Last week, we posted about a petition created by the National Asian Pacific American Women’s Forum for organizations to sign on and oppose the new requirement that female immigrants ages 11 to 26, seeking permanent residence or entry to the U.S. be immunized against the human papillomavirus (HPV).
In response to a high level of interest from individuals who also wanted to share their opposition to the requirement, NAPAWF has created a separate petition to allow individuals to express their opposition to the mandate. This petition to the CDC notes the financial burden of this vaccination, the lack of an HPV vaccine requirement for citizens, and the lack of freedom for informed decision-making and patient choice imposed by the requirement.
The deadline for sign-ons is the close of business on Friday, January 30. Go here to add your signature.
The National Asian Pacific American Women’s Forum (NAPAWF) is coordinating the creation of a letter to the CDC opposing the newly-imposed requirement that female immigrants ages 11 to 26, seeking permanent residence or entry to the U.S. be immunized against the human papillomavirus (HPV).
We’ve written about this issue in the past, noting that the CDC has indicated that they did not intend for this vaccine to be required for legal status, and the National Women’s Health Network’s action alert requesting calls to your Senators and Representatives asking for the removal of the vaccine from the U.S. Citizenship and Immigration Services (USCIS) requirements.
The NAPAWF letter asks that the CDC reexamine and “modify its current system of adding new vaccination requirements for immigrants to prevent future unintended additions to the list of mandatory vaccinations and undue burdens on immigrants.”
It also outlines several of concerns about the vaccine requirement, including the lack of a sufficient threat to public health, the lack of requirement that U.S. citizens receive the vaccine series, and the high cost which creates a financial barrier for immigrant women.
Finally, the letter acknowledges related concerns about health disparities women of color:
Research that disaggregates data based on race and ethnicity show that cervical cancer has a disproportionate impact on certain immigrants… However, the CDC’s and USCIS’s decision to mandate Gardasil for young immigrant women will not resolve these health disparities. For many immigrant women, the high expense of medical care, the lack of health insurance, and the difficulty in finding culturally competent services means that they forego routine preventative health care services such as pap smears. These inequalities in access contribute to the high rates of cervical cancer among immigrant women. While we support safe medical technologies that protect women’s health, mandating the use of medical procedures will not fully improve immigrant women’s lives.
We believe our focus should be on strengthening culturally-competent outreach efforts, increasing access to preventative health care services, such as Pap smears, for all groups of women facing a disproportionate risk of cancer. We also believe that all women should have the same right to informed decision-making over whether or not they want to get vaccinated against HPV.
Organizations can sign on to the letter prior to Friday, January 16 by emailing Nancy Chung of NAPAWF at nchung at napawf dot org.
Last month, I wrote about the new requirement that immigrants seeking permanent legal status in the United States receive the HPV vaccine (along with other required vaccines).
Briefly, my concerns about this change included “the lack of an opt-out provision (in contrast to requirements for U.S. citizens), the expense of the series, the lack of significant public health risk posed by omitting this vaccine, and the vulnerability of the affected population.” See the original post for more details and links to further commentary.
On Tuesday, the National Women’s Health Network issued a call for people concerned about this issue to contact their Senators and Representatives to request that they support “removing the HPV vaccine from the U.S. Citizenship and Immigration Services (USCIS) requirements for the adjustment of status” and suggesting a core message that “I, along with the National Women’s Health Network, support providing women with all possible tools to prevent cervical cancer but strongly oppose the USCIS HPV vaccine mandate.”
The organization explains:
“Based on the research made public to date the HPV vaccines appear to be highly effective and very safe. While the National Women’s Health Network (NWHN) supported FDA approval of Gardasil, it is important to acknowledge that it is a new technology and clinical experience with it is limited. There are some questions about the effectiveness of the vaccine that cannot yet be answered, and, as with any new product, there isn’t any data about its long-term safety.
Although the HPV vaccine is an important tool for reproductive health, it is a relatively new technology and the NWHN believes that obtaining it should be an informed decision rather than a response to a mandate for only one sector of the population. We urge you to take a moment and to call or email your members of Congress to ask them to reverse this policy. We need to ensure that immigrant women are not faced with yet another barrier to adjusting their status.”
You can find your Senator or Representative online. I’ll update this post with links to NWHN’s suggested phone and email scripts if they become available online.
Gay Marriage Legal in California, Massachusetts and now Connecticut: The Connecticut Supreme Court on Friday struck down the state’s civil union law with a 4-3 ruling that same-sex couples have a constitutional right to marry. From The New York Times:
The ruling, which cannot be appealed and is to take effect on Oct. 28, held that a state law limiting marriage to heterosexual couples, and a civil union law intended to provide all the rights and privileges of marriage to same-sex couples, violated the constitutional guarantees of equal protection under the law.
Striking at the heart of discriminatory traditions in America, the court — in language that often rose above the legal landscape into realms of social justice for a new century — recalled that laws in the not-so-distant past barred interracial marriages, excluded women from occupations and official duties, and relegated blacks to separate but supposedly equal public facilities.
View the full ruling here (PDF). Opponents spoke of steps to enact a constitional ban on same-sex marriage, but on Friday night the plaintiffs in the original court case filed four years ago and their supporters were jubilant.
Garret Stack, 59, introduced his partner, John Anderson, 63, and said: “For 28 years we have been engaged. We can now register at Home Depot and prepare for marriage.”
Group Sues Over Required Ultrasound: The Center for Reproductive Rights has filed a challenge to an Oklahoma law that mandates a woman must have an ultrasound and listen to the doctor describe what her fetus looks like before she have an abortion. And that’s not all:
At the same time, the law prevents a woman from suing her doctor if he or she intentionally withholds other information about the fetus, such as a severe developmental defect. The statute also requires doctors to use a specific regimen for administering the medical abortion pill, despite that regimen being less effective and more costly than the one strongly recommended by the American College of Obstetricians and Gynecologists (ACOG).
The lawsuit, filed Thursday in Oklahoma County District Court, says the requirement intrudes on a woman’s privacy, endangers her health and assaults her dignity.
Set to go into effect on Nov. 1, the law would make Oklahoma the fourth state to require the viewing of ultrasounds before an abortion. The other states are Alabama, Louisiana and Mississippi.
South Dakota Abortion Ban 2.0: Lynn Harris of Broadsheeet offers a full, and funny, assessment:
The ban’s primary liability, according to polls, was that it contained virtually no exceptions. But as ringleader Leslee Unruh of Vote Yes for Life said at the time, like Jason popping up out of Crystal Lake, “We started something here in South Dakota.” And now, as you may have heard, abortion opponents there are aiming to get the job done. Which means: The ban is back (PDF), in sheep’s clothing. It now makes convoluted exceptions for rape, incest and, when there is a full moon and Mount Rushmore spouts Strawberry Quik, the health or life of the woman.
Unruh (who says that over 90 percent of women seeking abortion are using it as “birth control”) calls Abortion Ban 2.0 “more moderate, more reasonable, more of a middle ground.” Yeah … no.
Birth Control Watch: While some voters think access to birth control is not a political issue, those of us who follow the activities of the Bush administration and legislatures around the country know better. Birth Control Watch has a great section on federal and state proposals that will limit our individual decision making and access — it’s called extreme schemes.
An excellent resource to pass along, it includes information on Colorado Proposition 48, a constitutional amendment that seeks to establish legal personhood from the moment of fertilization (which even self-described “pro-life” Catholic Gov. Bill Ritter opposes), and the proposed HHS regulations that would limit patients’ access to information and services.
Speaking of the HHS regulations, more than 150 Congressional Democrats stated their opposition in letters to HHS. The Senate letter concludes that the proposed rule is “damaging to the health care needs of women, their families and all Americans and will only serve to cause havoc, not clarity, among employers and employees in the health care field.”
Courts Failing Domestic Violence Victims: “For every man convicted in a Cook County court of beating his wife or girlfriend, five men brought in on similar charges walk away legally unscathed. And despite official promises to help women pursue abuse complaints, that conviction rate is only getting worse,” reports the Chicago Tribune.
The Trib also looks at a specialized unit of the Cook County state’s attorney office with a much higher conviction rate. The unit, Target Abuser Call, employs a more intensive investigatory approach for the most serious cases.
Plus: Programs for batterers are underfunded but should be supported to break the habit of abuse, say domestic violence experts. “No matter how many women you take in, it isn’t going to cure the problem,” said Toby Myers, vice chair of the National Center on Domestic and Sexual Violence.
Nobel Prize Winners: The 2008 Nobel Prize in Physiology or Medicine went to Harald zur Hausen of Germany, who discovered the human papilloma viruses that causes cervical cancer, and Luc Montagnier and Francoise Barre-Sinoussi, French researchers who discovered HIV, the virus that causes AIDS.
Montagnier and Barre-Sinoussi later told President Nicolas Sarkozy that they fear the world financial crisis will affect funding to fight AIDS.
One-Year Distribution Update On Gardasil: “About a quarter of the nation’s teenage girls received the controversial cervical cancer vaccine Gardasil last year in its first full year of distribution, federal authorities said Thursday,” reports the L.A. Times.
The Realities of Addiction: Writing in the Washington Post, Jacqueline M. Duda shares the painful story of her daughter’s drug addiction and death — including the difficulty the family had finding adequate medical treatment for addiction.
“Surely, we thought, college-educated suburbanites like us could locate professional help: drug counselors, doctors, therapists specializing in addiction. Surely detoxification centers would treat desperate addicts and work out a payment plan. Surely we could check her into some kind of residential treatment program with a minimum of delay,” writes Duda. “We were wrong.”
PSA to Raise Awareness Around “That’s So Gay”: “For the first time since the Advertising Council was founded in 1942, the organization — which directs and coordinates public service campaigns on behalf of Madison Avenue and the media industry — is introducing ads meant to tackle a social issue of concern to gays and lesbians,” writes Stuart Elliot in The New York Times.
The campaign, created pro bono by the New York office of Arnold Worldwide, urges an end to using derogatory language, particularly labeling anything deemed negative or unpleasant as “so gay.” That is underlined by the theme of the campaign: “When you say, ‘That’s so gay,’ do you realize what you say? Knock it off.”
There will be television and radio commercials, print and outdoor ads and a special Web site devoted to the campaign (thinkb4youspeak.com). Some spots feature celebrities, the young actress Hilary Duff and the comedian Wanda Sykes, delivering the message.
Combine girls, vaccines, and sex, and you apparently get a recipe for sensationalism and poor reporting. CNN yesterday featured a piece, “Should parents worry about HPV vaccine?” which notes that “Gardasil has been the subject of 7,802 ‘adverse event’ reports from the time the Food and Drug Administration approved its use two years ago.”
What the article doesn’t explain is how the Vaccine Adverse Event Reporting System (VAERS) system works. Reports to VAERS can be submitted by anyone, and are not verified or definitively linked to the vaccine without further investigation. This understanding was not demonstrated by the piece, which simply conceded,
“The company said in a statement that an adverse event report ‘does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.’”
This phrasing makes it seem as though it’s just the company (that stands to make money) that believes that reports don’t indicate a causal relationship – it seems designed to make the average reader believe that this characterization is just the vaccine maker protecting its financial interests. While OBOS often points out ways in which pharmaceutical companies and medical device companies prioritize their own financial interests above people’s health, in this instance the company is simply explaining how the reporting system works.
The piece also doesn’t address how this figure compares to anticipated adverse events estimated from the original studies, how it compares to the rates of adverse events for other vaccines, or that, due to the current system, there are always more/different side effects reported after a drug is approved (in the “post-marketing” period) due to the numbers of individuals involved. For example, if a drug causes death in 1 in 500,000 people, and was tested in 2,000, the possibility of the drug causing death is not likely to be realized until it is on the market and prescribed to a large population.
On the other hand (and unmentioned in the CNN article), many adverse events may occur that are not reported. “Post-marketing surveillance” – including analysis of reports from those who have received the drug or vaccine after it has been approved – is a crucial aspect of safeguarding the public from dangerous drugs. Because individuals and physicians may not associate an outcome with the vaccine, and many individuals may not realize that they are allowed to submit reports directly, underreporting of effects is both possible and likely. The FDA uses this surveillance system to make changes to labels, educate physicians about risks, and re-evaluate their approval of a drug or vaccine, so it remains important that adverse outcomes are reported, despite the cautions about making judgments based on raw numbers of reports and difficulties in later determining which of those outcomes were directly linked to a specific drug, vaccine, or other product.
“Finally, CNN presents us with the terrifying story of a teenager who developed pancreatitis not long after taking the vaccine. While I am not insensible to how horrifying such a serious illness would be for a young girl and her family, it should be CNN’s responsibility to verify whether or not her fear that it was related to the vaccine could be founded – by researching how many of those incident reports dealt with pancreatitis, for example, or other autoimmune diseases. This type of reporting is important, after all, since it could impact women’s decisions and, consequently, their health.”
This approach is not limited to CNN – Judicial Watch is currently featuring the large, bolded headline, “Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 ‘Serious’ Adverse Events Related to Gardasil.” However, the CDC has reported that of the 10 deaths they have analyzed, they could not establish a causal relationship between the vaccine and the deaths, and notes that “While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related.”
In their report, Judicial Watch also suggests that Gardasil wasn’t adequately tested for adverse effects because the comparison placebo vaccine contained an aluminum “reactive, potentially harmful substance.” Without reading the original studies, this probably makes the comparison more valid instead of less, because the real vaccine also contains an aluminum compound (as do many other vaccines), and omitting it from the placebo vaccine would have skewed the comparison by confusing adverse effects of the aluminum with adverse effects of the actual vaccine substance.
I have to wonder if we’d be seeing the same level of fear-mongering if this were another vaccine, if opponents hadn’t suggested that it would cause young girls to become sexually active and that girls from “good homes” don’t get HPV. Yes, of course we should keep watch when a new drug, vaccine or product is approved and is targeted to women. Of course we should attempt to tease out real and serious side effects that didn’t appear in the smaller trials, and be wary of the financial motives companies have to put the best light on their product. Of course we should be aware of mandates for vaccination and ensure that adequate information and opt-out provisions are available. It may still turn out that there are serious issues with Gardasil that warrant a different assessment of the risks and benefits. However, incomplete and inaccurate reporting and misrepresentation of the science does nothing to assist women and families in making decisions about vaccination and safety.
A new report commissioned by the Center for Health and Gender Equity (CHANGE) blames “bureaucratic obstacles, funding restrictions, and a lack of high level commitment to female condoms” for delaying the expansion of U.S.-funded female condom distribution efforts.
But the biggest deterrent — for both male and female condoms — lies within U.S. global policy concerning HIV prevention.
The report, “Saving Lives Now: Female Condoms and the Role of U.S. Foreign Aid,” takes to task the U.S. Office of the Global AIDS Coordinator, which prioritizes condom promotion programs under the President’s Emergency Plan for AIDS Relief (PEPFAR) only for “high-risk persons.”
Also damaging is the congressionally mandated requirement that PEPFAR spend 33 percent of all HIV prevention funds on abstinence-until-marriage programs, which funnel money toward programs that only promote abstinence and fidelity as means of preventing HIV.
“Saving Lives Now” is available for free at PreventionNow.net (download PDF), a global campaign to expand access to female condoms. CHANGE and its U.S. partners work with existing female condom campaigns in other countries such as Argentina, Ghana, and Zambia.
Female condoms account for just 0.2 percent of total global condom supply. The report found that female condoms are available in 108 countries, but they are not readily accessible in most countries. The United States has supplied female condoms to 30 countries in the past decade and to 16 countries in 2007. Nearly 26 million female condoms were distributed worldwide in 2007, compared to 11 billion male condoms.
“It is distressing that women make up half of those infected by HIV and policy makers are refusing to provide women with the tools they need to negotiate safer sex,” said Serra Sippel, CHANGE executive director. “The U.S. and other donors must increase comprehensive funding for the purchase, distribution and programming of female condoms to ensure that women and men have access to female condoms and know how to use them.”
Based on interviews with health experts and a review of current literature on female condoms, the report’s executive summary (PDF) offers the following findings and common-sense recommendations:
FINDING: U.S. agencies responsible for female condom programming and procurement do not have polices that promote the integration of female condoms into HIV prevention and family planning programs. Whether the U.S. procures female condoms in a given country is highly dependent on the personal biases of USAID mission staff.
RECOMMENDATION: USAID and OGAC should issue policy guidance promoting female condom procurement and programming within U.S.-funded development programs, including PEPFAR. As a signatory of ICPD, the U.S. should promote female condoms as a vital tool to prevent both pregnancy and HIV infection.
FINDING: The U.S. excels at assisting countries in female condom logistics and procurement.
RECOMMENDATION: The U.S. should expand technical assistance for female condom logistics and procurement to additional countries to increase HIV prevention efforts.
FINDING: Sustained product availability and effective programming is limited to a few countries. Accurate estimates for female condom needs do not exist.
RECOMMENDATION: The U.S. should apply intensive programming efforts to an additional three countries for scale-up and replication. These efforts could be used to create a more realistic assessment of global female condom needs for scale-up.
Plus: Here’s a post from last year on efforts to redesign the female condom and problems with raising money in the United States for the clinical trials required for FDA approval.
Alabama’s Response to Pregnant Drug Users: “Two worlds are colliding in this piney woods backcountry in southern Alabama: casual drug use and a local district attorney unsettled that children or fetuses might be affected by it. The result is an unusual burst of prosecutions in which young women using drugs are shocked to find themselves in the cross hairs for harming their children, even before giving birth,” reports The New York Times. The story continues:
Over an 18-month period, at least eight women have been prosecuted for using drugs while pregnant in this rural jurisdiction of barely 37,000, a tally without any recent parallel that women’s advocates have been able to find. The district attorney, Greg L. Gambril, acknowledges the number puts him at the “forefront,” at least among Alabama prosecutors. Similar cases have come up elsewhere, usually with limited success. But Alabama, and in particular this hilly, remote terrain just above the Florida Panhandle, is pursuing these cases with special vigor.
Birth Control for Others: In a review of Matthew Connelly’s new book, “Fatal Misconception: The Struggle to Control World Population,” Nicholas Kristof writes that Connelly, an associate professor of history at Columbia University “carefully assembles a century’s worth of mistakes, arrogance, racism, sexism and incompetence in what the jacket copy calls a ‘withering critique’ of ‘a humanitarian movement gone terribly awry.’”
Critics of family planning programs will seize gleefully upon this book, and that’s unfortunate, because two propositions are both correct: first, population planners have made grievous mistakes and were inexcusably quiet for too long about forced sterilization in countries like India and China; and second, those same planners have learned from past mistakes and today are fighting poverty and saving vast numbers of lives in developing countries.
“Fatal Misconception” is to population policy what William Easterly’s “White Man’s Burden: Why the West’s Efforts to Aid the Rest Have Done So Much Ill and So Little Good” (2006) was to foreign aid: a useful, important but ultimately unbalanced corrective to smug self-satisfaction among humanitarians. Connelly scrupulously displays a hundred years of family planners’ dirty laundry, but without adequately emphasizing that we are far better off for their efforts. One could write a withering history of medicine, focusing on doctors’ infecting patients when they weren’t bleeding them, but doctors are pretty handy people to have around today. And so are family planners.
An Epidemic No One Wants to Talk About: “A much-publicized study from the Centers for Disease Control and Prevention this month highlighted the high rates of sexually transmitted diseases among teenage Americans. But for those of us who work in public health, this ‘news’ is already old,” begins this Washington Post op-ed by three medical experts who argue convincingly for discussions that address race and poverty and other social conditions underpinning high rates of HIV and STIs in some communities.
For one thing, women in poor African American communities who engage in the lowest levels of risk behavior are dramatically more likely to acquire STDs than higher-risk women in communities with low background rates of infection. Where you live and choose sexual partners has an enormous impact on your risk, particularly if it is in a community with high incarceration rates. Imprisonment changes community male-female ratios, and these unbalanced numbers contribute to low marriage rates, a reluctance to negotiate “safe sex,” formation of concurrent partnerships and the maintenance of STDs within the networks in which members choose partners.
Simply put, we will never rid the United States of HIV and other STDs if our only weapon is medical treatment. And if we are unable to engage in a national dialogue about the sexual health of our youths and the social dynamics that drive STDs, this epidemic will go largely ignored, and many more lives will be lost.
HHS Challenges ACOG Ethics Opinion: Daily Women’s Health Policy Report has a nice round-up of information concerning an NPR report on the Bush administration’s criticism of an ethics opinion released last year by the American College of Obstetricians and Gynecologists that calls on physicians to provide referrals for patients seeking abortions, emergency contraception or other procedures if they are opposed to providing the service themselves.
Voices from the Sidelines: “To begin with, both those of us who oppose and those who support legal abortion agree that there’s unbearably little nuance in the public conversation on reproductive rights,” writes Anna Clark at RH Reality Check. “But that’s only the beginning of our common ground. While not one national anti-choice organization supports contraception or science-based sexuality education, many individuals who oppose legal abortion are making the connections on their own: birth control and education reduce the rate of unintended pregnancy and abortions.”
Targeting Health Disparities: What’s the connection between living in disadvantaged neighborhoods and early onset breast cancer? University of Chicago researchers are trying to find out. According to a release, “researchers are studying 230 black women with newly diagnosed breast cancers living in predominantly black Chicago neighborhoods to learn about environmental factors, such as neighborhood features that might lead to social isolation.”
Who Wants to Work in an Attractive Field?: “As thousands of medical students await word this week on residency programs, two specialties concerned with physical appearance — dermatology and plastic surgery — are among the most competitive,” reports The New York Times. “The vogue for such specialties is part of a migration of a top tier of American medical students from branches of health care that manage major diseases toward specialties that improve the life of patients — and the lives of physicians, with better pay, more autonomy and more-controllable hours.”
Overall, the percentage translates to 3.2 million female adolescents who have at least one infection. Human papillomavirus (HPV) was by far the most common STI, affecting 18 percent of the girls studied.
The study’s outcome stunned medical experts, some of whom immediately raised the question of how much damage has been done by abstinence-only education programs that don’t address prevention of STI’s. For those teens who acknowledged having sex, the infection rate was 40 percent.
“This is pretty shocking,” said Dr. Elizabeth Alderman, an adolescent medicine specialist at Montefiore Medical Center’s Children’s Hospital in New York.
The study shows “the national policy of promoting abstinence-only programs is a $1.5 billion failure, and teenage girls are paying the real price,” said Cecile Richards, president of Planned Parenthood Federation of America.
The teens were tested for four infections: human papillomavirus, or HPV, which can cause cervical cancer and affected 18 percent of girls studied; chlamydia, which affected 4 percent; trichomoniasis, 2.5 percent; and genital herpes, 2 percent.
Dr. John Douglas, director of the CDC’s division of STD prevention, said the results are the first to examine the combined national prevalence of common sexually transmitted diseases among adolescent girls. He said the data, now a few years old, likely reflect current prevalence rates.
Disease rates were significantly higher among black girls — nearly half had at least one STD, versus 20 percent among both whites and Mexican-Americans.
HPV, the cancer-causing virus, can also cause genital warts but often has no symptoms. A vaccine targeting several HPV strains recently became available, but Douglas said it probably hasn’t yet had much impact on HPV prevalence rates in teen girls.
The study found that among those with an infection, 15 percent had more than one type of infection.
Rachel notes that this study “didn’t even count HIV, gonorrhea, syphilis … Yikes.”
CDC researchers stressed the need for screening, vaccination and prevention strategies. Making sure schools educate boys and girls about the STI prevention, symptoms and treatment would be a good start.
Over at Scarleteen, Nicole writes, “When accurate or trust-worthy sources of information about sex and sexually transmitted infections are drowned out by conflicting and harmful messages about human sexuality, it’s difficult to know that there’s no shame — or should be [no] shame — in having sex and getting tested for STIs and using condoms — that, in fact, by using condoms and getting screened on a regular [basis] is showing that you care about your own health — and the health of your partner.”
Score One for the Patient: A breast cancer patient whose medical coverage was canceled by her insurer was awarded more than $9 million from her for-profit insurer, Health Net Inc., reports the L.A. Times. “The award issued by an arbitration judge was the first of its kind and prompted Health Net to announce it was scrapping its cancellation practices that are under fire from state regulators, patients and the Los Angeles city attorney.”
BCA Blasts Approval of Avastin: In a surprise move, the FDA approved the use of Avastin as a treatment for breast cancer. “The big question was whether it was enough for a drug temporarily to stop cancer from worsening — as Avastin had done in a clinical trial — or was it necessary for a drug to enable patients to live longer, which Avastin had failed to do. Oncologists and patient advocates were divided, in part because of the drug’s sometimes severe side effects,” writes Andrew Pollack.
“In the end, the agency found a compromise of sorts. It gave Avastin ‘accelerated’ approval, which allows drugs for life-threatening diseases to reach the market on the basis of less than ideal data, subject to further study.”
Breast Cancer Action blasted the decision. “The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today’s decision is a victory for drug companies, but not for patients,” BCA Executive Director Barbara A. Brenner said a statement posted at Prescription Access Legislation.
Short Maternity Leaves, Long Deployments: The Washington Post reports on the difficulty women in the military face if they want to have children and keep their jobs. Ann Scott Tyson writes:
The wars in Iraq and Afghanistan have placed severe strains on the Army, including longer deployments in which soldiers serve 15 months in the war zone, followed by 12 months at home. Under that system, a woman who wishes to have a child and remain with her unit must conceive soon after returning home so she can give birth, recover and prepare for her next overseas tour.
Female soldiers interviewed over the past year say the tight schedule cuts short precious time for mother and infant to bond and breast-feed, forcing women to choose between their loyalty to their comrades — as well as their careers — and nurturing their families.
Vaccinating Boys for Girls’ Sake?: The New York Times looks at efforts to convince parents to vaccinate boys to prevent the spread of human papillomavirus, or HPV, which can lead to cervical cancer. HPV also causes anal and penile cancers, but these are much more rare. (Read our previous coverage of the HPV vaccine Gardasil here.)
One woman tells the NYT, “You don’t want to say it’s just the girls’ problem … But my sons won’t contract cervical cancer. And genital warts are treatable. I’m very skeptical. What risks will I expose them to?”
Another woman comments, “If there was a vaccine I could take that would get rid of prostate cancer, why wouldn’t I? … If there was a vaccine that sons could get that would get rid of breast cancer, most parents wouldn’t hesitate. But cervical cancer is the ‘sex cancer.’”
Do Cellphones Affect Male Fertility?: Some studies suggest as much, but the data is limited, writes Tara Parker-Pope, adding, “There are some global concerns about declining male fertility in industrialized countries, but issues like pollutants, exposure to chemicals and smoking are likely far more worrisome culprits than cellphones.”
The Studies Surrounding DHEA: The L.A. Times “Healthy Skeptic” column looks at the anti-aging claims of DHEA and finds it’s no fountain of youth.
Jeff Tweedy hasn’t weighed in yet, but I did see Wilco Tuesday and Wednesday (braving cold and limited views) during the band’s five-night run in Chicago. Yeah, OK, that had nothing to do with women’s health, but I had to boast somewhere.
Metabolic Syndrome Is Tied to Diet Soda: “This is interesting,” said Lyn M. Steffen, an associate professor of epidemiology at the University of Minnesota and a co-author of the paper, which was posted online in the journal Circulation on Jan. 22. “Why is it happening? Is it some kind of chemical in the diet soda, or something about the behavior of diet soda drinkers?”
Feeling Bad?: Those susceptible to Seasonal Affective Disorder, take note: Chicago had 11 — count ‘em — 11 minutes of sunshine during the first eight days of February. Chicago Tribune health columnist Julie Deardorff writes that she is going to try a sauna that that “uses infrared energy to warm the body and release toxins.” Readers, if you have suggestions for coping with a long gray winter, please leave them in the comments.
Why I am an Abortion Doctor: “I can take an anxious woman, who is in the biggest trouble she has ever experiences in her life, and by performing a five-minute operation, in comfort and dignity, I can give her back her life.” — Canadian abortion doctor Garson Romalis, who has survived being shot and stabbed because of his work.
NYT Op-Ed on Same-Sex Marriage Ruling: “In a decision at once common-sensical and profound, a New York State appeals court ruled Friday that same-sex marriages validly performed in other jurisdictions are entitled to recognition in New York. It was common sense because it simply accorded same-sex marriages the same legal status as other marriages. It was profound because of the way it could transform the lives of gay people.” Continue reading …
A Health Law With Holes: “This idea of an individual mandate absent comprehensive reform – how to say this politely? – is nuts. It makes a social failure the problem of the individual,” writes Robert Kuttner in an op-ed published in the Boston Globe about health care in Massachusetts.
Health Cuts Trigger Crisis in Chicago: In a front-page story on Friday, the Chicago Tribune reported on what doctors are calling “an emerging health crisis” in the city, with “hundreds of women with abnormal Pap smears, unusual bleeding, pelvic masses and other worrisome symptoms are waiting for weeks or months to see gynecologists in the Cook County health system.”
“The longer women wait for care, gynecological experts warn, the more likely it is that untreated medical problems could worsen, exposing the women to severe pain, cancers that are harder to treat or even life-threatening emergencies.”
Breastfeeding and HIV-Infected Mothers: “An antiretroviral drug already in widespread use in the developing world to prevent the transmission of HIV from infected mothers to their newborns during childbirth has also been found to substantially cut the risk of subsequent HIV transmission during breast-feeding,” according to this release from the John Hopkins Center for Clinical Global Health Education. Approximately 150,000 infants are infected through breastfeeding each year.
Another study presented at the conference found that the risk of HIV transmission decreased by 90 percent within couples in which one person is HIV-positive and the other is HIV-negative — if the HIV-positive person took antiretrovirals, which drive down the level of HIV in the blood.
“Getting an early diagnosis, and getting treatment to drive down viral load, is going to be good for prevention,” said Dr. Rebecca Bunnell, a researcher for the CDC in Kampala, Uganda, told the San Francisco Chronicle.
SF Chronicle writer Sabin Russel described the study as “one of the few rays of hope” to come out of the conference, “a meeting that has been dominated by discussions of setbacks, such as the failure of a major AIDS vaccine trial that was abruptly ended in September.”
And The New York Times reports on yet another study that was discussed, one that showed that male circumcision did not result in a lower risk of transmission for female partners. “Although the findings did not reach statistical significance, they still underscore the need for more effective education among men who undergo circumcision and their female partners, the authors of the study said,” reports the Times.
Part of the problem is that in 15 years, there’s never been a second-generation product produced that improved upon the original version. Michael J. Free, head of technology at PATH, a nonprofit group based in Seattle that has redesigned the female condom, commented on the lack of competition in the development. “There’s no lack of interest, but we’ve been stalled,” he told The New York Times.
PATH is now seeking FDA approval for its version (more info on it here), which is supposed to offer improved ease of use and a more natural feeling sexual experience, but the process could be lengthy:
While the F.D.A. designates male condoms as Class 2 medical devices — meaning that a new maker has to pass tests only for leakage and bursting — it puts female condoms in Class 3, the same category as pacemakers, heart valves and silicone breast implants.
That decision was made in 1999 — after much debate, and well after the condom was in use overseas — because there was no clinical data on the effectiveness of female condoms, and failure could be life-threatening if the woman’s partner had AIDS. An advisory panel suggested not even calling it a “condom” and instead labeled it an “intravaginal pouch,” but the agency rejected that advice.
Names notwithstanding, the Class 3 listing means that any new design must pass clinical trials, which would cost $3 million to $6 million.
“That’s a huge, huge impediment, close to a 100 percent block, because no one’s willing to put up that sort of money,” Dr. Free said.
Design costs and prototype development have been covered by a combination of public and private funds, but no one is putting up money for the clinical trials or factory costs. Some investors cite the smaller-than-predicted American and European markets that never warmed to the original design.
There are some issues that even an abundance of development funds and a redesigned product can’t fix: the female condom can’t be used with discretion.
For that reason, married women, now one of the highest risk groups for AIDS in poor countries, rarely use it.
“I don’t want my husband to know that I am wearing a condom,” said Lois B. Chingandu, the director of SAfaids, an anti-AIDS organization in Zimbabwe.
“Condoms are almost undiscussable within a marriage” in Africa, she added. “It is something associated with casual sex. If a wife uses a condom, the message is that you have been unfaithful. If she even initiates the discussion, it tips the power scale. Men resist quite a lot, and it can result in violence.”
The female condom has developed a following among sex workers, however. And supporters say the condom’s failure in some countries was due more to poor marketing and inconsistent availability.
“People said, ‘Oh, it failed,’” said Mitchell Warren, former director of international affairs for the Female Health Company. “Well, it didn’t fail. It just wasn’t available, or its introduction was a bad program. People need to practice with it before it catches on.”
Plus: In 2005, health experts attended the Global Consultation on the Female Condom in Baltimore to review evidence of the female condom’s effectiveness in preventing pregnancy and sexually transmitted infections and to learn about countries’ program experiences. Slide presentations and panels from that conference are available online.
Each year, the Centers for Disease Control and Prevention releases a report on rates of sexually transmitted infections. The recently released 2006 report reveals a 5.6% increase in reported chlamydia cases over 2005, with 1,030,911 cases reported to the CDC, the first time that number has gone over one million. Gonorrhea rates also increased for the second consecutive year after a long period of decline, as did rates of syphilis, which hit an all-time low in 2000 and have been increasing ever since. It is unclear how much of the change is due to increased screening for the infections.
The CDC’s report includes numerous tidbits on how these infections affect women, such as:
“Untreated early syphilis in pregnant women results in perinatal death in up to 40% of cases and, if acquired during the four years preceding pregnancy, may lead to infection of the fetus in 80% of cases.”
“In women, chlamydial infections, which are usually asymptomatic, may result in pelvic inflammatory disease (PID), which is a major cause of infertility, ectopic pregnancy, and chronic pelvic pain.”
Gonorrhea infections, like chlamydia, “are a major cause of PID in the United States… In addition, epidemiologic and biologic studies provide strong evidence that gonococcal infections facilitate the transmission of HIV infection.”
A special section of the report addresses STI concerns in women and children, but focuses primarily on fertility and pregnancy.
Resources for learning more about sexually transmitted infections, including symptoms, transmission, and prevention:
Senate Votes to Repeal Global Gag Rule: “Defying a White House veto threat, the Democratic-controlled Senate voted Thursday to overturn a long-standing ban on U.S. funding for overseas family planning groups that support abortion,” reports the L.A. Times. “The vote was 53-41, short of the two-thirds majority needed to override a presidential veto on an issue that has been contentious on Capitol Hill since President Reagan instituted the ban. Even so, the vote was a sign of determination by Democrats to press for substantial changes in federal policies, even though they have only a narrow majority in the Senate.”
Ad Nauseum: Shannon Brownlee, author of “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer,” talks with Brooke Gladstone of NPR’s “On the Media” about the influence of direct-to-consumer drug marketing. One example given: When the sleep drug Lunesta hit the market, so did an epidemic of sleeplessness.
Stress and Pregnancy: The New York Times has a Q&A interview with Dr. Sarah L. Berga, “one of a handful of physician-scientists exploring how chronic stress may keep some women from ovulating and how relaxation techniques may help.”
Why More Cosmetic Companies Are Going “Paraben-Free”: “For years, parabens (methyl, ethyl, propyl and benzyl) have been considered a cheap and indispensable way to inhibit the growth of bacteria, yeasts and molds in personal-care products such as shampoos, conditioners, deodorants and sunscreens,” writes Chicago Tribune health reporter Julie Deardoff. “But studies have shown that some parabens can mimic the activity of the hormone estrogen in the body’s cells. Estrogenic activity in the body is associated with certain forms of breast cancer. And parabens are turning up in breast tumors.”
Condom Nations: Foreign Policy magazine presents data from the Durex Global Sex Survey, the world’s largest sex survey (317,000 participants in 41 countries). Why is it surprising that people in richer countries have more sexual partners than people in poorer countries?
Treating Men and Women Differently: “Research presented at the annual European Society of Cardiology meeting in Vienna suggested that surgeries which typically save men’s lives can be deadly for women,” reports the AP. “A small study of 184 women conducted by Dr. Eva Swahn of the department of cardiology at University Hospital in Linkoping, Sweden, found that women who had major heart operations like a coronary bypass were more likely than men to die.”
NFL Mirrors Society: From a USA Today editorial: “Even people who aren’t football fans have heard about Michael Vick, the star quarterback whose abuse of pit bulls led to a guilty plea on federal dogfighting charges, drew public vilification and spurred an indefinite suspension from the NFL. Far fewer people have heard of Michael Pittman, another NFL player accused of violence. In May 2003, the Tampa Bay Buccaneers running back was arrested on charges of ramming his Hummer into a car driven by his wife and carrying their 2-year-old child and a babysitter.”
“Well-Behaved Women Seldom Make History”: Laurel Thatcher Ulrich, who wrote that sentence in an article entitled “Virtuous Women Found: New England Ministerial Literature, 1668-1735″ two decades ago, has now written a book exploring the hidden history of women.
“‘Well-Behaved Women Seldom Make History’ is by no means jargon-ridden or academic in tone,” writes Michael Dirda in the Washington Post. “Ulrich’s style is plain and direct, agreeable but without frills, and she moves efficiently right along. The book is a pleasure to read.”
Madeline L’Engle Dies at at 88: L’Engle, a graduate of Smith, wrote the children’s classic “A Wrinkle in Time,” and other wonderful stories — many of which featured a girl as the protagonist. From The New York Times obit:
In the “Dictionary of Literary Biography,” Marygail G. Parker notes “a peculiar splendor” in Ms. L’Engle’s oeuvre, and some of that splendor is sheer literary range. “Wrinkle” is part of her series of children’s books, which includes “A Wind in the Door,” “A Swiftly Tilting Planet,” “Many Waters” and “An Acceptable Time.” The series combines elements of science fiction with insights into love and moral purpose that pervade Ms. L’Engle’s writing.
This really should come as no big surprise – vaccines in general, like flu shots, are intended to help prevent a disease, not to cure it.
The fact that the vaccine doesn’t cure infection raises an important point, however – much of the criticism when Gardasil was released stemmed from the need to vaccinate young girls before they become sexually active, and concerns that the vaccine would encourage them to have sex (despite the lack of evidence to support that fear).
This study adds weight to the idea that vaccination prior to the initiation of sexual activity is most effective in preventing HPV infection and possible cervical cancer, and represents the best use of the vaccine. An editorial in the issue (available with subscription) also makes this point:
The lack of therapeutic efficacy of the quadrivalent HPV vaccine was considered in deliberations by the Advisory Committee on Immunization Practices (ACIP). These data, along with data demonstrating the high likelihood of acquiring HPV infection soon after onset of sexual activity and data on sexual behavior in the United States, all contributed to recommendations for routine immunization at 11 to 12 years of age. Because the vaccine has no therapeutic efficacy, the greatest effect will be realized if the vaccine is administered before sexual debut, prior to exposure to HPV.
What better way to advertise to other beachgoers that you’re free of a sexually transmitted disease than to wrap yourself in this nicely designed terry velour towel, which measures 30 inches by 60 inches. Catch a wave and then use the towel to make clear to that attractive person nearby that genital warts or HPV won’t be a problem. Truly, this is a new way to advertise the advantages the vaccine has to offer. Frisky teenagers will love them!