Gynecology Medical News

Concentrations of the biomarkers CA125, human epididymis protein 4 (HE4), and mesothelin began to rise 3 years before clinical diagnosis of ovarian cancer, according to a new study published online December 30 in the Journal of the National Cancer Institute. However, the biomarkers became substantially elevated only in the last year prior to diagnosis. The stage of the cancer at the time of marker elevation is not known.

CA125, HE4, mesothelin, B7-H4, decoy receptor 3, and spondin-2 have been identified as potential ovarian cancer biomarkers, but their behavior in the pre-diagnostic period, with the exception of CA125, has not been evaluated previously.

In this study, Garnet L. Anderson, Ph.D., of the Division of Public Health Sciences at the Fred Hutchinson Cancer Research Center in Seattle, and colleagues analyzed stored serum samples from the Carotene and Retinol Efficacy Trial, a randomized, double-blind, placebo-controlled chemoprevention trial testing the effects of beta-carotene and retinol on lung cancer incidence among individuals at high risk for the disease. The researchers identified 34 patients who were diagnosed with ovarian cancer and had serum specimens available from the trial, as well as 70 matched control subjects.

Serum concentrations of CA125, HE4, and mesothelin began to increase slightly in cancer patients approximately 3 years before diagnosis but became substantially elevated only about a year before diagnosis.

These data suggest the presence of ovarian cancer up to 3 years before clinical diagnosis, but the likely lead time associated with these markers appears to be less than 1 year, according to the authors.

“Although these markers are not accurate enough to prompt early intervention in existing screening protocols, the multivariable regression analyses identified modest but statistically significant increases in risk associated with CA125, HE4, and mesothelin, which are consistent with many of the established epidemiological risk factors for ovarian cancer,” the authors write.

In an accompanying editorial, Patricia Hartge, ScD, of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute in Bethesda, Md., applauds the authors for taking the field one step closer to successful screening designs by showing that the levels of certain biomarkers do not increase early enough to be used for screening.

“The results of Anderson et al. are not the last word in serum markers or in combinations of markers,” the editorialist writes. “Serum markers likely will form a key element in any screening regimen, with the lead time and other parameters of each marker or combination of markers being taken into account. The careful evaluation technique applied in the current study fits into a staged approach necessary for testing performance of early markers of disease.”

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Link to editorial

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Journal of the National Cancer Institute Continue reading →

The Obama administration Friday issued draft guidelines limiting federal funding for embryonic stem cell research to cells derived from unused embryos created for fertility treatments and willingly donated by patients who have given written consent, the Washington Post reports. Although the guidelines “fell short of the open-ended policy” that some researchers and patient advocates would prefer, the new policy is “far less likely to spark controversy,” the Post reports. Obama in March signed an executive order lifting many restrictions on embryonic stem cell research that were put in place under the administration of former President George W. Bush. Bush in August 2001 had limited federal funding for the research to the two dozen cell lines in existence at the time.

Raynard Kington, acting director of NIH, which developed the new guidelines, said the Obama administration was guided by “broad public support” to create a policy that bans the creation of embryos specifically for research as well as any form of therapeutic cloning (Connolly, Washington Post, 4/18). The guidelines also state that the research must comply with the Dickey-Wicker Amendment, a policy included in the annual federal appropriation bills that prohibits HHS from using appropriated funds for creating or destroying embryos for research. The provision has been attached to every federal appropriations bill since the mid-1990s, according to BNA (BNA, 4/20).

The new guidelines also were designed to reflect legislation (H.R. 810) that Congress has twice approved and that Bush vetoed twice. Kington said congressional support for the legislation is “the strongest indication of public support.” He added, “There is not similar broad support for using stem cells from other sources” (Washington Post, 4/18). Reps. Diana DeGette (D-Colo.) and Michael Castle (R-Del.), sponsors of the vetoed legislation, said they would pursue legislative changes, including dropping the Dickey-Wicker Amendment, to increase funding for new stem cell lines (BNA, 4/20).

The new guidelines also specify that scientists must obtain written consent from embryo donors and that only voluntary donation is allowed, without pressure or financial incentives (Washington Post, 4/18). According to the Boston Globe, some scientists are concerned that the new restrictions on informed consent would block federal funding for research on stem cells that are already in use, as it may be impossible to identify the donors of the embryos. However, Kington said that research NIH currently supports would continue (Venkataraman, Boston Globe, 4/18). According to the Post, NIH is expected to receive $10 billion in funding from the economic stimulus package, and officials have said that a portion of that funding could be directed to embryonic stem cell research grants.

Reaction

The Post reports that many supporters of embryonic stem cell research praised the guidelines as a pragmatic approach to a controversial issue. Rachel Laser, a spokesperson for Third Way, said the policy is “thoughtful and balanced” and “demonstrates [Obama's] commitment to finding shared values on an issue that has long been divisive” (Washington Post, 4/18). Sean Morrison, director of the University of Michigan’s Center for Stem Cell Biology, said the new policy is “a reasonable compromise based on where the science stands now.” He added that NIH and scientists “may need to revisit some of the details down the road depending on how the science develops” (Neergaard, AP/Chicago Tribune, 4/18).

However, some scientists expressed disappointment that some research would continue to be restricted. In issuing the executive order last month, Obama stressed that political considerations would not hamper scientific research. Susan Solomon, CEO of the New York Stem Cell Foundation, said, “This seems to be a political calculus when what we want in this country is a scientific research calculus” (Washington Post, 4/18). Irving Weissman, director of the Stem Cell Biology and Regenerative Medicine Institute at Stanford University, said NIH was “putting this ideological barrier in the way” of treating disease.

Some abortion-rights opponents also criticized the Obama administration, according to the New York Times. Douglas Johnson of the National Right to Life Committee said the decision is “clearly part of an incremental strategy to desensitize the public to the concept of killing human embryos for research purposes.”

The guidelines will be published this week in the Federal Register, followed by a 30-day public comment period before the rules become final by July 7, the Times reports. According to the Times, the announcement of the new guidelines is “likely to kick off a rush” of research applications for federal funding (Harris, New York Times, 4/18).

Research Guidelines ‘Intelligent Solution’ to Controversial Issue, Post Editorial Says

The new NIH guidelines on embryonic stem cell research “offer an intelligent solution to an issue that demanded great sensitivity,” a Post editorial says. “While a decision with such deep moral and ethical considerations shouldn’t have been left to scientists alone, the NIH outcome is a good one,” the editorial says. It continues that “NIH apparently based its decision partly on scientific considerations — that the new limitations wouldn’t unduly restrict research — and partly on other considerations,” including public support. Although deciding whether to allow research on embryos from other sources is a “political assessment” that “really is a job for the White House, … delegation — or abdication, depending on your point of view — in this case produced a sensible result,” the editorial concludes (Washington Post, 4/19).

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

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The July 2007 issue of the Journal of the American Dietetic Association contains articles and research studies you may find of interest. Below is a summary of some of this month’s articles.

Children Prefer Large Portions — of Some Foods

Given the choice, Canadian fifth-graders prefer larger portions of snacks and fast foods and smaller portions of vegetables than the recommended amounts, according to researchers at Dalhousie University in Canada.

The researchers showed nearly 5,000 children a variety of portion sizes of french fries, meat, cooked vegetables and potato chips and asked them to indicate their ‘usual portion sizes.’ More than 63 percent of the children chose french fry portions that were larger than American and Canadian dietary recommendations, with boys more than twice as likely as girls to select bigger portions. ‘Significantly larger’ portions for meat and chips were selected by about 78 percent the children; for vegetables, 52 percent chose portion sizes smaller than or equal to dietary guidelines.

The study found kids who ate at fast-food restaurants more than once per week were more likely to consider large portions of fries and small portions of vegetables to be ‘usual,’ as did children from socioeconomically disadvantaged families and those who frequently ate while watching television.

“This study demonstrates that a great deal can be gained by expanding nutrition education with respect to moderation and choosing appropriate portion sizes,” the researchers write.

African-American Girls Consume Fewer Micronutrients than Caucasian Girls

African-American adolescent and teenage girls consume less vitamin A and D, calcium and magnesium compared to Caucasian girls, according to researchers at St. Joseph College, Wesleyan University and other institutions. Regardless of race, the researchers also found a ‘substantial’ percentage of girls had intakes of vitamin E, magnesium and folate that fall below recommended guidelines.

The researchers studied data from the National Heart, Lung and Blood Institute’s National Growth and Healthy Study of nearly 1,200 white girls and more than 1,200 African-American girls to determine their usual daily intakes of vitamins A, E, C, D, B6, B12, magnesium, folate, calcium and zinc.

The study reported that Caucasian girls tend to consume greater amounts of micronutrients compared to African-American girls, with the exception of vitamins E and C and zinc. Intakes of vitamins A, D and C; calcium; and magnesium tend to decrease with age for all girls, but the rate of decreased intake of vitamin D, calcium and magnesium is greater among African-American girls.

The researchers speculate that, as girls age, ‘the nutrient density of their diet (decreases), and this tendency (is) more pronounced among African-American girls. Food and nutrition professionals should focus their counseling efforts on improving diets of young girls, particularly those who are African-American.”

Additional research articles in the July Journal of the American Dietetic Association include:

* Beverage Patterns, Diet Quality and Body Mass Index of U.S. Preschool and School-Aged Children

* Examination of Weight Status and Dietary Behaviors of Middle School Students in Kentucky

* Predictors of Weight Loss in Low-Income Mothers of Young Children

* Predictors of Dietary Change and Maintenance in The Women’s Health Initiative (WHI) Dietary Modification (DM) Trial

* Child-Feeding Strategies are Associated with Maternal Concern about Children Becoming Overweight, but Not Children’s Weight Status

The Journal of the American Dietetic Association is the official research publication of the American Dietetic Association and is the premier peer-reviewed journal in the field of nutrition and dietetics.

With more than 67,000 members, the American Dietetic Association is the nation’s largest organization of food and nutrition professionals. ADA serves the public by promoting optimal nutrition, health and well-being. To locate a registered dietitian in your area, visit the American Dietetic Association at eatright/.

Source: Jennifer Starkey

American Dietetic Association Continue reading →

A paper published online by the journal Circulation concluded that, while men and women have a similar in-hospital death rate following acute myocardial infarction, women with STEMI had an adjusted mortality rate almost twice as high as men (10.2% versus 5.5%). These differences were associated with a lower likelihood of reperfusion therapy in women. The paper was widely reported in the press, with suggestions of disparity in care and outcome after AMI.

This study is one of many undertaken in the past 20 years on gender differences in the management of acute coronary events. Many, like this latest study, have found that women are treated less intensively in the acute phase. However, after adjustment for age, co-morbidity and severity of disease, some of these disparities have been found to disappear. Similarly, many studies have found gender differences in short-term survival rates after AMI, but such differences have not always persisted in the long term.

In Europe results from a Swedish cohort study of 53,781 subjects (of whom 37 per cent were women) also showed that overall women were less intensively treated than men, but, in cases of non-STEMI, had a better long-term prognosis than men.

Commenting for the ESC on the STEMI results in the Circulation paper, Professor Eva Swahn (University Hospital, Link?

Attorneys for Kansas abortion provider George Tiller on Friday in Sedgwick County District Court entered a not guilty plea to 19 misdemeanor charges filed by Attorney General Paul Morrison (D) alleging Tiller violated a Kansas law that requires an independent, consulting physician to approve some late-term abortions, the AP/Forbes reports (Hegeman, AP/Forbes, 8/3). Lee Thompson, one of Tiller’s attorneys, in a statement said, “The law permits first appearance in misdemeanor cases to be made by counsel, and that has been done,” adding, “A plea of not guilty has been entered” (Kansas City Star, 8/3).

Former state Attorney General Phill Kline (R) in 2004 subpoenaed the records of 90 women and girls who in 2003 underwent late-term abortions at Comprehensive Health in Overland Park, Kan., and Women’s Health Care Services in Wichita, Kan., which is owned by Tiller. Kline charged Tiller with 30 misdemeanors for allegedly performing 15 illegal late-term abortions in 2003 on women and girls ages 10 to 22 without properly reporting the details to the state. Kline hired attorney Don McKinney as special prosecutor in the case. Morrison — who defeated Kline in the November 2006 election — fired McKinney in January, and Morrison spokesperson Ashley Anstaett earlier this year said that 15 of the 30 charges Kline filed against Tiller were based on incomplete and substandard information.

However, Morrison in June filed charges alleging that before performing 19 late-term abortions in 2003, Tiller received a second opinion from physician Ann Kristin Neuhaus, who Morrison said had financial ties with Tiller. A 1998 Kansas law says that before an abortion of a fetus of 21 weeks’ gestation or more, two physicians must determine if continuation of a pregnancy will lead to death or “substantial and irreversible” harm to a “major bodily function.” The consulting physician agreeing on the necessity of a late-term abortion cannot have legal or financial ties to the abortion provider.

Tillers’ attorneys filed a motion last month to dismiss the charges. In the motion, his attorneys argued that the provision of the law requiring two or more doctors to sign off on late-term abortions is unconstitutional. The motion filed by Tiller’s attorneys stated that the requirement is unconstitutional because it is vague, it violates a woman’s right to obtain an abortion as outlined in previous court decisions and it places an undue burden on a physician’s right to practice medicine. “There is absolutely no guidance in the state as to what activities constitute legal or financial affiliation — or how a physician might avoid some prosecutor making such a filing,” the attorneys wrote. The attorneys also argued a provision in the law requiring the second opinion to come from a doctor licensed in Kansas increases possible dangerous delays and could illegally infringe on a woman’s right to travel between states for medical treatment (Kaiser Daily Women’s Health Policy Report, 7/3).

Tiller on Friday turned himself in to the Sedgwick County Sheriff’s Office for processing on misdemeanor charges and was released on his own recognizance, the Star reports. Tiller’s first court appearance was scheduled for Tuesday, but the unannounced move permitted his attorneys to enter a not guilty plea on all counts on Tiller’s behalf, the Star reports. Thompson said the next hearing, which is scheduled for August 10, will examine Tiller’s motion to dismiss the charges. Tiller’s clinic closed this week. His attorneys Dan Monnat and Thompson said the closure is because of “increased protests and acts of vandalism” (Kansas City Star, 8/3). If convicted, Tiller could face up to one year in jail and a $2,500 fine for each charge. The Kansas State Board of Healing Arts also could consider revoking Tiller’s license to practice if he is convicted (Kaiser Daily Women’s Health Policy Report, 7/3).

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

The fifth annual international conference of the African Science Academy Development Initiative (ASADI) will be held Nov. 9-11 in Accra, Ghana, in conjunction with the 50th anniversary of the Ghana Academy of Arts and Sciences. The theme of this year’s conference will be improving maternal, newborn, and child health in Africa, which will be discussed by top experts from around the world. ASADI V will kick off with the release of Science in Action: Saving the Lives of Africa’s Mothers, Newborns, and Children, a new report by several African science academies, assessing the effectiveness of interventions aimed at reducing maternal and childhood mortality — the focus of U.N. Millennium Development Goals Four and Five — in sub-Saharan Africa. The report will include estimates of lives that could be saved if proven scientific methods reached more parts of Africa.

Details:


The conference will be held in the Adae Kese Conference Room of the La Palm Royal Beach Hotel, Accra, Ghana. The opening ceremony takes place on Monday, Nov. 9, at 6 p.m. It will be preceded that afternoon by a press conference to release the Science in Action report (time to be determined). On Tuesday, Nov. 10, the conference runs from 8 a.m. to 6 p.m., and on Wednesday, Nov. 11, from 9 a.m. to 4:15 p.m. More information, including a draft agenda, is available at national-academies/asadi. ASADI is a collaboration among several African science academies and the U.S. National Academies to strengthen the capacity of the African academies to inform policy and public discourse through independent, evidence-based advice.

Source:
William Kearney

National Academy of Sciences Continue reading →

In an effort to curb the rising rates of HIV and sexually transmitted infections (STIs) along the Mexico-US border, a binational team of researchers led by the University of California, San Diego School of Medicine have shown that brief but personalized behavioral counseling significantly reduced rates and improved condom use among female sex workers in Tijuana and Ciudad Juarez, Mexico.

The researchers observed a 40 percent decline in the combined rate of new STIs (including HIV, syphilis, gonorrhea and Chlamydia) in the group of female sex workers who received the 30-minute one-on-one counseling intervention, compared to an encounter that was based on educational information only. The study, headed by Thomas L. Patterson, Ph.D., professor of psychiatry at UC San Diego School of Medicine, in collaboration with researchers from across Mexico, at UC Davis and Northeastern University, will be published on line September 17 in advance of the November edition of the American Journal of Public Health.

“An advantage to the counseling approach is that – instead of simply listening to a lecture – women are taught and can practice skills that are tailored to their personal situations,” Patterson said. “By working with the counselor, women identify for themselves the barriers to safer sex and discuss potential solutions as part of their goal setting.”

The study looked at 924 female sex workers aged 18 years or older, without known HIV infection, living in Tijuana and Ciudad Juarez – approximately equal numbers in both cities – who had recently had unprotected sex with clients. Half of the women took part in the Mujer Segura (Healthy Woman) counseling session with specially trained, local health care staff. The others participated in a face-to-face informational session, with prevention materials drawn from the U.S. Centers for Disease Control and Prevention guidelines for HIV counseling, testing and referral and from Mexico’s National Center for AIDS Studies.

“The major difference in the two approaches is that the Mujer Segura sessions focused on the participants assessing their personal risk factors, such as having unprotected sex with clients, and developing strategies for reducing that risk,” said Patterson.

Counselors helped the participants identify and understand behaviors and circumstances that put them at risk for contracting HIV or other STIs. They also provided positive reinforcement, helping the women to set small and achievable goals and providing motivational techniques and role-playing to reinforce ways of practicing safe sex.

Individuals in the intervention group reported significant improvements in their risk behaviors. In particular, not a single incidence of HIV infection occurred in the intervention group.

“In the absence of an effective HIV vaccine in the near future, the urgent need continues for effective, culturally appropriate interventions that can be used as stand-alone programs, or to support existing approaches,” Patterson said. “Our brief intervention, which counselors can be easily trained to deliver in a variety of settings, is an inexpensive and effect approach to reducing the risk of HIV and other STIs.”

Studies show that current rates of HIV infection (at six percent of FSWs in Tijuana and Ciudad Juarez) and active cases of STIs (at 25 percent, with one out of four women having at least one of the following: gonorrhea, chlamydia, syphilis or HIV) are increasing at a rate of two percent per year.

“These are diseases that recognize no borders, and it is critical that we work alongside health providers in Mexico to stem this disturbing trend,” Patterson said.

Additional contributors include Brent Mausbach, Shirley J. Semple, Prisci Orozovich, Daniela Abramovitz, and Steffanie A. Strathdee, UC San Diego; Remedios Lozada, Patronato Pro-COMUSIDA, Tijuana, Mexico; Hugo Staines-Orozco, Autonomous University of Ciudad Juarez, Mexico; Miguel Fraga-Vallejo, Autonomous University of Baja California, Tijuana, Mexico; Adela de la Torre, UC Davis; Hortensia Amaro, Institute on Urban Health Research and the Bouv?

Health Canada is advising women who are taking antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRI) and who are pregnant or intend to become pregnant to discuss the situation with their doctor due to potential risks to the baby.

Health Canada stresses that patients should not stop taking SSRI medication without first consulting their doctors, as they could experience serious side effects.

Generally, SSRI treatment should only be continued if the benefits to the individual patient are thought to outweigh the risks to the unborn child, while also considering the benefits and risks of switching to another treatment option or stopping treatment altogether. These precautions and the possibility of adverse health effects in newborns are mentioned in the current Canadian prescribing information and consumer information for SSRIs.

SSRIs and other newer antidepressants prescribed for the treatment of depression include the following drugs: Wellbutrin (bupropion), Celexa (citalopram), Cipralex (escitalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Remeron (mirtazapine), Paxil (paroxetine), Zoloft (sertraline) and Effexor (venlafaxine), and Zyban (bupropion) for smoking cessation.

A study published recently in the New England Journal of Medicine suggests that use of SSRIs during the second half of pregnancy may be associated with a condition called persistent pulmonary hypertension of the newborn. Newborns with this rare but life-threatening condition do not receive enough oxygen in the blood and require intensive-care treatment to survive. According to the study, babies born with this condition were six times more likely than healthy babies to have been exposed to SSRIs. This information is considered to be preliminary at this time.

Numerous reports in Canada and abroad have already indicated that some children exposed to SSRIs and other newer antidepressants during pregnancy may develop serious complications at birth. An increase in the overall risk of major birth defects has also been associated with SSRI use.

The safety of these drugs is vigilantly monitored and Canadians will continue to be informed if new concerns arise. Health Canada advisories on other SSRI-related complications in newborns are available on the Health Canada website (see August 9, 2004, October 6, 2005 and December 22, 2005).

Managing the adverse reactions of marketed health products depends on the active participation of both healthcare professionals and consumers in reporting these reactions. The spontaneous reporting of adverse reactions generally underestimates the risks associated with the use of marketed health products.

To report a suspected adverse reaction to SSRIs or other newer antidepressants, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: (Canada) 866-234-2345
Facsimile: (Canada) 866-678-6789

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney’s Pasture, AL 0701C, Canada

HEALTH CANADA

View drug information on Celexa; Effexor; LUVOX. Continue reading →

The American Medical Association (AMA), the nation’s largest physician group, voted at its Annual Meeting to adopt the following new policy.

According to the National Cancer Institute, minority women have a significantly higher cancer mortality rate than Caucasian women. In an effort to combat this troubling fact, the AMA adopted new policy urging more research and funding to address the racial and ethnic disparities in cancer screening, diagnosis, and treatment among minority women.

“There continues to be great disparities in the detection and treatment of cancer among minority women,” said AMA Board Member Samantha Rosman, M.D. “Physicians must work to promote cancer education to their minority patients in a way that is understandable and culturally sensitive.”

American Medical Association
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Two research
studies published today in The New England Journal of Medicine found taking
SSRIs (selective serotonin reuptake inhibitors), anti-depression drugs,
during pregnancy did not significantly increase the overall risk for most
birth defects. However, each study found that taking SSRIs during pregnancy
was associated with a small increase in the risk of certain rare birth
defects — but they were different birth defects.

Dr. Michael Katz, acting Medical Director of the March of Dimes, said
the studies show how important post-market surveillance is in assessing the
safety of medications in pregnancy. During pre-approval, drugs are tested
on relatively few subjects and only side effects with a large frequency are
detected. Once approved, many people take the medication and even very rare
side effects surface.

“Most prescription drugs are not tested on pregnant women,” said Dr.
Katz. “So we must start monitoring the effects of these medications as soon
as they reach consumers, and keep monitoring for as long as it takes to get
good data on risks to mothers and babies.”

The March of Dimes recommends women discuss the potential risks and
benefits of taking SSRIs during pregnancy with their doctors. Women who are
taking an antidepressant should not stop taking their medications if they
discover they are pregnant, but should immediately contact their health
care provider. It may be dangerous to stop taking an antidepressant
suddenly.

About 10 percent of pregnant women in the United States suffer from
depression, some of it undiagnosed.

Previous studies have found that some SSRIs may increase the risk for
other problems for babies, including:

— Withdrawal symptoms in newborns;

— Pulmonary hypertension of the newborn (PPHN), a rare, but serious heart
and lung disorder;

— Low birthweight or preterm delivery.

One study was led by researchers at the University of British Columbia
and the National Center on Birth Defects and Developmental Disabilities and
the other by researchers at Boston University’s Slone Epidemiology Center.

The March of Dimes works to improve the health of babies by preventing
birth defects, premature birth and infant mortality.

March of Dimes
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