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 [...]

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

HPV types 16/18 adjuvant vaccine shows long-term efficacy

Source: DocGuide.com Author: Jenny Powers NICE, France -- May 11, 2010 -- The human papillomavirus (HPV) vaccine (types 16 and 18) AS04-adjuvanted vaccine shows a sustained immune response, as demonstrated by high levels of neutralising antibodies, up to 8.4 years after first vaccination, researchers said here at the 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) on May 6. Cecelia Maria Roteli-Martins, MD, Hospital Leonor Mendes de Barros-Secretaria d Saude de São Paulo, in São Paulo, Brazil, headed an international team that evaluated the efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine by measuring neutralising antibody levels in a follow-up analysis yearly for up to 8.4 years post vaccination Healthy women aged 15 to 25 years who were DNA-negative for oncogenic HPV types, 16 and 18 with normal cytology at baseline received the vaccine (n = 560) or placebo (n = 553). A total of  223 women who were vaccinated with the active vaccine returned for extension studies, as well as 213 of the women who were given placebo. In these women, HPV-16 and 18 antibodies were measured annually. Cervical samples were taken every 6 months and gynaecological and cytopathological examinations were performed every 12 months. All (100%) of the women in the trial have remained seropositive for HPV-16 and -18 antibodies. After 2 years of follow-up, 5 incident infections and 1 infection of low grade squamous intra-epithelial lesion or higher (LSIL) associated with HPV 16 and 18 occurred in the placebo group. The vaccine efficacy [...]

2010-05-13T07:58:42-07:00May, 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 [...]

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

FDA approves GlaxoSmithKline’s Cervarix

Source: Philadelphia Business Journal Author: John George The Food and Drug Administration granted marketing approval Friday to Cervarix, the cervical cancer vaccine developed by GlaxoSmithKline. The London pharmaceutical company, which has major operations in the Philadelphia region, said the vaccine will be on the market before the end of the year. The FDA approved the drug for use in women and girls ages 10 to 25. GlaxoSmithKline (NYSE:GSK) will have a challenge taking market share away from Merck & Co. Inc. (NYSE:MRK), which launched its cervical cancer vaccine Gardasil in 2006. Gardasil had worldwide sales of $1.4 billion for Merck last year. Cervarix, which was previously approved in markets outside the United States including Europe, Japan and Australia, had sales of more than $200 million in 2007.

2009-10-16T10:56:58-07:00October, 2009|Oral Cancer News|

37% of U.S. teen girls got HPV vaccine

Source: www.medscape.com Author: Daniel J. DeNoon More than one in three U.S. teen girls has had at least one shot of Gardasil, a CDC survey shows, but only 18% of girls got the three shots needed for protection. The survey includes girls vaccinated through 2008, two years after Gardasil's approval. A second HPV vaccine, GlaxoSmithKline's Cervarix, is expected to be approved this year. Gardasil, from Merck, protects against the four strains of the sexually transmitted human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts. But other HPV strains also cause these diseases, so even vaccinated women still need regular Pap exams. Gardasil's acceptance varied widely by state. More than half of all teen girls aged 13 to 17 had at least one shot of the HPV vaccine in six states: Arizona, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont. Fewer than one in five girls got the vaccine in three states: Georgia, Mississippi, and South Carolina. Coverage was highest in Rhode Island (54.7%) and New Hampshire (54.4%) and lowest in Mississippi (15.8%) and Georgia (18.5%). Cervical cancer is more common in women of Hispanic descent and in people living below the poverty level. Perhaps because the Vaccines for Children (VFC) program provides the expensive vaccine to uninsured children, girls in these groups had higher rates of coverage than other girls. The CDC reported results of the survey in today's issue of Morbidity and Mortality Weekly Report. Source: MMWR, Sept. 17, 2009; vol 58: pp 997-1001.

2009-09-25T12:57:21-07:00September, 2009|Oral Cancer News|

Three clinical studies give GSK’s cancer vaccine an edge

Source: EH News Bureau Author: Staff GlaxoSmithKline Pharmaceuticals Limited (GSK) recently shared the results of three recently published clinical studies, conducted for its cervical cancer vaccine—Cervarix. Said Dr Hasit Joshipura, Vice President, South Asia and Managing Director, GSK India, "The findings confirmed that the vaccine offers protection against five of the most common cancer-causing virus types, generates significantly higher immune response compared to the other available vaccine Gardasil and provides high and sustained antibody levels for at least 7.3 years till date." The clinical studies involved 18,644 women and was published in The Lancet. The study confirmed that Cervarix is not only highly effective at protecting against the two most common cervical cancer-causing human papillomavirus (HPV) types, 16 and 18, but also provides additional cross-protection against HPV types 31, 33 and 45, the three most common cancer-causing virus types beyond 16 and 18. This additional efficacy could translate into approximately 11-16 per cent extra protection against cervical cancer over and above the protection afforded by efficacy against HPV 16 and 18 alone. In India, the same five HPV types are responsible for almost 90 per cent cervical cancer cases. "These results amply demonstrate that preventive vaccination is one of the most effective methods of primary prevention of HPV infection, the necessary cause of cervical cancer. In tandem with screening tests, it is perfectly positioned to lend a decisive edge against this deadly cancer. Extending the scope of protection beyond types 16 and 18 will allow prevention of the vast majority [...]

2009-08-21T04:48:45-07:00August, 2009|Oral Cancer News|

New evidence supports HPV vaccine

MONDAY, July 6 (HealthDay News) -- The human papillomavirus (HPV) vaccine is highly effective at preventing precancerous cervical lesions that can lead to cervical cancer, a new study shows. The researchers also found that the HPV-16/18 AS04-adjuvanted vaccine also appears to protect against other cancer-causing HPV types closely related to HPV-16/18, most notably HPV-31 and HPV-45. The study of women aged 15 to 25, who received three vaccine doses over six months, found that it was as much as 98 percent effective against HPV-16/18, and between 37 percent and 54 percent effective against 12 other cancer-causing HPV types. HPV-16/18 causes about 70 percent of cervical cancer cases, while the remaining 30 percent of cases are caused by other cancer-causing HPV types. The cross-protective effect of the HPV-16/18 vaccine could provide an additional 11 percent to 16 percent protection against cervical cancer. "Although the importance of continued tests for Pap or HPV in vaccinated and unvaccinated women must be emphasized, HPV vaccination has the potential to substantially reduce the incidence of cervical cancer and precancer, and the numbers of colposcopy referrals and cervical excision procedures," concluded Dr. Jorma Paavonen, of the University of Helsinki in Finland, and colleagues. The study, which was funded by GlaxoSmithKline Biologicals, maker of the HPV-16/18 AS04-adjuvanted vaccine Cervarix, appears online July 7 and in an upcoming print issue of The Lancet. In an accompanying editorial, two experts wrote that men must also be included in efforts to halt the spread of HPV. "Currently, the targets for [...]

2009-07-10T15:34:24-07:00July, 2009|Oral Cancer News|

‘Poor knowledge’ on cervical cancer

Source: The Press Association Author: Staff More than one in three girls does not know the causes of cervical cancer despite the "Jade Goody effect", a new poll suggests. A total of 38% of girls said they were unaware of the causes even though Goody - a former Big Brother star - raised the profile of the disease. Goody died in March aged 27 after a battle with the cancer, which had spread around her body. Anecdotal evidence from across the NHS suggests the number of women attending cervical screening has shot up as a result of her story. The poll of girls aged 12 to 18 was carried out for GlaxoSmithKline, which makes the Cervarix vaccine to protect against Human papillomavirus (HPV), which causes most cases of cervical cancer. Of the 255 girls questioned, 5% thought "sexual promiscuity" caused cervical cancer. Another 11% said "a type of virus" caused it but only 6% knew the HPV virus did. When the findings were compared with a survey of 139 girls aged 16 to 18 carried out before Goody was diagnosed, 40% said they did not know what caused the disease and 6% pointed to HPV. This could suggest that knowledge about HPV has not increased despite Goody's diagnosis. The more recent survey also found that 40% of girls thought a family history of the disease was a major factor in getting cervical cancer. Girls aged 12 to 13 are currently being vaccinated against HPV as part of an NHS campaign. [...]

2009-06-08T17:11:12-07:00June, 2009|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 [...]

Pharmaceuticals, patents, publicity…and philanthropy?

Source: The Lancet, Volume 373, Issue 9665, Page 693, 28 February 2009 Author: editorial 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 [...]

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