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 wanted to do a second surgery, opening up his neck, but by polling other experts he found a ­different team and a different option: chemo­therapy and radiation.

But it gnaws at Fowler, who thinks about vaccines all day long—Liquidia’s vaccine work made it the only startup to receive an equity investment from the Bill & Melinda Gates Foundation—that one that might prevent other boys, including his teenagers, from ever developing this cancer isn’t being used. Gardasil, one of two HPV vaccines, is already approved in boys to prevent anal and penile cancers, but because these diseases are rare, only 1% actually get it. And tests that might well prove that this Merck product can prevent the new throat cancer strain would take at least 20 years, until the boys sampled actually became sexually active and then contracted the disease.

“We’ve got this two- or three-decade window where more and more of these patients like myself are going to emerge,” says Fowler. “To me the ­[vaccine] risk is minimal, and I’d say, why not do that?”


The incidence of HPV throat cancer is rising

A big part of the answer is politics. Drug safety, vaccines, antibiotics and reproductive medicine—all have become proxies for the culture war, often tripping up public health in the process. Big Pharma hasn’t helped, with deep p.r. wounds that have made it anathema to both political parties. Nor has the FDA, which has shifted the goalposts on ­approving new antibiotics enough to scare away many innovators just as ­resistant bacteria have become a big health problem. Both parties undermined the FDA further by overruling it on how the Plan B emergency contraceptive should be used, weakening the agency’s authority. Now a coalition on the right is pushing to remove all testing of whether some medicines are ­effective, while many on the left still think the FDA ­remains too cozy with the drug industry.

“If you look at both sides of the political spectrum I’m amazed and appalled by the lack of knowledge that’s being put forward as knowledge,” says Robert Ruffolo, former head of research at Wyeth. “They’re not scientists, they’re not physicians, and many politicians will say almost anything during election season.”

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

HPV Vaccine Reduces All Subtypes of HPV Disease


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 3 doses of the quadrivalent HPV vaccine or placebo. They were subsequently followed for approximately 4 years.

The analysis focused on a subgroup of 2054 women who participated in these trials and who were subsequently treated for cervical, vulval, or vaginal disease.

More than half of this subgroup (1350 women) underwent cervical surgery (which included any method used to treat cervical disease) — 763 from the placebo group and 587 from the vaccine group.

The researchers calculate that the incidence of any subsequent HPV-related disease in the cervix was 6.6 in the vaccine group and 12.2 in the placebo group — a reduction of 46.2% with vaccination.

When only high-grade disease of the cervix was considered, this reduction is even greater; vaccination reduced the risk for any subsequent high-grade disease of the cervix by 64.9%.

The remaining women in the subgroup (229 in the vaccine group and 475 in the placebo group) were subsequently diagnosed with either genital warts or vulvar or vaginal intraepithelial neoplasia. Here, the incidence of any subsequent HPV-related disease was 20.1 in the vaccine group and 31.0 in the placebo group — a reduction of 35.2% with vaccination.

This was primarily driven by a reduction in the incidence of genital warts (63% reduction after vaccination), the authors note.

In all cases, the reduction was for all subtypes of HPV-related disease, including strains of HPV virus that were not included in the vaccine.

New Findings Welcome

These findings are “welcome,” Dr. Kim writes.

This study “moves us closer to understanding the full scope of benefits from HPV vaccination by showing for the first time that vaccine protection against disease can endure beyond the management of HPV-related disease in women already vaccinated,” she adds.

However, Dr. Kim takes issue with some of the conclusions drawn by the authors.

This study corroborates previous findings that the benefits of vaccination are not limited to the primary target group of young sexually naïve girls, Dr. Kim explains. The findings highlight the importance of vaccinating at an early age, when exposure to HPV is minimal, to maximize protection against all HPV types targeted by the vaccine.

Most important, she adds, this study examines a unique subgroup of women who were vaccinated before their first treatment for HPV-related disease. The authors suggest that these results could be generalized to women who are considering HPV vaccination after treatment for HPV-related disease, but Dr. Kim disagrees, and suggests that more data are needed.

“Only surveillance of vaccinated populations in the real world can provide clear evidence of the effectiveness of the vaccine in women who have been treated before vaccination,” Dr. Kim writes. “As we await this information, it is important to emphasize to providers and decision makers that generalizations of study findings are premature.”

The study was funded by Merck & Co. Dr. Joura reports receiving advisory board fees from Merck; and lecture fees from Merck, Sanofi Pasteur MSD, and GlaxoSmithKline. Several coauthors are employees of Merck & Co, and several report receiving funding from Merck and GlaxoSmithKline for HPV vaccine studies, and from other pharmaceutical companies. Dr. Kim has disclosed no relevant financial relationships.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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 in Medicine in 2008 for his pioneering discovery of the role of human papilloma virus (HPV) in the development of cancer of the cervix. He currently is professor emeritus, after having served as Chairman of the Management Board and Scientific Director of the German Cancer Research Center, Heidelberg, Germany.

Zur Hausen said approximately 275,000 women die each year of cervical cancer, some 85 percent in economic-constrained countries, with more than 500,000 new cases appearing in women globally each year.

About the SGO
The Society of Gynecologic Oncology (SGO) is a national medical specialty organization of physicians and allied healthcare professionals who are trained in the comprehensive management of women with malignancies of the reproductive tract. Its purpose is to improve the care of women with gynecologic cancer by encouraging research, disseminating knowledge that will raise the standards of practice in the prevention and treatment of gynecologic malignancies, and cooperating with other organizations interested in women’s health care, oncology and related fields. The Society’s membership, totaling more than 1,600, is primarily comprised of gynecologic oncologists, as well as other related medical specialists including medical oncologists, radiation oncologists, nurses, social workers and pathologists. SGO members provide multidisciplinary cancer treatment including chemotherapy, radiation therapy, surgery and supportive care. More information on the SGO can be found at

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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 cancer screening.

About 20 million Americans currently have an HPV infection, and an estimated 7,080 men and 14,720 women develop cancers associated with HPV types 16 and 18 every year, according to the CDC.

An estimated 80% of anal cancers, 65% of vaginal cancers, 50% of vulvar cancers, 35% of penile cancers and nearly all cervical cancers are HPV-related. Roughly 60% of oropharyngeal cancers are associated with HPV.

Disclosure: The researchers report no relevant financial disclosures.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Viruses recruited as killers of tumors

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 create viruses that are too weak to damage healthy cells yet strong enough to invade and destroy tumor cells. It has been a long, difficult challenge.

Researchers started down this road in 1904, when they discovered that women with cervical cancer temporarily recovered when given a rabies vaccination. By midcentury, physicians were administering live viruses to cancer patients. They tried infecting terminally ill children with polio and adenovirus. They injected patients with concoctions from the feces of normal children, from sick chickens, and from “feline spleen suspension” of rural kittens infected with “cat plague.”

These experiments proved ill fated. The cancer returned, or — in the worst cases — the injections themselves caused “the development of lethal infection in the host,” according to a 1964 American Journal of Pathology report.

The field was abandoned for a time. But in 1991, Dr. Martuza seized upon the idea of using the herpes simplex virus (HSV-1) as a cancer-fighter.

The genome of HSV-1 is comparatively large and can accommodate a number of mutations and deletions. Dr. Martuza weakened the virus by removing some of its genes. The modified virus was injected into mice with brain cancer, and it did bring about remission. But most of the mice died of encephalitis.

In 1990, Bernard Roizman, a virologist at the University of Chicago, found a “master gene” in the herpes virus. When this gene is removed, the virus no longer has the strength to overcome healthy cells’ defenses. As it turned out, the modified virus was so crippled that it could only slow tumor growth.

Then, in 1996, Dr. Ian Mohr, a virologist at New York University, stumbled on a way of further altering Dr. Roizman’s crippled virus. He exposed it repeatedly to cancer cells until a new viral mutant evolved with the ability to replicate in those cells.

Dr. Mohr and a doctoral student, Matt Mulvey, then engineered a way for their virus to evade the immune system, making it an even more potent cancer-killing agent.

Unlike chemotherapy, which can diminish in effectiveness over time, oncolytic viruses multiply in the body and gain strength as the infection becomes established. In addition to attacking cancer cells directly, some also produce an immune response that targets tumors.

Today, several potential cancer-fighting viruses are in trials, including two in Phase 3 trials.

An engineered form of vaccinia — the viral agent that helped eradicate smallpox — is being tested against advanced liver cancer, the third leading cause of cancer deaths globally. In a recent trial, survival for patients treated with high doses of the virus, called JX-594, doubled to 14 months from 7, compared with that of patients treated with low doses.

“To see that kind of response in a randomized trial is simply unheard of,” said Tony Reid, the director of clinical investigation at the Moores Cancer Center of the University of California, San Diego, who has no financial ties to the virus’s manufacturer.

A herpes virus based on Dr. Mohr’s original discovery is in advanced trials against melanoma; initial data showed a 26 percent response rate in patient regression and survival. A reovirus is being tested against head and neck cancers, often difficult to treat.

According to the researchers, the side effects of treatment with these viruses are minimal, and include nausea, fatigue and aches. “In comparison to what happens with standard chemotherapy, flulike symptoms are very manageable,” said Dr. Reid, who has treated hundreds of patients with oncolytic viruses.

Oncolytic viruses are likely to find a place in medicine, especially paired with other therapies targeting difficult and aggressive tumors, said Gary Hayward, a virologist at the Johns Hopkins Herpesvirus Research Program. But the “biology is complex,” Dr. Hayward warned, and progress is likely to be incremental.

Dr. Mulvey now heads a firm in Baltimore testing viruses to fight melanoma and bladder cancer. The biggest challenge now, he said, is simply convincing others that the new treatment is “not science fiction.”

“Thankfully, that hurdle is diminishing,” he said.

Canadian provinces weighing HPV vaccination of boys

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 208.2 (1.6), oral cavity 853.1 (6.5) and oropharynx 84.3 (0.64). The estimated portion of those cancers that are attributable to HPV is 63% for penal cancer, 92% for anal cancer and 89% for both oral cavity and orapharyngeal cancer.

The committee also advised that the provinces weigh whether an HPV vaccination program for boys is preferable to campaigns designed to increase female vaccination rates.

It also cautioned provinces against making the presumption that vaccinating boys would lower cervical cancer rates among girls. “While current models predict that addition of males to a routine HPV vaccination program would prevent additional cases of genital warts and cervical cancer among females to varying degrees, this is based on assumptions that such transmission from males to females will be reduced, rather than observational data.”

Data on the economic burden of HPV is often highly conditional on a series of assumptions. The Canadian Consensus Guidelines on Human Papillomavirus issued by the Society of Obstetricians and Gynaecologists of Canada in 2007 projected the annual economic burden at $300 million, with the bulk of that — $244 million — representing the cost of “more than 9.3 million Pap tests that produce negative or false-positive results; the rest ($53.7 million) is due to true genital or cervical disease. HPV types 6, 11, 16, and 18 are thought to be responsible for 100% of the cost of genital warts ($9.2 million), 36% of the cost of CIN 1 [cervical intraepithelial neoplasia] (total cost $15.7 million), 61% of the cost of CIN 2/3 (total cost $14.5 million), and 73% of the cost of cervical cancer (total cost $13.6),” (

The cost of a three-dose HPV vaccination, meanwhile, is generally projected to be in the neighbourhood of $450–$500. That can quickly add up, as evidenced by the decision to vaccinate girls aged 11–14, which in 2007 resulted in a federal government allocation of $300 million over three years.

Whether the federal government might provide a similar chunk of funds to vaccinate boys is unknown, says Dr. John Spika, director general of the Public Health Agency of Canada’s Centre for Immunization and Respiratory Infectious Diseases.

Naus notes that lower incidence rates of oral, anal and penile cancer, as compared with cervical cancer, make it much harder to justify the outlay of tax dollars for a generalized campaign for boys. She also indicated the provinces are awaiting the findings of a Public Health Agency of Canada commissioned cost–benefit analysis of HPV vaccination of boys expected to be completed this spring.

The provinces must also grapple with the advisory committee’s precaution that a program for boys must be weighed against measures designed to increase vaccination take-up by girls.

The Federation of Medical Women of Canada argues that vaccinating boys makes sense when there is a low uptake among girls, so it urges gender equity in the funding of HPV vaccination.

If a prove has less than an 85% uptake among girls, there is a benefit to immunizing both sexes, says Dr. Vivien Brown, a member of the federation’s board. “You cannot eradicate disease by simply vaccinating one sex,” Brown says. “We don’t have fantastic uptake of vaccine in women.”

Naus notes that the vaccination rate among eligible girls in BC is now 70% and climbing annually at a rate of 5%. But Brown notes the rate is only 55% in Ontario.

The provincial government is awaiting advice from Public Health Ontario before deciding whether to provide HPV vaccination of boys, says David Jensen, a spokesman for the province’s Ministry of Health and Long-Term Care, while Quebec is awaiting advice from its public health institute, says Stephanie Menard, a spokesperson for the Quebec Ministry of Health and Social Services.

Spika says another major consideration is whether the intent of a vaccination program will be to prevent only HPV-related cancers, or all HPV infections.

Both the Canadian and US advisory panels recommended against the use of one of those vaccines (Cervarix) for boys, on the grounds that its efficacy has not yet been proven.

Cervarix is not yet approved in Canada for use in boys but if it does become available and a province chooses to target only cancer-causing strains of HPV, that might reduce costs, Spika says. “Obviously, it’s a competitive process, and having two products on the market is better than one.”

No decisions are expected to be taken by provinces until the Canadian Immunization Committee, which represents provincial governments, finalizes its position on the issue.

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 that this cancer is a sexually transmitted disease, requiring oral sexual contact. It also explained why we’re seeing an epidemic of oral cancers and why it’s more common in men — who are three times as likely to get HPV-related cancer — and those who have had many sexual partners.

Q. So if oral sex is connected to oral cancers, why are we just seeing an increase now?

A. Because sexual encounters have changed over the last 30 or so years. The age of the first oral sexual encounter has dropped by about a decade and half since the 1980s and the number of people engaging in the practice has increased too. … We think mostly due to the AIDS epidemic and people trying to protect themselves. So, as oral sex became more common, so did oral cancers. The cancers take 20 to 30 years to develop, so sexual practices during your teens and 20s may put you at risk for cancer in your 50s. So those engaging in risky behaviors now may be setting the stage for later.

Q. There are many types of HPV, but only one type is linked to oropharynx cancer?

A. That’s essentially right. HPV-16 is strongly linked with oral cancer. That form was only found in about 1 percent of the people and, of those, less than 15,000 actually develop cancer.

Q. Do we know if the HPV vaccine that is supposed to protect against cervical cancer is also effective against HPV-related oral cancer?

A. Right now we do not know. There are some key immunologic differences between how our bodies respond to infections in the cervic and oral cavity. Nonetheless, we think the vaccines will be protective and they are approved for both females and males. Remember, these are preventative vaccines, so one has to be immunized before exposure to the virus — that is, before sexual contact.

Q. Is there any kind of screening for early detection?

A. No. We are working on that, but right now there is no “pap smear” for HPV-related oropharynx cancer.

Q. What are the symptoms for these oral cancers?

A. Sore throat, difficulty swallowing, a change in your voice or speech. If you have a lump in your neck that doesn’t go away in a week or two — those are all symptoms that you’d want to get evaluated by your doctor.

Q. As someone who has studied all oropharynx cancers for 12 years, what would you like people to know? Most Americans think if they’ve never smoked, it’s one disease they don’t have to worry about. A false sense of security?

A. Most patients with HPV-related oropharynx cancers never smoked. Yes, smoking increases your risk for head and neck cancer and everyone should talk to their doctor about stopping. But even if you have never smoked, you can still get oropharynx cancer, so if you have some worrisome symptoms, get them evaluated.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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

HPV a gender-neutral killer


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 Stolle, to at least get information about the vaccine to Virginia parents so they can make their own decision. Stolle is an obstetrician-gynecologist from Virginia Beach.

But conservative politicians and parents contend the vaccine will only encourage minors to have unprotected sex. As if the dim prospect of possibly developing cervical cancer in 20 or 30 years ever encouraged abstinence in teens.

The flip side of that reasoning, of course, is that if minors do have sex, they deserve whatever they get.

Vaccine proponents are gnashing their teeth. If only HPV weren’t identified as a “female problem,” they say, maybe lawmakers would take it more seriously. More compassionately. Maybe they’d give a damn.

Well, good news for everybody:

Researchers now predict that HPV will soon cause more head and neck cancers than cervical cancers.

A study published in the Journal of Clinical Oncology last October claims that rates of oropharyngeal cancer — a type of oral cancer — has jumped dramatically in the U.S. since 1984, “with HPV-related tumors accounting for a growing majority of new cases.”

“These increases may reflect increases in sexual behavior,” wrote the study’s lead author, Maura Gillison, “including increases in oral sex.”

Gillison is professor of medicine and Jeg Coughlin Chair of Cancer Research at The Ohio State University Comprehensive Cancer Center in Columbus.

In 1984, only 16 percent of oral cancer was HPV-related. By 2004, that number had rocketed to more than 72 percent. Based on these rates, researchers predict the incidence of oropharyngeal cancers will outpace cervical cancer by 2020.

The kicker? The HPV vaccine would also prevent virtually all HPV-positive oral cancers.

Do you think this revelation will sway social conservatives to stop the repeal?

Hell no. If anything, it will only convince holier-than-thous that the vaccine must be banished not only from Virginia public schools, but from the face of the God-fearing earth.

You see, such people can’t be reasoned with. They don’t care that a woman can stay chaste till marriage, only to be infected by a bridegroom who didn’t. They don’t care that a woman — or a child — can be raped. They don’t care that a woman can trust too much or make the wrong choices. They don’t care that men account for much of the increase in oral cancers.

And these people are in Richmond — running roughshod.

That’s not just a woman’s problem. That’s everybody’s problem.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.



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 years longer than that shown in the present trial.5 Sustained increased antibody titres and absence of breakthrough HPV-16/-18 outcomes in progressively longer follow-up of vaccinated cohorts are encouraging signs; even without boosters, protection for 10—15 years after primary immunization would prevent HPV-16/-18 infection at its peak incidence, lead to a sharp reduction in the secondary peak incidence of precancers, and eventually provide a proportional reduction in cancer. Life-long immunity is not a requirement for vaccine success, in view of the typically long latency between HPV acquisition and cancer outcome. With current vaccines administered at perimenarche, protection against HPV infection might last long enough to prevent most cervical cancers in that birth cohort.

The substantial cross-protection Cervarix provides against some other oncogenic types, especially against HPV-31/-33/-45, increases its effectiveness for prevention of pre-cancer and cancer, beyond the more limited cross-protection reported for Gardasil. The optimistic predictions about HPV vaccination are confirmed: we now know that Cervarix and Gardasil can have substantial public-health benefit. High coverage with Cervarix or Gardasil vaccination would probably prevent a substantial numbers of cancers, as the investigators note for Cervarix. Data from randomised trials and post-licensure monitoring support decisions by public-health agencies that both vaccines are generally safe and effective, although more extensive safety data to rule out rare or late adverse events are needed and pending. Either vaccine will likely not only prevent cervical cancer, but also a substantial proportion of vulvar and vaginal cancer, anal cancer,6 and possibly oropharyngeal cancer.

Now that Cervarix and Gardasil are proven effective, licensed, and in broad use, what remaining HPV-vaccine-related public health questions are most important? The choice of vaccine might be more of a commercial battle than a crucial public-health issue. The two vaccines are slightly different in preparation and activity. On the one hand, possibly because of its novel adjuvant, Cervarix shows increased cross-protection and generates higher antibody titres than Gardasil after vaccination. We are not sure whether higher titres immediately after vaccination lead to longer duration of protection, and do not know if cross-protection will last as long as protection against the targeted HPV types. On the other hand, Gardasil provides important population coverage against genital warts. Both vaccines are beneficial and it is difficult to decide between them. Universal uptake of vaccination with Cervarix, the present version of Gardasil, or a nine-type version of Gardasil that is in final trials, which protects against seven oncogenic types (HPV-16/-18/-31/-33/-35/-52/-58) plus HPV-6/-11, would likely prevent more than two-thirds of cervical cancers.

Accordingly, we believe that increasing coverage, particularly of sexually-naive adolescent females, is now the most important public-health issue in HPV vaccine efforts. Based on the aggregate data, including those presented by Lehtinen and colleagues and Wheeler and colleagues, we advocate focusing vaccination efforts in this core population to reduce cervical (and other) cancers. The irrefutable public-health benefit from a concerted effort to vaccinate adolescent females need not await resolution of contentious questions of whether to initiate catch-up or mid-adult female vaccination, or a decision on whether Gardasil is cost-effective for adolescent males, among whom vaccination might reduce HPV-related oropharyngeal, penile, and anal cancers.

We are particularly concerned about low vaccination rates in areas where cervical cancer incidence and mortality are high because of inadequate alternative prevention through effective cervical screening, and where nine of 10 cervical cancer deaths occur. Needed new developments that would promote vaccine coverage in these areas, and globally, include an inexpensive HPV vaccine, a formulation that does not require a cold chain to keep the vaccine frozen until administration, or a vaccine that requires only a single dose. The current vaccines are too expensive and difficult to deliver for many low-resource regions. Based on strong immunogenicity in younger adolescents, some regions in Canada and Mexico have decided to administer only two doses of vaccine, with plans to evaluate ongoing efficacy 5—10 years later. New evidence suggests that two doses of Cervarix provide adequate protection against HPV-16/-18 for at least 4 years; comparable data for Gardasil have not yet been presented.

Long-term proof of the safety of HPV vaccines is a public-health priority; uptake will increase as public trust in vaccine safety increases. One safety issue that would benefit from more data (currently being collected) is whether there is any link between vaccination during early pregnancy and miscarriage.
The exciting proof-of-principle phase of vaccine development is over. The practical aspects of vaccine uptake are now the most important issue in HPV vaccine research from a public-health perspective. Increasing uptake through further technological refinements and adaptations to regional circumstances will be the most effective ways to achieve wide-scale high coverage and fulfill the promise of HPV vaccination.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.













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



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 of oropharyngeal cancers, and HPV-related noncervical cancers (penile, anal, and oropharyngeal) may exceed the incidence of cervical cancer within a decade in industrial countries, where cervical screening is effective, causing reevaluation of male HPV immunization. In developing countries, few women are screened for cervical precancerous lesions, making immunization even more important. Currently, 26 primarily industrial countries routinely immunize girls with HPV vaccine, and GAVI will begin to accept applications in 2012 to fund vaccine in developing countries that can deliver the vaccine and if GAVI can negotiate an acceptable price (one manufacturer has already offered a price of $5 per dose). Cancer Prev Res; 5(1); 24–29. ©2012 AACR.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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