U.S. health officials in recent months have received reports of pain and fainting among teenage girls who receive Merck’s human papillomavirus vaccine Gardasil, the AP/International Herald Tribune reports (Stobbe, AP/International Herald Tribune, 1/3). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which cause about 90% of genital warts cases(Daily Women’s Health Policy Report, 10/5/07).

According to health officials, about 230 cases of vaccine-related fainting among girls were reported between 2005 and July 2007. Between 2002 and 2004, there were about 50 reports of fainting. About 180 of the cases reported between 2005 and July 2007 followed a dose of Gardasil, which reached the market in 2006. In addition, some girls say the pain associated with the vaccine is short-lived, but others say it is uncomfortable driving with or sleeping on the injection arm for up to a day after receiving the shot. Merck officials attribute the pain partly to the virus-like particles in the shot. Premarketing studies showed more reports of pain from Gardasil than from a placebo, and patients reported more pain when given shots with more of the particles.

However, it is unclear whether the pain associated with Gardasil is connected with the increase in reported fainting cases, Barbara Slade, an immunization safety specialist at CDC, said. Teens tend to faint from needles, so Gardasil’s three-dose regimen for adolescents would be expected to cause more cases of fainting, she added.

Preliminary studies indicate 10% to 20% of adolescents have received at least one dose of Gardasil. Researchers said those rates are because of reasons other than worries about pain, including:

* The vaccine’s $120 per dose cost;

* Limited initial supplies; and

* Mixed feelings among some parents and doctors about a vaccine that targets a virus that can be sexually transmitted (AP/International Herald Tribune, 1/3).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2007 The Advisory Board Company. All rights reserved.

pproximately 10,000 American women will learn they have cervical cancer/HPV this year, and nearly 4,000 will die from an advanced form of the disease. This January, during Cervical Health Awareness Month, the National Cervical Cancer Coalition (NCCC) is focused on educating women about the importance of the Pap test as a screening tool for cervical cancer/HPV and about vaccines that can further reduce the burden of this devastating disease.

It’s the start of a new year – a time many reflect on their health. To start the year right, we encourage women to contact their health care provider to schedule a Pap test to check for cervical cancer. This screening is a crucial part of a woman’s health care regimen, yet one that many overlook. “It’s important to remember that cervical cancer is a preventable disease – as long as it’s caught early enough,” says Ms. Sarina Araujo, Executive Director of the NCCC.

While routine administration of Pap tests is the best means of detecting cervical cancer at an early stage, vaccines have the potential to protect women from the disease, by targeting cancer-causing types of the human papillomavirus (HPV). HPV, a virus transmitted through sexual contact, is the single known cause of cervical cancer. Two forms of the virus, HPV 16 and HPV 18, account for more than 70 percent of all cervical cancer cases. Some medical experts believe that through a successful education, screening and vaccination program for women, we will have the potential to nearly eliminate cervical cancer in the U.S.

“These vaccines represent a major advancement in women’s health and in cancer prevention. With these new tools, we may be able to help ensure no woman in the United States has to endure cervical cancer,” says Juan C. Felix, MD, chairman of the NCCC medical advisory panel and chief of OB/GYN pathology at the Women’s and Children’s Hospital, University of Southern California Keck School of Medicine. “We hope these vaccines will make cervical cancer a concern of the past.”

Mr. Alan Kaye, the Chair of the Board of Directors of the NCCC states; “The United States has an inadequate delivery system for vaccines that may hinder mass immunization of women for the cervical cancer/HPV vaccine.” Mr. Kaye went on to state; “The United States healthcare system is not structured adequately to handle the widespread immunization of adolescents and young adults.”

About the National Cervical Cancer Coalition

The National Cervical Cancer Coalition (NCCC), founded in 1997, is a grassroots nonprofit organization serving women with, or at risk for, cervical cancer and HPV. The NCCC is the only organization dedicated exclusively to helping women address concerns about cervical health and disease. The group executes its mission to improve women’s cervical health outcomes through education, support and advocacy for women and health care providers.

The NCCC supports the nation’s first Cervical Cancer Hotline for women and family members who are battling issues related to cervical cancer. In addition, it promotes patient interaction and support though its Phone Pals and E-Pals Programs, which match cervical cancer survivors with other women who are now living with or have experienced similar circumstances. The NCCC raises awareness nationally through a variety of initiatives, including the Cervical Cancer Quilts Project, a traveling exhibit that puts a personal face on the battle against cervical cancer.

To learn more about the NCCC, visit http://www.nccc-online.org.

National Cervical Cancer Coalition

http://www.nccc-online.org

Natasha Spradley, a young mother of three, always thought she was healthy. For years, she assumed there was no reason for routine gynecological checkups.

That was before she was diagnosed with cervical cancer.

January is National Cervical Cancer Screening Awareness Month, and Dr. Tri Dinh, a gynecologic oncologist at The Methodist Hospital, urges women to see their gynecologist for regular exams.

“Cervical cancer is the only gynecological cancer that can be prevented by regular screening, and Pap smear screening is probably the single most important preventative measure that a woman can take to prevent the development of cervical cancer,” said Dinh. “The Pap smear is designed to detect changes on the cervix so that they may be treated, preventing the progression to cervical cancer.”

Dinh recommends annual Pap smear screenings within three years of the initiation of sexual activity or by age 21, whichever comes first. He says most women diagnosed with cervical cancer in the United States have not had a Pap smear in the three to five years prior to diagnosis.

Two years ago, Spradley felt extreme fatigue and noticed abnormal bleeding. After a Pap smear and biopsy, she was diagnosed with stage two cervical cancer and referred to Dinh, who performed surgery to remove the tumor.

Spradley returns to Methodist every six months and urges friends and family to get regular check-ups.

“I never in a million years thought this would happen to me; it was a major shock. I now preach to everyone that they need regular exams.”

Spradley’s lecture does not stop with her peers. Her 12-year-old daughter is receiving the human papillomavirus (HPV) vaccine.

“My daughter understands that I don’t want her to go through the same thing; the vaccine is a necessity.”

Since the summer of 2006, the FDA-approved vaccine Gardisil has been available to help prevent infection with certain types of HPV. The vaccine protects against four types of HPV, and although it is approved for women and girls ages 9-26, the vaccine is recommended for girls ages 11 and 12.

Dinh says Gardisil is potentially one of the most exciting developments in the fight against cervical cancer, but points out that annual Pap smear screenings are still the best way to prevent this disease.

About The Methodist Hospital Women’s Health Services

The Methodist Hospital’s department of obstetrics and gynecology holds esteemed national prominence. The department’s division of gynecological cancer services is an integral part of Methodist’s internationally recognized cancer program. Cancer therapy options include complex pelvic surgery, radiation therapy, chemotherapy, hormone therapy and immunotherapy. Clinical trials are also available.

The Methodist Hospital in Houston is one of the nation’s largest private, non-profit general hospitals. Dedicated to providing the highest level of patient care, Methodist has a 90 year legacy of medical breakthroughs, such as the world’s first multiple-organ transplant in the 1960s, gene therapy for prostate cancer, and the first islet cell transplants in Texas.

Methodist is ranked among the country’s top centers in 14 specialties in U.S News & World Report’s 2007 America’s Best Hospitals issue. The hospital ranked in more specialties than any other hospital in Texas. Methodist is also 9th on FORTUNE’s “100 Best Companies to Work For” in 2007.

Methodist Hospital, Houston
6565 Fannin St.
Houston, Tx 77030
United States

http://www.methodisthealth.com

Sen. Chuck Grassley (R-Iowa) in a letter on Tuesday asked HHS Inspector General Daniel Levinson to examine the use of antipsychotics in nursing homes, the possibility of payments to physicians who prescribe the medications and the drugs’ cost to Medicare and Medicaid, the Wall Street Journal reports. According to a Journal article published on Tuesday, which Grassley cited in the letter, antipsychotics have become the most expensive class of medications for Medicaid. Nursing homes often administer the medications to dementia patients to quiet their symptoms.

In 2005, Medicaid spent $5.4 billion on atypical antipsychotics, not including rebates that the federal government might receive. Grassley also asked CMS for information about how the agency responds to nursing homes that misuse antipsychotics, a practice he called “disturbing and alarming.”

A spokesperson for Levinson said that the HHS inspector general and his staff are giving the issue “very careful consideration.”

Separately, Grassley sent letters to companies that manufacture three antipsychotics asking for documents about efforts to market the medications directly or indirectly for use in nursing home patients. Johnson & Johnson and Janssen, a division of J&J that manufactures Risperdal; Eli Lilly, which manufactures Zyprexa; and AstraZeneca Pharmaceuticals, a division of AstraZeneca that manufactures Seroquel, received letters. Representatives from the companies said that they will cooperate with the request (Legnado, Wall Street Journal, 12/6).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Heavy smoking and drinking are known to cause head and neck cancer. Infection with human papillomavirus type 16 (HPV16), a common strain of the sexually-transmitted HPV virus, is another known risk factor for head and neck cancer, which affects about 500,000 people each year worldwide.

New Brown University research, however, shows that alcohol and tobacco use doesn’t further increase the risk of contracting head and neck cancers for people infected with HPV16. This finding, published in the Journal of the National Cancer Institute, is the strongest evidence to date that these major cancers have two distinct causes – and may represent two distinct classes of cancer – and would require different prevention and treatment strategies.

Karl Kelsey, M.D., a Brown professor of community health and pathology and laboratory medicine and the director of the Center for Environmental Health and Technology, said the research has public health policy implications.

While the Centers for Disease Control and Prevention recommends that girls and young women receive the HPV vaccine to prevent cervical cancer – HPV16 causes about half of all cervical cancer cases – boys and men cannot get the vaccine. An estimated 20 million Americans are currently infected with genital HPV and 50 to 75 percent of sexually active men and women are infected with HPV at some point in their lives, according to the National Institutes of Health.

“Our current HPV vaccine recommendations should change,” Kelsey said. “Head and neck cancers, regardless of their cause, are predominantly male diseases. If boys and men received the HPV vaccine, a lot of these cancers could be prevented.”

Kelsey and his team took on the research to test the concept of multiplicative risk. If HPV infection increases the risk of head and neck cancer, and alcohol and tobacco use also increases the risk, would a combination increase that risk exponentially”

To find out, the team studied 485 head and neck cancer patients who were diagnosed at nine Boston-area hospitals between December 1999 and December 2003. The team also studied 549 cancer-free comparison subjects who were closely matched with the study group based on age, sex and town of residence.

All the test subjects were asked about lifetime smoking and alcohol consumption and also gave a blood sample, which was screened for HPV16 antibodies, a sign that they were exposed to this strain of the virus. The team then conducted a statistical analysis to estimate the effects of the different risk factors.

The results: Smoking and drinking didn’t add to the risk of head and neck cancer for subjects exposed to HPV16. The strongest risk factors, by tumor site, were smoking for cancer of the larynx, alcohol with mouth cancer, and HPV infection with throat cancer.

“We have a profound bit of evidence that HPV16-associated head and neck cancer is a very different disease,” Kelsey said. “Under a microscope, it looks like the same cancer you get from smoking and drinking. But how you get this form of the disease – and how you would prevent and treat it – is quite different.”

Head and neck squamous cell carcinoma, which includes nearly all head and neck cancer, afflicts about 45,000 people each year in the U.S., according to the American Cancer Society, and costs an estimated $3.2 billion to treat.

“There is a huge prevention message here, which is that we could protect a lot of people from cancer if men and boys could get the HPV vaccine,” Kelsey said. “We should start testing this vaccine on men.”

New research does not show a link between drinking coffee and ovarian cancer, according to a study published in this month’s British Journal of Cancer.

With funding from World Cancer Research Fund (WCRF), the researchers from Maastricht University in The Netherlands looked at the tea and coffee drinking habits of 62,573 post-menopausal women. Of these, 280 women had already had ovarian cancer.

Tea was drunk by 89 per cent of the women, with average consumption being three cups per day. Coffee was consumed by 96 per cent of the women in the group, and they drank an average of four cups per day. The researchers could find no evidence of an increase in risk from drinking coffee and tea was found to have a small protective effect, although this is not statistically significant.

Many studies have looked at tea and coffee consumption and whether or not it has an effect on our health and risk of cancer. This is because they contain substances, such as caffeine and tannins, which have an effect on our bodies. Unfortunately research can often produce inconsistent results. This is why scientists do further studies and examine the level of consumption in large numbers of people in an aim to provide a definite answer.

Leading the study is Dr Leo Schouten from the Department of Epidemiology. He said: “It will be reassuring for women to know that we could find no risk of developing ovarian cancer from drinking tea and coffee. These drinks are commonly consumed around the world and that is why it is important for us to analyse their relationship with our health.”

Dr Greg Martin, Head of Science and Research at WCRF, said: “Several studies have looked at tea and coffee and risk of cancer and the results have been conflicting. That is why this piece of research is important in adding to other evidence which shows that these drinks don’t increase our risk of cancer which will be a big relief to women everywhere.”

Tea is the most popular drink in the UK with around 165 million cups drank each day. Coffee lags behind with 70 million cups consumed each day.

Notes:

World Cancer Research Fund (WCRF) helps people make choices that reduce their chances of developing cancer.

This includes research and education programmes on how cancer risk is related to diet, physical activity, and weight management.

The WCRF report, called Food, Nutrition, Physical Activity, and the Prevention of Cancer, was launched in November 2007 and is the most comprehensive report ever published on the link between cancer and lifestyle.