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Will FDA regulations and pre-emption silence Vytorin victims?

Many Americans assume that the Food and Drug Administration adequately tests new drugs for safety before they go on the market and become available to the general population. If your doctor prescribes a new drug to help you lower your cholesterol or help you quit smoking, then that drug must be safe, right? The answer is a surprising, and disconcerting, NO. Trials for new prescription drugs that are vying for a place in the market focus on efficacy rather than safety. If pre-market clinical tests find a drug to be effective and that drug does not appear to be unsafe, ... Read More

Physical therapist charged with unlicensed practice, forgery

Brent P. Dellarma was a practicing physical therapist employed by Genesis Rehabilitation at Sandy River Center for Health Care in Farmington, Maine, for nearly a year between 2007 and 2008, until management suspected something was awry with his paperwork. The man had worked as a physical therapy assistant and then as a physical therapist at Sandy River Center. He had documentation filed with the Board of Examiners in Physical Therapy in the state’s Department of Professional and Financial regulation. However, an investigation found that the paperwork Dellarma filed was bogus and that he had misrepresented his qualifications, according to the ... Read More

Lawmaker questions FDA investigation of heparin scandal

A Washington lawmaker is raising concerns about the FDA’s handling of the tainted heparin scandal earlier this year, claiming that the agency misrepresented deaths tied to the product and didn’t thoroughly investigate the situation, according to CNN Money. Batches of heparin were recalled by the FDA earlier this year after lots manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate. The investigation and subsequent recall followed reports of more than 80 deaths and thousands more illnesses of patients who had received doses of heparin from the lots in question. Rep. Joe Barton, R-Texas, last week pointed ... Read More

Researchers find new method to detect contaminant in heparin

Researchers have come up with an easy and effective method to detect contaminates in heparin, according to the Times of the Internet. A research team led from the University of Michigan and led by Mark Meyerhoff uses potentiometric polyanion sensors to detect heparin in blood. These sensors also can be used to distinguish pure heparin from heparin contaminated with small quantities of oversulfated chondroitin sulfate. This new method is easier and less expensive than analytical methods used previously, such as nuclear magnetic resonance and capillary electrophoresis. Meyerhoff and his team detailed the research in the journal of Analytical Chemistry. Oversulfated ... Read More

Iowa lawmakers receive money from nursing home lobby group

Iowa lawmakers who complain about state inspectors being overly aggressive in their surveys of nursing homes have been receiving thousands of dollars in contributions from nursing home officials, according to the Chicago Tribune. One such contributor is Tim Boyle, owner of Friendship Manor in Grinnell, Iowa, and president of the board of the Iowa Health Care Association, a lobby group that represents nursing homes. Friendship Manor made news recently after it was fined $112,650 – one of the largest fines ever imposed against an Iowa nursing home. The home was charged with neglecting an 89-year-old woman who died while in ... Read More

Coroner questions number of deaths at assisted living facilities

Richland, S.C., County Coroner Gary Watts is raising questions about the quality of care at Midlands-area assisted living homes, according to The State. Watts referred to three deaths in the past two years in the area. One of those deaths, which Watts is investigating, occurred after an unqualified staffer gave a 50-year-old man an overdose of insulin that ultimately killed him. Assisted living facilities differ from nursing homes in that they provide less skilled nursing care and in general have fewer state and federal regulations under which they must operate. Watts is questioning whether there are enough state inspectors to ... Read More

Study compares brands of heparin given to ICU patients

An intensive care doctor at St. Joseph’s Healthcare in Hamilton, Ontario, is questioning hospitals’ choice of using a newer heparin drug over another, raising concern that the choice is made not based on the quality of the drug but rather better marketing, according to The Hamilton Spectator. Dr. Deborah Cook, academic chair of critical care medicine at St. Joseph’s, is leading a study to determine whether the newer and more expensive version of the blood thinner is more effective for patients in intensive care than the older one. Fifty-six ICUs in Canada, Australia, Brazil, U.S. and Saudi Arabia will participate ... Read More

Man wanders from nursing home, killed by passing train

George King Sr., of Charleston, W.V., lived in Heartland of Charleston nursing home. He had Alzheimer’s Disease, and like many individuals suffering from the memory-loss disorder, King was prone to wander. Many nursing homes who care for patients with Alzheimer’s have practices in place to ensure patients who wander stay within the nursing home wing where they live. But few practices are foolproof. Late last month, King wandered from his nursing home. That evening around 8 p.m., staff noticed he was missing and notified police. After hours of searching for the 73-year-old man, police got a report of a pedestrian ... Read More

Hot flashes, sweats from anti-cancer drugs may be good sign

Women who take breast cancer drugs Arimidex or generic tamoxifen and suffer with menopausal symptoms such as hot flashes, night sweats or painful joints may be less likely to have a reoccurrence of their cancer tumors, according to Reuters. Researchers found that women who took the breast cancer drugs were 30 percent less likely to have their cancer return over the next nine years. The drugs essentially starve potential cancers of estrogen, which can cause menopause-like symptoms in the women who take them. While the side effects may be discouraging, they may also be showing how well the treatment is ... Read More

FDA opens first foreign office in Beijing this week

Following up on a story we brought you last month about the FDA setting up offices on foreign soil to provide guidance on U.S. food and drug quality standards, the FDA announced today that the first three of its offices will open this week in China, according to the Associated Press. The move is part of the agency’s effort to place more than 60 food and drug regulators worldwide over the next year. The offices replace the FDA’s previous practice of sending staffers on individual assignments to inspect foreign facilities. The agency’s Beijing office, which opens Wednesday, will be the ... Read More