Health Highlights: March 29, 2012

Metal-on-Metal Hip Replacements Focus of FDA Meeting 'Book of Cancer Knowledge' Will Advance Research Report Slams Approval Process for Medical Devices

HealthDay News

HealthDay News

Updated on March 29, 2012

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Metal-on-Metal Hip Replacements Focus of FDA Meeting

The risks and benefits of metal-on-metal hip replacements will be discussed at a two-day meeting of a U.S. Food and Drug Administration expert advisory panel meeting.

The June 27-28 meeting is being held to gather input from experts and patients. The FDA is currently considering whether to require more rigorous testing and pre-market review requirements for this type of hip replacement.

In May 2011, the FDA told manufacturers of metal-on-metal hip systems to conduct post-market surveillance studies to collect more safety data on the systems, including data related to metal ion concentrations in the bloodstream.

The FDA's concerns about the safety of the hip systems were heightened by a recent study that found an increasing failure rate in models with large-diameter femoral heads.

"We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers," Dr. William Maisel, deputy director of science at FDA's Center for Devices and Radiological Health, said in an agency news release.


'Book of Cancer Knowledge' Will Advance Research

The publication of the first volume of a "book of cancer knowledge" will help speed up efforts to develop new cancer drugs, according to the international team of scientists involved in the project.

The volume details how hundreds of different types of cancer cells respond to anti-cancer agents. The researchers said this data is a step towards tailoring cancer drugs to the genetic profiles of individual patients, BBC News reported.

The data is contained in two papers published in the journal Nature.

In total, the researcher screened about 1,100 cancer cell lines with 154 drugs in order to identify genetic signatures linked with drug sensitivity, BBC News reported.


Report Slams Approval Process for Medical Devices

U.S. regulators approved the Lap-Band weight loss device with little or no advance safety testing, according to a report issued Wednesday by Consumer Reports magazine.

It said the Food and Drug Administration's approval of the device was based on a clinical study of only 299 patients. Of those patients, 25 percent had their Lab-Bands removed before the end of the 3-year study due to complications or failure to lose enough weight.

"Imagine if a car had a recall rate that high. Consumers and regulators would be up in arms," said John Santa, director of the Consumer Reports Health Ratings Center, the Los Angeles Times reported.

Allergan Inc. has sold more than 650,000 Lap-Bands worldwide. Last year, the FDA approved the Lap-Band for use in less-obese patients. The approval was based on a study that showed 80 percent of patients who used the device lost at least 30 percent of their excess weight and kept it off for one year.

The Lap-Band "has been approved internationally since 1993, and as such has a 19-year safety and effectiveness record," Allergan spokeswoman Naziah Lasi-Tejani told the Times.

Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.

Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the University of California, San Francisco. She said it's those lenient federal standards that are the problem.

"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."

In a report issued last year, the Institute for Medicine said the current approval process for medical devices is flawed and called on the FDA to develop new regulations to ensure patient safety.

About 17 percent of American adults have an implanted medical device, according to a recent survey by the Consumer Reports National Research Center.



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