Women’s Health and the Media: Where do we find trustworthy information? What are the key challenges? Media portrayals of new medical research often inaccurate A societal embracing of the “quick fix” or “pill for every ill” approach Key Challenges…. Increasing influence of the pharmaceutical industry over physician prescribing practices as well as the educational and advertising materials aimed at the consumer or patient Amidst the plethora of websites, ads and other sources, how does one find trustworthy information? Know the source of your information and look out for conflicts of interest Utilize non-commercial websites prepared by those who know how to evaluate the quality of the research that they cite Use more than one source EXAMPLE OF CHILDBIRTH AND THE RISING CESAREAN SECTION RATES IN THE UNITED STATES Reasons for Rising Cesarean Rates (IOM 1989 report) 30% of the rise due to diagnosis of dystocia (abnormal or difficult labor) 25-30% due to repeat cesarean section 10-25% due to breech presentation 10-15% due to fetal distress Current reasons for rising cesarean rates Primarily changes in obstetrical practice, such as: - More repeat cesareans - More refusals to allow VBACs - Concerns about malpractice - More advocates of medicallyunnecessary cesareans NCHS TRACKING IN 2004 “Cesarean delivery rate rose 6 percent in 2004 to 29.1 percent of all births, the highest rate ever reported in the United States” From: http://www.cdc.gov/nchs/products/pubs /pubd/hestats/prelimbirths04/prelimbirth s04health.htm TRACKING in 2004 (cont.): “The rate has increased by over 40 percent since 1996. For 2003–04 the primary cesarean rate rose 8 percent, and the rate of vaginal birth after cesarean delivery (VBAC) dropped 13 percent. The primary rate has climbed 41 percent and the VBAC rate has fallen 67 percent since 1996.” NIH Meeting on Cesareans by “Maternal Request” (March 27-29, 2006) Will media coverage of this meeting and its report result in more cesareans with no medical indication (elective surgery)? QUESTIONS ADDRESSED AT THE NIH MEETING: What is the trend and incidence of cesarean delivery in the US and other countries? What are the benefits and harms of cesarean “by request” vs. attempted vaginal birth (both short-term and long-term)? (Cont.) QUESTIONS (cont.) What factors influence benefits and harms? What research should be done to get better evidence for making decisions regarding cesarean delivery “on request” vs. attempted vaginal delivery? Panel’s Recommendations Final report at www.consensus.nih.gov/2006 Insufficient evidence, so more research needed on benefits and risks of cesarean delivery on maternal request vs. planned vaginal delivery Until better evidence is available, any decision to do cesareans upon “maternal request” should be carefully considered Recommendations (cont.) Not recommended for women desiring several children given rising risks of placenta previa and accreta with each cesarean delivery No cesareans upon “maternal request” prior to 39 weeks or without verification of lung maturity (because of significant risks of neonatal respiratory complications) Recommendations (cont.) Effective pain management services should be available for all women so that fear of pain is not a motivating factor for an elective cesarean NIH (or other appropriate Federal agency) establish a website with upto-date information The final report did not adequately consider many recognized long-term adverse outcomes associated with cesarean surgery and did not take into account the impact that avoidable obstetric practices can cause during vaginal birth. From the national Listening to Mothers II Survey of the Childbirth Connection in NYC (http://www.childbirthconnection.org/article.asp?ck=10401): 56% of women who wanted a vaginal birth after having had a cesarean said a doctor denied them that option. 1 out of every 4 women polled who had caesarean said they felt pushed into having the surgery. Excellent discussions of this meeting: Diony Young’s editorial in the September 2006 issue of BIRTH –’ “Cesarean Delivery on Maternal Request”: Was the NIH Conference Based on a Faulty Premise?’ Henci Goer’s piece in Lamaze e-news (June 2006) Rona McCandlish’s article in MIDWIFERY (v.22, 2006): “Meeting maternal request for Cesarean section – paving the road to hell?” Possible consequences of these Recommendations An increasing trend towards considering cesarean birth as a “normal” birth with benefits/harms on par with vaginal birth Misleading coverage in the media Continued distortion of the concept of “women’s right to choose” “Maternal mortality and severe morbidity associated with low-risk planned cesarean delivery versus planned vaginal delivery at term” Liu et al. CMAJ Feb 2007 (This study used a breech group as a surrogate for an elective cesarean group) Among healthy women in the study: 27.3 per 1,000 women in the planned cesarean group (breech births) had severe complications (such as major infections or blood clots) vs. 9 per 1,000 women in the planned vaginal group From the CMAJ commentary: “This study provides additional support to a growing body of evidence suggesting that primary elective cesarean birth may place both mother and newborn at greater risk for adverse outcomes than planned vaginal birth” COSMETIC SURGERY is the fastest growing medical specialty in the U.S. Breast implants solely for cosmetic purposes are increasing in popularity despite substantial risks associated with both silicone and saline implants. See the booklet prepared by the US Food and Drug Administration for photographs and descriptions of adverse implant outcomes such as disfigurement, capsular contracture (when the breast becomes hard and misshapen), and deflation: www.fda.gov/cdrh/breastimplants) Sample Photo from Implant Maker’s Website Photo of Capsular Contracture From FDA Booklet This is the same 27-year old woman after her painful implants were removed Necrosis in mastectomy patient with implants for one week After removal of one woman’s leaking silicone implants According to the American Society for Aesthetic Plastic Surgery, 364,610 women got breast implants in 2005. The number was up 9 percent from 2004. “It's like being set free, from being trapped in a bad body, to being set free in a nice body.” From: ‘More women having ‘mommy makeovers’ by Kim Baer The Free Lance-Star (Fredericksburg, VA) March 13, 2007 A survey by the American Society of Plastic Surgeons showed that nearly 40 percent of plastic surgery patients believe they should have been more proactive in learning about potential side effects and complications before surgery. “There are over-the counter creams and lotions. And then there’s Botox Cosmetic. My doctor says they’re just not the same. She said only prescription Botox is approved by the FDA to treat the frown lines between your brows…” A large coalition of groups: See www.safecosmetics.org “Skin Deep” a report of the Environmental Working Group, helps consumers and workers to better protect themselves from known or suspected carcinogens and reproductive toxins. In October 2005, Governor Schwarzenegger signed the Safe Cosmetics Act into California law. As of January 1, 2007, cosmetics manufacturers in the state will be required to disclose any product ingredients that cause cancer or birth defects. Harmful Substances to Avoid Para-phenylenediamine, a chemical found in some dark hair dyes (may increase risk for bladder cancer in humans) Phthalates, typically used as a solvent and plastic softener and also found in many shampoos and other hair products, cosmetics, deodorants and nail polish (has been linked to cancer and to birth defects of the male reproductive system). To learn more, go to www.nottoopretty.org. To avoid (continued): Talc, in talcum powder (has been Propylene glycol, an ingredient linked to a 60% increase in the risk for ovarian cancer in women who use it in the genital area). found in some moisturizing products and skin creams (may damage the kidneys and liver). What to do to minimize risk Read labels carefully and choose all-natural alternatives, such as products made with olive oil, safflower oil or oatmeal, whenever possible. Direct-to-Consumer Advertising of Prescription Drugs: Misleading Ads and How They Hurt Us The Public Gets Misinformation Benefits are often overstated, while risks are understated FDA warning letters are issued after the ads run Corrective ads are rarely required Withdrawal of an ad is the only penalty Ads are geared primarily to selling more drug product, not educating the user The ads work: the most highly advertised drugs, accompanied by promotional campaigns geared to physicians, sell extremely well Top selling drug in the world? Lipitor (Pfizer) (with more than 13 billion dollars in sales in 2005) Drugs can be quite useful, but “Pills for Prevention” may not be the best approach. Important to promote a view of public health that stresses primary prevention – identifying and eliminating disease-causing agents in our food, water, and air. Precautionary Principle of Public Health: When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established. Science and Environmental Health Network: www.sehn.org Consider the example of an ad for SARAFEM (Prozac repackaged as a pink and purple capsule) at www.sarafem.com (ad since removed): ”Think it’s PMS? Think Again…it could be PMDD…” Picture of a young woman trying to zip her jeans (too bloated?); picture of another woman seemingly distressed… Then text follows: “Irritability, sadness, sudden mood changes, tension, bloating. If you suffer from many of these symptoms month after month and they clearly interfere with your daily activities and relationships you could have PMDD… “…PMDD, Premenstrual Dysphoric Disorder, is a distinct medical condition that is characterized by intense mood and physical symptoms right before your period.” “Sarafem can help. Doctors can treat PMDD with medication for PMDD” Constantly flashing, each shown consecutively: “Mood swings---irritability--bloated feeling” Drug regulators in Europe forced Eli Lilly to drop PMDD as one of the approved uses for Prozac (Sarafem), as the data did not provide adequate evidence of efficacy. Current content at this website has changed. Sample quote: “Many physicians believe that Sarafem helps to correct the imbalance of serotonin that could contribute to PMDD.” “Antidepressants increased the risk of suicidal thinking and behavior in children and teenagers with depression and other psychiatric disorders. Patients starting therapy should be observed closely for worsening depression symptoms, suicidal thoughts or behavior, or unusual changes in behavior. Sarafem is not approved for use in patients under the age of 18.” The ad was misleading because it mixed “relative risk” with “absolute risk,” noting, for example, the following: 44% fewer breast cancers in women taking tamoxifen vs. women taking a placebo But there was NO mention of the following relative risk: a 252% increased risk of endometrial cancer The ad also noted a risk of serious problems such as endometrial cancer or blood clots at “only” 1-2% (absolute risk) But left out was any mention that women have only a 1.8% chance of benefiting from the drug (absolute benefit) Unpaid advertising also a problem: Parade magazine, for example, put model Lauren Hutton on its cover for a piece on celebrity beauty tips, and quoted her saying her "No. 1 secret is estrogen. It’s good for your moods, it’s good for your skin. If I had to choose between all my creams and makeup for feeling and looking good, I’d take the estrogen.” The article didn’t mention that Hutton was a paid spokesperson for Wyeth Ayerst, and that she appeared in their ads. It also didn’t mention that Hutton's claims for estrogen's benefits were not backed up by valid scientific evidence. “Female Sexual Dysfunction” Is this a serious problem requiring primarily biomedical solutions, or is a different approach most often called for? In 1999, Pfizer consultants analyzed one question from a 1994 survey and produced an overly simplistic conclusion – that 43% of American women “suffer from” sexual dysfunction Idea Marketing A disease awareness campaign is now building a drug market using the 43% FSD statistic. (Slide Courtesy of Leonore Tiefer) To promote “The Hunt for the Pink Viagra” (Slide Courtesy of Leonore Tiefer) For more information about female sexual problems, see the website of the Campaign for a New View of Women’s Sexual Problems: www.fsd-alert.org Menopause Every day 5,000 women in the U.S. enter menopause, the so-called “change of life” What do we think about menopause? Some women see it as “the end of sex” or the “end of youth” Some see a passport to freedom (no fear of getting pregnant, no messing with pads and tampons, no more “shoulds” about how one needs to “look”) Possibly more time for oneself What influences our thinking? Media messages that worship youth, thinness, and suggest “it’s not OK to grow old” Conversations with other women about their actual experiences with menoapuse Opportunities for Medicalization Less/no interest in sex Hot flashes/vaginal dryness and loss of elasticity Loss of bone density More “spreading waistlines” and sagging skin Memory problems Depression Problems with sleep Approaches to dealing with sleep problems other than prescription sleeping drugs such as Ambien and Lunesta: Yoga/exercise Avoiding caffeine Deep breathing/massage at bedtime from a partner Sleep in a cool room Non-hormonal approaches to dealing with hot flashes Wear layered clothing Use fans Put palms or bare feet on a cold surface Cold pack under the pillow Exercise, yoga, deep breathing Less caffeine, less spicy foods, less alcohol (especially red wine) Removing health ovaries US federal data from the late 1990s: 78% of women 45-64 who have had a hysterectomy also had healthy ovaries removed (even though most were not at particular risk of developing ovarian cancer). Latest research shows that for women without a family history of ovarian cancer there is a significant reduction in death from heart disease and complications of osteoporosis IF THE OVARIES ARE KEPT, especially until the age of 65. KEY FINDINGS OF WILLIAM PARKER et al study in 2005: For 10,000 women 50-54 yrs old who undergo a hysterectomy with oophorectomy, there will be 47 fewer cases of ovarian cancer by the time these women reach 80 when compared with a similar group who keep their ovaries. BUT the oophorectomy group will suffer 838 additional deaths from coronary heart disease as well as 158 more deaths from hip fractures. (Numbers reflect women who do NOT have estrogen therapy – there is a smaller survival benefit to keeping the ovaries in women taking estrogen.) Ads for bone density screening now pitched at women around 50 yrs of age Creation of the ”T” score and a new classification called osteopenia (for -1 to -2.5 scores) Merck stopped by the FDA from using the claim “menopause is the single most important cause of osteoporosis” in their ads Cloning, Stem Cells and Inheritable Genetic Modification Special case of embryo cloning (somatic cell nuclear transfer) Research: the promises and the challenges Balancing our interest in developing new medical therapies with the need to protect research subjects and the need to preserve values of social justice and equity Developing technologies that will be accessible to most Often Ignored Concerns Risks to women’s health Gateway to “designer babies” Unethical experimentation on humans Fueling of a new eugenics movement Risks to Women’s Health from Research Cloning Also known as “therapeutic cloning” or “somatic cell nuclear transfer” (SCNT), SCNT requires the collection of many eggs from women willing to undergo egg extraction procedures. Some Concerns about Multiple Egg Extraction Use of leuprolide acetate (Lupron™), a GnRH agonist, to “shut down” the ovaries, is not FDA-aproved for this purpose (Antagon™, a GnRH antagonist that is also used, is approved for this use.) Use of drugs that hyper-stimulate the ovaries to produce multiple follicles As Spring of 1999, US Food and Drug Administration (FDA) had received 4228 reports of adverse drug events from women using Lupron.™ 325 of the adverse events for women reported to the FDA resulted in hospitalization, and additionally, 25 deaths were reported. The Research Cloning Debate The most vocal participants have been Anti-choice conservatives opposed to the destruction of embryos, who favor a permanent ban Biomedical researchers and their allies, who are wary of or opposed to regulatory oversight Good Resources National Women’s Health Network (DC) Breast Cancer Action (SF) Collaborative on Health and the Environment Science and Environmental Health Network Silent Spring Institute (Newton, MA) Teen Voices magazine (Boston) Center for Medical Consumers (NYC) Canadian Women’s Health Network (CWHN) www.ourbodiesourselves.org www.ourbodiesourselves.org May 2005