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.
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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.
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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.
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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.
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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."
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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."