The Food and Drug Administration approved a new hepatitis C drug from Vertex Pharmaceuticals Inc., marking the second such drug to be approved by the agency in less than two weeks after years without new treatments for the viral liver disease. Vertex's drug, called Incivek, joins Merck & Co.'s Victrelis. Both drugs have shown success in increasing the cure rates of the liver disease when added to current treatments, although Incivek has shown stronger effectiveness, simpler dosing and has a broader range of data. Although the drugs work in similar ways, it is difficult to directly compare different clinical studies, and no head-to-head trials of the two have been conducted. Hepatitis C is caused by a virus and can lead to liver failure, liver cancer and, in some cases, the need for a transplant. About 3.2 million Americans have the disease.
The Food and Drug Administration has told companies that make "metal on metal" artificial hips to take a closer look at how patients fare after their hip replacement surgery. The request involves about 20 manufacturers and comes in response to an increasing number of consumer complaints about the implants, along with last year's voluntary recall of an all-metal model made by DePuy Orthopedics, a division of Johnson & Johnson. Company officials say the company is paying for "reasonable and customary costs of monitoring" the recalled product, including the cost of surgery, if needed, to replace damaged artificial hips. There are many varieties of hip implants and numerous materials are used in their construction, including ceramics, plastics and metals. In the case of all metal implants, both the ball and socket of the artificial joint are made of metal. When those two parts rub together during normal wear and tear, minuscule particles of metal can shed and be released into surrounding tissue and even into the bloodstream. This causes severe damage to local tissue, including necrosis, infection and allergic reactions.
If you have a faulty heart valve and decide to get it replaced, a surgeon will implant an artificial one that has undergone rigorous examination by the Food and Drug Administration. But if you choose the option recommended for most patients -- repairing your valve with an annuloplasty ring -- there are no such guarantees, even though both devices are permanently stitched into the heart and considered life-sustaining. That's because, a decade ago, the FDA downgraded the regulatory class of the rings. Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies. "It's absolutely ridiculous. How could something that is permanently implanted in the heart be regulated this way?" said Diana Zuckerman, president of the National Research Center for Women & Families.
Hospital emergency rooms, particularly those serving the urban poor, are closing at an alarming rate even as emergency visits are rising, according to a report published on Tuesday. Urban and suburban areas have lost a quarter of their hospital emergency departments over the last 20 years, according to the study, in The Journal of the American Medical Association. In 1990, there were 2,446 hospitals with emergency departments in nonrural areas. That number dropped to 1,779 in 2009, even as the total number of emergency room visits nationwide increased by roughly 35%. Emergency departments were most likely to have closed if they served large numbers of the poor, were at commercially operated hospitals, were in hospitals with skimpy profit margins or operated in highly competitive markets, the researchers found.
Patients would have access to detailed histories of Illinois doctors ? including whether the physician has been fired, convicted of a crime or made a medical malpractice payment in the past five years ? under legislation headed to the governor's desk. After being thwarted by the doctors' lobby for more than a decade, the Patients' Right to Know Act passed out of the General Assembly as a stand-alone bill Tuesday for the first time, with supporters crediting a Tribune series showing that sex-offending physicians, even those convicted of crimes, have continued to practice. The bill passed unopposed in the House and Senate. Gov. Pat Quinn signaled he would sign it.
A little-known device is shaking conventional wisdom for reviving people who suffer sudden cardiac arrest: People may be able to go much longer without a pulse than the 20 minutes previously believed. The capnograph, which measures carbon dioxide being expelled from the mouth of the patient, can tell rescuers when further efforts at cardiopulmonary resuscitation, or CPR, are futile or whether they should be continued. It is the latest effort that cardiology experts and emergency teams are devising that aim to improve a patient's odds. The American Heart Association recently revised its guidelines for first responders, with particular emphasis on initiating hard, rapid chest compressions to keep the stricken victim's blood circulating. Rescue squads increasingly are chilling victims of cardiac arrest with ice packs and other cooling approaches, a technique known as hypothermia, in order to protect the brain from injury when blood flow is restored.