FDA: Just says NO — to ineffective drugs with side effects
Posted on December 22, 2012 by James Kohl.
FDA panel recommends against 1st drug for chronic fatigue syndrome December 21, 2012 by Steven Reinberg, Healthday Reporter in Medications
Excerpt 1: “…is a new type of drug called a nucleic acid compound, which uses specially made RNA to target a variety of diseases. Hemispherx believes the drug has the potential to fight HIV, kidney cancer and melanoma in addition to chronic fatigue syndrome. The drug is said to work by modulating the immune and antiviral functions in diseased cells.”
Excerpt 2: “Some experts think chronic fatigue syndrome is caused by a virus; others believe it is linked to a bacteria. It can begin after an illness from which a patient doesn’t quite recover, or the symptoms can appear almost overnight…”
My comment: I think I predicted, in part, this recommendation against the drug.
“Medical practitioners from ASAM and neuroscientists are more likely than psychologists to be aware that effective FDA-approved therapeutic intervention frequently involves pharmaceuticals that alter feedback on the GnRH neuronal system (Grumbach & Styne, 1992), which is the central neuronal system that is essential to species survival in all vertebrates (Kotitschke, Sadie-Van Gijsen, Avenant, Fernandes, & Hapgood, 2009) via its integral involvement in the acquisition of food and in sexual reproduction. ASAM seems to think that clinical psychologists should become more aware of currently accepted neuroscientific facts, which may be important to their understanding of… things that are not currently understood about the development of behavior.” – Kohl (2012).
A systems biology approach to chronic fatigue that incorporates neuroscientifically established fact is obviously required. For example, see GLYX-13, an NMDA Receptor Glycine-Site Functional Partial Agonist, Induces Antidepressant-Like Effects Without Ketamine-Like Side Effects
Retired medical laboratory scientist
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