A need for reorganization of the Food and Drug Administration.

The associate director for science and medicine in the Office of Drug Safety at the Food and Drug Administration (FDA), Dr. David Graham, reported that the FDA was incapable of protecting Americans from unsafe drugs. In testimony to the Senate Finance Committee, he stated that the FDA has let the American people down and betrayed public trust. Drastic changes and measures within the FDA must be made to ensure the safety of American consumers of drugs, products, and medical devices. Efforts such as the introduction of the Grassley-Dodd Bill, allowing the FDA to order immediate drug recall or increased risk warnings, followed by the FDA Safety Act of 2007, are still not enough to ensure the safety and efficacy of drugs, biological products, and medical devices that the American public use every day. In this report, we describe past and present efforts by congressional leaders, FDA representatives, and American citizens to effect changes within the FDA in order to protect America from unsafe drugs and medical devices. We describe our own struggles in passing a citizen’s petition to ban cornstarch in medical gloves, and the lack of response and responsibility that the FDA has displayed.

Revolutionary advances in the diagnosis of vitamin D deficiency.

Vitamin D deficiency has bee associated with bone diseases, cardiovascular diseases, cancer, and multiple sclerosis. Recent clinical studies have pointed out that these diseases could be prevented by either adequate sun exposure or oral vitamin D3 supplementation. In an effort to prevent these illnesses, emergency physicians and other clinicians must be aware of technological advances in the measurement of serum concentrations of 25-hydroxyvitamin D. Realizing the importance of diagnosing vitamin D deficiency, we reviewed the following advanced diagnostic techniques: liquid chromatography tandem mass spectrometry, radioimmunoassay, and DiaSorin's immunochemiluminometric automated analyzer LIASION®. On the basis of this review, we have found that each of these diagnostic tests has documented limitations, and therefore we recommend an international standardization of these assays to accurately diagnose vitamin D deficiency.

A case report: femoral fracture in a multiple sclerosis patient with vitamin d deficiency--a preventable injury.

In this report, we describe the management of a multiple sclerosis patient with a femoral fracture who had severe vitamin D deficiency. After the patient's preoperative laboratory studies revealed a normal platelet count, the orthopedic surgeon performed an intramedullary rod fixation on the patient's left femoral fracture. After the surgery, the diagnosis of vitamin D deficiency was made by measuring the circulating serum concentration of 25-dihydroxyvita-min D (25(OH)D) via Disorin's Vitamin D immunochemiluminometric assay LIASION by LabCorp (Laboratory Corporation of America). The patient's postoperative management included the oral administration of 4000 IU of vitamin D3 in a gel-cap suspension that resulted in an elevation of the blood serum concentration of 25(OH)D to an optimal concentration of >80 nmol/L (32 ng/ml).