- 'Conscience Rule' Gets Legal Challenge
- FDA Lax in Review of High-Risk Medical Devices: Report
- Health Care Reform Near Top of Public's Wish List for 2009
- Pneumonia Vaccine for Young Children Works: CDC
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
'Conscience Rule' Gets Legal Challenge
The Conscience Rule, one of the last items on President George W. Bush's health agenda, has been challenged in U.S. District Court.
The Washington Post reports that a lawsuit was filed Jan. 15 in Connecticut by that state's attorney general, Richard Blumenthal, seeking to block a new federal regulation that protects health workers if they refuse to perform medical services to which they object. The rule went into effect in December.
Blumenthal's suit included the states of California, Connecticut, Illinois, Massachusetts, New Jersey, Oregon and Rhode Island, the Post reported. Separate lawsuits were also filed by Planned Parenthood and the American Civil Liberties Union on behalf of the National Family Planning and Reproductive Health Association.
Central to the Conscience Rule, the newspaper reports, is that it stops federal funding to any health organization -- public or private -- if it doesn't allow health professionals the right to refuse to perform or take part in any health care services they consider objectionable on ethical, moral or religious grounds.
"On the way out, the Bush administration has left a ticking political time bomb that is set to explode literally on the day of the president's [Barack Obama] inaugural and blow apart women's rights," the newspaper quotes Blumenthal as saying.
Rebecca Ayer, a spokeswoman for the U.S. Department of Health and Human Services (HHS), told the Post that HHS would defend its actions in court. "The department followed appropriate procedures to put the regulation in place, and the regulation is fully supported by law," the newspaper quotes her as saying.
FDA Lax in Review of High-Risk Medical Devices: Report
From 2003 to 2007, the U.S. Food and Drug Administration approved some 228 medical devices -- some of them for sensitive uses -- without a full scale review, a Government Accountability Office (GAO) report said Thursday.
The report found that two dozen distinct types of devices -- such as metal hip joints, external defibrillators to assist heart attack victims, and electrodes for pacemakers -- were approved without close scrutiny, the Associated Press said.
Some devices approved have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. "It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk," Peter Lurie, deputy director of Public Citizen's health research group, told the news service.
While the report did not look into whether any patients were harmed as a result of the approvals, it does highlight calls for closer scrutiny of the FDA's medical device approval process, which has been subject to charges that scientists were pressured to OK some medical machinery against their professional judgment, the AP said.
In 1976, Congress established a three-tiered classification system for these devices, which include everything from tongue depressors to silicone breast implants to pacemakers, the AP said. Low-risk devices such as bandages could be cleared by notifying the FDA before going to market, while high-risk devices such as pacemakers would face tighter scrutiny. Manufacturers were required to provide evidence of safety and effectiveness, but subsequent gains in technology have increased not only the number of devices coming to market but also the number of upgraded products coming up for review, the news service said.
"In general, we agree with the conclusions and recommendations," FDA spokeswoman Karen Riley said. "We are considering legal and procedural options to accomplish this objective."
Health Care Reform Near Top of Public's Wish List for 2009