Health Headlines - April 7

Silicone Implants Linked to High Platinum Levels in Women: Study

High and potentially dangerous levels of the metal platinum were found in the bodies of women who'd had silicone gel breast implants for many years, according to research published this week in the journal Analytical Chemistry, published by the American Chemical Society.

The findings were released just as the U.S. Food and Drug Administration appears poised to allow silicone implants back on the market, the Washington Post reported.

Platinum is used in the implants as a catalyst to transform the silicone into a gel-like form.

The study found high levels of platinum salts in the hair, urine and breast milk of 16 women who'd had silicone gel implants for an average of 14 years. The researchers concluded that the platinum in the women's bodies was in a form that made it a potential source of toxic or severe allergic reactions.

The FDA is "carefully reviewing the article, and we don't know how long that will take," spokeswoman Susan Cruzan told the Post.

Last year, the agency deemed two applications to sell silicone gel implants to be "approvable," but the FDA has not yet given final approval to those applications.

"This is the first time the research has found platinum in this possibly harmful form in implanted women," Marlene Keeling, president of Chemically Associated Neurological Disorders, told the Post. The Houston nonprofit group helped fund the research, and Keeling has filed a citizen's petition with the FDA requesting that the two applications be delayed until further research is conducted into the platinum issue.

OTC Diet Drug Moves Closer to Market

An over-the-counter (OTC) version of the prescription diet drug Xenical received an "approvable" letter from the U.S. Food and Drug Administration, drug company GlaxoSmithKline said Friday.

The company is confident that the OTC product -- with the proposed name Alli -- could be in U.S. drugstores later this year, following further discussions with the FDA, Steven L. Burton, vice president of weight control products for Glaxo's consumer health division, told The New York Times.

That would make this drug the first FDA-approved weight-loss product sold without a doctor's prescription. The drug works by blocking fat absorption.

In January, an FDA advisory panel voted 11 to 3 that the lower-dose version of Xenical could be sold without a prescription. The OTC version would be cheaper than Xenical, which costs about $2 a pill, The Times reported.

Clinical studies of the OTC version found that people who used the drug lost an average of five to six additional pounds over six months, compared to people on similar diets who did not take the drug.

Norovirus Outbreak Kills 2 at Washington Retirement Home

Two people have died and more than 40 residents and staff at a Vancouver, Wash.-retirement home are sick after an outbreak of norovirus.

One patient died late Wednesday and the other Thursday morning.

The 180 residents of the Cascade Inn have been asked to remain in their rooms and their friends and families are being urged not to visit them. All social activities have been cancelled, the Associated Press reported.

Norovirus is common and includes symptoms such as diarrhea, nausea and vomiting.

Healthcare Worker Shortages Threaten 57 Countries: WHO

Many countries are vulnerable to disease outbreaks, such as a potential bird flu pandemic, because they lack enough doctors, nurses and midwives, the World Health Organization warns in its annual report released Friday.

The report estimates that 57 nations have "critical shortages" of healthcare workers and require another 2.4 million people to deal with health emergencies, Bloomberg news reported. Countries in sub-Saharan Africa and Southeast Asia have the worst healthcare worker shortages.

The report noted that health crisis funding is adequate but that "many national health systems are weak, unresponsive, inequitable, even unsafe."

Bird flu, which has killed more than 100 people worldwide since 2003, "is indicative of a more fundamental need for effective international capacity to marshal the requisite human resources" during disease outbreaks.

FDA to Increase Monitoring of Heart Devices

The U.S. Food and Drug Administration plans to strengthen its oversight of heart devices such as implantable defibrillators, a move partly prompted by criticism of the agency's past monitoring of such devices.

For the first time, the FDA will appoint outside medical experts to help the agency review the safety of units already on the market, The New York Times reported. The FDA has traditionally used advisory panels of experts to help the agency decide whether to approve the sale of new devices.

The experts reviewing heart devices currently being sold will assist the FDA in interpreting data from device manufacturers and will advise the agency on how best to respond to recalls and other problems, the Times reported.

The FDA's decision to boost its monitoring of heart devices is partly due to criticism about how it has done the job in the past, acknowledged Dr. Daniel G. Schultz, director of the agency's Center for Devices and Radiological Health.

The issue of heart-device safety received widespread attention last year when it was revealed that the Guidant Corporation decided not to alert doctors and patients about life-threatening defects in some models of implantable heart defibrillators.

FDA Plans Review of Wireless Phone Safety

A newly published analysis that suggests a link between long-term cell and wireless phone use and brain cancer is being met with skepticism by the U.S. Food and Drug Administration. Even so, the FDA said it plans to hold a meeting to evaluate potential health risks associated with cordless and cell phones.

The analysis, which used data from two Swedish studies in 2003 and 2005, concluded that more than 10 years of wireless phone use was associated with an increased risk of brain tumors.

The FDA said the new findings were inconsistent with earlier studies and were difficult to interpret, Bloomberg news reported.

The planned meeting will "evaluate research conducted to date and identify gaps in knowledge that warrant additional research," the FDA said in a statement on its Web site. It did not specify a date for the meeting.