Osteoporosis, a loss of bone mass that can precede serious and costly breaks or fractures, is of particular concern to women – current estimates suggest that “osteoporosis is a major public health threat for 44 million Americans, 68 percent of whom are women… One out of every two women and one in four men age 50 and older will have an osteoporosis-related fracture in their lifetime.”

Often overlooked in discussions of the condition, however, are questions related to the efficacy and potential harms of the tests and treatments used to measure and prevent bone loss.  In particular, women’s health advocates have concerns about the overuse of medications in women who have risk factors for osteoporosis, but do not actually have the disease itself.

The April issue of the American Journal of Nursing (AJN) includes a piece, “The Marketing of Osteoporosis,” which comments on the promotion of drugs to symptom-free women for bone fracture prevention.

Author Maryann Napoli (of the Center for Medical Consumers) writes:

“In the name of prevention, millions of Americans have accepted the idea that it’s reasonable to treat a risk factor such as bone loss or high cholesterol as if it were a disease…More people should question the wisdom of starting long-term drug therapy. Often the magnitude of the risk factor has been overestimated, or the danger of the disease itself exaggerated, by people trying to sell you something-like a drug you must take for the rest of your life.”

She describes how what was once a risk factor (bone loss) came to be thought of as a disease (osteoporosis), and notes the role of pharmaceutical companies such as Merck in shaping this thinking, as well as in encouraging women to have bone density scans and take drugs as a “preventive” measure.

Napoli notes that as drugs such as alendronate came on the market, middle-aged rather than elderly women became the targets of osteoporosis-related advertising and drugs. She explains:

“A multipage glossy ad campaign that ran frequently in the Annals of Internal Medicine, for example, featured a thin, 40-something white woman with a crumbling ancient stone column in the background. “Don’t wait for a fracture…. No matter what her degree of osteoporotic bone loss.” I wrote to the editor-in-chief of Annals, pointing out that alendronate had no proven benefit in women in early middle age or in those without a history of fracture. I never received a reply, but the journal stopped running the ad about six months later….

Today, women in the osteoporosis drug ads are usually in their early 60s. The 2002 guidelines for osteoporosis screening from the Agency for Healthcare Research and Quality recommend that bone-density scanning not begin until age 65 (or 60 in some high-risk cases).”

Christine has previously written about the potentially serious side effects medications for postmenopausal osteoporosis and non-drug prevention options, and OBOS’s Judy Norsigian and Heather Stephenson addressed the issue in a commentary for Women’s eNews, “Let’s Make May the Month to Tame Osteoporosis Hype.”

Side note: The current cover of the AJN features a piece of art called Nursing Bra, part of the Artfull Bras Project, a collection of 50 bras created by the Quilters of South Carolina to raise breast cancer awareness.

A “Too-Tall” Medical Tale: Christine Cosgrove, co-author with Susan Cohen of the new book “Normal at Any Cost: Tall Girls, Short Boys, and the Medical Industry’s Quest to Manipulate Height,” wrote a great piece in the L.A. Times about the history of doctors prescribing DES, a synthetic drug that acts like estrogen, to girls to stunt their growth.

Why? Because decades ago, “if a girl were heading toward 5 feet 8 inches, or, horrors, 5 feet 10 inches, not only would she have trouble finding clothes that fit, she’d have a hard time finding a husband. And in the days when there were few options besides marriage and children for women, well, that left an old maid.”

Thousands of girls, including Cosgrove, took the pills. Some have experienced myriad health problems, and an Australian study found a significant decrease in fertility among those who were treated.

Check out more about the book. Here’s an interview with the authors.

America’s Back — Now What?: Linda Hirshman and Gloria Feldt wrote a commentary on the significance of the U.N Cairo + 15 meeting:

On March 31, State Department Acting Assistant Secretary for Population, Refugees, and Migration, Margaret Pollack, told delegates to the United Nations Commission on Population and Development, meeting in New York, that America was back.

Marking a 180 degree turnaround from Bush administration policies that fought international efforts to enable people to control their own reproductive fate, the U.S. will once again defend the “human rights and fundamental freedoms of women” and support “universal access to sexual and reproductive health.” [...]

The global sigh of relief was palpable. For with all its money and diplomatic resources, the U.S. is the 10,000 gorilla in international reproductive policy. Now the question is, while this is certainly change we can believe in, is it all the change we need?

Film Critics Write Off Rape: Tiger Beatdown has a great analysis of the new Seth Rogen film, “Observe & Report,” and the reviews that give a pass to the rape scene. At least New York Times film critic Manohla Dargis will restore your faith. Rachel points to more links.

Why Women Stay: Hilzoy at Obsidian Wings has written the must-read post of all must-read posts about why women stay in abusive relationships. As one commenter put it, “If I always had a hilzoy around to explain it, I think I could understand every human phenomenon in the world.”

Johns Hopkins Bans Free Drug Samples, Gifts to Doctors: “Johns Hopkins is the latest big name in health care to try to restrict doctors’ ties to the drug and device industries,” reports the Wall Street Journal. “Its new policy ‘on interaction with industry’ bans free drug samples and says doctors can’t participate in consulting gigs in which they’re essentially paid for not doing anything.”

Plus: Iowa Republican Sen. Charles Grassley asked a nonprofit mental health organization about its funding as part of his investigation into drug company influence, reports Bloomberg.

Everybody Hurts Sometimes: “Long lines come up frequently in the American healthcare discussion, the symbol of all that is to be feared about a government-run system,” writes Ezra Klein on the L.A. Times op-ed page.

And it’s true that in Canada and Britain, the two countries most often cited in discussions of what nationalized healthcare might mean, some patients report having to wait months for some elective treatments. Sometimes.

But we’ve got waiting lines too — along with 50 million uninsured and a system that costs more than twice as much per person as that of any other country. We’ve just managed to hide our lines through clever statistical gimmickry.

Debate Over Digital Health Records: The Obama administration maintains health information technology is as an essential, cost-savings component of health care reform and has set a goal for every American to have an electronic health record by 2014. But critics fear the money to implement the system will be wasted if doctors and hospitals can’t share information, reports USA Today.

“We could head for a techno-Katrina,” said Sen. Barbara Mikulski, D-Md. “I do not want to do that, where we do a dollar dump, and at the end of the day, we have a lot of microchips floating around.”

Plus: Writing in the New England Journal of Medicine, National Coordinator for Health Information Technology David Blumenthal discusses the health IT provisions of the federal economic stimulus package — collectively called HITECH in the law. Read “Stimulating the Adoption of Health Information Technology.”

Vitamin Sales Up as Economy Falters: “Sales of vitamins and nutritional supplements, which have grown consistently for years, have surged in recent months, rising as the stock market has fallen,” writes Alex Williams in The New York Times. “People are clearly cutting back on many items, from bread and milk to designer jeans and flat-screen televisions, but they are stocking up on pills that they think can spare them expensive doctor visits.”

My Peeps: We end on a colorful note — Tis the season of the peeps. The Washington Post displays its 40 finalists here; don’t miss Peep/Tuck and Thelma and Louise: Peeps on the Run.

Here, first place winner Melissa Harvey discusses her gorgeous interpretation of Edward Hopper’s “Nighthawks” painting.

The winner of the Chicago Tribune contest created an imaginative Wizard of Peeps. And for political junkies, check out this portrayal, at TwinCities.com, of the Minnesota U.S. Senate Trial between Al Franken and Norm Coleman.

Today’s Boston Globe has a great op-ed piece from Marcia Angell on the direction FDA Commissioner nominees Margaret Hamburg and Joshua Sharfstein should take the FDA under their leadership.

Angell offers the following directives:

• “Congress should repeal the Prescription Drug User Fee Act
• Consultants for drug companies should no longer be permitted to serve on FDA advisory panels
• The agency should see that the post-marketing studies it mandates are actually carried out
• The FDA should review generic drugs as fast as brand-name drugs
• Congress should give the FDA the authority to require drug companies to compare new drugs with existing drugs of the same type
• The FDA should stop approving me-too drugs on the basis of surrogate endpoints
• The FDA should prohibit direct-to-consumer advertising for three years after drugs are approved”

All of these are important issues, and you should read the whole piece for Angell’s rationale. For example, she notes that the Prescription Drug User Fee Act:

“…authorizes drug companies to pay ‘user fees’ to the FDA for every drug the agency considers for approval. That puts the FDA on the payroll of the industry it regulates, and makes it more likely that drugs will be reviewed favorably – a bargain for drug companies. Drug companies should not be considered ‘users’ of the FDA; the public is the user, and it alone should support the agency.”

I would add to the list ensuring that decisions about drug approvals be made based on sound science free of political ideologies – see Christine’s recent post on the FDA’s approach to Plan B emergency contraception access for an example of why attention to this issue is needed.

Relatedly, Angell, a Senior Lecturer on Social Medicine at Harvard Medical School and former editor of The New England Journal of Medicine, is the author of a book I’m going to have to add to my to-read list: The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

An in-depth article on the same topic, published in The New York Review of Books in January, provides more on Angell’s perspective: see “Drug Companies & Doctors: A Story of Corruption.”

And finally, The Boston Globe looks at what the FDA could do to improve the information consumers are given about prescription drugs. The article quotes OBOS’s own Judy Norsigian.

I’ve been assuring myself lately that I’m not really as old as my driver’s license insists. My true age — a number determined by health and lifestyle habits — must be lower. All these years without red meat has to count for something.

To confirm my wishful thinking, I planned on taking an online quiz called RealAge that promises to help you find … your real age. Despite an intimidating 150 or so questions, I was courting the payoff: Every time I look in the mirror I would see a member of Generation Y, not X.

But even the virtual fountain of youth comes with a catch. While I was counting on re-setting my internal clock (assuming the test did not inquire about Grateful Dead concert attendance), RealAge has banked on its users turning over their health information to pharmaceutical companies. These companies would of course find something that would make them feel better — and younger.

Along with offering nutrition information, advice on de-stressing and organic gardening books, RealAge “makes its money by selling better living through drugs,” writes Stephanie Clifford in this front-page New York Times story.

“Pharmaceutical companies pay RealAge to compile test results of RealAge members and send them marketing messages by e-mail,” explains Clifford. “The drug companies can even use RealAge answers to find people who show symptoms of a disease — and begin sending them messages about it even before the people have received a diagnosis from their doctors.”

More than 27 million people have taken the test; one-third, or 9 million, have signed up to be members — encouraged by RealAge spokesman and adviser Dr. Mehmet Oz, a frequent guest on “The Oprah Winfrey Show” (oh, Oprah). RealAge only collects and shares medical information from members, and it does not reveal their names, but the privacy policy does not clearly state RealAge’s close relationship with drug companies. And it’s this point that concerns consumer health advocates.

“Literally millions of people have unknowingly signed up,” Peter Lurie, the deputy director of the Health Research Group at Public Citizen, told The Times. The company, he said, “can create a group of people, and hit them up and create anxiety even though the person does not have a diagnosis.”

Members receive emails from RealAge, and advertisements are labeled as such. Yet the super-precise targeting is designed to convince any semi-worried person that the perfect solution is just one click away.

Consider this scenario:

Steve Williamson, an executive at the medical company Hologic, uses RealAge to sell a treatment called NovaSure, which removes the endometrial lining in post-childbearing, premenopausal women who have heavy periods.

With RealAge, he buys lists of women who have answered a test question by saying they have heavy menstrual bleeding, among other criteria. He chooses the ones in the 37- to 49-year-old age range, then sends them a series of e-mail messages. Several of the messages do not mention NovaSure, they just identify heavy bleeding as a problem — then, he said, the messages suggest NovaSure as a solution.

“We’re trying to get out to those customers right now and let them know that it is an option for them,” said Mr. Williamson, the vice president for sales and marketing for the gynecologic surgical products division of Hologic. “A lot of women don’t know it’s a problem, and that’s the thing. It’s not something they necessarily talk about.”

A 31-year-old former pharmaceuticals saleswoman quoted at the end of the story said she isn’t bothered knowing that drug companies have access to her answers. Patients, she said, rely too much on their doctors for answers. “As a patient and a person, you have to take your health into your own hands,” she said.

Right. But in this case, your health isn’t in your own hands. The diagnosis doesn’t come from an unbiased source, but from a company that thinks it has just what you need — whether you really do or not.

Plus: The American Psychiatric Association announced on Wednesday that it would no longer allow drug company-financed medical seminars at its annual meeting and it would discontinue meals paid for by industry money, reports The New York Times.

And here’s a topical New York Review of Books article from January: Marcia Angell discusses three books that look at the relationship between drug companies and doctors. Two of the books are on the topic of fear-mongering — convincing patients (and their doctors) that they have medical conditions that can be helped by long-term drug treatment.

Overlooking Evidence: “When it comes to breast cancer, why is it so hard to get the most influential media to pay attention to the possibility that, in addition to better-understood risks, unnatural substances entering women’s bodies might also be a factor?” That’s the million-dollar question in this Fair! analysis on the surprising dearth of news coverage on environmental hazards and breast cancer. An excellent report by Miranda Spencer.

Skimping on Care: More than a third of people surveyed have skipped medical check-ups or dental visits over the past year due to concern over health care costs, and 27 percent have put off getting needed health care, according to the Kaiser Family Foundation’s first health care tracking poll of 2009.

Supreme Court: No Legal Shield in Drug Labeling: The Supreme Court on Wednesday ruled that people injured by drugs can sue the drug manufacturer in state courts, even if the drugs were approved by the Food and Drug Administration.

“The ruling could have significant implications beyond drug manufacturing,” writes Adam Liptak at The New York Times. “Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.”

The case involved a Vermont woman, a musician, whose arm had to be amputated following an injection of the anti-nausea drug Phenergan. Levine sued the drug maker Wyeth because Wyeth had not changed the label indicating that one method of administering the drug had a small risk of error which caused irreversible gangrene. Nina Totenberg did a good report on the ruling. The NPR link also includes excerpts from the oral arguments heard last November.

Sunshine State Keeps Teens in the Dark: The Healthy Teens Campaign of Florida and the Sexuality Information and Education Council of the United States (SIECUS) have released a report on failed abstinence-only sex education programs in Florida’s public schools: “Sex Education in the Sunshine State: How Abstinence-Only-Until-Marriage Programs Are Keeping Florida’s Youth in the Dark” (pdf).

“[O]ur research has exposed both the state’s appalling indicators of poor outcomes for young people and the equally appalling nature of how abstinence-only-until-marriage programs have become pervasive throughout the state,” writes Adrienne Kimmell at RH Reality Check.

Him/Her/They: Elizabeth Landau at CNN reports on the history of the search for gender-neutral pronouns, an issue that has recently been taken up on Twitter. An interesting story.

On the Issues: Good reads in the On the Issues Magazine cafe, including Diana Whitten‘s look at Women on Waves, a Dutch organization that provides on-ship abortions in international waters for women from countries where it is illegal. Women on Waves recently won an important victory in the European Court of Human Rights. And don’t forget to check out the winter issue, which features stories on topics from ratifying CEDAW to Second Life.

Moving Reproductive Services Off-Site (Six Feet Away): From Women’s eNews: For more than a decade, a hospital merger in New York state was held up by abortion politics. Last week, community activists gathered for a ribbon-cutting ceremony marking their hard-fought compromise. Rebecca Harshbarger reports.

Plus: Emily Douglas points to this Albany Times Union op-ed on the implications of a possible merger between two secular hospitals and one religious hospital in Rensselaer County, New York. The merger raises questions about reproductive health care for patients and employee health insurance benefits, since Catholic directives prohibit coverage for contraception.

In Translation: Over at Sociological Images, a blog sponsored by the American Sociological Association, there’s been some debate over the English and Spanish versions of a pamphlet for pregnant women offered by Kaiser Permanente. Kaiser provides a response.

The Economic Future and Women’s Roles: The Chicago Foundation for Women looks at how the stimulus package affects women’s economic security.

Teaching Domestic Violence Victims Safe Use of Technology: Via this press release, I learned about a Washington state program designed to help victims of domestic violence by increasing their knowledge of how to use technology safely.

“Domestic violence is built around control, not anger, and an abusive partner often limits a woman’s access to information and support. Monitoring computer activity is one of many ways to control a spouse,” said Jerry Finn, a University of Washington Tacoma professor of social work who also evaluates the effectiveness of human services programs.

The training covers how to prevent such things as identity theft; concealing browser history; how to be safe in a chat room; how to set up an e-mail account without using a real name; and how to prevent being followed with a GPS device. What a smart idea.

Welcome Particle, Wave, Astarte and …: To apologize for the late Double Dose, I offer some cute overload, via feminist poet and performance artist Diana Tigerlily, who also raises goats.

Meet the newest ones — five in all, if my counting is correct. Makes me think two dogs and two cats may not be enough : )

We have written a fair bit here in the past about direct-to-consumer drug advertising and drug industry payments to physicians, but a recent New York Times article points to another area in which drug industry dollars may have an unexpected influence – medical education.

The article offers this example:

In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

Zerden wasn’t the only concerned Harvard medical student – more than 200 of them, along with some faculty, are apparently riled up and working to expose these types of connections and payments. From other students:

“Harvard needs to live up to its name,” said Kirsten Austad, 24, a first-year Harvard Medical student who is one of the movement’s leaders. “We are really being indoctrinated into a field of medicine that is becoming more and more commercialized.”

David Tian, 24, a first-year Harvard Medical student, said: “Before coming here, I had no idea how much influence companies had on medical education. And it’s something that’s purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.”

Students such as these are also alarmed that Harvard Medical School received an “F” grade on the American Medical Students Association’s 2008 PharmaFree Scorecard, a rating of conflict of interest policies at academic medical centers in the United States.

The students’ efforts have apparently generated results, such that there is now “a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school.” A committee has also been established to re-examine the institution’s conflict-of-interest policies, and includes student members.

Relatedly, the Times also reports that last fall a Pfizer employee turned up on Harvard’s campus to photograph students who were protesting pharmaceutical industry influence on campus.

The AMSA scorecard mentioned in the article is freely accessible online, allowing users to browse and compare institutions and view policy information on gifts and samples, disclosure, site access, curriculum, and other factors.

Following up on our recent post on Chris Bobel’s article on menstrual activism, I discussed the topic further with the author. Bobel’s new book is due out in Spring 2010 from Rutgers University Press. Its working title is “New Blood: Third Wave Feminism and the Politics of Menstruation.”

Our Bodies, Our Blog: Can you tell me a bit about what is covered in the book, in addition to the menstrual activism history covered in your recent article?

Chris Bobel: The book is written for an undergrad/general public audience with lots of lively examples of the very cool activism I encountered — and pictures, too. In short, the book is at once a history and sociological study of menstrual activism using this little-known activism to track changes in feminist thinking and doing over time. There’s a lot of debate right now about the future of feminism: Is the movement dead? Is there something new going on? Is it really new or just recycled?

The newest iteration of feminism (in the West) is called third wave and I wanted to find a concrete way to tease out what third wave is and how it both reflects the past of feminism and takes off in new directions. We talk about feminism in the abstract a lot and we lose people. I wanted to show what third wave feminism looks like on the ground.
Read the rest of this entry »

This month’s issue of the journal Canadian Family Physician features a debate on direct-to-consumer advertising (DTCA) of prescription drugs, with arguments for and against allowing DTCA in Canada (where it is currently prohibited).

In putting forth her case for DTCA, Durhane Wong-Rieger says that such ads “contribute to public health by increasing appropriate consultation for undiagnosed or untreated health conditions.” This is a fairly common selling point from the drug companies themselves, who argue that prescription drug advertising is a form of education and a service for the public.

Dr. Barbara Mintzes, however, argues that “Any benefits could be better achieved through public health campaigns,” and expresses concern about increased prescribing of potentially dangerous drugs before the harmful effects are fully understood. Mintzes offers the following example, of a drug campaign targeted at women:

“The 2006 tegaserod ad for irritable bowel syndrome is emblematic of the hazards of prescription drug advertising. The eye-catching ad featured women baring their bellies to reveal slogans. Closing shots panned women of many different ages and races, suggesting widespread use. Relief of vague symptoms along with a comparison to fibre and laxatives implied use for mild problems. But key information on safety concerns, limited effectiveness, and the limited appropriate patient population was lacking. In 2007, the drug was withdrawn from the market because of cardiovascular risks. The first Food and Drug Administration safety warning, on risks of ischemic colitis, dated back to 2004. Tegaserod prescriptions rose by 56% in a US Medicaid population and 42% in English speaking Canada following exposure to US DTCA campaigns.”

Minztes also argues that advertisements may exaggerate benefits and target people with mild problems who are unlikely to benefit (perhaps such as in the YAZ example we discussed recently), and could lead to higher health care costs through “substitution of new, expensive drugs without treatment advantages.”

For related discussion, see this OBOS companion content. Time magazine also recently covered this topic, including whether a two-year moratorium on advertising new drugs may be achieved in the new administration, and Consumer Reports Health has critiqued the “stealth advertising” of Pfizer’s Chantix.

Bayer recently launched commercials for the contraceptive drug Yaz that feature a female spokesperson and begin with a statement that the FDA thought Bayer’s previous ads were inadequate and asked Bayer to clear up a few things. “The F.D.A. wants us to correct a few points in those ads.”

I’m pretty sure that’s the first time I’ve noticed an explicit “the FDA made us do this” message in a drug ad.

The FDA really did make them do it, though, issuing a warning letter [PDF] last October stating that “The TV Ads are misleading because they broaden the drug’s indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug.”

Don’t remember the ads in question? If you sing “we’re not gonna take it” or “goodbye to you” [the songs used in the ads] to yourself and you picture women kicking away or popping balloons with words like “irritability” and “fatigue,” the ads will likely come to mind. Sarah Haskins featured one of the ads in her hilarious Target Women: Birth Control bit, and you can likely find them on YouTube.

You see, YAZ is approved for “PMDD” – premenstrual dysphoric disorder, a diagnosis essentially of severe PMS with depression-like symptoms that entered the general consciousness when the patent on Prozac was running out and so its maker repackaged the drug as Sarafem. [See this related discussion on direct-to-consumer advertising from OBOS]

The ads, though, didn’t make that clear, that YAZ is not intended for regular PMS symptoms. The FDA warned that the:

“TV ads misleadingly suggest that YAZ is appropriate for treating women with PMS, who may not be appropriate candidates for this drug. We note that despite listing certain symptoms of PMDD, nowhere do the TV Ads use the full phrase ‘premenstrual dysphoric disorder,’ to more completely distinguish PMDD from PMS, thereby increasing the likelihood that a viewer, in light of the claims and presentations described below, will understand it to be the same as, or substantially similar to, PMS.”

Today’s New York Times has an article on the required new ads, including commentary from our own Judy Norsigian, who notes that this was an unusual move by the FDA:

“They rarely require these corrective campaigns,” said Judy Norsigian, the executive director of Our Bodies Ourselves, a health education and women’s advocacy group in Cambridge, Mass. But she said the popularity of the Yaz brand and the misleading ads had demanded a rare punishment. “These ads should never have been out there,” Ms. Norsigian said.

Unfortunately, this action by the FDA may not adequately discourage future misleading ads – one pharmacy administrator interviewed for the piece called the corrective $20 million ad campaign “chump change” and “just the cost of doing business,” adding that, “I don’t think it is likely to stop, unless there are more significant consequences.”

Ever since the Women’s Health Initiative study found that women taking supplemental hormones had an increased risk of breast cancer, heart disease, and stroke, women struggling with menopausal symptoms have searched for safer alternatives. Companies that make bioidentical hormones (also called natural or compounded hormones) have been quick to jump into the void, often claiming that their products are safer and more effective than traditional “synthetic” hormones.

Unfortunately, there is no evidence to suggest that this is true. Yesterday, the American College of Obstetricians and Gynecologists (ACOG) issued a press release on such hormones.

ACOG expressed concern about the lack of testing of these products and also criticized the salivary testing that is often done in bioidentical hormone users under the assumption that it provides information needed for selecting a dosage:

“Despite celebrity testimonials touting scientifically unfounded benefits of compounded bioidentical hormones, the bottom line is that most have not undergone rigorous clinical testing for safety or efficacy, nor are they approved by the FDA. ACOG also stresses that salivary testing of a woman’s hormone levels is not useful because they vary within each woman depending on her diet, time of day, the specific hormone being tested, and other variables. Although monitoring salivary hormone levels is promoted by some as a means of ‘tailoring’ a hormone treatment to an individual, hormone therapy does not require customized dosing. “

The organization previously released a committee opinion in 2005 stating that “There is no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies,” but indicated that recent media attention to the topic led to yesterday’s statement.

The FDA has also set up a page for consumers of myths vs. facts about compounded “bioidentical” hormones, and expressed concern that “claims like these [about the effects of the hormones] mislead women and health care professionals, giving them a false sense of assurance about using potentially dangerous hormone products.”

Related Posts: Outrage Over FDA Crackdown on Biodentical Hormones? Not So Fast, says National Women’s Health Network

OBOS Web Content: Natural Products: Phytoestrogens and Bioidentical Hormones; The Medicalization of Menopause

Among the many luminaries who died in 2008 are women who made significant contributions in the areas of women’s health and hospice care. Please add names and links we might have missed in the comments.

Pamela Morgan | b. 1949
In November, Our Bodies Ourselves lost one its founders, Pamela Morgan. A writer, editor and administrative manager of the organization in its early days, Morgan was “one of these extraordinarily multitalented individuals, and as a dancer, everything she did was with élan and flair,” said Judy Norsigian, executive director of OBOS.

Remembrances by other OBOS co-founders who had the privilege of working closely with Pamela can be read here.

Barbara Seaman | b. 1935
Barbara Seaman, a self-described muckraker, co-founded the National Women’s Health Network in 1975. A tireless advocate, she is credited with helping to create the concept of patients’ rights, particularly “informed consent,” and is well-known for her writings on women’s health. Her first book, “The Doctors’ Case Against the Pill” (1969), led to congressional hearings on the safety of oral contraceptives. “The Greatest Experiment Ever Performed on Women” (2003) was an expose of hormone replacement therapy.

OBOS co-founder Norma Swenson wrote wrote a rememberance of Barbara Seaman focusing on their involvement in the early women’s health movement.

Edwina Froelich | b. 1915
In the 1950s, Edwina Froelich was part of a group of suburban Chicago moms who met at each other’s homes to help new mothers with breastfeeding. The seven women, all Catholic housewives, founded the La Leche League.

“In those days you didn’t mention ‘breast’ in print,” Froehlich once said. “We knew that if we were ever going to get anything in the paper we would have to find a name that wouldn’t actually tell people what our organization was about.”

When we first wrote about her death in June, it sparked a discussion about La Leche and feminism. In an essay about Froelich published in The New York Times Magazine last week, Emily Bazelon addresses the history of the organization and its attitude toward working mothers.

Florence Wald | b. 1917
Here’s a hero we haven’t yet mentioned. In the 1960s, after attending a lecture by a British physician about opening the world’s first hospice, Florence Wald resigned her position as dean of the Yale School of Nursing to focus on developing a hospice care center in the United States.

“In those days, terminally ill patients went through hell, and the family was never involved,” she said. “No one accepted that life cannot go on ad infinitum.”

In 1974, Connecticut Hospice, the nation’s first home-care program for the terminally ill, opened its doors. A 44-patient hospice opened six years later. From The New York Times:

“This hospice became a model for hospice care in the United States and abroad,” the publication Yale Nursing Matters said this week, adding that Mrs. Wald’s role “in reshaping nursing education to focus on patients and their families has changed the perception of care for the dying in this country.”

There are now more than 3,000 hospice programs in the United States, serving about 900,000 patients a year.

In recent years, Mrs. Wald had concentrated on extending the hospice care model to dying prison inmates.

“People on the outside don’t understand this world at all,” Mrs. Wald told The New York Times in 1998. “Most people in prison have had a rough time in life and haven’t had any kind of education in how to take care of their health.”

Rosetta Reitz | b. 1924
Rosetta Reitz is best known for her support of women involved in early jazz and blues — stars who were overlooked in the shadow of male performers. With $10,000 borrowed from friends, Reitz created Rosetta Records, releasing 17 albums of lost music. But as The New York Times notes, music history was just one of Reitz’s accomplishments:

Ms. Reitz was at different times a stockbroker, a bookstore proprietor and the owner of a greeting card business. She was a food columnist for The Village Voice, a professor, a classified-advertising manager and author of a book on mushrooms. She was a founding member of Older Women’s Liberation. She reared three daughters as a single parent.

Ms. Reitz also wrote “Menopause: A Positive Approach” (1977), considered one of the first books to look at menopause from the viewpoint of women and not doctors. She listened to her recordings of women while she wrote the book, many of them celebrating the strength of women rather than treating them as victims.

“I was so alone and needed to be nurtured, and I found I was getting it from them,” she told The Los Angeles Times in 1992.

You may have missed this front-page Washington Post story on Friday about our wonderful CIA handing out Viagra to aging Afghan tribal leaders:

“Take one of these. You’ll love it,” the officer said. Compliments of Uncle Sam.

The enticement worked. The officer, who described the encounter, returned four days later to an enthusiastic reception. The grinning chief offered up a bonanza of information about Taliban movements and supply routes — followed by a request for more pills. [...]

In their efforts to win over notoriously fickle warlords and chieftains, the officials say, the agency’s operatives have used a variety of personal services. These include pocketknives and tools, medicine or surgeries for ailing family members, toys and school equipment, tooth extractions, travel visas, and, occasionally, pharmaceutical enhancements for aging patriarchs with slumping libidos, the officials said.

Problematic much? Consider the power trip:

“You didn’t hand it out to younger guys, but it could be a silver bullet to make connections to the older ones,” said one retired operative familiar with the drug’s use in Afghanistan. Afghan tribal leaders often had four wives — the maximum number allowed by the Koran — and aging village patriarchs were easily sold on the utility of a pill that could “put them back in an authoritative position,” the official said.

This response sums up, more succinctly than I could, why this is such revolting news:

Is the U.S. government “wholeheartedly committed to the full participation of women in all aspects of Afghan society,” as first lady Laura Bush stated on April 6, 2005? Or will women in Afghanistan continue to be sexual chattel to fickle aging and ailing warlords who can be bribed by American operatives so they can feel “back in an authoritative position”?

Or, if you prefer a visual response, check out Ann Telnaes’ animated cartoon (turn on your volume).

Statins — drugs intended for lowering cholesterol — have been in the news a lot over the past few years. Spending on the drugs increased from $8 billion in 2000 to $20 in 2005, and there have been a number of research papers during that time focused on the potential dangers of statin use in pregnancy, including questions about whether the drugs can cause birth defects.

Although not a full study report, a letter to Journal of Cellular and Molecular Medicine has been generating additional coverage of statins and pregnancy. In their letter, researchers from the University of Manchester note the role of cholesterol in normal fetal development and explain that their preliminary data suggest that water-soluble statins may affect placental development. They explain that this was previously suspected for fat-soluble statins, but that the water-soluble types may have the same detrimental effects.

Although the University of Manchester piece is not a full paper and so requires further detail and scrutiny to assess the authors’ findings, the topic in general is one that merits further attention. A news headline from earlier this year suggested that statins may reduce the chance of miscarriage in women with antiphospholipid syndrome, although the research was done only in mice. In those reports, statin use during pregnancy was described as something safe and normal, despite existing research to the contrary.

Meanwhile, the information from the FDA on these drugs generally indicates that women who are pregnant or planning to become pregnant should not take the drugs. A larger debate is ongoing about whether statins effectively reduce the risk of heart disease (especially in women), the main reason people seek to lower cholesterol. Holy mixed messages, Batman.

For related information, see our companion content Women and Heart Disease: Selling Statins and Debate over Statins. A post from this summer at Junkfood Science also discusses pregnancy and statins.

National Women’s Health Network has posted a health alert concerning FDA oversight of bisphosphonates, such as Fosamax, and is urging women to carefully evaluate whether they should be on the drugs:

After two bisphosphonate studies showed problems with heart damage, the FDA examined the effect of these drugs on the heart and found that women taking zoledronic acid (Reclast) and alendronate [Fosamax] were more likely to have dangerous irregular heart beats (atrial fibrillation). After examining all the available data, the FDA wasn’t able to confirm that the drugs cause the irregular heart rhythms, but it can’t rule it out, either. The FDA says it will do further studies of this issue, but in the meantime it has alerted women about the possible problem.

The FDA advised women currently taking bisphosphonates not to stop. However, NWHN believes there may be many women taking the drugs for whom the benefits don’t outweigh the risks, and we urge women and prescribers to carefully evaluate whether they should be on the drugs. For example, healthy middle-aged women whose only reason for taking the drug is that a test showed some loss of bone density may decide they don’t want to increase their risk for heart problems to ward off a bone fracture that might or might not happen. (For more on the over-use of bone density screening tests, see the NWHN Osteoporosis fact sheet.)

Read the full alert, which also discusses the FDA announcement that it has put off deciding whether to approve another osteoporosis drug, lasofoxifene (Fablyn). Cindy Pearson, NWHN’s executive director, had urged the FDA not to approve the drug until there was more long-term safety data.

A study published in the December issue of The Lancet reports on a three-year trial of Carraguard gel for HIV prevention and found that the microbicide, developed by the Population Council and derived from seaweed, is no better than a placebo at reducing HIV infections.

The researchers enrolled more than 6,000 sexually-active, HIV-negative women aged 16 years and older from three South African sites. The women were randomized to receive either the Carraguard gel and condoms or a placebo gel and condoms for use in vaginal intercourse, and were followed until they became pregnant or tested positive for HIV (up to two years). Clinical follow-up sessions each included counseling on HIV risk reduction and family planning for both groups.

There were no significant differences in time to HIV infection between the two groups, indicating that Carraguard did not work any better than a placebo. Carraguard was also about the same as placebo in terms of adverse effects.

A commentary in the same issue notes that this finding “continue[s] the discouraging wake of other coitally related topical products,” such as nonoxynol 9, cellulose sulfate, and the SAVVY gel. Researchers have focused on these insertable products as potential female-controlled methods of HIV prevention. Scientific American has a good, recent summary of the current state of this research. OBOS also provides companion content on microbicides.

PS: In another article in the current issue of The Lancet, I learned that the UK’s National Health Service is working on a “a guidance document designed to ensure that goods purchased for use in the NHS are manufactured ethically,” meaning adherence to basic international labor standards and workers paid a living wage. According to the article, the guidance document would inform the spending of £20 billion a year in NHS contracts, but would need adoption by the NHS Trusts to have the most impact.