By MEGAN MCARDLE I found it very odd to see Paul Krugman complaining that “patients are not consumers” as if “consumer” were some sort of horrible, low-status role that should never taint the sacred realm of health care. In my economics classes, “consumer” was not a value judgement; it was a descriptor. A consumer is…
By TURNA RAY By integrating comparative effectiveness research in its review processes, the US Food and Drug Administration is hoping to gain more insight into the safety and efficacy of drugs in subpopulations of patients and advance personalized medicine. In a report FDA released this week outlining its strategic priorities for the next five years,…
By JENNIFER CORBETT DOOREN For developers of new drugs and treatments, one of the toughest hurdles has nothing to do with medicine. It’s recruiting patients for clinical trials. And when it comes to recruiting minority patients, the challenge is even greater. New approaches are being tried that can dramatically speed up the recruiting process and…
By DERRICK GINGERY Sponsors may have negotiated a four-month reprieve for the required pre-submission meeting in the proposed new application review system expected to be implemented with PDUFA V. FDA has agreed the pre-submission meeting does not have to be a minimum of six months before the application is filed. At industry’s prodding, the agency…
By WILL DUNHAM Elizabeth Edwards, a best-selling author and the driving force behind her husband John Edwards’s political career before it was destroyed by his infidelity, died on Tuesday at age 61. Edwards died of cancer on Tuesday morning at her home in Chapel Hill, North Carolina surrounded by her family, they said in a…
By GREGORY TWACHTMAN With members of the Patient-Centered Outcomes Research Institute’s Methodology Committee expected to be named by early in 2011, one area where they could start to improve comparative effectiveness research is in providing solid guidance for conducting observational studies. “We need more guidance about when observational research is adequate for the task,” Vanderbilt…
By ANDREW POLLACK, For the last decade cancer drug developers have tried to jam the accelerators that cause tumors to grow. Now they want to block the fuel line. Cancer cells, because of their rapid growth, have a voracious appetite for glucose, the main nutrient used to generate energy. And tumors often use glucose differently…
By ALICIA MUNDY Medicare officials are debating whether the agency should cover a new prostate-cancer treatment that costs $93,000 per patient, sparking criticism from Dendreon Corp. investors and patient advocacy groups who earlier pushed the Food and Drug Administration to approve the novel therapy. A Medicare advisory panel is set to meet Wednesday to discuss…
By LISA RICHWINE Lawmakers should think carefully before cutting taxpayer funding for the Food and Drug Administration in an effort to reduce government spending, the agency’s chief said on Tuesday. Republicans, who will take over the U.S. House of Representatives in January, campaigned on promises to cut funding for federal government operations, a plan that…
By MELINDA BECK The grim statistics have become a rallying point for activist groups: Some 72,000 Americans aged 15 to 39 are diagnosed with cancer every year, and more than 10,000 die. They make up less than 10% of all cancer patients, but survival rates for teens and young adults have barely budged since 1975,…
