GSK – Oral Cancer News

Data Published in the Lancet Oncology Support High Efficacy Previously Demonstrated By Cervarix

Source: Therapeutics Daily Author: Staff LONDON, Nov. 9, 2011-An analysis published today in The Lancet Oncology reinforces previous findings showing that GlaxoSmithKline’s Cervarix®, provided protection against advanced precancerous lesions (CIN3+), above that expected from a vaccine that protects against human papillomavirus (HPV) types 16 and 18. CIN3+ is the immediate step before invasive cervical cancer and data showing protection against this type of lesion are considered the most stringent evidence of potential cervical cancer prevention.1 Results from the largest efficacy trial of a cervical cancer vaccine to date (PATRICIA), show that Cervarix provided 93%† efficacy against CIN3+ irrespective of the HPV type associated with the CIN3+ lesion.1This pre-defined, exploratory analysis was conducted in women with no evidence of past or current HPV infection.‡ These women are thought to be representative of young girls prior to the onset of sexual activity – the primary target population for organised vaccination programmes. These findings have been incorporated into the European label for Cervarix, updated by the European Commission in September 2011. Additional data from the same end-of-study analysis have been published in a separate article in TheLancet Oncology. These data demonstrate that Cervarix provided 82%* efficacy against CIN3+, associated with a composite of 12 cancer-causing HPV types not included in the vaccine, in the same population as the analysis discussed above.2 This analysis excluded cases co-infected with HPV 16 and/or 18 and is therefore a conservative estimate of cross-protective efficacy. Non-vaccine HPV types, including the 12 studied in this analysis, together account for approximately 30% of cervical cancers globally.3 The authors [...]

Charlotte Parker2011-11-16T12:04:02-07:00November, 2011|Oral Cancer News|

The cancer-causing sex virus

Source: Forbes Author: Matthew Herper Martin Duffy, a Boston consultant and economist, thought he just had a sore throat. When it persisted for months, he went to the doctor and learned there was a tumor on his tonsils. Duffy, now 70, had none of the traditional risk factors for throat cancer. He doesn't smoke, doesn't drink and has run 40 Boston marathons. Instead, his cancer was caused by the human papilloma virus (HPV), which is sexually transmitted and a common cause of throat and mouth cancer. HPV tumors have a better prognosis than those caused by too many years of booze and cigarettes. But Duffy "is in the unlucky 20%" whose cancer comes back--despite rounds of chemotherapy and radiation that melted 20 more pounds off a lean 150-pound frame. Now the cancer has spread throughout his throat, making eating and talking difficult. "I made my living as a public speaker," he says. "Now I sound like Daffy Duck." Duffy believes he has only a few months left. "How do you tell the people you love you love them?" he asks. Nine Things You Need To Know About HPV Most strains of the HPV virus are harmless, but persistent infections with two HPV strains cause 70% of the 12,000 cases of cervical cancers diagnosed annually in the U.S. Other forms of the sexually transmitted virus can cause penile and anal cancer, and genital warts. The HPV throat cancer connection has emerged in just the last few years and is so new that [...]

Charlotte Parker2010-07-25T20:13:00-07:00July, 2010|Oral Cancer News|

FDA’s risk aversion is endangering children

Source: Forbes.com Author: Henry Miller The agency has sown confusion by asking physicians to stop administering a vaccine that even they admit is safe. By applying its now-customary excessive precaution, the FDA has painted itself into a most interesting corner. The result will likely be confusion among pediatricians and the public and parents reluctant to permit their children to get an important vaccination. And that in turn will cause unnecessary cases of rotavirus infection, debilitating diarrhea and, in a few children, death. The FDA last March asked pediatricians to stop administering GlaxoSmithKline's ( GSK - news - people ) Rotarix, a vaccine that prevents rotavirus infection, a diarrheal illness that commonly affects infants and children and that can cause severe dehydration. Their rationale was self-contradictory and unpersuasive. On one hand, the FDA seemed still to be confident about the vaccine, explaining that, "Extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine." And the positive experience of countless infants and children vaccinated since the licensing of the vaccine two years ago further confirms its safety. So why do regulators want a "pause" in administration? Because using a new ultra-sensitive assay, small amounts of DNA from a pig virus were detected in the vaccine preparation. That might sound like a good reason for concern--except that the FDA itself confirms "that the material has been present since the early stages of product development, including during clinical studies." In other words, all of the studies that confirmed the [...]

Charlotte Parker2010-05-13T07:58:04-07:00May, 2010|Oral Cancer News|

Pharmaceuticals, patents, publicity…and philanthropy?

Source: The Lancet, Volume 373, Issue 9665, Page 693, 28 February 2009 Author: staff Tensions between provision of and payment for health care are familiar. Though doctors assume principal responsibility for patients' health, those who work for pharmaceutical companies view the patented medicines they design as key components of health care. Creative ways are continually found to make such drugs available to as many patients in high-income countries as possible, the profits contributing to future investment in development and leaving national drug budgets affordable, just. Yet, a few hours' flying away, patients in developing countries usually have no access to these very same patented drugs. GlaxoSmithKline (GSK) has grown in size and influence by successful drug development, timely takeovers, and shrewd management. Andrew Witty, who ascended to the vertiginous position of chief executive at GSK in the past year, has attracted attention by a surprising presentation at Harvard Medical School on Feb 13. He promises that GSK will now not only make its medicines available much more cheaply to patients in low-income countries, but also make a bolder commitment to research into neglected diseases. As one blogger puts it, “arise Sir Andrew Witty (or is it Saint Andrew?)”. Does this announcement mark a sea change in pharma's attitude to the provision of drugs in poor countries, or could it be more reminiscent of the zany hybrid vehicles that distract attention from car manufacturers' shamelessly polluting stock in trade? Witty's words were carefully weighed to cast a rosy glow around GSK's [...]

Oral Cancer Foundation News Team - A2009-05-08T18:54:41-07:00May, 2009|Oral Cancer News|