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Here are some of the latest health and medical news developments, compiled by editors of HealthDay: FDA Rejects Non-Prescription Sales of 'Morning After' Pill In a move that went against the overwhelming recommendation of its own advisory panel, the U.S. Food And Drug Administration has denied over-the-counter sale status for the "morning after" birth control pill. According to the Associated Press, FDA officials said it was concerned about the lack of evidence that teens younger than 16 could safely use the pills without a doctor's guidance. In December 2003, an FDA advisory panel considered the over-the-counter proposal by Barr Laboratories, which makes a version of the pill, known as Plan B. The morning-after pill is a higher dose of the birth control pill that regulates menstrual cycles. According to its manufacturer, if it is taken within 72 hours of intercourse, the pills can reduce the possibility of becoming pregnant by up to 89 percent. It is currently available only by prescription. The advisory panel voted 23-4 to approve Barr Laboratories' request. It is rare that the FDA doesn't follow one of its review panels' recommendations. And in fact, according to the AP, the agency's scientific advisers recommended approval. But, according to internal FDA memos the wire service says it obtained, top officials were concerned about unsupervised use by very young females. "Some staff have expressed the concern that this decision is based on non-medical implications of teen sexual behavior, or judgments about the propriety of this activity," the AP quotes the memo as written by FDA acting drug chief Dr. Steven Galson. "These issues are beyond the scope of our drug approval process, and I have not considered them in this decision." According to the wire service, the FDA did leave open the possibility for Barr Laboratories to try again. It said it needed "either data showing young teens could use the pills safely without a prescription or details on how to make the mixed-marketing approach work." And Barr's top executive Bruce Downey told the wire service, "It's a matter of weeks and months to deal with this objection. Clearly ... the door's open, and we plan to go through it." ----- Folate Requirement Cuts Birth Defects The incidence of neural tube defects has fallen 25 percent since the United States mandated that fortified grain products like cereal contain folic acid. The U.S. Centers for Disease Control and Prevention reported Thursday that, since the rule took effect in 1998, the number of pregnancies affected by such birth defects as spina bifida and anencephaly (the absence of a brain) has fallen from 4,000 a year to 3,000. The CDC is claiming only a "partial success story," however. The agency said that at least another 1,000 babies would be born without these defects if all women of childbearing age took 400 micrograms of folic acid a day through diet or supplements. According to the CDC, between 50 percent and 70 percent of neural tube defects are the result of a lack of folate. ----- Lyme Disease Rate Rose Sharply in 2002 The incidence of Lyme disease, which the government health officials called a "persistent and growing public health concern," rose 40 percent in the United States between 2001 and 2002. The U.S. Centers for Disease Control and Prevention said there were 23,763 reported cases of Lyme disease in 2002, the last year for which complete figures are available. In 2001, the CDC said, 17,029 cases of the tick-borne illness were reported nationwide. The CDC, writing in its publication Morbidity and Mortality Weekly Report, said part of the reason for the sharp rise is an increase in deer populations that support the disease-carrying tick. Other reasons include more development in wooded areas, the movement of ticks to new regions, and increased surveillance and recognition of Lyme disease. According to the report, 12 states accounted for 95 percent of all reported cases: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Wisconsin. ----- Report: States Fall Short on Women's Health Many states are taking a "two-steps-forward-one-step-back" approach when it comes to taking care of women's health, according to a new report. The National Women's Law Center found great disparities in care from state to state, and no single state received a "satisfactory" rating. Among the findings:
"State policy makers' piecemeal approach to our health-care crisis has resulted in a complex and ineffective system that fails to meet the health care needs of women," Judy Waxman, the NWLC's vice president for health, said in a statement. ----- 18 State Attorneys General Support Prescription Drug Importation The attorneys general of 18 states have sent a letter urging the Bush Administration to support the growing movement to legalize the importing of lower-cost prescription drugs from Canada. The letter was sent a day after President Bush's top health official, Health and Human Services Secretary Tommy Thompson, conceded to reporters that passage of a Congressional drug import bill was all but inevitable, the Associated Press reported. In the letter, the top state law enforcement officials urged Thompson to "act immediately to help provide our citizens with affordable prescription drugs while ensuring drug safety," according to the wire service. The attorneys general come from Arizona, California, Colorado, Connecticut, Illinois, Iowa, Maine, Maryland, Massachusetts, Mississippi, New Hampshire, New Mexico, New York, Ohio, Oregon, Rhode Island, Vermont, and Wisconsin. Under their proposal, all of the imported drugs would be manufactured at facilities sanctioned by the U.S. Food and Drug Administration. Sophisticated tracking devices would be used to thwart counterfeiters, the letter said. The groundswell to legalize drug imports from Canada and elsewhere included at statement Wednesday by the chief executive of CVS Corp., who broke with others in the pharmaceutical industry by calling for temporarily legalizing such imports, the AP reported. The Bush administration and Republican leaders in Congress, as well as the pharmaceutical industry, have opposed legalizing drug imports, citing safety concerns. ----- Last Updated: May-06-2004 |