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.
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‘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.
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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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