The project has garnered top tier talent on both sides of the camera. Executive Producers include Jennifer Aniston, Marta Kauffman, Paula Wagner, and Kristin Hahn. Helming the director’s chairs are Demi Moore, Alicia Keyes, Patty Jenkins, Penelope Spheeris—and Aniston. Participating actors cover the generational continuum, from Bob Newhart portraying a doctor, to Rosario Dawson as an independent career woman.  Patricia Clarkson, well known in the indie film sphere, brings edginess to her character “Mia,” in a tale that combines caustic humor with hope and redemption.

Woven into the scripts are facts including “one in eight women will be diagnosed with breast cancer,” references to the BRCA gene, dialogue on the trajectory from diagnosis to mastectomy and reconstruction, and the too often ignored detail that men also get breast cancer (one in 1,000).

The narrative begins in 1969, as a family gathers around a television to watch Apollo 11 land the first man on the moon. Young Pearl is aware that her mother is sick, but she is left in the dark about the extent of the illness. Although 1969 was also the year of Woodstock and growing domestic unrest, Pearl’s family dynamics reflect a sensibility and a rigid framework that seems more in keeping with 1960. The inadequate way that her mother’s imminent death is handled will push Pearl to find answers and empowerment through a career as an oncologist. Later, when she receives her own diagnosis of breast cancer, Pearl will be in the role of the parent. Deciding how to inform her daughter, she agonizes over how to create an experience for her child—the same age as she was—that will stand in sharp contrast to the trauma that so deeply impacted her. In the process, Pearl gains insight into her father’s struggle and his inability to provide the parenting she so desperately needed.

The five stories encompass concerns that reflect the multitude of challenges facing a patient who has received a breast cancer diagnosis. Addressed are the topics of asking for help, interacting with caregivers, reframing life attitudes, family relationships, challenges based on age demographics, and cultural messages about women’s bodies.

In the segment titled “Cheyanne,” a dancer in her twenties must confront how her self-identity and career, which have been enmeshed with her breasts as physical attributes, will be impacted by an acute prognosis. The camera does not shy away from showing a visual of her upper torso, post-mastectomy. Rather, it uses the imagery to illustrate the evolution of her intensely sexual relationship with her husband as it morphs from lust and passion to tenderness, appreciation, and a different form of love.

I spoke with Executive Producer Hahn by telephone, to get a deeper understanding of the impetus behind the project. She related that Susan G. Komen for the Cure had approached her with the “seeds of an idea,” which she saw as a challenge “to push the envelope to create something that felt fresh—combining humor and irreverence with drama.” The producing team got the “best five writers” to brainstorm on potential stories, with each person contributing a script. According to Hahn, it was important that each segment work “both individually and as part of a whole.” It was at this point that Lifetime came on board.

Hahn said, “I hope the film will truly inspire dialogue.” She related an experience about an e-mail she had received from a woman who had attended a preview screening. It said, “I’m Stage 4. After seeing this film, I had my first real conversation.”

Getting through the “fear of asking questions, stimulating research dollars, and bringing the issues to light,” were core objectives enumerated by Hahn. “We all know someone who has been impacted,” she said. “It’s more than an epidemic.”

In a graphic featuring data culled from the American Cancer Society and the National Cancer Institute, stats show that there are 2.5 million breast cancer survivors in the United States. The median age at diagnosis for breast cancer is 61. The median age at death for breast cancer is 68. In 2011, 39,520 women and 450 men are expected to die from the disease.

To capitalize on the momentum of the movie, Lifetime has partnered with top cancer organizations to form the FIVE Coalition (Dr. Susan Love Research Foundation, LIVESTRONG, the National Breast Cancer Coalition, the Noreen Fraser Foundation, the Prevent Cancer Foundation, Stand up to Cancer, and Susan G. Komen for the Cure). The network is donating airtime to Public Service Announcements, and has provided a discussion guide written by Hahn. Action links have been set up at mylifetime.com/stopbreastcancer. Currently, Lifetime is spearheading an initiative to ensure that health insurance companies give their approval to making a 48-hour hospital stay after a mastectomy the “standard of care.” Previously, Lifetime was able to mobilize 26 million signatures in support of The Breast Cancer Protection Act.

In our conversation, Hahn reiterated the theme of the astronauts as a metaphor for the miracle and wonder of science. She reflected, “If we can land a man on the moon, we can cure breast cancer.”

All photos courtesy of Lifetime Television

This article originally appeared on the women’s health site Empowher.

Up until now, advice from your mother or best friend that unprotected sex is a bad idea may not have made an adequate impression. Perhaps you haven’t seen the stats.  Globally, half of the people living with HIV/AIDS are women.  For those of reproductive age (15–44), HIV/AIDS is the leading cause of death and disease worldwide. In the United States, AIDS diagnoses for women have tripled since 1985.

Enter Lady Gaga, teaming up with the MAC Cosmetics philanthropic arm, MAC AIDS Fund, for the VIVA GLAM campaign.  The objective: To launch a new lipstick and lipglass shade where every penny of the purchase price goes to the MAC AIDS Fund.  Working off of her personal brand of distinct individuality, Lady Gaga is the perfect model for self-advocacy.  As this year’s official VIVA GLAM spokesperson (last year she shared the role with Cyndi Lauper), she has instructed her admirers “to live passionately, but do it safely.”  Perhaps her strongest advice is, “Be your own biggest fan and protect yourself.”

I sat down with Nancy Mahon, Global Executive Director of the MAC AIDS Fund.  She spoke to me about the company’s “corporate responsibility” model, which has been “embedded in the MAC Cosmetics DNA” from its inception.  The MAC AIDS Fund was started in 1994—as a response to the AIDS epidemic. This giveback philosophy permeates the company.  It encompasses not just the executive level, but also the diverse sales force that feels a part of something beyond “just selling lipstick.”

The Fund has an impressive track record.  They have raised over $202 million and sold over 13.8 million VIVA GLAM lipsticks.  They focus on highlighting the link between “poverty and AIDS” and on targeting “underserved populations.”  The results of what one VIVA GLAM sale can do are impressive.  Internationally, their Mothers2Mothers program enables a two-day support group for pregnant women “newly diagnosed with HIV/AIDS.”  In America, The Women’s Collective Program provides a minimum of 45 minutes of “lifesaving HIV prevention skills” for girls and women in groups of 20 to 74 people.  That’s critically important, especially because domestically, HIV/AIDS is the leading killer of women of color.

In Washington, D.C. alone, 3 percent of African-American women are living with HIV/AIDS.  Going to “places where there are problems” is a primary strategy of the MAC AIDS Fund.  One of their grantees based in the District of Columbia (The Women’s Collective) provides a female-centric model of care.  As a community based organization, they are talking to women about using female condoms, and showing proper usage techniques.

The interview circled back repeatedly to the topic of “female initiated prevention”—both in terms of a tangible product for protection and the wherewithal to use it.  Mahon broke down why it was important to reach women on a wide continuum.

• Younger women are not practicing safe sex.
• Older women think that if they can’t get pregnant, they don’t need protection. They are reluctant to make demands that might make them “lose the guy.”  Online dating and male use of Viagra have increased risk factors as people are engaged with multiple partners.
• AIDS is the leading cause of death for African-American women in the age bracket of 25 to 34 in the United States.

Mahon spoke at length about the female condom. The Female Health Company, a manufacturer that worked with The Women’s Collaboration, has developed a product (available at Walgreens), which is in its second-generation iteration. The FC2 female condom received FDA approval in March 2009.  As explained by Avert, an HIV and AIDS information website:  “The FC2 female condom is a nitrile sheath or pouch 6.5 inches in length. At each end there is a flexible ring. At the closed end of the sheath, the flexible ring is inserted into the vagina to hold the female condom in place. The other end of the sheath stays outside the vulva at the entrance to the vagina. This ring acts as a guide during penetration and it also stops the sheath from moving up inside the vagina.”

The Female Health Company has a helpful page devoted to guiding women on how to discuss concerns with a partner.  The Lady Gaga VIVA GLAM campaign is creating high-level visibility.  However the ultimate step is up to each individual woman.  As Mahon observed, “If women are not using protection, they need to have a serious conversation with themselves.”

Image Courtesy of MAC Cosmetics.

This article originally appeared on the women’s health site EmpowHER.

The director of No Woman, No Cry, Christy Turlington Burns, experienced a similar situation as my mother.  It pushed her to take a look at why 1,000 women around the globe die daily due to complications from pregnancy or childbirth, particularly as 90 percent of those deaths are preventable.

Most immediately recognizable as a top fashion model, Turlington Burns took on the mantle of activist back in the early 1990s with her efforts toward rebuilding war torn El Salvador, the homeland of her mother. She worked on the ground with the Salvadoran American Humanitarian Foundation.  In 1997, when her father died of lung cancer, she became pro-active in smoking prevention.  She connected with CARE, as their Advocate for Maternal Health. This experience motivated her to embark on getting a Masters in Public Health at Columbia University.

Turlington Burns was involved in the film’s production for two years.  She observed four different women and their pregnancies in Tanzania, Bangladesh, Guatemala, and the United States.  The anecdotal threads are anchored by her gentle voice over.  She begins the story with home footage of her pregnancy.  Through the choice of her narratives, Turlington Burns lays out her points while exploring basic facts about maternal mortality.

Reproductive health problems are the top cause of death for women ages 15-19 in the developing world, with approximately 70,000 young women dying because their bodies are not yet ready for childbearing.  Over 200 million women who want to plan their families don’t have access to modern birth control.  This option would reduce the amount of maternal deaths due to unsafe abortion by 82 percent.

At the Paley Center in New York City, I attended a screening of the documentary, followed by a panel discussion with Turlington Burns and experts Dr. Suellen Miller and Ann M. Starrs. Turlington Burns explained, “It’s a global tragedy, and I wanted to show that.”  She continued, “I constantly marvel at the power and strength of women.”

Maternal health is considered a benchmark of how a country’s health care measures up.  Turlington Burns cannily juxtaposes an American segment, to echo the issues that are at the root of problems in developing countries.  For those previously unaware of the American stats, they may be shocked to learn that the United States comes in 50^th on the scale of how well a country provides its citizens with maternal health care.  It has dropped from a previous ranking of 41^st, trailing Canada and a host of European countries. Race and economics are a primary factor:

• African-American women are three to four times as likely to die from pregnancy related causes as white women.
• The maternal mortality ratio for Native American and Native Alaskan women is four times higher than the 2010 national goal set by the government.
• Women living in low-income areas across the country are twice as likely to suffer a maternal death as women in affluent areas.

Superficially, it’s easy to believe that the obstacles facing women in other nations are dramatically different than those in America.  Yes, a van ride to a hospital in Tanzania costs $30, more than a family’s monthly wages.  However, Jennie Joseph, LM, CPM, Midwife and Executive Director of The Birth Place, which operates in Florida near Orlando, points out in her onscreen interview, “There’s no real access for disenfranchised women.”  On the expenditures needed for pre-natal care she says, “This is an upside down system.  Health care is anything but free.”

Many economically disadvantaged American women are getting their care through hospital emergency rooms.  There, they are often victims of judgments emanating from a core lack of understanding about why they can’t get prenatal services.  With two American women dying each day from pregnancy related problems, you have to question access and equality.  A pervasive tone of condescension from some of the doctors permeates all four stories.  It may be culture specific, but it’s there.

The mother-to-be in Tanzania, who consistently invokes the “will of Allah” as an explanation for events, replies with resignation to the question posed to her about how she is faring. “It’s okay.  I haven’t died, so I’m alive,” she says wearily.  While learning about the woman in Bangladesh who has finally conceived her second child, and is relieved that her husband won’t leave her for a more fertile mate, we find out that there are fourteen local words for a woman who can’t bear children.

In Guatemala, a woman suffering from the aftermath of a failed abortion refuses to admit it — because the stigma is so great. Abortion is illegal in Guatemala, except to save a woman’s life. Procedures under unhygienic conditions lead to 65,000 unsafe abortions performed each year.  These factors are contextualized in the film by Dr. Linda Valencia, who directs Planned Parenthood Federation of America’s support for programs in Guatemala.

Since barriers in the United States — not unlike those in foreign countries, exist — Turlington Burns has created a multi-pronged approach to bring awareness to this national and global crisis.  She has founded and put into play Every Mother Counts, a platform to link a grassroots mobilizations campaign with the steps of “engagement, education, and advocacy.”  Using a social media strategy to get eyeballs and action on several levels, the documentary is being rolled out on Oprah Winfrey’s new network OWN on May 7^th, with repeats the following day. People are being encouraged to host screening parties.  Starbucks will be selling a CD entitled “Every Mother Counts,” with tracks by “mom artists” including Rosanne Cash, Ani DiFranco, Jennifer Lopez, and Toshi Reagon.  It will be available through the end of 2011.  Starbucks will donate $8.00 of the selling price to CARE, a partner with Every Mother Counts.

When I spoke to Turlington Burns at the Paley Center, she told me that she was headed down to Washington, D.C. to be a speaker at the Capitol Hill briefing on the Maternal Health Accountability Act (H.R. 894) sponsored by Rep. John Conyers (D-MI).  The goal of the bill is to help set up “maternal mortality review committees” in each state, and to help “eliminate disparities in maternal health outcomes.”

Amnesty International will also be testifying. I wrote an article last year about their March 2010 report, Deadly Delivery: The Maternal Health Care Crisis in the USA. They have since released a 2011 update to their previous findings. Based on new evaluations by the Maternal Child Health Bureau, it shows that in America “low-income women face substantial barriers to obtaining medical care during pregnancy,” extending beyond finances to include transportation and a lack of professionals in their area.  Asking the public to get pro-active on maternal mortality through a Mother’s Day card action to legislators, Amnesty International is supplying cards free, which will then be distributed to members of Congress.

Throughout the world, maternal obligation is seen as tantamount.  In some locales, that may come at the expense of maternal death.  It is time to go beyond the lip service paid to mothers for a life-long role that is exalted, but so often poorly supported.  Turlington Burns’ clear-eyed documentary is a step toward bringing recognition and tangible action to the struggles of women worldwide.                                                                              

Photos courtesy of Every Mother Counts

This article originally appeared on the women’s health site Empowher.

Dr. Barbara DePree began focusing her practice on mid-life women eight years ago when she noticed that her intake questionnaire pointed to the need for a resource dealing with women who were having trouble with their sexual health.  An ob-gyn doctor with a twenty-year track record, DePree is the Director of the Women’s Midlife Services at Holland Hospital. “Providers aren’t always up to date,” she told me in a telephone conversation.  She added, “They also may not feel comfortable dialoguing.”

The topic in question?  The medical term is “vaginal atrophy.”  As DePree explained, “As a woman gets older, the vagina gets shorter and more narrow.  The walls become thinner and more fragile—as well as less elastic.  The color becomes a pale pink, which reflects a lack of blood supply.”  Another way of referencing the situation is to say that a woman is “losing patency.”  The biological definition of patency is “the state or quality of being open, expanded, or unblocked.”

It doesn’t have to be that way.  DePree called up the adage, “Use it or lose it.”  That advice was for women in relationships who were finding intercourse uncomfortable, as well as for single women who wanted to maintain optimum vaginal health so that their vaginas would be functional for future sexual activity.

Her four-point program and goals are simple.  To increase a significant blood supply to the genital area in order to maintain vaginal health.  She suggested:

• Vaginal moisturizers and lubricants to prevent dryness, keeping vaginal tissues moist and strong.
• Vaginal dilators to develop or restore the vaginal opening, and help keep vaginal tissues elastic and comfortable.
• Regular clitoral stimulation to maintain blood flow and keep the clitoris strong and responsive.
• Kegel exercises, which not only help women maintain strong orgasms, but help them retain urinary continence.

DePree supports the use of “localized estrogen,” because she maintains that it is “well tolerated” and “very effective in bringing more bloody supply to the area”—so that not only are tissues healthier but “it adds to arousal.”  She did acknowledge that not all women were interested in using estrogen, and that there were other options to keeping the vagina “supple and moist.”

Michele Carelse, who heads up the Native Remedies’ Expert team, takes the naturopathic perspective—which is to look at the larger picture. Carelse believes in going beyond just the symptoms to see a broader context.   Noting that a woman’s “hormonal balance is constantly changing,” she said, “Our point of view is to help the body to achieve hormonal balance. Look at the underlying imbalances, not just the symptoms.”  Making clear that she was not in opposition to traditional medications, Carelse said that she encourages women to speak with their doctors and discuss the Native Remedies that they are using.  She did, however, express a concern with “menopause being viewed as an illness” and “medicalizing a normal process and part of a woman’s life.”

A change in the vaginal cell walls, coming from an imbalance, can lead to inflammation, contractions, and a predisposition to urinary tract infections.  Carelse elucidated that when pH levels have changed and there is dryness of the vaginal walls, it makes it easier for bacteria to enter those walls.  Rather than turn to estrogen, Native Remedies offers a “natural vaginal lubricant” (no parabens, sodium laurel sulphate, or petrochemicals) that features the ingredients of wild yam, essential oils, and aloe.

Dr. Michael Wald, Director of Nutritional Services at Integrated Medicine, suggested via e-mail a series of alternatives for those women who are concerned about using synthetic estrogens and progestins.  They included:

• Various herbal combinations such as Red Raspberry leaf, which is a uterine tonic that helps increase blood flow to the uterus and vaginal tissues.
• Vitamin A rich foods and Vitamin A supplements, which can help vaginal atrophy.  Vitamin A is required for the production of the specialized cells that line the vagina.  No more than 15,000 IUs of vitamin A should be taken in the form of vitamin A supplements.  Foods rich in vitamin A can be consumed liberally and include liver, potatoes, carrots, mangos, spinach, cantaloupe, dried apricots, milk, egg yolks, and mozzarella cheese.
• Zinc is absolutely essential for helping to reverse vaginal atrophy or to slow it down.  Zinc is a mineral that helps to rejuvenate many different types of cells throughout the body, including the specialized cells that line the vagina.  Zinc in the form of nutritional supplements should not exceed 75 mg per day.  Zinc rich foods include: oysters, wheat germ, veal liver, sesame flour and Tahini (Sesame butter), low fat roast beef, roasted pumpkin and squash seeds, dried watermelon seeds, cocoa powder and chocolate, lamb and peanuts.
• Indole 3 carbinol—A nutritional compound found in cruciferous vegetables (broccoli, cabbage, bok choy, cauliflower, eggplant) that helps hormone regulation.
• EPA/DHA fish oil, which helps improve tissue integrity throughout the body. 1-2 grams per day.

• Lactobacillus acidophilus in the form of a vaginal suppository, which is available at health food stores. It is also available in a dairy free form for those with dairy sensitivity.
• Gingko biloba—Improves blood flow to the vagina. The dosage should be the recommended dosage on the bottle or as directed by your healthcare practitioner.
• Arginine—Improves blood flow to the vagina. The dosage should be the recommended dosage on the bottle or as directed by your healthcare practitioner.
• Vitamin D—Helps cellular regeneration throughout the body. The dosage should be the recommended dosage on the bottle or as directed by your healthcare practitioner.

In following up on DePree’s recommendation for vaginal dilators, I connected with Mark Carter, who has been a force in bringing resources and information about the medical condition of vaginismus to a population that he characterized as being “poorly served.”  He discussed how the dilator set (five pieces which are graduated in size) can “gently stretch out the vaginal canal” which has lost its elasticity. He described the dilators as being made from the highest-grade medical plastic in a United Kingdom factory that is ISO-9000 compliant. In response to my questions, Carter confirmed that the dilators were PCB-free and without phthalates. The construction is seamless with a mirrored finish, and they are tapered at the front with a rounded tip.

Fighting back against the aging woman stereotype is not always easy.  In the 21^st century, women demanding information about their changing bodies shouldn’t have to encounter obstacles.  As DePree wrote in a follow up e-mail, “As we grow older our vaginas change. It’s a natural part of the aging process, not something to be embarrassed about or intimidated by. The important thing is to be proactive. Using your vagina will help keep it elastic and comfortable for sex. We work hard after 40 to maintain our skin, hair, body, brain, and heart. Why not our vulvovaginal tissues too?”

For all those single ladies out there, her final sentence was, “Strong vaginas aren’t just for couples!”

This article originally appeared on the women’s health site Empowher.

Dr. Deborah Rhodes, Courtesy of the Mayo Clinic

At the recent TEDwomen conference in Washington D.C., one of the presenters was Dr. Deborah Rhodes, an internist who has become a leader in assessing breast cancer risk.  She delivered her talk in quiet and measured tones.  Her passion and intensity underscored her commitment to a new diagnostic tool she has developed with a group of colleagues.  Rhodes became immersed in the challenge of how to effectively detect breast tumors in women with dense breast tissue when one of her pregnant patients, in her forties and with a family history of breast cancer, asked her for an honest appraisal of the odds of finding a tumor in its early stages.

Rhodes understood that for women with dense breast tissue, “the mammogram doesn’t work well at all.”  In fact, as she wrote to me via e-mail, “Breast tissue density poses a higher risk for breast cancer than having a mother or sister with the disease, but 9 out of 10 women don’t know this—or how dense their breast tissue is.”

Breast density is genetically determined.  Rhodes qualifies it as the “culprit” for inadequate readings of mammograms. She explained that two-thirds of women in their 40s have dense breast tissue.  If a mammography cannot detect the early onset of cancer in one out of six women in the age range of 40-49, this is a major issue. Although breast density usually declines as a woman ages, up to one-third of women retain breast density for years after they reach menopause.

How important is it for women to know about their breast density? Very.  You can learn this information from your mammogram report.  Rhodes showed slides that illustrated the four categories of breast density.  There are two groups who are at greater risk for not having a tumor detected.  They are those in the heterogeneously dense group (51-75 percent density) and those in the extremely dense group (over 75 percent density).  Both tumors and dense breast tissue appear as white on mammograms.  For those with fatty breasts there is an 80 percent probability of finding a cancer, as opposed to the 40 percent likelihood of finding a cancer in a dense breast.

There has been little change in the field of mammography since the 1960s other than the development of digital mammography—which is still an x-ray of the breast.  Ultrasound is used, as are MRIs—which are costly.

The aha moment for Rhodes came when she was introduced to Michael O’Connor, a nuclear physicist.  He told her about gamma technology.  Gamma rays are not affected by breast density.  Rhodes and O’Connor, along with a core hub of two radiologists and a bio-medical engineer, have formed the Molecular Breast Imagery (MBI) Research Team at Mayo Clinic. They are currently working on a “dual-head” gamma camera that can detect tiny tumors in dense breast tissue.

For imaging, a patient receives an intravenous injection of a radiotracer, which is then picked up by tumorous cells.  Rhodes

Left: Mammo gives negative reading Right: MBI shows 17mm Cancer Courtesy: newsblog.mayoclinic.org

explained, “MBI exploits the different molecular behavior of tumors” which is unaffected by breast density.  In addition, unlike the traditional mammogram, the MBI delivers “light pain free compression.”

With chances for a cure dropping off as the size of a tumor increases, finding a tumor at 1 centimeter gives a patient a 90 percent chance for successful treatment.  The work that Rhodes and her group are doing got them a major nod in 2004, when they received a grant from the Susan G. Komen Breast Cancer Foundation.  They were funded to study 1,000 women with dense breast tissue, and compare the results with mammography.  (The women chosen were already in the Mayo Clinic system.)  With mammography, 25 percent of cancers were detected; with MBI, the result was 83 percent.  A combination of the two yielded a 92 percent detection rate.

Concentrating on lowering the radiation dose, they have achieved using an amount that is “equivalent to the effective dose from one digital mammogram.” With this reduction, they have moved forward with their screening study.  Rhodes showed an example of how a 67-year old woman who had received a clean bill of health with a digital mammogram was found to have a 3.7-centimeter tumor with an MBI.

Getting their findings published in the January 2011 issue of the Journal of Radiology has helped them gain traction and exposure in the larger medical community.  Now they need to finalize the screening studies using the low dose.  Protocol demands that the study has to be “replicated” at other institutions.  That could encompass a period of five or more years.

Although the MBI unit has been FDA approved, it is still not widely available.  Rhodes referenced “economic and political forces,” in addition to the science, as contributing factors.

While this technology is continuing to be advanced, Rhodes recommended the following guidelines to women:

• Know your breast density (only the state of Connecticut has mandated that women receive notification of their breast density after taking a mammogram).
• If you are pre-menopausal, try to schedule your mammogram during the first two weeks of your menstrual cycle, when breast density is relatively lower.
• If you notice a persistent change in your breast, insist on having additional imagery screening.
• Have a mammogram every year for women with dense breasts 40 and older.

Via e-mail, Rhodes also expressed what she considered four important features to consider when developing a screening technique that is “well suited to women with dense breasts.”  They are:

1. It has to be better than what we have (mammography—which
works beautifully in women who don’t have dense breasts, but
much less well in women with dense breasts).

2. It cannot generate too many unnecessary biopsies.

3. It has to be safe and comfortable (not too much radiation, adverse reactions, etc.).

4. It has to be affordable.

Rhodes advised that women with dense breasts should discuss all options with their doctors.  For those specifically with “at risk factors” for breast cancer, Rhodes suggested exploring if they are eligible for a breast MRI, which has a higher rate of sensitivity.  She pointed out that not only is an MRI expensive, but that most insurance carriers require that patients meet specific criteria (Typically 20% or greater estimated lifetime risk of developing breast cancer).

A strong believer in women’s self-empowerment through learning about their breasts, she wrote, “I think it is important for women to understand the limitations of a test that they are having year after year – so we can collectively advocate for developing [such] an alternative.”

Rhodes ended her talk at the conference with a final reference to her patient, whose child was now in middle school.  After losing her sister to breast cancer, she made the choice to have a prophylactic mastectomy. Rhodes concluded, “We can and must do better.”

This article originally appeared on the women’s health site Empowher.

In 1991, Dr. Bernadine Healy wrote in The New England Journal of Medicine, about a situation she named The Yentl Syndrome. Her premise was that women were treated less favorably than men for the management of coronary heart disease. She used the name of the title character of an Isaac Bashevis Singer short story about a woman who had to disguise herself as a man in order to attend school in 19th century Poland.

Today, heart disease is the number one killer of women in the United States.  Sudden cardiac death is the most frequent presentation of the disease in women.  The statistics from the American Heart Association are eye opening:

·  1 in 5 females in the U.S. have some form of heart disease.

·  1 in every 3 women dies of heart disease.

·  A woman dies from heart disease every 34 seconds.

·  The prevalence of high blood pressure in minority women in the U.S. is among the highest in the world.

·  Coronary heart disease rates in women after menopause are 2-3 times those of women the same age before menopause.

·  Heart disease claims more women’s lives than the next eight causes of deaths combined – including breast cancer.

·  Nearly two-thirds of American women who die suddenly of a heart attack had no prior symptoms.

It sounds very overwhelming, until you learn that cardiovascular heart disease can be prevented.  Every doctor that I spoke with underscored “prevention” as the key to changing the picture.  In fact, they have built their practices on that premise.

Dr. Suzanne Steinbaum was unequivocal in her view that individuals have control over heart disease.  “80 percent of the time, heart disease is reversible,” she told me.  Her mission is to “change people’s mindsets” and show them how to make lifestyle changes.  As the Director of Women and Heart Disease of the Heart and Vascular Institute of Lenox Hill Hospital in New York, her credo is, “You never need to get sick from heart disease.” She explained, “It’s different then getting cancer.  The more you know, the more information you get, the more changes you can make.” Her “Blood Sugar Self-Quiz for Professional Women” pinpoints what you need to understand about managing your blood sugar.

An advocate of eating complex carbohydrates (whole grains and multigrain items) and limited sugar, Dr. Steinbaum said, “Often times, increasing triglycerides in the diet, increases calories and increases belly fat.” Simple sugars (a form of triglycerides) such as pasta, white rice or sweets, often lead to increasing abdominal fat.  “With increasing abdominal fat, the mechanisms to metabolize sugars become dysfunctional, and eventually diabetes may ensue.”  For women, diabetes leads to a seven-fold increase in heart disease.  Dr. Steinbaum gave me the news that it was better to have a pear shaped figure than an apple shaped figure. Or, in her words, “It’s better to have a big butt than a big belly.”  If your waistline measures more than 35 inches, it’s time to get proactive. As Dr. Steinbaum emphasized, “It’s a progressive disease.  It takes awhile to manifest, so the goal is to start early.”

Combining the traditions of Eastern and Western medicine informs the philosophy of Dr. Rashmi Gulati, who is a board certified internist and MD of pathology.  Dr. Gulati told me that she has seen both the over treating and under treating of patients, with neither approach unearthing the root cause of the problem.  She applauds the diagnostic expertise of Western medicine and its ability to treat acute illness.  However, she made a choice to look at the larger picture by taking a year off to study integrative medicine at the American Holistic Medical Association and the Institute of Functional Medicine. At a time when the national debate on health care is at a fevered pitch, Dr. Gulati asserted, “The insurance model has to change.  We should move to wellness and prevention.”  With her approach to patient care, the “seven to nine minute visit” does not work.

Looking at risk factors and lifestyle, Dr. Gulati cites the mind-body connection. Stress can come from various areas of our lives including finances, relationships, and work. In terms of heart health, I asked her what stress does to the body. Dr. Gulati responded, “Chronic stress exposes your body to unhealthy, persistently elevated levels of stress hormones like adrenaline and cortisol, elevates your blood pressure and heart rates, and creates oxidized molecules.” She noted that some studies link stress to changes or increases in blood viscosity – which can lead to blood clots and increases the risk of heart disease.

Her suggestions for getting on the right track includes modalities such as exercise (qualified by a doctor’s guidelines), yoga, meditation, and acupuncture.  A diet that avoids foods that raise the blood sugar and then drop it (cookies, candy, soda, potato chips, bagels, and white flour products) is essential. Adding supplements that help boost heart health, including co-enzyme Q 10 and an Omega 3-6-9 combo, is also helpful.

Women do not present with the typical symptoms of the “elephant on your chest” sensation or a tightening and numbness of the left side.  Dr. Gulati recommended between ages 40 to 50, when women’s hormones begin to change, that they get screened with baseline tests.  She believes that a stress test, and non-invasive EBT scans or CT scans of the heart should be promoted the same way colonoscopies are.

The question is why are women, who have been thoroughly educated about the importance of breast self-exams and Pap smear, so far behind the curve on heart care issues?  Patti Armus, a registered nurse who is a “Cardiac Health Coach,” is working to change the status quo.  She related circumstances she witnessed as a nurse saying, “Women are not treated the same as men when it comes to heart disease.  They are less likely to have an ECG done on arrival to the Emergency Room, and are less likely than men to receive discharge medication and referral to cardiac rehab programs.”  For Armus, it’s also personal. She related, “My mother had a family history of drop-dead heart disease.”  Armus provides her clients with “a road map and guidance” on how to prevent heart disease, and encourages them to be more assertive.  “Women need to demand the proper care from their physicians, and they need to look at their risk factors.”

Heading off these dangers has added another dimension to the conversation for several physicians.  Dr. John M. Kennedy, an invasive cardiologist, has just written The 15 Minute Heart Cure which outlines how to cope with stress through breathing techniques.

Dr. Richard Collins, Medical Director of Cardiac Rehabilitation and the Lifestyle programs at South Denver Heart Center in Colorado, has become known as “The Cooking Cardiologist.”  He wrote me by e-mail, “I actually was an interventional cardiologist a number of years ago, but I hung up all my catheters and balloons and became a preventive cardiologist. So I am sort of a forest ranger, rather than a fire fighter. I teach people that helping your heart starts right in the kitchen.”

Explaining the importance of diet in preventing and controlling heart disease, Dr. Collins uses the guidelines of “fruit, fiber, fluids (good quality), and fewer fats.”  He believes that healthy cooking can be as simple as choosing the right preparation methods. Serving fruits and vegetables raw, or cutting just before cooking minimizes the loss of vitamin C. Heating vegetables in a microwave will actually preserve more vitamins than boiling or steaming. When using frozen vegetables he recommends, “Avoid thawing before cooking, preheat the water first, and remember that microwaving is best.”

Reading nutritional labels and food content is high on Dr. Collin’s list. He suggests looking for foods that are rich in vitamin C. (Vitamin C can support heart health by helping to neutralize free radicals that can cause cell and tissue damage). He points out that not all fats are bad. While you should avoid saturated fats and trans fats, Omega-3 fats (found in foods such as walnuts, flaxseed and fatty fish – like salmon or tuna) may help reduce the risk of heart disease and stroke. Finally, beware of hidden salt by checking labels for sodium content. Limiting your sodium intake can help to reduce blood pressure. According to the CDC, current dietary guidelines for Americans recommend that adults in general should consume no more than 2,300 mg of sodium per day. (See one of Dr. Collin’s recipes below.)

It took a Hollywood star and activist, Barbra Streisand, to make a dramatic statement on behalf of the 42 million American women who are currently living with cardiovascular disease. In 2008, Streisand endowed 5 million dollars to Cedars-Sinai for the creation of the Barbra Streisand Women’s Cardiovascular Research and Education Program.  Streisand commented, “The medical system has failed to recognize female-pattern heart attack symptoms…current testing and treatments are geared to male physiology.”  Funds have been earmarked to support sex-specific cardiovascular research and education, and for raising awareness of the disease within the medical community.

There is a wave of doctors who are making prevention and lifestyle change the preeminent tool in the fight against cardiovascular disease.  It’s now up to women to take the next step.

Orange-Apricot Chicken Tagine Makes 4 servings

1 tablespoon canola oil

4 small skinless chicken breasts, approximately 4 ounces each

1 yellow onion, sliced

1 tablespoon minced fresh garlic

1 tablespoon minced fresh ginger

1 cup 100% orange juice

1 tablespoon turmeric

1 teaspoon ground nutmeg

1 teaspoon ground cinnamon

1 saffron thread, optional

1 (15-ounce) can garbanzo beans, drained

1 cup dried apricots

1 cup diced fresh tomatoes

½ cup cashews, chopped and toasted

2 tablespoons fresh cilantro, chopped

Heat oil in tagine and brown chicken breasts for 3 to 5 minutes; remove chicken breasts and reserve. Add onion, garlic and ginger to tagine; sauté for 3 minutes. Add orange juice, turmeric, nutmeg, cinnamon and saffron, if desired. Simmer for 3 minutes; do not boil. Add garbanzo beans, apricots and tomatoes. Bring to simmer; add reserved chicken breasts. Cover tagine and cook for 20 to 30 minutes over low heat until chicken is thoroughly cooked. Garnish with cashews and cilantro; serve immediately.

This article originally appeared on the women’s health site Empowher.

As parents sought to navigate a situation where their healthy daughters had become sick and, in the worse case scenario – died, they turned to the Internet for answers.  Scouring the web for information, checking message boards and chat rooms, they found out that their predicament was not isolated.  They reached out to others; harnessed the power of social media; created support systems and advocacy networks. They began to build a grassroots movement to square off against Merck & Co., the producer of Gardasil.  Most importantly, for families who were at the start of an overwhelming and arduous process, they found a space to enter which had been constructed by those who had been there before them.

In 2009, Rosemary Mathis and Marian Green started the website TheTruthAboutGardasil.  It comes up in a Google search for Gardasil second, directly underneath the Gardasil website.  With a play on Merck’s advertising pitch, their tagline is “I don’t want to be ‘One Less.’ Investigate before you vaccinate.” I spoke with both women in a joint interview by telephone.  They explained their struggles to understand why their daughters’ health had become impaired.

Lauren, Mathis’ 12 year-old, had been told by her pediatrician that the Gardasil vaccine was “the best thing for her.”  The first shot left Lauren with nausea and headaches.  She had the same symptoms three to four weeks after her second shot, and was advised that she had a “virus.”  The third shot, which Lauren received in mid-August of 2008, disabled her.  By September 4th, she had pains in her legs and side.  A series of hospital visits determined that her gall bladder was only functioning at 7 percent of its capability. Wake Forest University Baptist Medical Center found that her gall bladder was, in fact, healthy – but that something else was going on.  Massive doses of antibiotics helped, but Lauren was put on a modified school schedule.  At Duke University Hospital, a doctor who was slated to retire in four weeks told Mathis that her daughter had “vaccine injuries,” and prescribed medication for the ulcers in her stomach.  In February of 2009, after six months of medical visits, Mathis filed a report with VAERS.  Lauren missed 100 days of school.  Mathis told me, “I honestly did not know if that child was going to live or die.” She continued, “She is still disabled, because she had to redo her modified school schedule this year.  She is still not able to attend school on a normal basis without a lot of absences.”

Marian Greene feels that her 16-year-old daughter, Holly, was pushed to get the vaccine.  An athletic girl and top runner who was being recruited by colleges, Holly had recently lost a coach and a grandfather to cancer.  This predisposed her to seek protection by getting the “cervical cancer” vaccine.  Holly got her first dose of Gardasil on a Thursday, and on Saturday had what she thought was an allergy attack.  Sunday, she had problems breathing and took her asthma medication.  The following Monday, she had severe chest pains and could not breathe.  Her pallor was grey.  Over nine days she repeatedly visited the emergency room, telling her mother that her “chest hurt so badly it felt like someone was ripping her heart out.”  She had pericarditis, a swelling and inflammation that surrounds the heart with fluid.  The doctor said it was directly caused by Gardasil, and wrote that in his report.  Holly now has a team of five doctors she is working with: a cardiologist, a rheumatologist, an allergist/immunologist, a naturopath, and a pediatrician.

Mathis questions the role of pediatricians who promote Gardasil as a vaccine to prevent cervical cancer, without a complete enough disclosure and informed consent process.  She e-mailed me a letter from Lauren’s doctor who expressed his concern, while admitting that he was not convinced of the link to Gardasil.  He wrote, “As you know, however, I am not convinced that Gardisil is the root cause of the problem.  I say this not because I trust Merck, because I don’t fully trust any of the drug companies.  But I do trust the CDC, as well as the American Academy of Pediatrics and the ACIP, who thoroughly review the vaccine research and make recommendations to the CDC.  That being said, I know that new info always can show up later, so I just plan on keeping an open mind about this vaccine, like I try to do with all of the various medicines and treatments.   However, I rely on the experts, and at this time they still recommend giving the vaccine.”

Green noted that in her experience with doctors in the hospital setting, there is an acknowledgement of a potential Gardasil and illness relationship.  However, most of these doctors are being told by the legal departments of their institutions not to speak out publicly.

As Mathis elucidated, “You are on your own when this happens.  The Internet has been a lifeline.” So their site has been set up to centralize and store information, create easy reference links, sign a petition, make connections with “Guardian Angels,” and to contextualize the fifty deaths that have occurred post-vaccine.  Mathis explains, “It helps Moms just coming into the process.” Their site’s outreach is international.  The countries that appear on their hits stats include Israel, the Netherlands, Australia, New Zealand, Greece, Canada, the United Kingdom, Singapore, India, Belgium, Spain, Germany, Italy, Mexico, and Scotland.

Jodi Speakman, the administrator of the Facebook group, “Stop Gardasil! Victoria’s Story,” spoke to me about the power of her Facebook connections.  She is currently working to promote awareness of the potential side effects of Gardasil, and the issue of informed consent. “I’ve never had a problem with vaccines,” she stated flatly.  “If I could vaccinate my children against anything, I would.”  However, her point of view changed when two and a half weeks after her daughter Victoria received the Gardasil shot, she began having seizures and full body tremors.  She was advised at Jeanes Hospital in Philadelphia that her daughter was having an “allergic reaction to something.”  It didn’t occur to her to mention the vaccine.  As Victoria’s symptoms grew worse, she missed her entire senior year of high school.  “All of her friends have graduated and gone to college,” Speakman said.  Now her goal, as she described it, “is to get help for our daughters, as we have been abandoned by the medical establishment.”  She has contacted her state representatives, but was disappointed when all she received was “form letters in return.”

Others are reaching out to officials as well.  Karen Maynor, a New Mexico mother whose 20-year-old daughter Megan died in November 2008, wrote a four-page letter to Dr. Margaret Hamburg, the Commissioner of the FDA.  She expressed her belief in the “common link” between the young girls who have died and Gardasil.  Her frustration is palpable in her statement, “No one seems to care.”  Points in her correspondence included a call for tests on autoimmune disease genetics before Gardasil is administered; the inefficiency of VAERS to track adverse reactions; lack of doctor knowledge about VAERS protocol and informed consent; the explanation of the full range of side effects.  The letter was sent by e-mail and postal mail to a slew of high-level people including Michelle Obama, Hillary Clinton, Maria Shriver, and Sen. Kay Bailey Hutchinson (R-TX).  Maynor wrote, “Someone has to take responsibility to initiate an immediate investigation into why these deaths and illnesses occurred.”

In Australia, Stephen Tunley, founder of gardasilactiongroup.com, had a face-to-face meeting with Australian Health Minister Nicola Roxon and the Chief Medical Officer of Australia, Professor Jim Bishop. As Tunley wrote via e-mail, he presented them with a “comprehensive file of data to consider regarding Gardasil and health issues.”  The response from Bishop, responding to “specific issues” Tunley had raised at the meeting, was, “The objective scientific evidence supported by experts and governments around the world is that Gardasil remains a safe and effective vaccine.” Bishop’s final sentences in the letter states, “I trust this information will address your concerns around this vaccine. Thank you again for bringing these to my attention.” This phrase can be viewed as conscientious, or as a supreme brush off.

David and Freda Birrell have been active in Scotland.  Freda Birrell, who is involved with ICAP.org, sent me comments via e-mail about her political experience in the United Kingdom.  Her advice to her American counterparts was “to try to alert as many elected representatives” about the vaccine as possible.  In New Zealand, efforts have been put forth by Julie Smith, with her website offtheradar.co.nz.  Medications.com has 269 entries on Gardasil, including a link to a CNN report.  Numerous sites point to genetic traits or predispositions that can be triggered by Gardasil, and warnings not to get the vaccine bundled with other shots.

Another website that is prominent in posting and disseminating information has been HolyHormones.com, run by Leslie Carol Botha, a health educator and broadcast journalist.  In an e-mail exchange she discussed how her site, a repository for articles on women’s health, has featured close to 700 articles on Gardasil.  She wrote, “I think that the social media networking has made all of the difference in the world – and changed the fabric of how information is passed.  This is the first time that Big Pharma has seen a ground swell of people come out against their vaccine.”  Her archives include “research papers posted on the vaccines and numerous PDF files on adverse reactions.”  Botha attributes the worldwide connections to creating a movement of awareness.

The grandmother of Jessica Ericzon found Botha’s site when she was searching for answers to Jessica’s death.  I spoke with Jessica’s mother, Lisa Ericzon.  She has been in touch with three other women who have lost their daughters.  “We call each other when we are down,” she told me.  Before ending our conversation she said, “I never want to hear another mother say, ‘I didn’t have an idea.’  Because,” she added, “I didn’t have a clue.”

This article originally appeared on the women’s health site Empowher.

As the average American tries to make sense of the constantly shifting health plan and attendant debates, one issue remains crystal clear. Women’s reproductive rights are being used as a football and bargaining chip in the fight to secure a long awaited health care bill.

The Women’s Media Center, whose tag line is “Making Women Visible and Powerful in the Media,” has created a site with a full menu of tools to encourage people to get proactive. With a strong graphic presence in black and red, icons direct the visitor to venues including petitions to sign, how to connect with elected representatives, and insights from the National Women’s Law Center (They coined the phrase “Being a Woman Is Not a Pre-Existing Condition”).

The Get Informed link, identified by a light bulb, gives a timeline with the most recent developments on the legislative voting, dating from November 7, 2009. The list of facts on the health care bill is link-rich, and encourages visitors to go off-site for additional information.

In an example of the how the power of Social Media can be harnessed, ways to connect on Facebook, Twitter, and “Tell Your Friends” are encouraged.

Contacting Jehmu Greene, President of the Women’s Media Center, by e-mail, I asked her for some back-story on the evolution of the “Not Under the Bus” platform. She responded,

“We oppose legislation that throws women under the bus, which both the House and Senate bill now do. There are major fixes that need to happen, and we will continue to work to fix anti-woman provisions in health care. Our goal is to keep working to rescind the Hyde amendment and to pass the Freedom of Choice Act to guarantee reproductive justice to women.”

Jessica Arons, Director of the Women’s Health and Rights Program at the Center for American Progress, explained it to me why she believes it is so important for people to “speak up right now.”

“The final bill is being hammered out in the next week. Originally, pro-choice groups tried to be nice and work out a compromise on the Hyde Amendment because they realized how important health reform is. But hard line abortion opponents refused to play fair and meet in the middle. Yet we’re the ones being asked to take one for the team and accept brand new restrictions on abortion coverage. We’ve compromised enough by agreeing to extend the Hyde Amendment to the new exchange and we can’t bend anymore.
The House and Senate bills not only apply the Hyde Amendment to a new group of women – everyone participating in a new health insurance exchange – the bills also impose federal restrictions on abortion coverage under private health plans for the first time ever.

I think the intent of both bills is to encourage private health plans to drop abortion coverage. The Stupak Amendment in the House bill only allows a plan that includes abortion coverage to be sold to people who can pay 100% of their premiums themselves. That’s only 14% of people participating in any new health exchange. No insurer is going to offer a product that only 14% of the market can purchase. And the Senate language that Sen. Nelson insisted on would make insurers charge enrollees two separate premiums each month – one for abortion coverage and one for everything else. There is absolutely no justification for this rule if your only concern is to keep taxpayer money from going to abortion, since neither premium would come from the government. The only reason to require a rule like that is to make it so cumbersome that insurers and enrollees don’t want to be bothered with it, and decide to deal only with plans that exclude abortion.

Regardless of what the new health market looks like, it will be large enough to influence the rest of the market (i.e., the employer market). Even though abortion coverage in employer plans is the norm right now, if insurance companies decide to drop abortion coverage from their plans in a national or state exchange, they may also decide to drop it from their employer-sponsored plans. If either of the Stupak or Nelson provisions makes it into the final health bill, abortion-inclusive coverage could become much more difficult to obtain in the new health insurance market and eventually in every health insurance market.”

In creating a process by which women can learn, act, and empower themselves, the “Not Under the Bus” action day encourages those who want to be heard a simple and direct way to become part of the dialogue.

In the larger conversation, perhaps no one professional has been quoted, and misquoted, more frequently than Dr. Diane Harper.  The recipient of a Masters Degree in Public Health, Dr. Harper is a Professor and Vice-Chair of Research at the University of Missouri-Kansas City School of Medicine, specializing in Community and Family Medicine, Obstetrics and Gynecology, Bioinformatics and Personalized Medicine.

I first contacted Dr. Harper in September 2009 to get a primer on the Gardasil vaccine, and to gain insight into the issues that were being raised about the marketing and the safety of the vaccine.  In addition to the questions that I raised this month with Dr. Harper, I asked her to contribute a statement that would clearly elucidate her point of view in her own words.  She sent me what follows  via e-mail.

Statement:

“The most important point that I have always said from day one, is that the use of this vaccine must be done with informed consent and complete disclosure of the benefits and harms of Pap screening and HPV vaccines. The decision to be vaccinated must be the woman’s (or parent’s if it is for a young child), and not the physician’s or any board of health, as the vaccination contains personal risk that only the person can value.

As all of the information in the United States concerned Gardasil, since that was the only vaccine approved in the U.S. from June 2006 until this past October 2009, my comments have been focused on Gardasil.

My points are as follows:

The Benefits of Pap Screening:

• Individual benefit to detect early precancers.
• Public health benefit: Only when 70% of the population has been screened will the population incidence of cervical cancer drop.
• Pap tests do not kill or handicap.

The Harms of Pap Screening:

• Screening must be repeated throughout a woman’s life. One screen is not sufficient to protect her from cervical cancer.
• False negative rate of cytology screening:  Among the women who develop cervical cancer in the U.S., 30% are women who have been routinely screened, and all their Paps have been normal.
• False positive rate of cytology screening:  Women who screen abnormal are psychologically upset, anxious and left doubting the medical process (i.e. Her Pap was abnormal, but her colposcopy and biopsy were normal, with no explanation why her Pap was abnormal).
• Quality of life harms:  Women with abnormal Paps have anxiety as high as women diagnosed with cervical cancer undergoing their surgical treatment.  The stress of going to colposcopy and biopsy can be high for many women. The contemplation of a cervical biopsy and a scraping of the endocervical canal can lead to fear of pain.
• Relationship harms: Once women are told they have an abnormal Pap and that the Pap is abnormal because of a STD called HPV, most relationships are stressed as the partners attempt to understand who brought the infection to the relationship.
• Excisional treatments for detected precancerous lesions cause preterm deliveries in subsequent pregnancies, with concomitant low birth weight infants (which puts the infant at risk for life). In addition, scarring from the treatments lead to an increased cesarean section delivery method (as the cervix does not dilate normally due to scarring from prior excisions).  These reproductive morbidities occur between 70%-300% more often in women with excisions.
• Recurrence of HPV associated cervical/vaginal/anal cancers at a rate of 3-12 times higher than those women who never had a cervical cancer precursor or cancer. These recurrences happen around ten years after treatment with peak recurrences between ten and twenty years from the initial treatment.

The Benefits of HPV vaccination:

• Cervarix protects against five cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
• Gardasil protects against three cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
• Cervarix induces antibody titers for HPV 16 and 18 that are at least ten fold higher than natural infection titers; the antibody titers for the other three cancer causing types (HPV 31, 45, 33) are also significantly higher than natural infection titers, and the titers stay high for at least 7.4 years – lasting the longer of either vaccines.
• Gardasil only maintains antibody titers for HPV 16 (not 18, not 11, not 6) at five years, making the true long lasting (five years) coverage of Gardasil only for one type of cancer causing HPV.
• If vaccination occurs within one year of the onset of sexual activity, there will be 57/1000 cases of all CIN 2+ types and persistent HPV 16/18 infections prevented, as compared to only 17/1000 cases prevented if virgins are vaccinated.

The Harms of HPV Vaccination:

• Duration of efficacy is key to the entire question.  If duration is at least fifteen years, then vaccinating 11-year-old girls will protect them until they are 26 and will prevent some precancers, but postpone most cancers.  If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.
• Safety: There is at least one verified case of auto-immune initiated motor neuron disease declared triggered by Gardasil [presented by neurologists at the 2009 American Neurological Association meeting in Baltimore, Maryland). There are serious adverse events, including death, associated with Gardasil use.
• No population benefit in reduction of cervical cancer incidence in the United States with HPV vaccination as long as screening continues.
• Incidence rate of cervical cancer in the United States based on screening is 7/100,000 women per year.
• Incidence rate of cervical cancer if women are only vaccinated with Gardasil is 14/100,000 per year (twice the rate of cervical cancer if young women vaccinated with Gardasil do not seek Pap testing at 21 years and the rest of their life).
• Incidence rate of cervical cancer with Cervarix vaccination is 9/100,000 per year– better than with Gardasil, but still more than with screening alone.
• Incidence of cervical cancer without screening and without vaccination is nearly 90/100,000 per year.  The combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level.  Those women who do not participate in Pap screening, and who are vaccinated, will have some personal benefit for five years for Gardasil and 7.4 years for Cervarix (maybe longer), but they will not affect the population rates.

Boosters for Gardasil after antibodies wane makes the cost of vaccination escalate significantly, and cause implementation challenges to reach those women who might want to be revaccinated.”

Questions:

Can you explain what your role as a “principal investigator (PI) for clinical vaccine trials” for Merck (Gardasil) and GlaxoSmithKline (Cervarix) entailed?

“Principal investigator means that I was responsible for assembling a research team to recruit participants, deliver the health care during the study, collect biological specimens at the correct time, and retain subjects over the entire time frame of the study. After the data collection is complete, I have a professional/medical/clinical obligation to review the data for interpretation, comment and publication. There are instances when industry will exclude a PI from participating in the data publication process.  In total, for Merck and GSK, our team enrolled and followed nearly 3000 women in these studies. We have been participating in these trials as early as1997 when the first protocols were written.”

Some reports state that you received no compensation; others qualify you as a “paid consultant.” What was your relationship with these companies?

“The institutions at which I conducted the clinical trials were reimbursed for the costs of conducting the trials.  I received no direct money for conducting the trials.  I was a consultant for both GSK and MERCK, for which I was paid.”

The public has identified you as a doctor knowledgeable about HPV and the vaccines, potentially without an agenda. Can you explain what you support about the Gardasil vaccine and what you see as its faults?

“I am an international expert in HPV science, its vaccines, its clinical disease and treatment.  I have personally seen tens of thousands of women with abnormal Pap smears and have a referral clinic/office that includes women coming from all continents of the world to consult for my opinion on their personal care.

Gardasil offers sexually active women, who do not currently have HPV 6, 11, 16, or 18 infections, protection from genital warts and CIN 2+ disease for five years.  If the vaccinated person is not sexually active during the five years of its efficacy, then the vaccine has not protected her from disease (as we do not have evidence that Gardasil offers efficacy any longer than five years).  Its faults include tiny antibody titers for all HPV types other than HPV 16; limited protection; limited duration of efficacy; and safety concerns (as outlined in my opening statement).”

Can you comment on the disconnect between the fact that efficacy was proven only in the 16-26 year old demographic, yet Gardasil is being approved for those in the 9-26 year old demographic.

“Immunologically, the disconnect is explained by two studies. One study in the 16-26 year old women showed both antibody titers and efficacy.   The second study in 9-15 year olds showed similar antibody titers to those induced in 16-26 year olds where efficacy was seen.  Hence, the inference is that efficacy must exist in 9-15 year olds. The fault in this logic is that 9-15 year olds may not be exposed to the virus until after the vaccine has waned.”

Do you believe that the Gardasil vaccine, as it currently stands, could present more risks to a young girl or woman than the possibility of cervical cancer?

“Pap smears have never killed anyone.  Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone.

Gardasil is associated with serious adverse events, including death.  If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit – and only risk – for the young girl.  Vaccinating will not reduce the population incidence of cervical cancer if the woman continues to get Pap screening throughout her life.

If a woman is never going to get Pap screening, then a HPV vaccine could offer her a better chance of not developing cervical cancer, and this protection may be valued by the woman as worth the small but real risks of serious adverse events. On the other hand, the woman may not value the protection from Gardasil as being worth the risk knowing that 1) she is at low risk for a persistent HPV infection and 2) most precancers can be detected and treated successfully. It is entirely a personal value judgment.”

Has the original Gardasil marketing campaign of “one less” muddied the waters and misinformed the public, who heretofore believed that a Pap smear was sufficient to protect them from cervical cancer?

“If women were participating in Pap screening, or if as a parent you educated your daughter to seek Pap screening at the appropriate age (21 years) for her entire life, then she would have been very unlikely to be at risk for being “one” and would not be “one less”.  She would not have been “one” to begin with!

Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines as described above, an informed and valued decision would have been able to be made.  Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years.”

Are the protocols of the CDC and VAERS (Vaccine Adverse Event Reporting System) properly processing reports of adverse reactions and deaths due to the vaccine? What do you see as the weak link in the VAERS system of collecting data?

“VAERS is biased in both directions, not allowing any veritable conclusions to be drawn about vaccine safety.  If an association with an adverse event is detected statistically, there is not enough information collected in VAERS to determine causation, which is a multi-step process.  Likewise, if no association with an adverse event is detected statistically, there is not enough information to reassure the public that no serious adverse events occur.  With our new health care reform, we need to budget money to collect true registries of vaccinated individuals and what happens to them after vaccination so that appropriate conclusions can be drawn.”

Could you clarify the content and context of the statements that you made at the 4th International Public Conference on Vaccination in October 2009, which have been so widely read and misquoted? Specifically the reported quote, “The rate of serious adverse effects is greater than the incidence rate of cervical cancer.”

“The rate of serious adverse events reported is 3.4/100,000 doses distributed. The current incidence rate of cervical cancer in the United States is 7/100,000 women.  This is what I said.”

Should there be an informed consent/full disclosure statement that doctors are compelled to deliver to parents before advising them about giving the injection to their daughters, stating that there are small but real risks of death surrounding the administration of Gardasil?

“The informed consent/full disclosure as I described initially must be disclosed to parents and young women.  The questions should be raised, ‘How do you want to prevent cervical cancer? Pap screening? Vaccination? Both?”

Do you think that those who have received the HPV vaccine will become lax with getting their Pap smears, ultimately leading to a greater rate of cervical cancer within the United States population?

“No one wants the incidence of cervical cancer to increase.  But, there is a problem with women’s’ understanding of what Gardasil offered them. Many vaccinated women have returned to me in clinic with more abnormal Pap tests and more HPV disease. They are tremendously disappointed when told that Gardasil does not protect against all types of HPV, and that they are still at risk for cervical cancer.

In answer to your question, Yes.  Finland has shown us that even a lack of screening for five years, resulting in less than 70% of the population being screened, is enough to increase the population incidence rate of cervical cancer.  Yes, there is a real risk that cervical cancer will increase in the U.S. if those women getting Gardasil do not realize that:

• Gardasil will not protect them for life
• They can get other HPV infections that lead to cancer that are not covered by Gardasil
• They need to continue to have Pap tests throughout their lifetime”

Recent reports state that Gardasil may have triggered MS (Multiple Sclerosis) in some girls receiving the vaccine.  What are your thoughts on this?

“Neurologists at the American Neurological Association have indeed concluded that Gardasil is temporally associated with autoimmune attacks on the neurologic system.  The range of neurologic disorders is unknown.”

Can you point out specific “misstatements” that Merck has promulgated about the Gardasil vaccine?

“Less misstatements, than incomplete statements. For instance, the cumulative incidence of HPV infections for women in the U.S. through the age of 50 years old is 80%. That statement is true. That statement infers that nearly every one is infected with HPV at least one point in their life.

What is left out is that 95% of all HPV infections are cleared spontaneously by the body’s immune system.  The remaining 5% progress to cancer precursors.  Cancer precursors, specifically CIN 3, progresses to invasive cancer in the following proportions:  20% of women with CIN 3 progress to invasive cervical cancer in five years; 40% progress to cervical cancer in thirty years. There is ample time to detect and treat the early precancers and early stage cancers for 100% cure.

Other examples include inferences that Gardasil will last a lifetime, with no mention of boosters or limited protection possible.  Regarding wart protection promotion, there is no mention that the data showed protection against genital warts in men for only a 2.4-year period of time.

Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection. not the development of cervical cancer.”

Are there any final comments that you would like to make about the Gardasil vaccine?

“Until Merck funds a multi-ethnic efficacy study lasting at least fifteen years, the vaccine should be used primarily by women within the first six years of their onset of sexual activity, to gain the most protection possible…if they choose to be vaccinated.  The women can also choose to continue Pap screening for their lifetime.

Within the “first six years” comes from the National Cancer Institute data compiled from the Guanacaste study (Rodriguez – first author) that shows that the prevention rate is 32/1000 women, still much higher than the 17/1000 rate when vaccinating virgins who go on to become sexually active, but less than the 57/1000 women if vaccinated within the first year of sexual activity.

Cervarix is the superior cervical cancer vaccine, in that it prevents five types of cancer causing HPV infections. Gardasil is the superior vaccine in preventing HPV types causing genital warts.”

This article originally appeared on the women’s health site Empowher.

Dr. Margaret Lewin, M.D., F.A.C.P., is the Medical Director of Cinergy Health, an insurance benefits provider.  She advises the board on patient related issues and public health concerns.  Lewin is board-certified in Internal Medicine, Hematology, and Medical Oncology.  Lewin is affiliated with New York Presbyterian Hospital and the Hospital for Special Surgery.

Dr. Alan Gibstein, M.D., F.A.C.S., F.A.C.O.G., is a Clinical Assistant Professor of Obstetrics and Gynecology at NYU School of Medicine.  He is board-certified in Obstetrics and Gynecology, and is affiliated with North Shore University Hospital.  He was president of the LIJMC medical staff from 1982-9183.  In addition to his work as an attending gynecologist, he has been actively involved in medical and residency teaching.

On why they supported the vaccine:

Dr. Lewin wrote:

“The evidence clearly shows that the quadrivalent HPV vaccine prevents cervical intraepithelial neoplasia caused by 70% of known HPV subtypes as well as preventing genital warts – both of which are highly contagious (even without sexual penetration), cause significant distress, substantial cost, and cannot reliably be permanently eliminated. There are published reports of oral cancer caused by the HPV virus.  Oral cancers and their treatment are devastating, and the ability to avoid HPV-related oral cancers strongly increases my support from the vaccine.”

Dr. Gibstein wrote:

“Gardasil produces lasting immunity against the four most common types of HPV that we see in the vast majority of men and women. Types 6 and 11 are a benign virus that causes warts.  Types 16 and 18 – most common associated types – causes pre-cancer or a cancerous cervix. Published results have shown that Gardasil blocks these four types of HPV, and therefore women will not get genital warts or dysplasia of cervix. If a series of injections are completed, this gives complete immunity against the four majority types and it can eradicate cervical cancer.

The most important aspect of the need for and value of the Gardasil vaccine is not just cervical cancer prevention, (which is extremely important), but the prevention of invasion by HPV in the first place. Only someone in a busy clinical practice could begin to describe and understand the enormous emotional impact that the first abnormal Pap smear has on any woman, but especially a young one. Women are well aware, by Internet, etc., about HPV and STDs. Unfortunately not all practioners, or even gynecologists, are aware of the natural pathogenesis of most HPV infections to “cure” themselves. This ignorance or greed leads to the beginning of a cycle of repeat examinations, repeat biopsies, colposcopies, conizations, LEEPs, etc. In other words, fear, anxiety, social upheaval and accusations, time, enormous expense and risk of real damage. This can be prevented with Gardasil in the vast majority.

Gardasil will also protect against HPV infections of the vulva, vagina and cervix, as well as tongue, throat and floor of the mouth where cancers also occur linked to HPV.  In my practice, I examined every male consort of my patients with HPV and found evidence of warts in virtually 100% of them. Since abstinence is a proven failed social condition, and because HPV literally coats the earth, eventually the majority of sexually active adolescents and young adults will be exposed. The amount of expense, time, and emotion expended to treat HPV amounts to scores of millions of dollars per year, nearly all of which would be prevented by vaccination.”

On the reports of young girls who have suffered adverse side effects to the vaccine:

Dr. Lewin wrote:

“The adverse effects of the vaccine are grossly overstated in the lay media.  The post licensure safety surveillance for this vaccine (via VAERS: the Vaccine Adverse Event Reporting System) has reported 12,424 adverse events (53.9 per 100,000 doses distributed).  772 of these have been serious.  The rates of most of the serious adverse events are not greater than the background rates for other vaccines, except for the following:

• Syncope (passing out) – in 0.2 per 100,000 doses, leading to the recommendation that the recipient receive the vaccine while lying down and be observed in the physician’s office for 15 minutes after it has been administered
• Venous thromboembolism (abnormal blood clots).  90% of those who had blood clots had a known risk factor for such clots, such as the use of oral contraceptives – a pre-condition well-known to cause such clotting.  The possibility of a causative relation to the vaccine is being closely investigated.
• 32 reported deaths, of which 12 could not be verified by review of the medical records.  There was no common pattern to the remaining deaths that would suggest they were caused by the vaccine, and the cause of the deaths can be explained by factors other than the vaccine.  For example, 2 were from vaccine-unrelated diabetic ketoacidosis, 6 were cardiac related, and 1 was associated with prescription drug abuse.”

Dr Gibstein wrote:

“Critics seem to forget the uproar in the past to reactions to the polio vaccine, the varicella vaccine (including neurologic reactions) and the triple vaccines. Gardasil can and does cause local reaction, pain and redness in many, some syncope in a small number, and perhaps can trigger serious neurologic disorders such as Guillane-Barre or ALS in a few. Gardasil is composed of DNA (protein) gotten from the envelope (capsule) of the human papilloma virus. As such, it is not a live virus and cannot directly cause infection or disease.  But it contains several metals and minerals, and is made in yeast. Therefore it can, like many other vaccines, trigger hypersensitivity reactions in susceptible individuals. Except for people known to be allergic to yeast, most of these reactions would not be predictable.”  Gibstein acknowledged that the vaccine has a fair amount of local reaction with soreness/redness 48-72 hours, and that a small percentage of recipients have a bit of mild flu reaction.”

Gibstein referenced Dr. Martin M. Fisher, Director of Adolescent Medicine at Schneider’s Children’s Hospital at North Shore/Long Island Jewish Hospital, who is advising that Gardasil be recommended to all women from age 12 to 26. Both Dr. Gibstein and Dr. Fisher agree that adverse reactions are 97% local and transient, and the severe reactions as reported by the CDC are occurring at no greater frequency than occur spontaneously in the general population of the same age.

Dr. Lewin maintained that a 5-year clinical trial was ample time to do the necessary follow-up, with the “understanding that close post licensure studies continued.” Responding to my query on the point of giving the vaccine as early as 9 years old if the vaccine does not last fifteen years she wrote:

“It is not yet clear how long the vaccine lasts and it might be necessary to give a booster after ten years or so as is the case with mumps and polio, for example.  Since it takes several months for the vaccine to be fully effective, starting at a young age is necessary to protect young girls from this highly contagious virus, which can be transmitted by any skin-to-skin contact.  In addition to the unfortunate early beginning of consensual sexual activity (whether oral, vaginal or simply intimate ‘petting’), it cannot be ignored that many young girls are victims of non-consensual contact.”

Gibstein suggested that time would tell if the protection is durable, and if complications can be directly attributable to the vaccine.

Both doctors had strong words about the marketing tactics of all pharmaceutical companies.  They had read the JAMA article, “Marketing HPV Vaccine.”  Dr. Lewin responded, “I am outraged by all Pharma advertising to the lay public.”  Dr. Gibstein stated, “Drug companies like Merck and others often behave both unethically and disgracefully in both their limited reporting of adverse reactions and their abhorrent advertising on TV, radio, etc. The advertising for Gardasil is, in my opinion, inexcusable. The high cost of the vaccine is another example of price gouging by Pharma, but is worth it to offset the cost of treating HPV infections.”

In reaching out for this piece, a sidebar of interest arose.  Adina Nack, Ph.D., author of Damaged Goods? Women Living with Incurable STDs and professor of medical sociology and sexuality studies at California Lutheran University, contacted me to emphasize her concern for the advocacy of “comprehensive HPV education, and for allocating resources to improve the development and provision of testing and treatment options for those who contract the variety of HPV infections and HPV-related cancers.”  Her work has focused on these concerns, in addition to her support of the development of Gardasil.

This article previously appeared on the women’s health site Empowher.