rhIGF-1 (Myotripin®Chiron and Cephalon), a recomninant growth factor protein,is approvable for the treatment of amyotrophic lateral sclerosis [Lou Gehrig's Disease].Last year a FDA advisory committee recommended against approval after two clinical trialsdemonstrated conflicting results. The companies reevaluated the data and subsequentlysubmitted a different analysis of the same data.

The FDA has granted marketing approval for basiliximab (Simulect®/Novartis)for the prevention of acute rejection episodes in kidney transplant patients. The compoundis a monoclonal antibody that is administered in two doses. The first dose is given withcyclosporine and corticosteroids on the day of transplant with a second dose of the drugson the fourt day. Clinical trials demonstrated a one-third reduction in acute rejection.

Approvable status has been granted for citalopram (Celxa®/Forest), a selectiveserotonin reuptake inhibitor, for the treatment of depression. It will be co-marketed byForest and Warner-Lambert.

Marketing approval has been granted for tirofiban (Aggrastat®/Merck) fortreatment of patients with unstable angina. The drug is the first of a new class known asglycoprotein Iib/IIIa inhibitors [platelet blockers]. In one clinical trial the compounddemonstrated a 32% reduction in the risk of death, new heart attack or refractory ischemiawhen administered with heparin and aspirin as compared with heparin and aspirin alone. Themost common side effect was bleeding when administered in the above combination.

The FDA has granted marketing approval for the first oral micronized progesteronecapsules (Prometrium®/Solvay) for treatment of Secondary amenorrhea. Side effectsinclude abdominal cramping, headache, dizziness, and breast pain.

Eptifibatide (Integrilin®/Schering-Plough) has been approved for marketing as atreatment of acute coronary syndrome. It is approved for administration in the treatmentof patients undergoing percutaneous coronary intervention who do not present with a acutecoronary syndrome. It will be co-marketed in the United State by Schering-Plough and CORTherapeutics.

BONE DENSITY TESTING

Bone consists of an organic matrix that is primarily collagen fibers in which aredeposited salts of calcium and phosphate in crystals of hydroxyapatite. The tensilecapacity of collagen and the compressional ability of calcium salts combine to give boneits density and strength. Peak bone mass is reached around the age of 25-33 years of ageeven though the long bones cease growing in length around age 20. The less dense the bone,generally, the greater the chance of developing osteopenis and/or osteoporosis later inlife.

Bone density testing is becoming more popular and as new devices are marketed, field isvery confusing. Some experts in women's health anticipate that bone density testing mayeven become part of the annual physical examination. these peripheral testing methodsgenerally use x-ray absorptiometry methodologies to determine measurements. However, it isimportant to understand what is actually being measured. Bone mineral density (BMD) ismeasured in mg/cc² and is a measurement of mineral content by area. Bonemineral density is in mg/cc³ and is a measurement of mineral volume [density].Some devices report BMC but have actually measured BMD (and vice versa).

In one study conducted on 124 women at the University of California at San Fancisco, itwas estimated that 20% to 30% of women with low bone density at the spine or hip may bemissed with peripheral testing. However, that means that these tests will potentiallycatch between 70% to 80% with low bone mass and potential development of osteoporosis.

Some of the current bone density methodologies are listed in the following table: