The Federal Trade Commission has issued a public advisory notice urging consumers to be cautious when purchasing at-home genetic tests. Citing statements and studies from FDA and the Centers for Disease Control, the FTC says that some of the tests lack scientific validity and others are only meaningful in the context of a full medical evaluation. In particular, the commission says, people should be wary of claims of measuring the risk of developing a particular disease and the likelihood of being able to withstand environmental exposures. While it is probably not fair to characterize all such products as snake oil, it is also prudent to put the results from these tests in their proper context. That means consulting your doctor.
It seems that the campaign by device companies and hospitals to convince CMS to revise its controversial reimbursement plan are paying off. The Hill reports that at least 245 members of Congress have signed letters requesting that CMS delay implementation of the changes, in addition to similar requests to CMS made by AdvaMed and MDMA.
CMS administrator Mark McClellan said he had heard the complaints loud and clear, and that he had taken them to heart. Since the final version of the regulation could be issued as soon as next Tuesday, industry may soon see whether he really did.
People with carotid stenosis may suffer from depression associated with the condition. New research reported in the journal Radiology shows promising results.
Wolfgang Mlekusch, MD, specialist of clinical angiology and internal medicine at Vienna General Hospital and Medical School in Vienna, Austria, conducted the experiment.
His team studied 143 patients with carotid stenosis. Those with a high level of carotid stenosis (greater than 80%) exhibited substantial depressive symptoms compared with controls. Another 33.6% of the patients with carotid stenosis had depressive symptoms, compared with 16.7% of the control patients.
Four weeks after carotid stenting, only 9.8% of the patients with carotid stenosis exhibited depressive symptoms.
Mlekusch believes that stenting had an advantage over other surgical treatment for stenosis. He cautions that carotid stenting may be able to reduce symptoms associated with vascular depression, but it is not a cure or treatment for major depression.
Several potentially significant products have received FDA approval this week:
Medtronic won clearance for its Guardian REAL-Time continuous glucose monitoring system. It will alert diabetes patients to high or low glucose levels. Unlike existing technologies, it can reveal day-to-day fluctuations based on more than one data point.
Akzo Nobel’s Organon USA Inc. unit received approval for a contraceptive rod that can prevent pregnancy for up to three years. The Implanon works by releasing a slow stream of progestin.
Abbott has won the right to market the first fully automated confirmatory and screening test for Hepatitis B Surface Antigen. It will be used to test those donating blood, blood components, and organs.
And St. Jude Medical got approval for two defibrillators, branded under the Atlas II name, geared to patients whose hearts are especially hard to defibrillate. One is an implantable cardioverter-defibrillator and the other is a cardiac resynchronization therapy defibrillator.
Isn’t it nice to see the agency so productive?
Industry giant Medtronic Inc. yesterday agreed to pay the federal government $40 million to settle accusations that its spinal unit, Medtronic Sofamor Danek, paid kickbacks to doctors to induce them to use its products, the New York Times reports. The company did not admit any wrongdoing but settled in order to avoid protracted litigation. The Justice Department said the kickbacks took the form of “sham consulting agreements, sham royalty agreements, and lavish trips to desirable locations.” Medtronic has agreed to create a database that tracks transactions not related to device sales, and to have the data reviewed by internal and external panels. Sounds like something other firms should be doing, too.
The rise in joint-replacement surgeries in the United States can be attributed in part to increased obesity, reports the Boston Globe. Boston-area hospitals estimate that, contrary to the perception that physically active people are more likely to need joint replacement, one-half to two-thirds of patients who undergo knee or hip replacement surgery are overweight or obese. These patients face higher risks of surgical complications. Unfortunately the obesity trend is getting worse, so there will be no shortage of demand for artificial joints in the coming years.
An implantable telescope that would serve as a bionic eye has received a setback in development after FDA’s ophthalmic devices panel voted 10-3 against approval, the Associated Press reports. The panel cited safety concerns in its recommendation against approval of the Implantable Miniature Telescope from VisionCare Ophthalmic Technologies Inc. (Saratoga, CA). The device is targeted at patients with age-related macular degeneration. FDA is not required to follow the advice of its panels, but usually does.
FDA has canceled the Blood Products Advisory Committee meeting scheduled for today because of calls for it to be made open to the public. At issue, reports the Boston Globe, is the blood substitute made by Biopure Corp. (Cambridge, MA), the trial of which calls for it to be given to trauma patients in ambulances without their consent. The outcry over the protocol has led Public Citizen to sue FDA to make the panel meeting public. FDA has placed Biopure’s application on hold. The meeting has been postponed until FDA, the company, and the Navy (which is involved in the product’s development) can figure out a way to hold a public meeting without compromising trade secrets. Such is the way of democracy.
Conshohocken, PA-based Viasys Healthcare, Inc., named one of the 50 Companies to Watch in MD&DI’s June issue, has acquired Tiara Medical Systems Inc., which specializes in sleep therapy, the company announced in a release available on devicelink.com. Viasys is a market leader in sleep diagnostics and the Tiara acquisition gives it a foothold in sleep therapeutics. Tiara makes Continuous Positive Airway Pressure masks, which treat sleep apnea, and related products. The purchase price is about $24.3 million. Viasys was also in the news earlier this year when it won a Medical Design Excellence Award.
FDA announced that it met last week with Boston Scientific to discuss its latest recall plan and that it endorses the steps the company has taken so far. The firm has asked hospitals to remove certain models of pacemakers and implantable cardioverter-defibrillators (developed by Guidant before Boston Scientific bought it out) and asked doctors to perform follow-up exams on patients who might be affected. The problem is linked to certain lots of a supplier’s low-voltage capacitor, which controls how the device holds its power supply. Five malfunctions (but no deaths so far) have been reported in the 27,700 patients in whom the affected devices were implanted. Boston Scientific is doing the right thing by being forthcoming about the problem, which was not the case with Guidant before it was sold.
