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If the bill passes SARMs will join steroids as Schedule III controlled substances, making their sale illegal, unless they are approved by the Food and Drug Administration and are administered by doctors. The DEA has recently said that it will only grant permits to three of five manufacturers for SARMs (Almirall, Actemel, and Amprosal) as they continue to meet requirements but the FDA only requires manufacturers to submit 10 products per year to prove that their drugs are safe and effective. In March, the FDA approved Adrafinil, which is currently the only approved SARMs. The FDA's rationale for approving Adrafinil was that studies had shown that SARMs improve daytime sleepiness and could also reduce seizures in children with epilepsy. But in reality, studies, including the FDA's own, are showing that only 25% of adults with epilepsy have improved seizure control after first using Adrafinil and only 4% of patients who use Adrafinil successfully achieve significant improvements after using it for three months. Also, while Adrafinil has a seizure inhibitor effect and improves sleep in children with epilepsy, that is not the same as relieving seizures entirely. In fact, several major medical organizations – including the Pediatric Endocrine Society – caution pediatricians and parents against all SARMs, specifically Adrafinil, due to the lack of evidence that the drug has any real effect on seizure control at any time. And the evidence the FDA cited for approving Adrafinil is from 2007 and is based solely on two studies funded by the companies it approved – one by the University of California Irvine School of Medicine and the other by the Medical University of South Carolina. In both studies, Adrafinil had no effect on child sleep patterns, or on children over the age of one. And if using Adrafinil can lead to long term harm for the children it is supposed to help, what is stopping others from using it? While the FDA has recently admitted that one of the studies they funded, which was published in 2014, showed no effect on sleep, they refused to withdraw the study's title. In fact they refused to reveal when the study was published. And in a similar case, two studies which the FDA originally cited to support their approval of Adrafinil in 2009, are now being withdrawn by the FDA because the results are not in the "right direction." Despite the FDA's best efforts that Adrafinil will ultimately prove to be safe, even the FDA has said there is Related Article: