Health Highlights: Dec. 13, 2011
FDA Issues Warning Letters About Lap-Band Ads Numerous Problems at Heart Start Centers: Report Court Hears Morning-After Pill Arguments Man Dies After Taking MS Drug Medtronic Pays $23.5 Million to Settle Kickback Allegations Child Abuse, Neglect Decline in U.S.
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Issues Warning Letters About Lap-Band Ads
Warning letters have been sent to a number of California surgical centers and a marketing firm about misleading advertising of the Lap-Band weight-loss device, the U.S. Food and Drug Administration said Tuesday.
The Lap-Band is FDA-approved for weight loss in obese adults. The warning letters inform the recipients that their billboards and advertising inserts promoting the Lap-Band do not provide required risk information, including warnings, precautions, possible side effects and contraindications.
In addition, the font size of advertising insert information outlining risks may be too small to be read by consumers, the FDA said.
The warning letters were sent to: Beverly Hills Surgery Center; Palmdale Ambulatory Center; Valley Surgical Center; Top Surgeons LLC; Valencia Ambulatory Center LLC; Cosmopolitan Plastic & Reconstructive Surgery; San Diego Ambulatory Center LLC; and to the marketing firm 1-800-GET-THIN.
If the companies don't take action to correct these issues, the FDA says it is prepared to take further measures, including product seizures or fines.
Numerous Problems at Heart Start Centers: Report
Expired infant formula in the fridge, a screw protruding from a bookcase at child-height level, a machete near a play area, and household chemicals accessible to preschoolers are among the numerous violations found at Head Start centers across the United States, according to a report by the Inspector General of the U.S. Health and Human Services Department.
Head Start is a federal program that gives grant dollars to public, nonprofit and for-profit programs to provide early education services to nearly 1 million low-income children nationwide, the Associated Press reported.
The review of 24 audits of Head Start "grantees" running 175 facilities in seven states found that 21 of the 24 grantees did not comply fully with rules requiring them to conduct criminal and other background checks of instructors.
The Inspector General also found that toxic chemicals labeled "keep out of reach of children" and cleaning supplies were accessible to children at 90 percent of the Head Start facilities.
More than 70 percent of the facilities had open or broken gates leading to parking lots, streets or unsupervised areas, and inadequate or broken fences. More than half had playground equipment that was not in good repair, the AP reported.
Court Hears Morning-After Pill Arguments
Arguments over whether the U.S. government's restrictions on younger teens' access to the morning-after contraceptive pill are constitutional will be heard this week by a federal judge in Brooklyn, N.Y.
The contraceptives are being held to a different and non-scientific standard than other drugs and politics have influenced decision making, according to the Center for Reproductive Rights and other groups, the Associated Press reported.
The morning-after pill is practically the same as abortion, according to social conservatives.
Two years ago, Judge Edward Korman ordered the U.S. Food and Drug Administration to allow 17-year-old girls to obtain the morning-after pill without a prescription. At the time, he said the federal government was letting "political considerations, delays and implausible justifications for decision-making" interfere with the approval process.
In court papers filed prior to this week's hearing, Assistant U.S. Attorney Scott Landau said the government had lowered the minimum age for over-the-counter sales of the drug from 18 to 17, thus complying with the judge's orders, the AP reported.
Landau contended that the plaintiffs "unfairly accuse FDA of bad faith and delay."
Last week, U.S. Health and Human Services Secretary Kathleen Sebelius overruled FDA scientists and announced that the morning-after pill would only be available without prescription to those 17 and older who can prove their age. President Barack Obama backed the decision.
Sebelius said the studies submitted to the FDA did not include data on all ages and did not establish that over-the-counter sales of the pill were suitable for younger teens, the AP reported.
Man Dies After Taking MS Drug
The death of an American man after taking the multiple-sclerosis pill Gilenya for the first time has led to questions about the drug's safety.
The 59-year-old patient received his first dose of Gilyena on Nov. 22 and died a day later. The exact cause of death has not been established, according to drug maker Novartis AG, Dow Jones Newswires reported.
Because the drug can slow a patient's heart rate, heart monitoring in a doctor's office is recommended. This patient completed six hours of post-dose observation without incident, said Novartis, which has submitted details of the case to the U.S. Food and Drug Administration.
Gilyena was approved by the FDA in 2010. At the time, experts said the safety profile of the drug was acceptable, but patients needed to be aware that it can lower heart rate, trigger a small decrease in lung function, and cause eye problems, Dow Jones reported.
"This is the first reported death event occurring within 24 hours of the first dose of Gilenya in more than 28,000 patients who have received Gilenya to date," Novartis said.
Medtronic Pays $23.5 Million to Settle Kickback Allegations
Medical device maker Medtronic Inc. has agreed to pay $23.5 million to settle allegations that it paid kickbacks to doctors to implant its heart pacemakers and defibrillators, the U.S. Justice Department announced Monday.
Minnesota-based Medtronic, the world's largest maker of medical devices, did not admit any wrongdoing as part of the civil settlement, the Associated Press reported.
The federal government alleged that Medtronic paid doctors fees of $1,000 to $2,000 per Medicaid or Medicare patient.
"Medicare and Medicaid beneficiaries depend on their physicians to make decisions based on sound medical judgment, especially when they are choosing which pacemaker or defibrillator to implant," B. Todd Jones, U.S. attorney for Minnesota, said in a statement, the AP reported. "Medical device manufactures must not be permitted to use improper payments to cloud that judgment."
Child Abuse, Neglect Decline in U.S.
Child abuse, neglect and related deaths declined in the United States between 2008 and 2010, according to an annual report from the Department of Health and Human Services.
The estimated number of victimized children fell from 716,000 in fiscal year 2008 to 695,000 in 2010. The number in 2006 was 825,000, the Associated Press reported.
The number of deaths from abuse and neglect dropped from an estimated 1,720 in 2008 and 1,750 in 2009 to 1,560 in 2010. About 80 percent of the children who died were 3 years old or younger.
The number of children who were sexually abused fell from 65,964 in 2009 to 63,527 in 2010, which is down more than 55 percent from the peak of about 150,000 in 1992, the AP reported.
The findings suggest that worries about the recession leading to an increase in child abuse and neglect were unfounded.
"The recession hasn't had the draconian effect that some feared," Richard Gelles, dean of the University of Pennsylvania's School of Social Policy and Practice and an expert on child welfare, told the AP. "The doom and gloom predictions haven't come true."