ACOG Committee on Sex Selection
While it is ethical for physicians to use sex selection to prevent sex-linked genetic disorders, they should not participate in sex selection for other reasons, according to an opinion from the American College of Obstetricians and Gynecologists Committee on Ethics. The committee opposed the use of sex selection for social, economic, cultural, and personal reasons, including family balancing. However, in some cases physicians may not be able to avoid providing information that may lead to sex selection. For example, when performing a procedure that reveals the sex of the future child, the information should not be withheld from a pregnant woman who requests it, the committee wrote. “To minimize the possibility that they will unknowingly participate in sex selection, physicians should foster open communication with patients aimed at clarifying patients' goals,” the committee wrote. “Although health care providers may not ethically withhold medical information from patients who request it, they are not obligated to perform an abortion, or other medical procedure, to select fetal sex.”
FDA Guidance on Cord Blood Products
Under draft guidance published in January, the Food and Drug Administration outlined a new approach for regulating cord blood hematopoietic stem/progenitor cells that are minimally manipulated, used to replenish bone marrow in patients with blood-related malignancies, and used in recipients unrelated to the donor of the stem cells. Under the draft guidance, cord blood banks could cite existing data in their biologics licensure applications, instead of having to submit their own clinical data. “Cord blood hematopoietic stem/progenitor cells offer the potential for tremendous therapeutic benefit,” Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said in a statement. “In this draft guidance, FDA provides recommendations on a streamlined path to licensure for these promising products that also ensures their safety and effectiveness.” The document is available at
www.fda.gov/cber/gdlns/cordbld.pdf
Pharmacy Refusals Likely to Continue
Despite FDA's decision to make emergency contraception available to women 18 and older without a prescription, women may still encounter access problems, according to a report from the National Women's Law Center. Since emergency contraception is now available behind the counter, women must still ask a pharmacist or other pharmacy personnel to get it, the group noted in a report outlining various pharmacy refusal laws and practices. And the report noted that Michigan and Missouri both have pending legislation to counteract FDA's decision.
Birth Defects Tab: $2.6 Billion
Birth defects accounted for 139,100 hospital admissions and $2.6 billion in treatment costs in 2004, according to a report compiled by the Agency for Healthcare Research and Quality. Heart anomalies, such as atrial and ventricular septal defects, were the deadliest and accounted for the highest number of admissions—one-third—and the highest costs, $1.4 billion. The second-most common cause of admission was for digestive conditions such as pyloric stenosis. According to the report, between 1997 and 2004, the rate of admission increased by more than 25% for these two leading categories of birth defects, when they were listed as either the principal or coexisting condition. Genitourinary defects and nervous system anomalies accounted for the third- and fourth-leading causes of admissions, followed by other problems such as cleft palate, hip deformity, skull and facial bone defects, and spinal and foot deformities. The report can be found at
www.hcup-us.ahrq.gov/reports/statbriefs/sb24.pdf
Antidepressant Side Effects Vary
Second-generation antidepressants generally have similar rates of effectiveness but have variable side effects, according to an analysis from the Agency for Healthcare Research and Quality. On average, about 61% of patients will experience at least one side effect from taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI), according to the analysis. However, the type of side effect varies by drug. AHRQ researchers analyzed 293 published studies to compare the risks and benefits of second-generation antidepressants in the treatment of major depressive disorder, dysthymia, and subsyndromal depression. “Second-generation antidepressants provide hope for many of the millions of Americans who struggle with depression,” Dr. Carolyn Clancy, AHRQ director, said in a statement. “But often, trying to find the right drug is trial and error, and in many cases relief is temporary or comes with serious side effects. It's clear we need more evidence to help patients and their doctors make the best choices.” The study is available at