Federal regulators are dropping plans to tightly control a procedure that is becoming increasingly popular for treating people stricken by life-threatening infections of the digestive system. The Food and Drug Administration says the agency will exercise enforcement discretion and no longer require doctors to get the agency's approval before using "fecal microbiota for transplantation." The procedure is being used to treat people suffering from infection with the bacterium Clostridium difficile, or C. diff. These infections cause inflammation of the colon and severe, sometimes life-threatening diarrhea. They can be extremely difficult to treat and are becoming more common. About 14,000 Americans die from C. diff every year, according to the federal Centers for Disease Control and Prevention.
The newest patient for a former Philadelphia surgeon is the City of Rome. Last week, Ignazio Marino won 64 percent of the votes in the Italian capital's mayoral race. He resectioned Rome's ties to incumbent Mayor Gianni Alemanno, promising to suture the Eternal City with a more transparent government. Marino, 58, worked extensively in Philadelphia before his foray into politics. From 2002 to 2006, he did nearly 200 organ transplants at Thomas Jefferson University Hospital. In his last year, he headed the transplant division.
Researchers have long argued that a heralded spinal treatment sold by the nation's largest device maker, Medtronic, was no better than an older one and possibly more risky. Now with the company?s help, they have the proof. The evidence, published on Monday in a medical journal, is the first fruit of a movement aimed at helping doctors and patients make better treatment choices. Its goal is to have companies make clinical data about a drug or a medical device available to a wide range of researchers, not just a few handpicked ones.
A former top Obama administration health official, Don Berwick, formally announced Monday that he is running for governor of Massachusetts. Berwick, a Democrat, is a physician and health policy expert who ran the Centers for Medicare & Medicaid Services for President Barack Obama. But amid the heated politics of health reform, Republicans refused to confirm him to the position atop CMS. They said his comments praising Britain's health care system suggested he favored rationing, an interpretation he disputed.
A divided U.S. Supreme Court ruled Monday that some "pay-for-delay" settlements between drug companies and their competitors violate antitrust laws. The 5-3 decision, a limited victory for the Obama administration, paves the way for federal regulators to challenge such deals in court. Pay-for-delay settlements typically occur when a company develops and patents a new drug to be released into the marketplace. Competitors that wish to introduce a generic version often challenge the patent. Rather than fight the challenge, patent-holding drugmakers have found it more lucrative to simply pay the competitor to keep generics off the market. The two firms then share monopoly profits that are, in some cases, much higher than open competition would yield, critics charge.
NATIONAL HARBOR, MD – Farzad Mostashari, MD, the national coordinator for healthcare IT, asserted today there would be no extension of the deadline for switching from the ICD-9 medical coding system to ICD-10. The deadline for conversion would remain Oct. 1, 2014, Mostashari said in a keynote delivered this morning at the HIMSS Media ICD-10 Forum in National Harbor, Md. "There are no plans for any more extensions," he told attendees, repeating it twice, for emphasis. The current extension, from Oct. 1, 2013 to Oct. 1, 2014 was partly due to looking at the incremental changes needed in reforming healthcare, and realizing that "sometimes, extensions are needed," Mostashari said.