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Brand-Name Drugs Do Not Appear Superior to Generic Drugs for Treating Cardiovascular Diseases

Drug News • • HeartDec 03 08

Contrary to the perception of some patients and physicians, there is no evidence that brand-name drugs are clinically superior to their generic counterparts, according to an article in the December 3 issue of JAMA, which examined studies comparing the effectiveness of generic vs. brand-name drugs for treating cardiovascular diseases.

“The problem of rising prescription drug costs has emerged as a critical policy issue, straining the budgets of patients and public/private insurers and directly contributing to adverse health outcomes by reducing adherence to important medications. The primary drivers of elevated drug costs are brand-name drugs, which are sold at high prices during a period of patent protection and market exclusivity after approval by the Food and Drug Administration (FDA),” the authors write. To control spending, many payers and clinicians have encouraged substitution of inexpensive bioequivalent generic versions of these drugs after the brand-name manufacturer’s market exclusivity period ends.

Some patients and physicians have expressed concern that generic drugs may not be equivalent in their effectiveness. “Brand-name manufacturers have suggested that generic drugs may be less effective and safe than their brand-name counterparts. Anecdotes have appeared in the lay press raising doubts about the efficacy and safety of certain generic drugs,” the authors note.

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Women with Mitral Valve Prolapse Are Treated Less Aggressively than Men and May be at High Risk

HeartDec 02 08

Disturbing evidence of higher mortality and lower surgery rates in women versus men with mitral valve prolapse and severe leakage may be related to the complexity of evaluating the condition’s severity in women, according to findings of a Mayo Clinic study published this month in the Annals of Internal Medicine.

Mitral valve prolapse affects approximately 150 million people worldwide and often requires cardiac surgery, preferably valve repair rather than replacement, to restore life expectancy of patients with severe leakage, says senior author Maurice Enriquez-Sarano, M.D., a cardiologist at Mayo Clinic. Cardiac valves allow the heart to move blood forward without leakage. Mitral valve prolapse occurs when the leaflets and supporting cords of the mitral valve have excessive tissue and weaken, leading to leakage (regurgitation), he says.

Previous studies on mitral valve disease have examined several sex-based differences, discovering, for example, that mitral valve prolapse is more common in women than men, and that more men than women undergo mitral valve surgery.

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MRI shows new types of injuries in young gymnasts

TraumaDec 01 08

Adolescent gymnasts are developing a wide variety of arm, wrist and hand injuries that are beyond the scope of previously described gymnastic-related trauma, according to a study presented today at the annual meeting of the Radiological Society of North America (RSNA).

“The broad constellation of recent injuries is unusual and might point to something new going on in gymnastics training that is affecting young athletes in different ways,” said the study’s lead author, Jerry Dwek, M.D., an assistant clinical professor of radiology at the University of California, San Diego and a partner of San Diego Imaging at Rady Children’s Hospital and Health Center.

Previous studies have reported on numerous injuries to the growing portion of adolescent gymnasts’ bones. However, this study uncovered some injuries to the bones in the wrists and knuckles that have not been previously described. In addition, the researchers noted that these gymnasts had necrosis, or “early death,” of the bones of their knuckles.

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New statistical model could help reduce breast-lesion biopsies

Cancer • • Breast CancerDec 01 08

A new method of characterizing breast lesions found during an MRI exam could result in fewer biopsies of benign tumors with the benefits of reduced pain and expense for patients and providers, according to a paper that will be presented today (Sunday, Nov. 30) at the annual meeting of the Radiological Society of North America (RSNA).

Wendy DeMartini, M.D., and colleagues in the breast imaging department at the Seattle Cancer Care Alliance developed a preliminary statistical model that breast radiologists could use eventually when deciding whether a lesion found on breast MRI is likely to be malignant or benign. Their retrospective review of almost 2,600 breast MRI exams performed during a four-year period at the SCCA found three crucial patient and lesion characteristics that, when used in combination, could predict the likelihood of malignancy, including identifying some lesions with probabilities of cancer close to zero.

Such a model, if confirmed by more research, could be beneficial because MRI exams are so sensitive that they reveal cancerous and non-cancerous lesions that often look alike and behave similarly when contrast dye is injected into the patient. Biopsy is often necessary to determine whether a lesion is cancerous. Statistical models may improve the ability to distinguish between such lesions and avoid unnecessary biopsies.

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