The Los Angeles Times reported: “Use of unapproved Ebola drug ZMapp could lead to unintended, negative consequences, experts say. Distribute an experimental Ebola drug to West African patients? Not so fast, medical experts and ethicists say. Is an experimental Ebola drug helping Kent Brantly and Nancy Writebol? There’s probably no way to know.”
“Patient advocates who believe the drug is helpful are asking when it can be made available to the hundreds of West Africans who are ill.”
“But what looks like a simple case of humanitarian goodwill could lead to some unintended and very negative consequences, experts said…”
“Although there could be a short-term gain for a dying patient, in the long run it would undermine scientists’ ability to determine whether the drug was actually safe and effective.”
“The Food and Drug Administration has elaborate rules for evaluating drugs before they are approved for widespread use. The process can take years, involving hundreds or thousands of patients and costing drug companies millions of dollars.”
“The rules are designed to make sure that a medication doesn’t make patients more sick than they are and that it fights the disease it was created to fight. They are also used to figure out the minimum dose needed to get the desired effect.”
“The centerpiece of these rules is the clinical trial, which allows researchers to show that patients who took the drug fared better than patients who didn’t.”
“In this case, there will be no way to tell whether Dr. Kent Brantly and hygienist Nancy Writebol were helped by the experimental Ebola drug, said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases.”
Click here to read the full LAT article “Use of experimental Ebola drug raises red flags among medical experts” by Monte Morin.
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Jonathan M. Metsch, Dr.P.H., is Clinical Professor, Preventive Medicine, Icahn School of Medicine at Mount Sinai; and Adjunct Professor, Baruch College ( C.U.N.Y.), Rutgers School of Public Health, and Rutgers School of Public Affairs and Administration.
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