7/16/2004 FDA News Release Changes Designed to Improve Efficiency and Consistency of Cancer Product Reviews On July 16, the Food and Drug Administration (FDA) announced plans to make significant changes to its organizational structure to provide for an even stronger and more consistent approach to the review process for drugs and most therapeutic biologics used to diagnose, treat and prevent cancer. "Biomedical research in the United States is second to none, and it is our responsibility to see that patients reap the fruits of that research," said Health and Human Services Secretary Tommy G. Thompson. "We are committed to creating the most effective and efficient review process possible to ensure life-saving treatments are made available to cancer patients." "This new structure highlights FDA's on-going commitment to finding new and better ways to get safe and effective treatments to cancer patients," said Dr. Lester M. Crawford, Acting FDA Commissioner. "FDA has worked closely with the cancer community to plan these changes, which have the support of many stakeholders in the fight against cancer." "This initiative by the FDA will benefit cancer patients in the future by helping important cancer drugs reach the community," said NCI Director Andrew C. von Eschenbach, M.D. "As NCI promotes research to develop new interventions to prevent, detect and treat cancer, we look forward to supporting FDA's efforts." FDA will create a new oncology office, called the Office of Oncology Drug Products (ODP), to be housed in the Center for Drug Evaluation and Research (CDER). This new [...]

7/15/2004 London, UK Staff writers Manchester News / and Lancet Britain's cervical screening program is helping save the lives of 5,000 women a year and has prevented a cancer epidemic, experts said today. National screening for cervical cancer started in 1988 after deaths from the disease among women aged under 35 increased three-fold in the previous 30 years. Now researchers have estimated that the lives of 100,000 women born between 1951 and 1970 will be saved thanks to screening. Writing in The Lancet, they said that 15 years ago the country was heading for a devastating outbreak of the disease. But since the introduction of screening, that trend has been reversed, at a cost per life saved of about £36,000. The latest research compared falling death rates from cervical cancer since 1988 against the projected increase if screening had not been introduced. Prof Julian Peto, who led the study for Cancer Research UK, said that changes in sexual behavior since the 1960s led to epidemic levels of sexually transmitted diseases. This meant that the HPV (human papillomavirus) infection - which can go on to cause cervical cancer - became more common among sexually active women. Up to half of young women in Britain have been infected with a high-risk strain of HPV by the time they are 30. The virus usually clears up on its own, but if it persists if can lead to changes in the cells in the cervix which may lead to cancer if untreated. These early [...]

7/15/2004 See end of article for authors Journal of Clinical Oncology Preliminary Results of Radiation Therapy Oncology Group 97-03: A Randomized Phase II Trial of Concurrent Radiation and Chemotherapy for Advanced Squamous Cell Carcinomas of the Head and Neck PURPOSE: To define further the role of concurrent chemoradiotherapy for patients with advanced squamous carcinoma of the head and neck. PATIENTS AND METHODS: The Radiation Therapy Oncology Group developed this three-arm randomized phase II trial. Patients with stage III or IV squamous carcinoma of the oral cavity, oropharynx, or hypopharynx were eligible. Each of three arms proposed a radiation schedule of 70 Gy in 35 fractions. Patients on arm 1 were to receive cisplatin 10 mg/m2 daily and fluorouracil (FU) 400 mg/m2 continuous infusion (CI) daily for the final 10 days of treatment. Treatment on arm 2 consisted of hydroxyurea 1 g every 12 hours and FU 800 mg/m2/d CI delivered with each fraction of radiation. Arm 3 patients were to receive weekly paclitaxel 30 mg/m2 and cisplatin 20 mg/m2. Patients randomly assigned to arms 1 and 3 were to receive their treatments every week; patients on arm 2 were to receive their therapy every other week. RESULTS: Between 1997 and 1999, 241 patients were entered onto study; 231 were analyzable. Ninety-two percent, 79%, and 83% of patients on arms 1, 2, and 3, respectively, were able to complete their radiation as planned or with an acceptable variation. Fewer than 10% of patients had unacceptable deviations or incomplete chemotherapy in the [...]

7/13/2004 Collins, Jensen University of Michigan School of Journalism Everyone knows quitting is hard, but what about switching? Some scientists and researchers are suggesting that an effective way to quit smoking may be switching to smokeless tobacco, an alternative that anti-tobacco groups decry as hazardous and reckless. Smokeless tobacco includes moist snuff, dry snuff, plug or twist tobacco and chewing tobacco. Moist snuff, by far the most popular form of smokeless tobacco, is taken in small pinches and placed between the gums and lips, where it delivers the nicotine that the user craves into the bloodstream. Chewing tobacco has been described by many as a particularly disgusting habit, but the suggestion that it can save your life? “That’s something that the anti-tobacco groups in this country are not too happy about,” said Dr. Brad Rodu, professor of pathology and senior scientist at the University of Alabama/Birmingham Cancer Center. “They are not willing to accept the science involved.” Rodu, who has been publishing research about smokeless tobacco since 1994, said that smokeless tobacco is an acceptable alternative to smoking. His university received a five year grant in 1999 from tobacco companies to research smokeless tobacco products. He said this grant money connection to the tobacco industry was well documented in all of his reports, and the grant included a clause that stated the companies could not revoke the grant if the findings were unfavorable to them. He put forth his “harm reduction strategy” in his book, For Smokers Only: How Smokeless [...]

7/12/2004 By JOAN LOWY Scripps Howard News Service The Bush administration is using a variety of methods to suppress scientific research, information and viewpoints that are unfavorable to industry, speakers at a national conference on scientific integrity said Monday. Scientific research and regulation related to the environment and public health is also being undermined by an aggressive effort by corporate interests to challenge scientific information, even when that information represents a clear consensus of scientific opinion, scientists and public health advocates said. "Within the scientific community the effects of the administration's (actions) have been chilling and demoralizing," Rep. Brian Baird, D-Wash., a clinical psychologist and former university professor, told the conference, sponsored by the Center for Science in the Public Interest, a public advocacy group. "Researchers are practicing self-censorship or avoiding government careers entirely," Baird said. "Lifetimes of study are being abandoned, international collaborations are being curtailed, studies and data that could lead to valuable life-saving information are being neglected or blocked ... and some of the best scientific talent in the world is starting to leave our country." Eric Schaeffer, who resigned two years ago as chief of enforcement at the Environmental Protection Agency in protest over the administration's air pollution policies, said the agency recently decided to exempt two-thirds of plywood manufacturing plants from an air pollution regulation after determining that the health benefits would be outweighed by the costs of complying with the regulation. The EPA based its decision in part on a new industry study that [...]

7/8/2004 Cleveland, OH The Cleveland Clinic Foundation PRNewswire Hollywood screenwriter Joe Eszterhas has released "One-Hundred-Year-Old Man," the third installment in his trilogy of public service announcements designed to highlight the dangers of smoking. Eszterhas, writer of such films as Basic Instinct, Flashdance and Jagged Edge, wrote and produced all three PSAs, which were directed by Tony Kaye (American History X.) "One-Hundred-Year-Old Man" shatters the myth that anyone is immune to the dangers of smoking. Eszterhas, who began using tobacco at age 12, says he once believed he would be "that hundred-year-old man that you read about who stills smokes." When he was diagnosed with throat cancer, however, his illusion vanished. Eszterhas teamed up with The Cleveland Clinic in 2002 after his successful treatment for cancer to form the "Join Joe Campaign," an award-winning, grass- roots effort that spreads his anti-smoking message. The web-based campaign can be accessed at http://www.clevelandclinic.org/joinjoe . "Hollywood simply has to confront its complicity in the deaths of millions of smokers," Eszterhas said. "For the past year and a half, I have been engaged in a struggle both through the media and behind the scenes to ban smoking in films. By filming this public service announcement, I am hoping that my cancer and my voice will neutralize the pro-smoking message." Eszterhas, whose films have grossed more than a billion dollars at the box office, is the first major Hollywood figure to criticize his own role in the glamorization of smoking on screen and to call for a [...]

7/8/2004 Glasgow, Scotland Doug Gillion The Herald One of the darkest stories in Olympic history was the vilification of the American Indian, Bright Path, otherwise known as Jim Thorpe. The 1912 pentathlon and decathlon winner was congratulated by the King of Sweden as "the most wonderful athlete in the world". Thorpe allegedly replied: "Thanks, King." His twin had died aged eight, and both parents by the time he was 15. Thorpe was educated in an Indian school before winning college colours in 11 different sports. He discovered his athletic talent when walking past a track where the high jumpers were failing to clear 5ft 9in. He cleared it in his working clothes. Five years later he was in the Olympics. Between the pentathlon and decathlon he placed fourth in the high jump and seventh in the long jump. His decathlon total would still have won silver medal in 1948. Within months, however, it transpired that Thorpe had been paid $25 a week for playing baseball. His medals were all forfeit. Avery Brundage, who had finished sixth in the pentathlon (and was president of the International Olympic Committee for 20 years) did nothing to help Thorpe's fight for reinstatement. MGM paid just $1500 for the film rights to Thorpe's life, and when he needed treatment for oral cancer he was a charity patient. He died in 1953. Only in 1982, after Brundage had gone, did the IOC restore his records and give the medals to his family.

7/8/2004 Irlam, UK Rebecca Eames Salford Adertiser A Irlam teenager inspired to hold a charity walk by her mother’s battle against cancer was joined by a nine-year-old boy paying a tribute to his beloved late grandad, who lost his battle with the disease. Nathan Lynch, whose grandad Arthur died of throat cancer, aged 74, last year, teamed up with more than 100 walkers who lined up alongside 15-year-old Kate Gowland for a three-mile hike around Irlam. The walk, held last weekend, was all in aid of Cancer Research UK. Nathan, a Cadishead Primary School pupil, joined in the walk after reading the Advertiser’s report about Kate’s sponsored walk. She organised the trek because her mum, Kay, was diagnosed with mouth cancer. And Nathan was eager to sign up and took part in the walk proudly bearing a T-shirt with a picture of his granddad on it. His mum, Angela Lynch, of Devon Road, was thrilled the walk had been organised and that her son had decided to take part. Angela said: "We were talking about doing something to raise funds for Cancer Research, but just didn’t really know how to go about it. So when we saw the walk advertised, it was just right, and Nathan really wanted to do it. It was a great idea as there are not that many things like this to do in Irlam and Cadishead. "Nathan really enjoyed it. When he got back he said that he had done the walk not only for [...]

7/8/2004 Hershey, PA Valerie Gliem Penn State College of Medicine Penn State College of Medicine researchers have discovered the first molecular therapy to target cancer-causing components and thereby destroy a bona fide human papillomavirus (HPV) infection. "Our results suggest that targeting therapies to the RNA that encodes a specific pair of proteins in HPV may break a chain that, left unhindered, promotes cellular proliferation and, potentially, cervical cancer," said Gary Clawson, M.D., Ph.D., professor of pathology, and biochemistry and molecular biology, Penn State College of Medicine. "Until now, there have been no effective and specific molecular treatments reported for HPV infections or for related papillomavirus infections." The study, titled "The Inhibition of papilloma progression by antisense oligonucleaotides targeted to HPV11 E6/E7 RNA" was published July 1, 2004, in the online version of the journal Gene Therapy. HPV is one of the most common causes of sexually-transmitted infection in the world. Types of HPV can cause fast-growing lesions such as genital and planter warts, and a number of HPV types are considered to be "high-risk" for development of cervical dysplasia, a known precursor to cervical cancer. According to the U.S. Department of Health and Human Services, 20 million Americans are already infected with HPV. To survive and proliferate, HPV-infected cells require continued production of two proteins called E6 and E7, which are created according to the instructions of RNA, or ribonucleic acid, templates. Clawson and his team supposed that by destroying RNAs used for production of E6 and E7 proteins, the [...]

7/7/2004 Toni Baker Medical College of Georgia A vaccine that appears to protect against four common strains of human papillomavirus virus – two that cause cervical cancer and two that cause genital warts – is under study at the Medical College of Georgia in women age 24-45. "We have studied this vaccine in younger women and in children, who will be the primary target for vaccination in the future. However, there are millions of older women who may also want to be vaccinated against HPV," said Dr. Daron G. Ferris, family medicine physician, director of the MCG Gynecologic Cancer Prevention Center and a principal investigator on the vaccine study. HPV, one of the most common sexually transmitted infections in the country, is the biggest risk factor for cervical cancer and a cause of penile cancer and genital warts. MCG has been involved in several national trials pursuing the efficacy of different HPV vaccines in different populations. The quadrivalent vaccine currently under study protects against types 6 and 11, the top two wart-causing strains, and types 16 and 18, the two most-common cancer-causing strains. Dr. Ferris and his colleagues are concluding studies of the vaccine in women age 16-23 and in boys and girls age 10-15. Many of the mothers with children in the previous study have expressed interest in participating in this latest study. "It's only natural now to look at the moms," Dr. Ferris said. "Although the greatest risk for HPV infection is in the 15- to 25-year-old age [...]