FDA: More Study Needed on Life-Saving Baby Drug
Dr. Mark Puder of Boston Children’s Hospital developed a treatment with a drug made with fish oil called Omegaven that he’s been using to help reverse fatal liver disease in infants. Despite the drug’s effectiveness, it has yet to be approved by the FDA. Puder says the FDA has told him they want the usual rigorous controlled study where half the patients get the experimental drug and the other does not. Puder refuses to do the tests saying that some infants will die.