating in the livers of primates
THURSDAY, Dec. 3 (HealthDay News) -- A new drug to treat hepatitis C has shown promise in a primate study.
The drug, called SPC3649, uses a new strategy to prevent the hepatitis C virus from replicating. Unlike other antivirals that target the virus itself, the new DNA-based drug targets a small RNA molecule in the liver that hepatitis C needs to replicate, the researchers explained.
By inhibiting the molecule, SPC3649 reduced hepatitis C virus levels in the liver and in the bloodstream in chimpanzees that received the highest dose by 350-fold.
Importantly, the virus showed no signs of resistance to SPC3649, developed by the Denmark-based company Santaris Pharma A/S. And levels of the virus remained low several months after the chimps had ended treatment, raising the possibility that the medicine would only need to be taken temporarily, the researchers added.
"It is a conceptually new approach. Instead of directly targeting the virus, the drug targeted a liver-specific molecule necessary for replication," said study author Robert Lanford, a scientist at the Southwest Foundation for Biomedical Research in San Antonio, Texas. "If we take that away from the virus, it can't replicate anymore."
Viruses replicate inside cells. Like small factories, they require all of the "machinery" inside the cell to accomplish this, explained Lanford. "The beauty of this drug is it takes away the host factor that the virus needs to replicate, and the virus cannot gain a mutation that allows it to be resistant to it."
The study appears in the Dec. 3 online edition of Science.
Hepatitis C, which is spread by contact with the blood of someone who is infected, infects the liver. About 70 percent to 80 percent of those with the virus have no symptoms initially, according to the U.S. Centers for Disease Control and Prevention. But over time, between 60 percent and 70 percent will develop chronic liver disease. Eventually, the virus can cause enough damage to the liver to lead to the formation of scar tissue, and eventually cirrhosis. The virus can also cause liver cancer.
There are about 170 million people infected with hepatitis C worldwide, according to background information in the study. Many don't know they have it.
The standard treatment is a two-drug cocktail of interferon, which makes the immune system more effective in eradicating the virus, and ribavirin, an antiviral, which cures about half of those infected, said Dr. Bruce Bacon, director of the division of gastroenterology and hepatology at Saint Louis University and co-director of the Saint Louis University Liver Center.
However, the side effects can be grueling, including flu-like symptoms, fatigue, depression and low white blood cell counts. Some patients have to be on the drugs for about six months, while some need about a year of treatment to kick the infection, Bacon said.
For those who don't respond to the two-drug cocktail, there are few options, Lanford said. Blacks are more likely to be among those in whom the treatments do not work, possibly due to genetic factors, Lanford noted.
SPC3649 may one day replace interferon, or be combined with the other drugs to augment it, Lanford said. Some evidence indicates it may work in those who don't respond to interferon. In the study, researchers gave four infected chimps SPC3649 intravenously for 12 weeks.
While the findings are exciting, the study involved only four chimps and there's a long way to go before this drug is ready for humans, Bacon said.
"What they have shown is successful reduction in the virus and no clear evidence of resistance, which are two of the major principals that need to be achieved with new therapies," Bacon said. "But what they have to prove now is whether this is a durable response. If you take the drug away, does the patient relapse."
Secondly, better treatments for hepatitis C are on the horizon. Phase 3 trials for two new protease inhibitors are wrapping up. The drugs have the potential to increase the cure rate to 70 percent to 80 percent when added to the two-drug interferon/ribavirin cocktail, Bacon said.
"The bar over which new discoveries much leap is that they have to have a better cure rate than the 70 or 80 percent we are going to see inside of two years," Bacon noted.
Phase 1 clinical trials for SPC3649 in people without hepatitis C are underway, Lanford said. Phase 2 trials in patients with hepatitis C should begin next year.
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December 4, 2009
Reused Syringe Victims Eye Insurers in Vegas
http://www.courthousenews.com
By Nick Divito
LAS VEGAS (CN) - Two patients who say they got hepatitis C at clinics at the heart of the reused syringe scandal are seeking damages from insurance companies. The Endoscopy Center of Southern Nevada and the Gastroenterology Center of Nevada have been accused of reusing syringes on thousands of patients, exposing them to hepatitis and HIV.
In separate lawsuits in Clark County Court, June Downing and Henry Chanin say the Health Plan of Nevada was negligent when it "chose to contract" with the Endoscopy Center and the Gastroenterology Center to provide services to its policyholders.
Last year, the Southern Nevada Health District urged more than 40,000 former patients of the clinics to get tested for hepatitis B and C and HIV after accusations surfaced that doctors and nurses reused syringes and vials of anesthesia on patients over a 4-year period.
Plaintiffs say the insurance company had a duty to "evaluate and monitor the effectiveness of health care services provided by the clinics to its insureds ... and should have known that the clinics engaged in unsafe medical practices."
Defendants include the Health Plan of Nevada, Sierra Health Services and affiliates, and United Health Healthcare Insurance Co. and an affiliate.
The plaintiffs are represented by Robert Cottle with Mainor Eglet.
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December 5, 2009
Diclofenac Linked to Liver Failure, Death
www.medscape.com
Deborah Flapan
December 5, 2009 — Treatment with all products containing diclofenac sodium, including Voltaren Gel, may increase liver dysfunction, resulting in severe hepatic reactions and liver transplantation or death, the US Food and Drug Administration (FDA), Endo, and Novartis announced late last night.
Cases of drug-induced hepatotoxicity have been reported within the first month of treatment with diclofenac but can occur at any time during treatment.
"Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure," according to an alert sent last night by MedWatch, the FDA's safety information and adverse event reporting program. "Some of these reported cases resulted in fatalities or liver transplantation."
Physicians should discontinue diclofenac treatment immediately if patients continue to have abnormal or worsening liver test results, if liver disease symptoms develop, or if systemic manifestations occur, such as eosinophilia, rash, abdominal pain, diarrhea, or dark urine, according to a letter from Endo and Novartis to healthcare professionals.
The companies also recommend that physicians advise their patients receiving diclofenac of the signs and symptoms of hepatotoxicity, including nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and flulike symptoms, and what to do if these signs and symptoms appear.
To reduce the risk for hepatotoxicity in patients receiving diclofenac sodium, the lowest effective dose should be used for the shortest time possible.
Postmarketing Data
In their letter to healthcare professionals, Endo and Novartis advise physicians to measure transaminase levels regularly in patients receiving long-term therapy with diclofenac "because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known."
Clinical trial data and postmarketing experiences suggest that transaminase levels should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. "However, severe hepatic reactions can occur at any time during treatment with diclofenac," they note.
Transaminase levels have been elevated at borderline or higher levels in about 15% of diclofenac-treated patients, the companies say in the letter to healthcare professionals. Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase) is the recommended hepatic function marker for monitoring liver injury, they say.
However, in clinical trials, clinically important elevations (>3 times the upper limit of normal range [ULN]) of aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase) occurred in approximately 2% of about 5700 patients during diclofenac treatment (ALT was not measured in all patients). In a smaller open-label study of 3700 patients, similar elevations of ALT and/or AST levels were seen in approximately 4% of patients and "marked" elevations (>8 times the ULN) occurred in about 1% of patients. In this open-label study, "a higher incidence of borderline (<3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs [nonsteroidal anti-inflammatory drugs]," the companies point out.
In addition, elevated transaminase levels were more common in patients being treated for osteoarthritis than in those with rheumatoid arthritis.
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
More information is available on the FDA's MedWatch Web site.
Adverse events related to the use of diclofenac 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, MD 20852-9787.
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