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Merck's Gardasil Effective At Preventing HPV, Cervical Disease In Older Women, Study Finds
Merck"s human papillomavirus vaccine, Gardasil, was 90% effective in preventing infection with the virus and cervical disease in women ages 24 to 45, according to a study published Monday in the medical journal Lancet, Reuters reports (Fox, Reuters, 6/1). In the U.S., the vaccine currently is FDA-approved for girls and women ages nine to 26. Centers for Disease Control and Prevention guidelines recommend routine three-dose vaccination of girls ages 11 and 12 and for girls and women ages 13 to 26 who have not yet been vaccinated (CDC fact sheet, June 2008). It is designed to protect against HPV types 16 and 18, which cause about 70% of all cervical cancer cases, and HPV types 6 and 11, which cause genital warts.The new study, led by Nubia Munoz of the National Institute of Cancer in Bogota, Colombia, and funded by Merck, involved women ages 24 to 45 with no history of cervical disease or genital warts who either received the vaccine or a placebo injection. The study found that women who received the vaccine were significantly less likely to be infected with certain strains of HPV than those who received placebo shots. According to the researchers, four women out of 1,900 who received the vaccine developed HPV or cervical disease after two years, compared with 41 women out of 1,900 in the placebo group.Reuters reports that the results of the study could help Merck as it seeks approval for marketing Gardasil for use in older women. The researchers said in the study that older women might be at risk for HPV infection as "[c]hanges in sexual behavior during the past 30 years ... have led to more widespread premarital sexual intercourse and acquisition of new sexual partners around middle age." They added, "As the potential for HPV infection and disease exists in women in their third, fourth and fifth decades of life, these women could benefit from prophylactic HPV vaccination." According to Reuters, a mathematical model published in October 2005 showed that vaccinating older women could cut rates of cervical cancer in women through age 45 by half. Merck also has released data showing the effectiveness of the vaccine in preventing genital lesions in men.According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection worldwide, and about 20 million U.S. residents are infected with it. The virus is the leading cause of cervical cancer, which causes about 3,870 deaths in the U.S. and 300,000 deaths globally every year, and it also can cause anal, penile, mouth and neck cancer (Reuters, 6/1).
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Coalition To Protect Patients' Rights Urges Congress To Slow Down Health Reform And Do It Right
Dr. Donald Palmisano, former president of the American Medical Association and current spokesman for the Coalition to Protect Patients" Rights (Coalition) and over forty doctors from across the country today urged Members of Congress to slow down health system reform and do it right. The Coalition held a press conference at the National Press Club to urge legislators to put patients first when developing a system overhaul.
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Thousands At Risk From Hidden Heart Condition
Thousands of people in England are unaware that they are at risk of developing heart disease due to an undiagnosed genetic condition, says the Royal College of Physicians. Familial hypercholesterolaemia (FH) is an inherited condition causing high levels of LDL cholesterol, and increased risk of coronary heart disease in men in their 50s and women in their 60s. Early treatment with statins has been shown to reduce risk and improve life expectancy to normal.
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NEJM Study Points To New Era In Hepatitis C Treatment

For patients with the most common form of hepatitis C, the addition of a hepatitis C specific protease inhibitor called telaprevir to the current standard therapy can significantly improve the chances of being cured, and it does it in half the time of standard therapy alone. Results of the Phase IIb clinical trial -- led by Duke Clinical Research Institute (DCRI) and 36 other sites, including NewYork-Presbyterian Hospital/Weill Cornell Medical Center -- are published in the April 30th issue of the New England Journal of Medicine. The study was funded by Vertex Pharmaceuticals Incorporated, the maker of the drug telaprevir. The drug works by blocking an enzyme that the hepatitis C virus needs in order to replicate itself. "These findings point the way to a new era in the treatment of hepatitis C," says Dr. Ira M. Jacobson, a co-author of the study and chief of the Division of Gastroenterology and Hepatology at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Clinical Medicine at Weill Cornell Medical College. "Not only does adding telaprevir make standard hepatitis C treatment more effective, but it makes it work much more quickly. We showed that the duration of therapy can be reduced from 48 weeks to 24 weeks for most patients. This could help reduce the potentially severe side effects of longer regimens with standard therapy." The randomized, double-blinded trial followed 250 patients with untreated hepatitis C genotype 1. Researchers measured rates of sustained viral response or viral cure -- an undetectable quantity of hepatitis C virus -- 24 weeks after the end of completion of therapy. They compared a 12-week regimen of telaprevir combined with two different durations of the standard therapy -- peginterferon alfa-2a and ribavirin -- to a control group taking 48 weeks of standard therapy alone. Results showed that 67 percent of patients taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 36 weeks were cured; and 61 percent of those taking telaprevir in combination with standard therapy for 12 weeks followed by standard therapy alone for 12 weeks were cured. This is compared to 41 percent cure rate in the 48-week control group. The study also showed that the percentage of patients who relapsed in the 24-week and 48-week telaprevir-based groups (2 percent and 6 percent, respectively) was much lower than the control group (23 percent). The most common reported side effect in the telaprevir groups was rash, and contributed to some patients discontinuing the therapy. Peginterferon alfa-2a is an antiviral drug given by injection that is also used to treat HIV and hepatitis B; it works in conjunction with a drug called ribavirin, a nucleoside analogue, to suppress the viral activity of hepatitis C. Side effects can include severe flu-like symptoms, depression, fatigue, insomnia and anemia. "Treating genotype 1 hepatitis C, the most common form of the infection in the United States, can be challenging because the side effects are difficult for many people to endure, the duration of treatment is long, and traditionally less than half of patients are able to be cured of their disease," says Dr. Andrew Muir, a gastroenterologist at Duke Clinical Research Institute and a senior investigator on the study. "Even though telaprevir does produce side effects of its own, its addition to standard therapy was able to improve response rates and shorten the duration of treatment necessary -- either one alone would have been an advance, and to be able to achieve both is a significant step in the right direction when it comes to treating hepatitis C." The study"s lead author is Dr. John McHutchison, a hepatologist and gastroenterologist and researcher at the Duke Clinical Research Institute. Additional co-authors include Drs. Gregory Everson of the University of Colorado Health Science Center; Stuart Gordon of Henry Ford Hospital; Mark Sulkowski of Johns Hopkins School of Medicine; and Robert Kauffman, Lindsay McNair and John Alam of Vertex Pharmaceuticals. Drs. Jacobson, McHutchison and Muir have received consulting fees and/or grant support from Vertex, Roche (maker of peginterferon) and Schering-Plough (maker of ribavirin). The study"s results match those of a similar study conducted in Europe that was reported on in the same issue of the New England Journal of Medicine. An accompanying editorial recounts the history of hepatitis C treatments, beginning 25 years ago with the discovery of interferon. It comments on the two studies: "Telaprevir appears to be a material advance in the therapy of hepatitis C, beginning a new era of treatment -- an era of antiviral agents developed specifically to target this virus." Two Phase III studies currently under way at NewYork-Presbyterian/Weill Cornell and centers worldwide will attempt to confirm the results, potentially leading to FDA approval of telaprevir. One study is looking at 12 weeks of telaprevir in combination with standard therapy (peginterferon alfa-2a and ribavirin) followed by either 12 or 36 weeks of standard therapy alone depending on patients" response to therapy. A second study is comparing 8-week and 12-week regimens of telaprevir in combination with standard therapies followed by at least 12 weeks of standard therapy, depending on patients" response to therapy, to a placebo group taking 48 weeks of standard therapy alone. Both studies are currently closed to recruitment. Hepatitis C Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the hepatitis C virus (HCV), which is spread primarily through contact with the blood of an infected person. HCV is a serious public health concern, affecting 3.4 million individuals in the United States. There are six major genotypes of the hepatitis C virus, which are indicated numerically. About 70 percent of hepatitis C patients in the United States have genotype 1. Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person"s risk for developing long-term infection, chronic liver disease, cirrhosis or death. It is the leading reason for liver transplantation in the United States. Co-infection with HIV is common and rates among HIV positive populations are higher. Most people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs. NewYork-Presbyterian Hospital/Weill Cornell Medical Center NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson"s disease; the first indication of bone marrow"s critical role in tumor growth; and, most recently, the world"s first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children"s Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. NewYork-Presbyterian Hospital


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