A couple of implantable devices recently received new scrutiny with negative results. Medtronic issued a “medical device correction” about possible diminished battery life of its infusion pump, the SynchroMed II. The device is surgically implanted to deliver painkilling medication. According to About Lawsuits.com, of 140,000 implants worldwide, 55 were reported to have reduced battery performance…..
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Prescription Medicine: The Argument for Letting Generics Look Like the Brand Name Original
You fill a prescription with a brand-name medication. The pills are light-blue ovals that come in a plastic bottle. When the generic version becomes available, your insurance company insists that you purchase only that, and your doctor agrees. This time, the pills are round, white and come in a carboard blister pack. If the medicine….
Continue ReadingThe Going Rate for Compromising A Surgeon’s Principles and Patient Safety: $16 Million
That’s the sellout price for a spine surgeon. Give or take a few million. Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine….
Continue ReadingOnce Again, the FDA and Avastin Are Doing the Hokey Pokey
A couple of months ago we gave a shout-out to a physician who had written a commentary about Genentech’s efforts to have the FDA bless the use of its drug Avastin for treatment of certain breast cancers. He had objected to the use of patient testimonials as compelling evidence to support such appeals because they’re….
Continue ReadingSupreme Court Strikes Two Blows Against Patient Safety
On one side you have what Justice Hugo Black evocatively called “organized money” — the corporate interests dressed, in this case, in the garb of drug manufacturers: White coats with hundred dollar bills stuffed in the pockets. On the other side: Regular folks: consumers, patients, and individual doctors. Who wins in the U.S. Supreme Court?….
Continue ReadingThe feds get serious about table-saw safety
The contest between flesh and bone versus the spinning blade of a table saw is always a rout. The 40,000 Americans who land in emergency rooms every year with such injuries are testimony that table saws are the country’s most dangerous commonly used power tool. This spring, the issue of table-saw safety has found a….
Continue ReadingDiabetes drug Avandia will be gone from retail shelves by November
Diabetes medication Avandia will be pulled from pharmacy shelves in November because it poses a major risk of heart attack, the Food and Drug Administration has announced. Under a new program effective Nov. 18, 2011, only certified physicians will be allowed to prescribe the drug, and then only to patients who’ve been informed of the….
Continue ReadingIs Grandfathering of Medical Devices Bad for Your Health?
The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it’s similar to something already on the market, according to a recently published study. Of the 113 devices recalled from 2005 to 2009 because….
Continue ReadingPatients ask judge to bar equipment maker from selling to back surgeon
Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein. According to the complaint, Mylotec allegedly….
Continue ReadingFDA sets new limits for prescription combination products with acetaminophen
To avoid the risk of “severe liver injury,” the Food and Drug Administration (FDA) wants manufacturers of prescription combination products containing acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. Manufacturers also will have to update warning labels on these products to alert consumers about….
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