News January 2005 Issue

In the News: 01/05

FDA Buckles To Critics, Taps Outside Agency To Review Drug Safety System

In the wake of growing complaints that the Food and Drug Administration has dragged its feet in warning about medication safety, the agency has announced that it will hire the Institute of Medicine, the nation’s top scientific review board, to determine the efficacy of its drug safety program. Following the Vioxx recall in September, the British medical journal The Lancet charged that Merck, the maker of Vioxx, was well aware four years ago of the possible heart-attack risk that the drug posed. Said Lancet editor Dr. Richard Horton, “This points to astonishing failures in Merck’s internal systems of postmarketing surveillance, as well as to lethal weaknesses in the FDA’s regulatory oversight.” The message apparently hit home. The FDA has promised to submit its procedures for outside review. Reacting to charges that it ignored the findings of its own drug safety officials, the FDA will begin an internal appeals process. The agency said it would also step up the search for a new director of its Office of Drug Safety, a post which has been vacant for nearly a year. Last, it promises before the first of the year to draft and distribute guidelines to assist drug manufacturers in managing inherent product risks.

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Artificial Spinal Disc Gets Official Nod

The Food and Drug Administration has approved the first-ever artificial disc for spine arthroplasty. The medical community has greeted the SB Charité III, developed by DePuy/Johnson & Johnson, as a welcome alternative to spinal fusion for people with chronic lower back pain. The device, which consists of a high-density polyethylene core sandwiched between two metal plates, is considered preferable to spinal fusion, in which metal plates or rods are inserted into the bones of the spine above and below a defective disc, then fused by inserting bone material to hold them in place. The downside of spinal fusion has been added pressure to the discs surrounding the fused segment, which often leads to further back surgery.

In a two-year study leading up to the FDA’s approval, patients implanted with the disc improved more quickly than those who had undergone spinal fusion, they scored higher in pain scores, they had greater freedom of movement, and they were discharged earlier from the hospital. Candidates for the procedure should be between 18 and 60 years of age, have a diagnosis of serious degenerative disc disease, and have had at least six months of prior conservative treatment. The Charité is not designed for people with previous spinal fusion surgery, who suffer from osteoporosis or other metabolic bone disease, or who have a history of chronic steroid use. Pregnancy or morbid obesity also rule out a candidate.

The Charité has sparked studies on a number of other artificial discs, with several devices from U.S. and overseas companies now in the development stage. The Charité has been used as a spinal implant in Europe since the mid-1980s, when it was first developed in Berlin

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Double-Jointed? If In The Hand, You May Be Spared OA

Although double-jointed people have long been believed to be particularly susceptible to osteoarthritis, a study published in Arthritis & Rheumatism found that hypermobility (double-jointedness) in the hands may actually protect hand joints against the development of OA. The study, one of the few to focus on the link between double-jointedness and OA of the hand, sampled a large population—1,043 individuals, age 40 to 96, with present or past hypermobility. Those with extremely flexible joints showed evidence of lower odds of OA in the PIP joint, the joint in the middle of the finger that is most closely associated with gripping and pinching strength. Results of the study, say the researchers, have important implications for string players, computer keyboardists, and others who routinely perform repetitive movements with stress to the finger joints.