6/8/2004 NEW ORLEANS, LA Matthew Herper Forbes After helping to develop some of the hottest new biotech drugs, Memorial Sloan-Kettering cancer doctor Leonard Saltz has come down with a bad case of sticker shock. The price tag for treating patients has increased 500-fold in the last decade. Ten years ago, doctors could extend the life of a patient who had failed to respond to chemotherapy several times by an average 11.5 months using a combination of drugs that cost $500 in today's dollars. Now, new medicines such as Genentech's (nyse: DNA ) Avastin and Sanofi-Synthelabo's (nyse: SNY ) Eloxatin can extend survival to 22.5 months, but at a total cost of $250,000. And that doesn't include pharmacy markups, salaries for doctors and nurses, and the cost of infusing the drugs into patients in the hospital. That kind of cost is unsustainable. "Sooner or later the bubble is going to pop," Saltz says. Fears about the high cost of new drugs and the changing financial environment for treating cancer are major concerns among doctors gathered here at the annual meeting of the American Society for Clinical Oncology. Doctors are beginning to discuss treating cancer as a chronic disease that could be kept in check with a cocktail of pills. But that puts cancer drug firms on a collision course with both the private sector's crackdown on high healthcare costs in the United States and the new Medicare law, which will go into effect in less than two years. As the government [...]

6/7/2004 New Oleans, LA Matthew Herper Forbes.com The annual meeting of the American Society for Clinical Oncology is a much-watched arena for biotech concerns, which get their first chance to present new data to investors. Here are four companies that have doctors talking about their drugs. ImClone Systems Erbitux Colon Cancer, Head-And-Neck Cancer For the first time, ImClone Systems' (nasdaq: IMCL ) Erbitux has been proven to extend patients' lives. (In previous studies, it shrank tumors.) The new results for the drug are in head-and-neck cancer, a kind of tumor in the throat and mouth that is difficult to treat. The results are seen as proof of the drug's efficacy. "It takes a monkey off the back of a drug that's taken some hits," says Leonard Saltz, an oncologist from Memorial Sloan-Kettering who played a role in Erbitux's development. For ImClone and partner Bristol-Myers Squibb (nyse: BMY), that's good news indeed. Millennium Pharmaceuticals Velcade Myeloma, Lung Cancer Some analysts are disappointed with the sales of Millennium's (nasdaq: MLNM) Velcade as a treatment for multiple myeloma, a cancer of the blood. Yet many are watching to see whether the drug can work in other cancers, particularly those that form big, solid tumors. Early evidence came from a presentation using Velcade in non-small-cell lung cancer in a mere 53 patients. Bruce Johnson, an oncologist at the Dana-Farber Cancer Institute, says the results look good, but very preliminary. Roman Perez-Soles, chairman of the department of oncology at the Albert Einstein College of Medicine, [...]

6/6/2004 By Avery Comarow No matter how friendly the ads and cheery the redecorated rooms, hospitals are not hotels. Patients aren't pampered, especially with nurses and other key hospital workers in short supply. Besides, would you go to a hotel if told you had a 1 in 30 or so chance of not emerging? That's true for many surgical procedures. Even great hospitals have their tragedies. A year ago, in June, a healthy 24-year-old woman died after volunteering for a study at Johns Hopkins Hospital in Baltimore. Last January, a healthy man who had donated part of his liver to his ailing brother died at Mount Sinai Medical Center in New York; his surgeon is tops at live-donor liver transplants. Face it: People who check into hospitals are there because they are too ill, or need treatment that is too ambitious or difficult, to be outpatients. Elite in a grim way, they are a class in decline. In 1980, about 1 hospital patient in 7 stayed overnight. By 1990 that had dwindled to 1 in 10 and by 2000 to a scant 1 in 16. The sicker the patient, the more pressing the need for the best care–which is why U.S. News is publishing its 13th annual edition of "America's Best Hospitals." They rank 205 top medical centers, winnowed from 6,045, in 17 specialties. These hospitals excel partly because their doctors perform large numbers of tricky and risky procedures. Study piled upon study has shown the critical role of volume. [...]

6/5/2004 WASHINGTON DC The NCI, ACS, and CDC More Americans are surviving cancer for five years or more and deaths from cancer overall are steadily declining, according to the latest annual report on cancer published Thursday in the journal Cancer. For the first time, fewer women are being diagnosed with lung cancer, the joint report from the American Cancer Society, Centers for Disease Control and Prevention, the National Cancer Institute, and the North American Association of Central Cancer Registries finds. Not everyone is reaping the gains: Minorities still are more likely than whites to die from cancer, says the report. Cancer remains the second leading cause of death in the United States behind heart disease. This year 1.368 million Americans will learn they have cancer and 563,700 will die of it. The “Annual Report to the Nation on the Status of Cancer, 1975-2001” finds that cancer rates dropped 0.5 percent per year from 1991 to 2001, while death rates from all cancers combined dropped 1.1 percent per year from 1993 to 2001.This is due to better prevention, screening that catches cancer early enough to treat it and better therapies. Most striking in this latest tally is what’s happening with the No. 1 cancer killer: Rates of female lung cancer diagnoses have declined about 2 percent a year since 1998, years after men began a similar improvement. Smoking became common among men long before women, and the resulting lung cancer consequently struck men sooner. Lung cancer remains the nation’s top-killing malignancy [...]

6/2/2004 Laurie Barclay, MD Journal of the National Cancer Institute Exclusive pipe smoking confers a risk of tobacco-associated disease similar to that of cigar smoking but less than that of cigarette smoking, according to the results of a prospective cohort trial published in the June 2 issue of the Journal of the National Cancer Institute. Although many studies have examined the adverse health effects of pipe smoking combined with other forms of tobcco use, few have included large numbers of exclusive pipe smokers," write S. Jane Henley, from the American Cancer Society in Atlanta, Georgia, and colleagues. "The prevalence of pipe smoking has declined since the 1960s, yet usage is still common regionally, especially among older populations." Previous studies of exclusive pipe smoking were small and could not exclude potential confounding factors, such as socioeconomic status and alcohol use. Pipe tobacco is the least commonly used tobacco product in the U.S., with overall use decreasing from 14% in 1965 to 2% in 1991. However, pipe smoking remains common among the American Indians and some other populations, and it has been increasing among American middle and high school students since 1999. Of 138,307 men enrolled in the Cancer Prevention Study II, 15,263 men were current or former pipe users, and 123,044 men had never used tobacco. During the 18-year follow-up, there were 23,589 deaths. Based on this mortality data, the investigators compared the risks of death from nine cancers (bladder, colon/rectum, esophagus, kidney, larynx, lung, oropharynx, pancreas, and stomach) and three [...]

6/2/2004 Phoenix, AZ BUSINESS WIRE Zila, Inc. (Nasdaq:ZILA) announced today that the Code Revision Committee of the American Dental Association (ADA) has approved a new dental reimbursement code for oral cancer screening products. Zila's ViziLite(R) product provided the pathway for the new code, and Zila anticipates that OraTest(R) will also satisfy the code requirements once its FDA clearance is obtained. Zila said it recently received notice that the Committee approved a code for an "adjunctive pre-diagnostic test that aids in detection of mucosal abnormalities including pre-malignant and malignant lesions, not to include cytology or biopsy." Douglas D. Burkett, Ph.D., Chairman, CEO and President of Zila, Inc., said, "The ADA Committee's action is further evidence that the dental profession recognizes the importance of early detection in the prevention and treatment of oral cancer." Dr. Burkett continued, "There has never been such a reimbursement code available to dentists, because there has never been an FDA approved product for oral pre-cancer and early cancer identification -- until ViziLite. ViziLite's recent clinical efficacy data was cited as a factor in the Committee's decision. We are unaware of any available products, other than ViziLite, that will be covered under this new code. We expect that the code will encourage the use of ViziLite, and we anticipate that this reimbursement code will be available for OraTest when its regulatory approval is achieved." Zila envisions ViziLite and OraTest to be synergistic products that provide a means for all adults to benefit from improved identification of oral pre-cancers [...]

6/11/2004 By JANET McCONNAUGHEY The Associated Press High concentrations of the virus that causes mononucleosis can help doctors predict the spread of a type of cancer that develops behind the nose, a study found. Epstein-Barr virus levels in the blood may also help predict the course of Hodgkin's disease and some other cancers of the immune system, said lead researcher Jin-Ching Lin of Taiwan. Researchers do not know exactly how the virus is connected to those cancers, but a link has been found in the past. The study is too small to draw any final conclusions, said Dr. Ralph Vance, national volunteer president of the American Cancer Society. ``It will be interesting to see if it can be duplicated by others,'' said Vance, a professor in the University of Mississippi School of Medicine's department of oncology. Epstein-Barr is one of the most common human viruses - as many as 95 percent of U.S. residents have been infected by age 40. Most have no symptoms, though up to half of those infected as adolescents and young adults develop mono, according to the National Institutes of Health. After infection, the virus can lurk in a few cells, occasionally becoming active again. Lin, of the department of radiation oncology at Taichung Veterans General Hospital, studied a cancer that is rare in the United States but common in southeastern China - cancer of the nasopharynx, an area above the soft palate. All 99 patients in the study in Thursday's New England Journal of Medicine [...]

6/1/2004 Newport Beach, CA The Oral Cancer Foundation It would seem that the debate on this issue is yet to be resolved. Two studies published at the same time in respected peer reviewed journals come to different conclusions. The studies appear below. Marijuana Use and Risk of Oral Squamous Cell Carcinoma. Rosenblatt KA, Daling JR, Chen C, Sherman KJ, Schwartz SM. Department of Community Health, University of Illinois at Urbana-Champaign, Champaign, Illinois. Previous laboratory investigations, case reports, and a hospital-based case-control study have suggested that marijuana use may be a risk factor for squamous cell head and neck cancer. We conducted a population-based case-control study to determine whether marijuana use is associated with the development of oral squamous cell carcinoma (OSCC). Case subjects (n = 407) were 18-65-year-old residents of three counties in western Washington State who were newly diagnosed with OSCC from 1985 through 1995. Control subjects (n = 615), who were similar to the cases with respect to age and sex, were selected from the general population using random-digit telephone dialing. Lifetime histories of marijuana use and exposure to known OSCC risk factors were ascertained using a structured questionnaire. Information on genetic polymorphisms in glutathione S-transferase enzymes was obtained from assays on participant DNA. Odds ratios for associations with features of marijuana use were adjusted for sex, education, birth year, alcohol consumption, and cigarette smoking. A similar proportion of case subjects (25.6%) and control subjects (24.4%) reported ever use of marijuana (adjusted odds ratio, 0.9; 95% confidence interval, [...]

6/1/2004 London, UK Medical News Today Cigarette smoke transforms healthy saliva into a deadly cocktail that can accelerate mouth cancer, according to new research in the British Journal of Cancer. Normally, saliva provides a protective buffer between toxins and the lining of the mouth because it contains important enzymes that fight and neutralize harmful substances. But the new research shows that the chemicals in tobacco smoke combine with saliva with devastating effect. They destroy the protective components of saliva – leaving a corrosive mix that damages cells in the mouth and can eventually turn them cancerous. The researchers in this study wanted to examine saliva's role in the development of mouth cancer. The study recreated the effects of cigarette smoke on cancerous cells of the mouth. Half of the cell samples were exposed to cigarette smoke and the other half to the saliva and cigarette smoke mixture. Cancerous cells were used in order to quickly assess whether the saliva and smoke mixture would speed the cancer's development. The study revealed that the longer the mouth cells were exposed to the contaminated saliva, the more the cells were damaged. Dr Rafi Nagler, based at the Technion-Israel Institute of Technology, who co-led the study, says: "Most people will find it very shocking that the mixture of saliva and smoke is actually more lethal to cells in the mouth than cigarette smoke alone. "Our study shows that once exposed to cigarette smoke, our normally healthy saliva not only loses its beneficial qualities but [...]

5/26/2004 Datamonitor Services GSK is awaiting the outcome of a Phase III trial to evaluate an anti-cervical cancer vaccine. GlaxoSmithKline's [GSK.L] four-year clinical trial of an HPV vaccine could have a significant affect on cervical cancer treatment, as HPV is a known contributory factor to the disease. However, GSK will need to consider how this product should be positioned, especially with regard to use in pediatrics, so as to maximize revenues. GSK's global Phase III PATRICIA HPV vaccine trial will involve 90 sites and approximately 13,000 young women aged 15-25 worldwide, lasting for approximately four years. HPV is associated with cervical cancer, the second most common cause of cancer in women worldwide, and the leading cause in the developing world. Furthermore, cervical cancer develops early in life, with a median age of 38 years. Although there are more than 100 different types of HPV, approximately 70% of all cervical cancers are associated with just two types, namely HPV 16 and HPV 18. It is against these oncogenic strains that the HPV vaccine is intended to confer protection. GSK's main challenge will be identifying the optimal target population. Judging by the proposed trial, it can be inferred that GSK anticipates its target population to be young women, from mid-teens to early twenties. This means that the HPV vaccine will not be included on the US pediatric immunization schedule, which is the most commercially attractive sector for vaccine manufacturers due to its large patient population and high compliance rates. Consequently, GSK will [...]