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CLINICAL ROLE -

Community/Retail
| Hospital
| Oncology
| Pharmacy Technician
| Student

Article

September 26, 2016

Trending News Today: Controversy Surrounds Muscular Dystrophy Drug Approval

Author(s):

Lauren Santye, Assistant Editor,Laurie Toich, Assistant Editor

Top news of the day from across the health care landscape.

Despite the FDA approval of eteplirsen (Exondys 51) for the treatment of Duchenne muscular dystrophy on a provisional basis, controversy still remains. According to NPR, the FDA made a scientific judgement call, based on observations that the drug prompted patients to produce at least a small amount of dystrophin. However, others have opposed the drug’s approval, including a key scientist, which may have led to his departure, the article noted. Overall, the FDA decision approves the drug on an accelerated basis, but the approval is still contingent on follow-up studies, and can be withdrawn.

Cardiologist Harry Selker is working to stop heart attacks, and is pursuing a medical treatment comprised of glucose, insulin, and potassium (GIK) to help save lives, reported NPR. Although in previous research the drug cocktail was effective on animals, it didn’t stop people from having heart attacks. However, patients who received GIK were less likely to suffer cardiac arrest or death in the hospital. Furthermore, it reduced the amount of heart damage by 80%. Unfortunately, pharmaceutical companies are not interested in selling it, because for them there is no big payoff, according to the article. The NPR report noted that Selker is far from deterred, and is currently in talks with the FDA about the details of a definitive clinical trial to determine the efficacy of GIK in acute coronary emergencies. He hopes that the next clinical trial for GIK will take place by early next year, NPR reported.

Cases of medical record mix-ups are becoming more common due to the complexities of health care, a recent study found. However, in the study, 91% of mix-ups were caught before patient harm occurred. Healthcare professionals are now running more lab and imaging tests, doing more procedures, and there are more transitions through the system, according to The Wall Street Journal.

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