Monthly Archives: December 2013

Surgery beats chemotherapy for tongue cancer, U-M study finds

Source: www.eurekalert.org
Author: press release

Patients with tongue cancer who started their treatment with a course of chemotherapy fared significantly worse than patients who received surgery first, according to a new study from researchers at the University of Michigan Comprehensive Cancer Center.

This is contrary to protocols for larynx cancer, in which a single dose of chemotherapy helps determine which patients fare better with chemotherapy and radiation and which patients should elect for surgery. In larynx cancer, this approach, which was pioneered and extensively researched at U-M, has led to better patient survival and functional outcomes.

But this new study, which appears in JAMA Otolaryngology Head and Neck Surgery, describes a clear failure.

“To a young person with tongue cancer, chemotherapy may sound like a better option than surgery with extensive reconstruction. But patients with oral cavity cancer can’t tolerate induction chemotherapy as well as they can handle surgery with follow-up radiation. Our techniques of reconstruction are advanced and offer patients better survival and functional outcomes,” says study author Douglas Chepeha, M.D., MSPH, professor of otolaryngology – head and neck surgery at the University of Michigan Medical School.

The study enrolled 19 people with advanced oral cavity cancer. Patients received an initial dose of chemotherapy, called induction chemotherapy. Those whose cancer shrunk by half went on to receive additional chemotherapy combined with radiation treatment. Those whose cancer did not respond well had surgery followed by radiation.

Enrollment in the trial was stopped early because results were so poor.

Ten of the patients had a response to the chemotherapy, and of that group, only three had a complete response from the treatment and were cancer-free five years later. Of the nine patients who had surgery after the induction chemotherapy, only two were alive and cancer-free after five years.

The researchers then looked at a comparable group of patients who had surgery and sophisticated reconstruction followed by radiation therapy and found significantly better survival rates and functional outcomes.

“The mouth is a very sensitive area,” Chepeha says. “We know the immune system is critical in oral cavity cancer, and chemotherapy suppresses the immune system. If a person is already debilitated, they don’t do well with chemotherapy.”

“Despite the proven success of this strategy in laryngeal cancer, induction chemotherapy should not be an option for oral cavity cancer, and in fact it results in worse treatment-related complications compared to surgery,” Chepeha adds.

December, 2013|Oral Cancer News|

Changes in circulating microRNAs after radiochemotherapy in head and neck cancer patients

Source: 7thspace.com
Author: staff

Introduction:
Circulating microRNAs (miRNAs) are easily accessible and have already proven to be useful as prognostic markers in cancer patients. However, their origin and function in the circulation is still under discussion.

In the present study we analyzed changes in the miRNAs in blood plasma of head and neck squamous cell carcinoma (HNSCC) patients in response to radiochemotherapy and compared them to the changes in a cell culture model of primary HNSCC cells undergoing simulated anti-cancer therapy.Materials and methods: MiRNA-profiles were analyzed by qRT-PCR arrays in paired blood plasma samples of HNSCC patients before therapy and after two days of treatment. Candidate miRNAs were validated by single qRT-PCR assays.

An in vitro radiochemotherapy model using primary HNSCC cell cultures was established to test the possible tumor origin of the circulating miRNAs. Microarray analysis was performed on primary HNSCC cell cultures followed by validation of deregulated miRNAs via qRT-PCR.

Results:
Unsupervised clustering of the expression profiles using the six most regulated miRNAs (miR-425-5p, miR-21-5p, miR-106b-5p, miR-590-5p, miR-574-3p, miR-885-3p) significantly (p = 0.012) separated plasma samples collected prior to treatment from plasma samples collected after two days of radiochemotherapy.

MiRNA profiling of primary HNSCC cell cultures treated in vitro with radiochemotherapy revealed differentially expressed miRNAs that were also observed to be therapy-responsive in blood plasma of the patients (miR-425-5p, miR-21-5p, miR-106b-5p, miR-93-5p) and are therefore likely to stem from the tumor. Of these candidate marker miRNAs we were able to validate by qRT-PCR a deregulation of eight plasma miRNAs as well as miR-425-5p and miR-93-5p in primary HNSCC cultures after radiochemotherapy.

Conclusion:
Changes in the abundance of circulating miRNAs during radiochemotherapy reflect the therapy response of primary HNSCC cells after an in vitro treatment.

Therefore, the responsive miRNAs (miR-425-5p, miR-93-5p) may represent novel biomarkers for therapy monitoring. The prognostic value of this exciting observation requires confirmation using an independent patient cohort that includes clinical follow-up data.

Authors: Isolde Summerer, Maximilian Niyazi, Kristian Unger, Adriana Pitea, Verena Zangen, Julia; Hess, Michael J Atkinson, Claus Belka, Simone Moertl, Horst Zitzelsberger

Source: Radiation Oncology 2013, 8:296

December, 2013|Oral Cancer News|

Fifteen Years after Tobacco Settlement, States Falling Short in Funding Tobacco Prevention: Q&A with Danny McGoldrick

Source: Robert Wood Johnson Foundation 
Published: December 10, 2013
By: Danny McGoldrick

 

On November 23, 1998, 46 states settled their lawsuits against the nation’s major tobacco companies to recover tobacco-related health care costs, joining four states—Mississippi, Texas, Florida and Minnesota—that had reached earlier, individual settlements.

These settlements require the tobacco companies to make annual payments to the states in perpetuity, with total payments estimated at $246 billion over the first 25 years.

Yesterday a coalition of health advocacy groups released the latest edition of A Broken Promise to Our Kids, an annual report on state use of tobacco funds for tobacco prevention and cessation efforts. As in years past, the report finds that most states fall short in the amount of money they allocate to prevent kids from smoking and to help current smokers quit.

The groups that jointly issued the report include the Campaign for Tobacco-Free Kids, the American Heart Association, American Cancer Society Cancer Action Network, the American Lung Association, the Robert Wood Johnson Foundation and Americans for Nonsmokers’ Rights.

Key findings of the 2013 report include:

• Over the past 15 years, states have spent just 2.3 percent of their total tobacco-generated revenue on tobacco preventionand cessation programs.

PH2

• The states this year will collect $25 billion from the tobacco settlement  and tobacco taxes, but will spend just 1.9 percent of it—$481.2 million—on tobacco prevention programs. This means the states are spending less than two cents of every dollar in tobacco revenue to fight tobacco use.

• States are falling short of the U.S. Centers for Disease Control and Prevention’s (CDC) recommended funding levels for tobacco prevention programs. Altogether, the states have budgeted just 13 percent of the $3.7 billion the CDC recommends.

• Only two states—Alaska and North Dakota—currently fund tobacco prevention programs at the CDC-recommended level.

To discuss the ramifications of the latest edition of the Broken Promises report, NewPublicHealth recently spoke with Danny McGoldrick, vice president of research at the Campaign for Tobacco-Free Kids.PH3

NewPublicHealth: Can you give us some background on the Tobacco Master Settlement Agreement?

Danny McGoldrick: This is the 15th anniversary of the Tobacco Master Settlement Agreement, when 46 states and the District of Columbia settled their lawsuits against the tobacco companies mostly to recover the costs that they’d incurred treating smoking-caused disease in their states. Four other states had settled individually with the tobacco companies prior to the Master Settlement Agreement, and so this provided for some restrictions on tobacco company marketing; they promised never to market to kids again, which is ironic, but it also resulted in the tobacco companies sending about $250 billion over just the first 25 years of the settlement for the states to spend as they saw fit. They left that to the province of the state legislators and governors to decide how those funds should be spent.

 NPH: Why do states do with the funds not used on tobacco prevention and cessation efforts?

McGoldrick: States have used a portion of the funds to deal with budget deficits as well as a number of other things, some worthy programs. But what they haven’t done is fund tobacco prevention programs at anywhere near the levels recommended by the U.S. Centers for Disease Control and Prevention, which provides guidance not only on the amount of money the state should spend for these lifesaving and moneysaving programs, but also the science behind exactly what kind of programs to run.

These are science-based interventions that we know work when funded and implemented properly. They consist of hard-hitting media campaigns that get the word out about the dangers of tobacco use in ways that resonate with kids and with smokers to encourage them to quit. They include community-based programs that reach people where they live, work, play, and learn with messages about tobacco use, again preventing kids from starting and encouraging smokers to quit and involving young people in talking to each other about not only the harms of tobacco, but the role of tobacco companies in targeting them. And finally, they include help for smokers who want to quit. And there’s a science behind each of these interventions, but when we put them together in a comprehensive program we know they work through reduced tobacco use among both kids and adults.

NPH: On average, what percentage do the states use? Is that a good number? Does that really tell us that most states tend to use the same percentage of funds?

McGoldrick: It really varies because states are different sizes and they spend the money in different ways. What we look at is how states are spending relative to what the CDC recommends, and it’s a pretty dismal picture. Overall, states are spending only about 2 percent of the $25 billion they received in the most recent fiscal year from their master settlement payments and their tobacco taxes. This is just a travesty. Only two states are funding at the level the CDC recommends—those are North Dakota and Alaska—and only four more at spending at even half the level that the CDC recommends—those are Delaware, Wyoming, Hawaii and Oklahoma. So almost half the states, 24 states, are spending less than 10 percent of what the CDC recommends for these programs that we know work and that they have the money for. Three states are spending less than 1 percent of what the CDC recommends—New Hampshire, Alabama and Missouri. New Jersey is spending no state dollars on tobacco prevention.

So, when you look at it in terms of what the CDC recommends, when you look at it in terms of what the states are getting in terms of all of this revenue, when you look at it compared to what the tobacco companies are spending to get people to smoke and when you look at it compared to what we’re spending treating tobacco-caused disease, it just makes no sense that states aren’t doing a better job keeping the promise of the tobacco settlement.

NPH: What are the key recommendations for what states should be doing?

McGoldrick: We know that states have a lot of issues that they’re dealing with and programs that they need to fund, but it would only take about 15 percent of the revenue that states are taking in from their master settlent payments or their settlement payments and their tobacco taxes to fund these programs. So that should be priority one and would still leave tens of billions of dollars to fund other important programs in the state.

It really is penny wise and pound foolish not to invest this money because we know that states not only save lives by investing in these programs, but they save health care dollars. Tobacco-caused diseases are a big reason for the health care crisis in our states. We spend almost $100 billion every year treating tobacco-caused disease in this country, all of that absolutely and completely preventable. So when you invest in these programs, you not only save lives, you not only save kids a lifetime of addiction and premature death, but you actually reduce your healthcare costs so these programs pay for themselves. Our governors and legislators are not only not doing the right thing with the money—they’re not doing the smart thing for their own budgets. It’s really unbelievable that they could not only save lives but actually save money in the long run by investing in these programs, and they’re just making shortsighted and foolish decisions.

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

December, 2013|Oral Cancer News|

Lymphoseek designated fast track status in head and neck cancer

Source: www.empr.com
Author: press release

Navidea announced that the FDA has granted Fast Track designation to Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

Lymposeek Injection was evaluated in a prospective, open-label, multicenter, within-patient study (NEO3-06). It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection. A minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease was required. Thirty nine subjects out of over 80 subjects enrolled were determined to have pathology-positive lymph nodes.

Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before the end of 2013. Lymphoseek is already approved for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

December, 2013|Oral Cancer News|

Head and neck cancer patients improves with hyperfractioned radiotherapy

Source: health-beauty-2468.blogspot.com
Author: Kris Borowczyk

neck

Compared with the standard radiation therapy, intensified form of radiotherapy proves to be more effective in improving the survival chances of people with head and neck cancer. This is the result of studies conducted by the ECC2013 or European Cancer Congress 2013. About 11,000 patients were subject to altered fractionation radiotherapy and fractionation radiotherapy. The AFRT group showed an 8% reduction in risks for death while the other group showed nine percent in decrease. Radiation oncologist Dr. Pirre Blanchard plans to tell the congress that despite the fact that CRT or concomitant chemo radiation and chemotherapy in general is considered the standard treatment for cancer, AFRT should still be considered if patients want more intensified intervention. He said, “The CRT is not feasible because of other pre-existing conditions such as cardiac and renal diseases.” AFRT is a radiotherapy treatment intensified to be given in different schedules. It is associated with some acute side effects but not those late side effects caused by SFRT.

December, 2013|Oral Cancer News|

Certain genetic alterations may explain head and neck cancer survival disparities

Source: www.sciencecodex.com
Author: staff

Certain genetic alterations to the PAX gene family may be responsible for survival disparities seen between African-American and non-Latino white men with head and neck cancer, according to results presented here at the Sixth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Dec. 6-9.

“During the last 30 years, the overall five-year relative survival rates for head and neck squamous cell carcinoma (HNSCC) have increased, but despite that, the gap in overall survival rates between non-Latino white patients and African-American patients has remained unchanged,” said Rafael Guerrero-Preston, Dr.P.H., assistant professor at Johns Hopkins University in Baltimore, Md. “This disparity may be due to differences in genetic and epigenetic alterations among African-American patients.”

To test this theory, Guerrero-Preston and colleagues performed a two-stage epigenomic study. In the stage-one discovery phase, the researchers used next-generation sequencing and array-based technologies to evaluate 107 HNSCC samples. In the stage-two validation phase, they validated the findings of the discovery phase and evaluated their effect on survival rates in 279 patient samples from The Cancer Genome Atlas project.

“Our results highlight the differential genomic and epigenomic alterations in PAX, NOTCH, and TP53 pathways between African-American and non-Latino white HNSCC patients, which underlie the complex biology of morphologically similar tumors and explain HNSCC survival disparities,” Guerrero-Preston said. “If further validated in larger cohorts, these discoveries could be used to develop genomic and epigenomic panels that will enable more treatment options, a reduction in treatment cost, and improvement in survival rates for patients with HNSCC.”

The researchers found that African-American HNSCC patients had higher frequencies of p53, FBXW7, and NOTCH1 mutations and no differences in PAX1 or PAX5 methylation across all tumor sites combined. However, when they looked at data based on each tumor site, some differences were discovered.

African-American patients with HNSCC had higher ZIC4, PLCB1, and PAX5 promoter methylation and p53 mutations compared with non-Latino white patients. African-American patients also had no NOTCH1 mutations in nonoropharynx HNSCC. However, in the oropharynx, African-American patients had a higher frequency of combined NOTCH1 mutations and PAX1 methylation.

In contrast, non-Latino white patients with HNSCC had a higher frequency of PAX5 promoter methylation and combined p53 mutation or PAX5 methylation in the oropharynx compared with African-American patients.

All patients with greater PAX5 methylation and p53 mutations had worse overall survival, the researchers found.

Source: American Association for Cancer Research

December, 2013|Oral Cancer News|

Genetic markings could spot cancer before it develops

Source: www.thealmagest.com
Author: press release

Unique DNA markings on certain genes may “predict” the risk of developing head and neck cancer, according to new research led by Queen Mary University of London.

The findings, published in the journal Cancer, raise the potential for the development of non-invasive tests which could pick up these tell-tale signs of early cancer initiation.

Head and neck cancers are cancers that develop anywhere in the head and neck, including mouth cancer and throat cancer. About 16,000 people in the UK are diagnosed with head and neck cancer every year*.

In this study scientists analysed clinical specimens of malignant tissue from 93 cancer patients from Norway and the UK. These were compared with either tissue donated by healthy individuals undergoing wisdom tooth extractions, or with non-cancerous tissue from the same patients.

They were trying to identify whether there were any epigenetic changes in the cancerous cells which were not seen in the healthy cells. Epigenetics is the study of changes in gene expression caused by mechanisms other than changes in the underlying DNA sequence.

Not all genes are active all the time and there are many ways that gene expression is controlled. DNA methylation marks act as ‘switches’, either turning genes on or off. Abnormal DNA methylation is known to precede cancer initiation.

Lead researcher Dr Muy Teck-Teh, from the Institute of Dentistry at Queen Mary, said: “In this study we have identified four genes which were either over or under-expressed in head and neck cancer. The expression of these genes was inversely correlated with particular DNA methylation marks, suggesting the genes are epigenetically modified in these cancers.

“These epigenetic markers could be clinically exploited as biomarkers for early pre-cancer screening of head and neck cancer. However, further work is needed, as we are purely at the discovery stage at the moment and have not used this as a diagnostic test as yet.

“The eventual aim would be to test asymptomatic patients and/or people with unknown mouth lesions. An advantage of epigenetic DNA markers is that it may be possible to measure them using non-invasive specimens. So it could enable the use of saliva, buccal scrapes or blood serum for early cancer screening, diagnosis and prognosis.”

Consultant oral and maxillofacial surgeon Professor Iain Hutchison, co-author on the study, said he was excited by the possibility of diagnostic tests as a result of the research.

“All of us mouth cancer surgeons want to catch the cancer early when the chances of cure are high and the effects of surgery on the patient are minimal. A simple test using the patient’s blood or saliva could mean many patients with pre-cancer changes in the mouth or throat will be treated early and the cancer will never progress.”

The study was partly funded by the research charity Saving Faces – The Facial Surgery Research Foundation. Professor Hutchison founded the charity, which aims to reduce facial injuries and diseases through medical research.

December, 2013|Oral Cancer News|

Katie Couric show on HPV vaccine sparks backlash

Source: CBS News
Published: Thursday, January 5, 2013
By: Ryan Jaslow

 

Katie Couric’s talk show “Katie” has drawn ire from doctors and journalists for a recent segment on the HPV vaccine that presented what it called “both sides” of the “HPV controversy.”

The segment included personal stories from two moms who claim their daughters suffered serious harm from the vaccine (one of them died). In addition, the show featured two physicians: one who researched the vaccine and thinks its long-term protection benefits are oversold, and one who recommends it to her patients, in line with recommendations from the Centers for Disease Control and Prevention and the American Academy of Pediatrics.

Ahead of the show, which aired Dec. 4, Couric tweeted:

Screen shot 2013-12-06 at 12.01.48 PM

Dr. Arthur Caplan, director of the division of medical ethics at NYU Langone Medical Center in New York City, did not feel it was appropriate to juxtapose the anecdotal stories with the medical evidence. He had hoped more weight would be given to the scientific evidence of the vaccine’s safety profile and effectiveness at preventing cervical cancer.

“The show was kind of inexcusable in terms of damage done versus positive contribution,” he told CBS News.

Any time you’re vaccinating hundreds of thousands of people, Caplan said, you can expect that some people in that population will have health incidents occur. But their ailments may not necessarily be connected to the vaccine. What needs to be weighed is the cause and effect, versus what may be just coincidence. Mentioning such incidents in that context would have been one thing, but giving them more air-time than the bevy of evidence about safety and efficacy is another.

“The problem in TV and all media, (is) the human interest drives the story,” said Caplan. “In science and public health, it doesn’t, or it’s at risk of grave harm.”

“If you want to do a show every day that spotlights anecdotal claims about the health effects of cell phones or curative powers of megavitamins or dangers of airplane contrail vapors, you can certainly fill up lots of programming,” said added. “But I don’t think you’re doing anyone a service.”

While the show has certainly sparked debate, what’s not debatable is that HPV is a significant factor in cancer cases in the United States.

Human papillomavirus, or HPV, is an infection that is so common that it will occur in virtually all sexually-active people at one point or another. About 79 million Americans are currently infected with HPV, according to federal estimates.

There are more than 150 related viruses that make up HPV, but about 40 can be transmitted sexually, and some play a bigger role in causing genital warts while others increase risk for cancers of the cervix, anus, oropharynx (throat and back of the tongue), vulva, vagina and penis.

About 90 percent of genital warts are caused by the HPV 6 and 11 strains, while the majority of cancers related to the infection — about 70 percent — are caused by strains 16 and 18.

But most people won’t have a problem. The CDC points out 90 percent of all HPV infections, including the cancer-causing strains, will be cleared or undetectable in two years without any treatment, with many leaving the body within six months due natural immunity.

It’s the ones that don’t clear that are worrisome. Virtually all cervical cancer cases each year – there are 12,340 new ones expected in 2013 — are caused by high-risk strains of HPV, according to the National Cancer Institute.

Rates of oropharyngeal cancer have soared in recent years, studies have found, and HPV from oral sex is thought to be to blame, as Michael Douglas spotlighted in June by disclosing his throat cancer was caused by the infection.

That’s where vaccines aim to help, by preventing HPV in the first place. The two approved vaccines are Cervarix, which prevents HPV types 16 and 18, and Gardasil, which prevents HPV 16 and 18 as well as the genital-wart causing HPV 6 and 11 strains.

Both vaccines are given in three doses over a six-month period, recommended for females aged 13 through 26, and males between 13 and 21 years old.

“The vaccines that are available right now are one of our only protections against HPV,” Dr. Nieca Goldberg, director of the Joan H. Tisch Center for Women’s Health at NYU Langone Medical Center, told CBS News in June.

A CDC study in June reported rates of HPV strains related to genital warts and some cancers have dropped 56 percent among American teen girls since a vaccine was introduced in 2006, from 11.5 percent of 19-year-olds infected before the vaccine was introduced, to 5 percent by 2010.

Dr. Diane Harper, chair of family medicine at the University of Louisville who researched the vaccine, told Couric that the vaccine’s protection wears off after five years, so men and women could still be at risk for HPV down the road.

The CDC, however, says studies with up to six years of follow-up data have found no evidence of waning effectiveness from the vaccine, a point Caplan also emphasized. One study found even one dose was 82 percent effective, though all three doses are recommended.

The CDC adds that if 80 percent of teens got all three doses of the vaccine, an estimated 53,000 additional cases of cervical cancer could be prevented over the lifetimes of girls aged 12 and older. For every year that increases in coverage are delayed, another 4,400 women will go on to develop the disease.

That’s not to that say the HPV vaccine, or any vaccine, can’t cause side effects.

The CDC’s Vaccine Adverse Event Reporting System (VAERS) has received at least 22,000 reports of adverse events in girls and women who got the vaccine between June 2006 through March 2013. Over this time, about 57 million doses of the vaccine were distributed in the United States.

Ninety-two percent of the reported side effects were considered nonserious. They included injection-site pain and swelling, fainting, dizziness, nausea, headache, fever and hives.

The other almost 8 percent of serious side effects included headache, nausea, vomiting, fatigue, dizziness, fainting and generalized weakness.

“Editors, producers want a face,” said Caplan. “Public health wants data, statistics, and boring compilations.”

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

 

http://worldofdtcmarketing.com/irresponsible-journalism-that-can-cause-loss-of-life/in-the-news/

http://www.forbes.com/sites/matthewherper/2012/05/03/here-is-how-we-know-gardasil-has-not-killed-100-people/

 

 

December, 2013|Oral Cancer News|

Four Ways Katie Couric Stacked The Deck Against Gardasil

Source: Forbes
Published: Wednesday, December 4, 2013
 
 

This afternoon, Katie Couric ran a long segment on her daytime talk show, Katie, about what she called the “controversy” over the vaccines against human papilloma virus, or HPV, an infection that causes cervical, throat, penile, and anal cancers. She featured one mother who says that Gardasil, the HPV vaccine made by Merck , killed her daughter, and a young woman, seated with her mother, who said that Gardasil had caused years of illness that made her think she might die. (GlaxoSmithKline GSK +0.15% makes another HPV vaccine, Cervarix, that is less commonly used in the U.S.)

Katie Couric

Alongside those stories, Couric also featured two medical experts: Dr. Diane Harper, the chair of family and geriatric medicine at the University of Louisville, who helped test Gardasil but has since argued that the vaccine has been over-marketed and its benefits oversold; and Mallika Marshall, a Harvard Medical School doctor who is Couric’s in-house medical correspondent. Marshall defended the vaccine; strangely, only her arguments appear on the show’s Web site.

Despite the attempt at balance, I think most viewers will be left with the impression that the vaccine is dangerous and that its benefits don’t outweigh its risks – a conclusion that is not shared by the American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, or the Centers for Disease Control & Prevention.

Here’s how Couric stacked the deck against the HPV vaccine:

1. By downplaying the effectiveness of the vaccine: Harper argued that HPV vaccines offer only short-term protection, lasting just five years. This elicited a shocked reaction from Couric – understandably. Why would national guidelines recommend that 11-year-old girls and boys get a vaccine that wears off by the time they are sixteen?

But the statement isn’t true. It’s more true to say that the vaccine’s effectiveness can only be measured using the data we have so far, which at one point was only five years. A recent analysis of 4,900 women in Nordic countries, which use more robust medical records systems than the United States, found Gardasil “is effective up to 6 years following vaccination with a trend of continuing protection up to 8 years following vaccination.” A second analysis, conducted by Merck, also indicates that people still have immune responses 8 years after getting the shot.

“The antibody levels would indicate that immunity is going to be for many, many years beyond five years,” says William Schaffner, a professor of preventative medicine at Vanderbilt Medical School. “We don’t know for how long.”

It’s possible that Gardasil could offer lifetime protection; or patients may need a booster shot. HPV is also different than many other infections, because it takes decades to cause cancer, so protection over the short term may actually be enough.

2. By overplaying the power of Pap smears: Harper also argued that the combination of Pap smears and HPV DNA testing could catch all cervical cancer cases – she said they were 100% accurate. The tests are really incredibly accurate, and women should get them regardless of whether or not they have had the HPV vaccine. But nothing is perfectly effective, and some women will fail to get regular screening, so a vaccine may still help. “That’s a remarkable statement because that is incorrect,” says Schaffner. “She overstated the case enormously.”

3. By underplaying the risk of cancer: Harper dismissed other cancers caused by HPV as extremely rare, implying that they shouldn’t be part of a risk-benefit calculus about the vaccine. But that’s not fair. Between 2004 and 2008, the CDC estimates that there were 11,967 cases of cervical cancer caused by HPV each year and 11,726 cases of head and neck cancer, meaning they could be seen as equally big problems. Work by authors including Maura Gillison of Ohio State University, a pioneer in studying the HPV/throat cancer link, indicates that by 2025 HPV throat cancer will be more common than cervical cancer, thanks largely to pap smears and HPV DNA tests. The CDC estimates that HPV causes 26,000 cases of different cancers each year.

A caveat: use of HPV vaccines to prevent head and neck cancer has not been approved by the Food and Drug Administration, and it probably never will be, because the studies would be too difficult to conduct. In cervical cancer, researchers could look for precancerous lesions; these are harder to detect in the tonsils, where throat cancer starts.

4. By pulling viewers’ heartstrings: Couric told moving stories about vaccine risks using live interviews with people who said they had been harmed. Defenses of Gardasil were offered in dry platitudes. There were no interviews with people who suffered from cancer that might have been prevented by the vaccine.

I started writing about the link between HPV and throat cancer in 2009. Generally speaking, head-and-neck cancer caused by HPV is less deadly than other types of head-and-neck cancer. But the patient I spoke to for that story – an economist named Martin Duffy who had run 40 consecutive Boston marathons – was killed by his disease. “I made my living as a public speaker,” he told me before he died. “Now I sound like Daffy Duck.” Without his voice, he asked, “How do you tell the people that you love you love them?”

We can’t ignore the stories of the girls Couric reported on, either. She said that eleven cases allege that HPV vaccines have caused death, according to the National Vaccine Information Center, an anti-vaccine group. (For comparison, Merck has shipped 62 million doses of Gardasil.) Vaccine makers and the CDC should redouble their efforts to make sure that if there is a risk of death from the vaccine, we know that. I think Merck in particular should be making an effort to approach these families and find out if there is anything it can learn about its vaccine. Is there any biologically plausible way that Gardasil could be having these effects? It seems unlikely, but we can’t be careful enough.

But deaths – including deaths by seizures or unexplained causes – do occur for all sorts of reasons, without explanation, and just because a death happened 18 days after a vaccine was given, as in the example on Katie’s show, does not mean the vaccine caused it. So far, investigations trying to link Gardasil and Cervarix to serious side effects have come up empty.

A study of 997,000 girls in Nordic countries found no link to autoimmune, neurological, and venous thromboembolic adverse events from the vaccine. A CDC analysis published in the Journal of the American Medical Association in 2009 also found no link between HPV vaccines and serious side effects. Schaffner says the main side effects he sees are sore arms and fever.

So far, despite the fact that many families do opt not to get the vaccine, Gardasil is performing better than expected. In the seven year period ending in 2010, the prevalence of HPV infection in girls and women fell 56% to 5.1% of the population. Thomas Frieden, the director of the CDC, told NBC the reduction was “better than we hoped for.” Let’s hope that can continue.

 

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

 

December, 2013|Oral Cancer News|