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FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination
In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10).
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Post-Surgery Distress In Children Eased By Hormone Treatment
A scary unknown for many children, the prospect of surgery can cause intense preoperative anxiety. While some amount of stress is normal, what many parents do not know is that extreme anxiety before surgery can contribute to the occurrence of emergence delirium, a distressing incidence of acute behavioral changes experienced when "waking up" from anesthesia.
News of the day
Inovio Biomedical To Present At International DNA Vaccine Conference
Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that it will make multiple presentations at the Annual Conference of DNA Vaccines in Asia 2009 being hosted by the International Society of DNA Vaccines July 9 - 10 at the Beijing International Convention Center. The conference, with the theme, "Advancing DNA Vaccine Technology," is co-chaired by David B. Weiner, Ph.D., professor of pathology, University of Pennsylvania School of Medicine, and chairman of Inovio"s scientific advisory board.
Nutrition

Patient Upside Murky In Drug-Price Cases

"The prices of hundreds of brand-name drugs are about to be cut 4%, and millions of Americans may soon receive a check in the mail as compensation for having overpaid for their prescriptions," but "the extent to which the average consumer will benefit isn"t yet clear," the Wall Street Journal reports. "The price cuts and expected payments are the result of federal class-action settlements involving two drug-price publishers and a major drug wholesaler that were accused of inflating drug prices." The price rollbacks may save $100 billion in the first year, with about $100 million of that amount "saved directly by patients, while the balance would accrue to employers and private health insurers." But critics say that "because drug pricing is so opaque and complex, patients won"t likely get meaningful and long-lasting relief." Eighty-four million dollars may go to pay attorney fees, and pharmacies are still trying to stop the price rollbacks, "which could shrink their profit margins." In addition to price cuts, under the settlement, "uninsured patients who filled prescriptions for such widely used drugs as Pfizer Inc."s Lipitor, Sanofi Aventis SA"s Ambien and hundreds of other medicines between August 2001 and Jan. 23, 2009 are eligible for reimbursement checks from an about $60 million pot that has been set aside." According to testimony for the plaintiffs, the extra costs for insurers and patients comes to $2.9 billion. Many insured patients were also likely "affected indirectly because the higher costs added to a rise in health-insurance premiums." In order to qualify for the reimbursement funds, patients must have "kept good records" of their purchases and must submit claim forms by July 9 to a settlement administrator" (Rubenstein, 6/11). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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