The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine

Source: Forbes Magazine, written by Matthew Herper Neal Fowler, 50, the chief executive officer of a tiny biotech called ­Liquidia, was assuming a position common to road-warrior entrepreneurs: leaning his elbows on the seat-back tray in an airplane so he could gaze at the screen of his laptop. That’s when he felt the lump in his neck. Fowler, a pharmacist, figured his lymph node was swollen by a recent cold, but the oncologist seated next to him—his chairman of the board—thought they’d better keep an eye on it. The chairman was right. Over the next week the lymph node got bigger and harder. It was not sore to the touch, as happens during a cold. Fowler went to the doctor, then a specialist who knew exactly what he was seeing: a new form of throat cancer that ear, nose and throat specialists across the U.S. now say dominates their practices. Some 8,000 of these tonsil tumors turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer. Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing. His prognosis was good—80% of those with this new tumor survive. His status as a drug industry veteran and chief executive of a biotechnology company didn’t hurt, either. He went from diagnosis to having the primary tumor removed from his tonsil in just a day. His first team of doctors [...]

2012-04-05T21:25:34-07:00April, 2012|Oral Cancer News|

HPV Vaccine Reduces All Subtypes of HPV Disease

Source: Medscape.com Human papillomavirus (HPV) vaccination substantially reduced the risk for subsequent HPV disease in women who already had 1 bout of HPV-related disease, according to a study published online today in BMJ. "These are, to our knowledge, the first results in vaccinated women who have undergone treatment for HPV-related disease," write the authors, headed by Elmar Joura, MD, from the Medical University of Vienna in Austria. The data come from a subgroup of women who participated in trials of the quadrivalent HPV vaccine Gardasil (Merck & Co). Women who had HPV infection at the time of vaccination and who developed cervical, vulvar, or vaginal HPV disease had a substantially reduced risk of developing subsequent HPV-related disease after the first definitive treatment. HPV vaccination substantially reduced the risk for subsequent HPV disease — not only that caused by the 4 viral strains in the quadrivalent vaccine (HPV subtypes 6, 11, 16, and 18), but also that caused by other strains of HPV-related disease. This study "reinforces much of what we already know about the protective properties of the quadrivalent vaccine, including cross-protection against nonvaccine HPV types and vaccine benefit despite HPV exposure," writes Jane Kim, assistant professor of health decision science at Harvard School of Public Health, Boston, Massachusetts, in an accompanying editorial. Subgroup of Women The study analyzed data collected from 2 large company-sponsored placebo-controlled trials of Gardasil, known as FUTURE I and FUTURE II. Together, they involved 17,622 women 15 to 26 years of age who were randomized to receive [...]

2012-04-02T09:21:38-07:00April, 2012|Oral Cancer News|

Nobel Laureate Makes Strong Case for Vaccinating Young Males Against HPV to Prevent Cervical Cancer in Females

Source: Therapeutics Daily AUSTIN, Texas, March 26, 2012 /PRNewswire-USNewswire/ -- Nobel Prize winner Harald zur Hausen called for vaccinating both young males and females for human papilloma virus (HPV) in an achievable quest to eradicate cervical cancer, which is the second leading type of women's cancer worldwide. Zur Hausen made his remarks at a gathering of more than 1,600 members of the Society of Gynecologic Oncology during its 43rd Annual Meeting on Women's Cancer® in Austin. "If we wish to eradicate these types of infections – then theoretically we can do it," zur Hausen said. "And if we wish to achieve this (eradication of HPV) in a foreseeable period of time, then we should vaccinate both genders globally." He pointed out that educational, cultural and religious barriers contribute to the lack of knowledge or willingness to address or discuss the subject by public health officials, teachers, parents and even some physicians. Zur Hausen also said that if society were to vaccinate just one gender to prevent the spread of cervical-cancer causing HPV, it would be more effective to vaccinate just males, highlighting the potential medical value of male HPV vaccinations. Zur Hausen also noted that research shows that early fears of the side effects of the HPV vaccine were overblown, and Australian research shows that there is about one adverse reaction in 100,000 vaccinations, which confirms the safe nature of the vaccine. Keynote speaker for this year's Annual Meeting on Women's Cancer, Harald zur Hausen was awarded the Nobel Prize [...]

2012-03-27T09:45:37-07:00March, 2012|Oral Cancer News|

AAP Now Recommends HPV Vaccine for Boys and Girls

Source: HemOnc Today The American Academy of Pediatrics Committee on Infectious Diseases issued an updated policy statement on human papillomavirus vaccination that recommends both boys and girls be immunized. The policy statement notes vaccination reduces the incidence of sexually transmitted infections and reduces cancer risk. “Persistent infection with high-risk HPV types is responsible for most cervical and anal cancers in females,” the statement reads. “In males, high-risk HPV types are responsible for a large proportion of cancers of the mouth and pharynx, which are increasing in recent years, and of anal and penile cancers.” There currently is one approved HPV vaccine (HPV4; Gardasil, Merck) for boys and two vaccines — HPV4 and HPV2 (Cervarix, GlaxoSmithKline) — approved for girls. The committee recommended that: Girls aged 11 to 12 years should receive three doses of HPV2 or HPV4 — administered intramuscularly at 0, 1 to 2, and 6 months — even if they already are sexually active. Boys aged 11 to 12 years should receive three doses of HPV4 using the same schedule. Females aged 13 to 26 years and males aged 13 to 21 years who were not previously immunized or who are missing a vaccination should complete the full series. Men aged 22 to 26 years who were not immunized previously or who are missing a vaccination may receive the HPV4 series, but “cost-efficacy models do not justify a stronger recommendation in this age group.” The policy statement recommended that women who receive the vaccine continue to undergo cervical [...]

2012-03-21T10:35:17-07:00March, 2012|Oral Cancer News|

Viruses recruited as killers of tumors

Source: nytimes.com Author: Rachel Nuwer In 1951, a 4-year-old boy with leukemia contracted chickenpox. His liver and spleen, swollen by the cancer, soon returned to normal, and his elevated blood cell count fell to that of a healthy child. His doctors at the Laboratory of Experimental Oncology in San Francisco were thrilled by his sudden remission, but the blessing was short-lived. After one month, his leukemia returned and progressed rapidly until the child’s death. In the early 1900s, not much could be done for cancer patients. Unless surgeons could excise a tumor, the disease typically spelled a swift and inevitable end. But in dozens of published cases over the years, doctors noticed a peculiar trend: Struggling cancer patients sometimes enjoyed a brief reprieve from their malignancies when they caught a viral infection. It was not a coincidence. Common viruses sometimes attack tumor cells, researchers discovered. For decades, they tried to harness this phenomenon, to transform it into a cancer treatment. Now, after a long string of failures, they are nearing success with viruses engineered to kill cancer. “It’s a very exciting time,” said Dr. Robert Martuza, chief neurosurgeon at the Massachusetts General Hospital and professor of neuroscience at Harvard Medical School. “I think it will work out in some tumor, with some virus.” Candidates are already in advanced trials, he noted. Cancer cells are able to replicate wildly, but there’s a trade-off: They cannot ward off infection as effectively as healthy cells. So scientists have been looking for ways to [...]

Canadian provinces weighing HPV vaccination of boys

Source: www.cmaj.ca/ Author: Laura Eggertson Provinces weighing the merits of implementing the National Advisory Committee on Immunization's recommendation to offer human papillomavirus (HPV) vaccine to boys and men aged 9–26 are facing a tricky trade-off between benefits and costs. “I think the benefits are there, but the costs are high,” which is a crucial issue for publicly funded programs, says Dr. Monika Naus, medical director of immunization programs and vaccine-preventable diseases for the British Columbia Centre for Disease Control. The National Advisory Committee on Immunization last month recommended extending the human papillomavirus vaccine to boys and men aged 9 to 26 “for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, anal cancer, and anogenital warts”. The move followed on the heels of an October 2011 recommendation from United States Centers for Disease Control and Prevention advisory panel recommendation that HPV vaccine be given to boys aged 11–12 to ward off genital warts, anal cancer and “possibly” head and neck cancer. In deciding whether to proceed, the provinces should note that “the public health and economic burden of AGWs [anogenital warts] in Canada is considerable, particularly among men whose incidence rates and incidence rate ratios compared to females have been increasing in recent years,” the committee stated. The committee’s report also noted that the number of annual cases (and average annual incidence per 100 000) of penile cancer among men in Canada is 127.4 (1.0 per 100 000), while the number for cancer of the anus is [...]

2012-02-26T10:01:29-07:00February, 2012|Oral Cancer News|

HPV Connected to Oral Cancers Too

Source: Chicago Tribune It's common knowledge that HPV — or human papillomavirus — is linked with cervical cancer, thanks to the controversy over the vaccine. But far fewer people know that this same sexually transmitted viral strain is connected to oral cancers, according to a new study, recently published in the Journal of the American Medical Association. For years, clinicians thought these kinds of cancer — affecting the tongue and tonsil areas — were almost exclusively caused by tobacco use, since they mostly struck heavy smokers and drinkers. But according to Dr. Maura Gillison, an oncologist and researcher at Ohio State University, it's not cigarettes that are the culprit, but oral sex. The good news: Most people with oral HPV will never develop cancer. Dr. Ezra Cohen, a specialist in head, neck, thyroid and salivary gland cancers at the University of Chicago, helped explain what it all means: Q. In general, mouth cancers are increasing? A. Oropharynx cancer is on the rise dramatically. It's gone up 3 percent a year for the last three decades and will surpass all other sites for head and neck cancers. Q. And HPV-positive oral cancers? A. They will surpass cervical cancers within the next three years. It's only relatively recently that we've come to realize the scope of HPV-related cancers. Q. What have we learned from this study? A. Quite a lot, actually. It told us about prevalence — that about 7 percent of adults in the U.S. are infected with oral HPV... and [...]

2012-02-15T10:45:22-07:00February, 2012|Oral Cancer News|

HPV a gender-neutral killer

Source: DailyPress.com Socially conservative lawmakers will likely repeal Virginia's requirement that schoolgirls get vaccinated against a sexually transmitted virus called HPV that can, and now will, kill many of them. They're repealing it in the name of sexual abstinence, family values and apple pie. In the name of keeping government out of private health-care decisions — and, yes, they say that with a straight face. A body count doesn't bother them. Virtually all cervical cancer is caused by the human papillomavirus, which infects about 80 percent of sexually active adults by age 40. Most don't even know they have it. But, in some women, the virus mutates cells lining the cervix, turning them into cancerous lesions. About 12,000 women each year are diagnosed with cervical cancer, and 4,000 of them will die of it, according to the National Cancer Institute. This vaccine would prevent nearly all that cancer. All that death. Yet for moral reasons, not medical, the GOP-controlled House voted last month to eliminate the state's 2007 requirement that girls receive the vaccine before enrolling in sixth grade. (The vaccine is most effective before the onset of sexual activity.) The bill now goes to the GOP-controlled Senate, where it's also expected to pass. Lawmakers in Richmond weren't swayed by appeals to conscience, to logic or to medicine. They didn't care that the law already allows parents to decline the vaccine for their child for any reason whatsoever. They even rejected an amendment by a socially conservative colleague, Del. Chris [...]

2012-02-15T10:16:31-07:00February, 2012|Oral Cancer News|

Success of HPV vaccination is now a matter of coverage

Source: The Lancet Oncology, Volume 13, Issue 1, Pages 10-12, January 2012 In a pair of articles in The Lancet Oncology, Lehtinen and colleagues and Wheeler and colleagues present 4-year end of study data from a trial of a prophylactic human papillomavirus (HPV)-16/-18 vaccine (Cervarix, GlaxoSmithKline) in young women aged 15-25 years. From a public-health perspective, these studies have several important contributions. The results assure us that among HPV-naive women in the 15—25 year age range, Cervarix has extremely high efficacy against HPV-16/-18-associated persistent infection, CIN2, and CIN3 or worse, the best ethical surrogate endpoint for prospective studies of invasive cervical cancer risk. Combined with other trials of Cervarix and Merck's quadrivalent Gardasil vaccine against HPV-16/-18/-6/-11,3 the evidence is strong for near 100% prophylactic vaccine efficacy in HPV-naive women at any age. Nonetheless, even with vaccine efficacy near 100% in HPV-naive women, the efficacy in the total vaccinated cohort decreased steeply with increasing age, showing an absence of therapeutic effect against already-acquired infections and associated lesions. We know from natural history studies that new HPV transmission (incidence, not prevalence) decreases with age in most cultures.4 Together, natural history data and results of trials for both vaccines suggest that vaccination before sexual debut, or around the time of menarche, will achieve the greatest reduction in cervical cancer rates. The 4-year trial data shows no decline in vaccine efficacy in HPV-naive women with time since vaccination.1 We know from other trials of the two vaccines that the duration of protection is several [...]

Preventing Cancer with Vaccines: Progress in the Global Control of Cancer

Source: CancerPreventionResearch.AACJournals.org Abstract The cancer control community is largely unaware of great advances in the control of major human cancers with vaccines, including the dramatic control of hepatocellular (liver) cancer with hepatitis B virus (HBV) vaccine, now used routinely in more than 90% of countries. The biotechnology revolution has given us a new generation of highly effective vaccines against major global killers, global funding for immunization is orders of magnitude higher than ever before, and the vaccine delivery infrastructure has improved very significantly even in the poorest countries. Liver cancer is the greatest cause of cancer deaths in men of sub-Saharan Africa and much of Asia. Even in highly endemic countries such as China, the prevalence of HB surface antigen carriers has fallen from 10% to 1%–2% in immunized cohorts of children, and liver cancer has already fallen dramatically in Taiwanese children. The Global Alliance for Vaccines and Immunization (now called the GAVI Alliance) has greatly expedited this success by providing HBV vaccine free for five years in most of the world's 72 poorest countries. HBV vaccination can serve as a model for the global control of human papillomavirus (HPV)–related cervical and other cancers with HPV vaccines. Cervical cancer is the greatest cause of cancer death in women in many developing countries; HPV vaccines are highly effective in preventing HPV infection and precancerous lesions in women, and the quadrivalent vaccine also prevents genital warts in men and women and precancerous anal lesions in men. HPV is causing a growing proportion [...]

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